Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),In cooperation with the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas it is important that measures should be adopted with a view to the progressive establishment of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which freedom of movement is ensured for goods, persons, services and capital;Whereas there is growing public interest in the relationship between diet and health and in the choice of an appropriate diet to suit individual needs;Whereas the Council and the Representatives of the Governments of the Member States meeting within the Council, in their resolution of 7 July 1986 on the European programme against cancer, considered the improvement of nutrition to be a priority;Whereas knowledge of the basic principles of nutrition and appropriate nutrition labelling of foodstuffs would contribute significantly towards enabling the consumer to make this choice;Whereas the provision of nutrition labelling should assist action in the area of nutrition education for the public;Whereas, for the benefit of the consumer on the one hand, and to avoid any possible technical barriers to trade on the other, nutrition labelling should be presented in a standardized form applying throughout the Community;Whereas foodstuffs bearing nutrition labelling should conform to the rules laid down in this Directive;Whereas all other forms of nutrition labelling should be prohibited but foodstuffs bearing no nutrition labelling should be able to circulate freely;Whereas, to appeal to the average consumer and to serve the purpose for which it is introduced, and given the current low level of knowledge on the subject of nutrition, the information provided should be simple and easily understood;Whereas application of this Directive for a certain length of time will enable valuable experience on the subject to be gained and consumer reaction to the way in which nutrition information is presented to be evaluated thus enabling the Commission to review the rules and propose any appropriate amendments;Whereas in order to encourage interested parties, especially small and medium-sized undertakings, to provide nutrition labelling for as many products as possible, measures to make information more complete and more balanced should be introduced gradually;Whereas the rules laid down in this Directive should also take into account the Codex Altimentarius guidelines on nutrition labelling;Whereas general labelling provisions and definitions are contained in Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (4), as last amended by Directive 89/395/EEC (5); whereas this Directive can therefore be confined to those provisions pertaining to nutrition labelling,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as ‘mass caterers’).2. This Directive shall not apply to:- natural mineral waters or other waters intended for human consumption,- diet integrators/food supplements.3. This Directive shall apply without prejudice to the labelling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and specific Directives as referred to in Article 4 of that Directive.4. For the purposes of this Directive:(a) ‘nutrition labelling’ means any information appearing on labelling and relating to:(i) energy value;(ii) the following nutrients:- protein,- carbohydrate,- fat,- fibre,- sodium,- vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10;(b) ‘nutrition claim’ means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it- provides,- provides at a reduced or increased rate or- does not provide,and/or due to the nutrients it- contains,- contains in reduced or increased proportions or- does not contain.A reference to qualities or quantities of a nutrient does not constitute a nutrition claim in so far as it is required by legislation.In accordance with the procedure laid down in Article 10, it may be decided in certain cases whether the conditions described in this point are satisfied;(c) ‘protein’ means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25;(d) ‘carbohydrate’ means any carbohydrate which is metabolized in man, and includes polyols;(e) ‘sugars’ means all monosaccharides and disaccharides present in food, but excludes polyols;(f) ‘fat’ means total lipids, and includes phospholipids;(g) ‘saturates’ means fatty acids without double bond;(h) ‘mono-unsaturates’ means fatty acids with one cis double bond;(i) ‘polyunsaturates’ means fatty acids with cis, cis-methylene interrupted double bonds;(j) ‘fibre’ means the material to be defined in accordance with the procedure laid down in Article 10 and measured by the method of analysis to be determined in accordance with that procedure;(k) ‘average value’ means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary.Article 21. Subject to paragraph 2, nutrition labelling shall be optional.2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory.Article 3The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in

Article 1
1. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as ‘mass caterers’).
2. This Directive shall not apply to:
– natural mineral waters or other waters intended for human consumption,
– diet integrators/food supplements.
3. This Directive shall apply without prejudice to the labelling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and specific Directives as referred to in Article 4 of that Directive.
4. For the purposes of this Directive:
(a) ‘nutrition labelling’ means any information appearing on labelling and relating to:
(i) energy value;
(ii) the following nutrients:
– carbohydrate,
– vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.
Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10;
(b) ‘nutrition claim’ means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it
– provides,
– provides at a reduced or increased rate or
– does not provide,
and/or due to the nutrients it
– contains,
– contains in reduced or increased proportions or
– does not contain.

Article 2
1. Subject to paragraph 2, nutrition labelling shall be optional.
2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory.

Article 3
The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in Article 1 (4) (a) (ii) and to substances which belong to or which are components of a category of those nutrients. Provisions restricting or prohibiting nutrition claims within the meaning of this Article may be adopted by the procedure laid down in Article 10.

Article 4
1. Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order:
(a) energy value;
(b) the amounts of protein, carbohydrate and fat.
(b) the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium.
2. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given shall consist of group 2.
3. Nutrition labelling may also include the amounts of one or more of the following:
– mono-unsaturates,
– polyunsaturates,
– cholesterol,
– any of the minerals or vitamins listed in the Annex and present in significant amounts as defined in that Annex.
4. The declaration of substances which belong to or are components of one of the categories of nutrients referred to in paragraphs 1 and 3 shall be compulsory where a nutrition claim is made.
In addition, where the amount of polyunsaturates and/or mono-unsaturates and/or the cholesterol rate is given, the amount of saturates shall also be given, the declaration of the latter not constituting – in this case – a nutrition claim within the meaning of paragraph 2.

Article 5
1. The energy value to be declared shall be calculated using the following conversion factors:
– carbohydrate (except polyols) 4 kcal/g – 17 kJ/g
– polyols 2,4 kcal/g – 10 kJ/g
– protein 4 kcal/g – 17 kJ/g
– fat 9 kcal/g – 37 kJ/g
– alcohol (ethanol) 7 kcal/g – 29 kJ/g
– organic acid 3 kcal/g – 13 kJ/g
2. Provisions concerning the following points shall be adopted in accordance with the procedure laid down in Article 10:
– amendments to the conversion factors mentioned in paragraph 1,
– the addition to the list in paragraph 1 of substances which belong to or are components of one of the categories of nutrients referred to in that paragraph and their conversion factors in order to calculate more precisely the energy value of foodstuffs.

Article 6
1. The declaration of the energy value and of the proportion of nutrients or their components shall be numerical. The units to be used are the following:
1.2 // – energy – kJ and kcal // // – protein // // – carbohydrate // // – fat // grams (g) // – fibre // // – sodium // // – cholesterol // milligrams (mg) // – vitamins and minerals // the units specified in the Annex
2. Information shall be expressed per 100 g or per 100 ml. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated.
3. In accordance with the procedure laid down in Article 10 it may be decided that the information in paragraphs 1 and 2 may also be given in graphical form according to formats to be determined.
4. The amounts mentioned shall be those of the food as sold. Where appropriate, this information may relate to the foodstuff after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for consumption.
5. (a) Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance (RDA) given in the Annex for the amounts as specified in paragraph 2.
(b) The percentage of the recommended daily allowance (RDA) for vitamins and minerals may also be given in graphical form. Rules for implementing this subparagraph may be adopted in accordance with the procedure laid down in Article 10.
6. Where sugars and/or polyols and/or starch are declared, this declaration shall immediately follow the declaration of the carbohydrate content in the following manner:
1.2 // – carbohydrate // g // of which: // // – sugars // g // – polyols // g // – starch // g
7. Where the amount and/or type of fatty acid and/or the cholesterol rate is declared, this declaration shall immediately follow the declaration of total fats in the following manner:
1.2 // – fat // g // of which: // // – saturates // g // – mono-unsaturates // g // – polyunsaturates // g // – cholesterol // mg
8. The declared values shall, according to the individual case, be average values based on:
(a) the manufacturer’s analysis of the food;
(b) a calculation from the known or actual average values of the ingredients used; (c) a calculation from generally established and accepted data.
The rules for implementing the first paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure laid down in Article 10.

Article 7
1. The information covered by this Directive must be presented together in one place in tabular form, with the numbers aligned if space permits. Where space does not permit, the information shall be presented in linear form.
It shall be printed in legible and indelible characters in a conspicuous place.
2. Member States shall ensure that the information covered by this Directive appears in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such information from being indicated in more than one language.
3. Member States shall refrain from laying down requirements more detailed than those already contained in this Directive concerning nutrition labelling.

Article 8
In the case of non-prepackaged foodstuffs put up for sale to the ultimate consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or prepackaged with a view to immediate sale, the extent of the information referred to in Article 4 and the manner of its communication may be determined by national provisions until the eventual adoption of Community measures in accordance with the procedure laid down in Article 10.

Article 9
Any measures likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food set up by Decision 74/234/EEC (1).

Article 10
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (2) (hereinafter referred to as ‘the Committee’) by its chairman, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
(c) If, on expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

Article 11
1. Member States shall take the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to:
– permit trade in products complying with this Directive by 1 April 1992,
– prohibit trade in products which do not comply with this Directive with effect from 1 October 1993.
2. Until . . . . (five years following notification of this Directive), the declaration in nutrition labelling, either on a voluntary basis or following a nutrition claim, of one or more of the following nutrients; sugars, saturates, fibre, sodium, shall not trigger the obligation set out in Article 4 (1) and (2) to declare all these nutrients.
3. The Commission shall, by . . . . (eight years after notification of this Directive), submit to the European Parliament and the Council a report on the application of
this Directive. At the same time, it shall submit to the Council any appropriate proposals for amendment.

Article 12
This Directive is addressed to the Member States.
Done at Brussels, 24 September 1990.
For the Council
The President
V. SACCOMANDI
(1) OJ No C 282, 5. 11. 1988, p. 8 and OJ No C 296, 24. 11. 1989, p. 3.
(2) OJ No C 158, 26. 6. 1989, p. 250 and OJ No C 175, 16. 7. 1990, p. 76.
(3) OJ No C 159, 26. 6. 1989, p. 41.
(4) OJ No L 33, 8. 2. 1979, p. 1.
(5) OJ No L 186, 30. 6. 1989, p. 17.
(1) OJ No L 186, 30. 6. 1989, p. 27.
(1) OJ No L 136, 20. 5. 1974, p. 1.
(2) OJ No L 291, 19. 11. 1969, p. 9.

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),In cooperation with the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas it is important that measures should be adopted with a view to the progressive establishment of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which freedom of movement is ensured for goods, persons, services and capital;Whereas there is growing public interest in the relationship between diet and health and in the choice of an appropriate diet to suit individual needs;Whereas the Council and the Representatives of the Governments of the Member States meeting within the Council, in their resolution of 7 July 1986 on the European programme against cancer, considered the improvement of nutrition to be a priority;Whereas knowledge of the basic principles of nutrition and appropriate nutrition labelling of foodstuffs would contribute significantly towards enabling the consumer to make this choice;Whereas the provision of nutrition labelling should assist action in the area of nutrition education for the public;Whereas, for the benefit of the consumer on the one hand, and to avoid any possible technical barriers to trade on the other, nutrition labelling should be presented in a standardized form applying throughout the Community;Whereas foodstuffs bearing nutrition labelling should conform to the rules laid down in this Directive;Whereas all other forms of nutrition labelling should be prohibited but foodstuffs bearing no nutrition labelling should be able to circulate freely;Whereas, to appeal to the average consumer and to serve the purpose for which it is introduced, and given the current low level of knowledge on the subject of nutrition, the information provided should be simple and easily understood;Whereas application of this Directive for a certain length of time will enable valuable experience on the subject to be gained and consumer reaction to the way in which nutrition information is presented to be evaluated thus enabling the Commission to review the rules and propose any appropriate amendments;Whereas in order to encourage interested parties, especially small and medium-sized undertakings, to provide nutrition labelling for as many products as possible, measures to make information more complete and more balanced should be introduced gradually;Whereas the rules laid down in this Directive should also take into account the Codex Altimentarius guidelines on nutrition labelling;Whereas general labelling provisions and definitions are contained in Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (4), as last amended by Directive 89/395/EEC (5); whereas this Directive can therefore be confined to those provisions pertaining to nutrition labelling,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as ‘mass caterers’).2. This Directive shall not apply to:- natural mineral waters or other waters intended for human consumption,- diet integrators/food supplements.3. This Directive shall apply without prejudice to the labelling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and specific Directives as referred to in Article 4 of that Directive.4. For the purposes of this Directive:(a) ‘nutrition labelling’ means any information appearing on labelling and relating to:(i) energy value;(ii) the following nutrients:- protein,- carbohydrate,- fat,- fibre,- sodium,- vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10;(b) ‘nutrition claim’ means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it- provides,- provides at a reduced or increased rate or- does not provide,and/or due to the nutrients it- contains,- contains in reduced or increased proportions or- does not contain.A reference to qualities or quantities of a nutrient does not constitute a nutrition claim in so far as it is required by legislation.In accordance with the procedure laid down in Article 10, it may be decided in certain cases whether the conditions described in this point are satisfied;(c) ‘protein’ means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25;(d) ‘carbohydrate’ means any carbohydrate which is metabolized in man, and includes polyols;(e) ‘sugars’ means all monosaccharides and disaccharides present in food, but excludes polyols;(f) ‘fat’ means total lipids, and includes phospholipids;(g) ‘saturates’ means fatty acids without double bond;(h) ‘mono-unsaturates’ means fatty acids with one cis double bond;(i) ‘polyunsaturates’ means fatty acids with cis, cis-methylene interrupted double bonds;(j) ‘fibre’ means the material to be defined in accordance with the procedure laid down in Article 10 and measured by the method of analysis to be determined in accordance with that procedure;(k) ‘average value’ means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary.Article 21. Subject to paragraph 2, nutrition labelling shall be optional.2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory.Article 3The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in
1. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as ‘mass caterers’).
2. This Directive shall not apply to:
– natural mineral waters or other waters intended for human consumption,
– diet integrators/food supplements.
3. This Directive shall apply without prejudice to the labelling provisions of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) and specific Directives as referred to in Article 4 of that Directive.
4. For the purposes of this Directive:
(a) ‘nutrition labelling’ means any information appearing on labelling and relating to:
(i) energy value;
(ii) the following nutrients:
– carbohydrate,
– vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.
Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10;
(b) ‘nutrition claim’ means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it
– provides,
– provides at a reduced or increased rate or
– does not provide,
and/or due to the nutrients it
– contains,
– contains in reduced or increased proportions or
– does not contain.
1. Subject to paragraph 2, nutrition labelling shall be optional.
2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory.
The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in Article 1 (4) (a) (ii) and to substances which belong to or which are components of a category of those nutrients. Provisions restricting or prohibiting nutrition claims within the meaning of this Article may be adopted by the procedure laid down in Article 10.
1. Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order:
(a) energy value;
(b) the amounts of protein, carbohydrate and fat.
(b) the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium.
2. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given shall consist of group 2.
3. Nutrition labelling may also include the amounts of one or more of the following:
– mono-unsaturates,
– polyunsaturates,
– cholesterol,
– any of the minerals or vitamins listed in the Annex and present in significant amounts as defined in that Annex.
4. The declaration of substances which belong to or are components of one of the categories of nutrients referred to in paragraphs 1 and 3 shall be compulsory where a nutrition claim is made.
In addition, where the amount of polyunsaturates and/or mono-unsaturates and/or the cholesterol rate is given, the amount of saturates shall also be given, the declaration of the latter not constituting – in this case – a nutrition claim within the meaning of paragraph 2.
1. The energy value to be declared shall be calculated using the following conversion factors:
– carbohydrate (except polyols) 4 kcal/g – 17 kJ/g
– polyols 2,4 kcal/g – 10 kJ/g
– protein 4 kcal/g – 17 kJ/g
– fat 9 kcal/g – 37 kJ/g
– alcohol (ethanol) 7 kcal/g – 29 kJ/g
– organic acid 3 kcal/g – 13 kJ/g
2. Provisions concerning the following points shall be adopted in accordance with the procedure laid down in Article 10:
– amendments to the conversion factors mentioned in paragraph 1,
– the addition to the list in paragraph 1 of substances which belong to or are components of one of the categories of nutrients referred to in that paragraph and their conversion factors in order to calculate more precisely the energy value of foodstuffs.
1. The declaration of the energy value and of the proportion of nutrients or their components shall be numerical. The units to be used are the following:
1.2 // – energy – kJ and kcal // // – protein // // – carbohydrate // // – fat // grams (g) // – fibre // // – sodium // // – cholesterol // milligrams (mg) // – vitamins and minerals // the units specified in the Annex
2. Information shall be expressed per 100 g or per 100 ml. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated.
3. In accordance with the procedure laid down in Article 10 it may be decided that the information in paragraphs 1 and 2 may also be given in graphical form according to formats to be determined.
4. The amounts mentioned shall be those of the food as sold. Where appropriate, this information may relate to the foodstuff after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for consumption.
5. (a) Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance (RDA) given in the Annex for the amounts as specified in paragraph 2.
(b) The percentage of the recommended daily allowance (RDA) for vitamins and minerals may also be given in graphical form. Rules for implementing this subparagraph may be adopted in accordance with the procedure laid down in Article 10.
6. Where sugars and/or polyols and/or starch are declared, this declaration shall immediately follow the declaration of the carbohydrate content in the following manner:
1.2 // – carbohydrate // g // of which: // // – sugars // g // – polyols // g // – starch // g
7. Where the amount and/or type of fatty acid and/or the cholesterol rate is declared, this declaration shall immediately follow the declaration of total fats in the following manner:
1.2 // – fat // g // of which: // // – saturates // g // – mono-unsaturates // g // – polyunsaturates // g // – cholesterol // mg
8. The declared values shall, according to the individual case, be average values based on:
(a) the manufacturer’s analysis of the food;
(b) a calculation from the known or actual average values of the ingredients used; (c) a calculation from generally established and accepted data.
The rules for implementing the first paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure laid down in Article 10.
1. The information covered by this Directive must be presented together in one place in tabular form, with the numbers aligned if space permits. Where space does not permit, the information shall be presented in linear form.
It shall be printed in legible and indelible characters in a conspicuous place.
2. Member States shall ensure that the information covered by this Directive appears in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such information from being indicated in more than one language.
3. Member States shall refrain from laying down requirements more detailed than those already contained in this Directive concerning nutrition labelling.
In the case of non-prepackaged foodstuffs put up for sale to the ultimate consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or prepackaged with a view to immediate sale, the extent of the information referred to in Article 4 and the manner of its communication may be determined by national provisions until the eventual adoption of Community measures in accordance with the procedure laid down in Article 10.
Any measures likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food set up by Decision 74/234/EEC (1).
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (2) (hereinafter referred to as ‘the Committee’) by its chairman, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
(c) If, on expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
1. Member States shall take the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to:
– permit trade in products complying with this Directive by 1 April 1992,
– prohibit trade in products which do not comply with this Directive with effect from 1 October 1993.
2. Until . . . . (five years following notification of this Directive), the declaration in nutrition labelling, either on a voluntary basis or following a nutrition claim, of one or more of the following nutrients; sugars, saturates, fibre, sodium, shall not trigger the obligation set out in Article 4 (1) and (2) to declare all these nutrients.
3. The Commission shall, by . . . . (eight years after notification of this Directive), submit to the European Parliament and the Council a report on the application of
this Directive. At the same time, it shall submit to the Council any appropriate proposals for amendment.
This Directive is addressed to the Member States.
Done at Brussels, 24 September 1990.
For the Council
The President
V. SACCOMANDI
(1) OJ No C 282, 5. 11. 1988, p. 8 and OJ No C 296, 24. 11. 1989, p. 3.
(2) OJ No C 158, 26. 6. 1989, p. 250 and OJ No C 175, 16. 7. 1990, p. 76.
(3) OJ No C 159, 26. 6. 1989, p. 41.
(4) OJ No L 33, 8. 2. 1979, p. 1.
(5) OJ No L 186, 30. 6. 1989, p. 17.
(1) OJ No L 186, 30. 6. 1989, p. 27.
(1) OJ No L 136, 20. 5. 1974, p. 1.
(2) OJ No L 291, 19. 11. 1969, p. 9.
Vitamins and minerals which may be declared and their recommended daily allowances (RDAs)
Vitamin A µg 800
Vitamin D µg 5
Vitamin E mg 10
Vitamin C mg 60
Thiamin mg 1,4
Riboflavin mg 1,6
Niacin mg 18
Vitamin B6 mg 2
Folacin µg 200
Vitamin B12 µg 1
Biotin mg 0,15
Pantothenic acid mg 6
Calcium mg 800
Phosphorus mg 800
Magnesium mg 300
Iodine µg 150
As a rule, 15 % of the recommended allowance specified in ths Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.

Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over the period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas trade in foodstuffs occupies a very important place in the internal market; Whereas indication of the lot to which a foodstuff belongs meets the need for better information on the identity of products; whereas it is therefore a useful source of information when foodstuffs are the subject of dispute or constitute a health hazard for consumers; Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (4), as last amended by Directive 89/395/EEC (5), contains no provisions on indication of lot identification; whereas some Member States have meanwhile adopted national measures requiring such indication; Whereas at international level there is now a general obligation to provide a reference to the manufacturing or packaging lot of prepackaged foodstuffs; whereas it is the Community’s duty to contribute to the development of international trade; Whereas it is therefore advisable to adopt rules of a general and horizontal nature in order to establish a common lot identification system; Whereas the efficiency of this system depends on its application at the various marketing stages; whereas it is nevertheless desirable to exclude certain products and operations in particular those taking place at the start of the distribution network for agricultural products; Whereas the concept of a lot implies that several sales units of a foodstuff have almost identical production, manufacture or packaging characteristics; whereas that concept therefore could not apply to bulk products or products which, owing to their individual specificity or heterogeneous nature, could not be considered as forming a homogeneous batch; Whereas, in view of the variety of identification methods used, it is up to the trader to determine the lot and to affix the corresponding indication or mark; Whereas, in order to satisfy the information requirements for which it is intended, this indication must be clearly distinguishable and recognizable as such; Whereas the date of minimum durability or ‘use by’ date, may, in conformity with Directive 79/112/EEC, serve as the lot identification, provided it is indicated precisely, HAS ADOPTED THIS DIRECTIVE:

Article 1
1. This Directive concerns the indication which allows identification of the lot to which a foodstuff belongs.
2. For the purposes of this Directive, ‘lot’ means a batch of sales units of a foodstuff produced, manufactured or packaged under practically the same conditions.

Article 2
1. A foodstuff may not be marketed unless it is accompanied by an indication as referred to in Article 1 (1).
2. However, paragraph 1 shall not apply:
(a) to agricultural products which, on leaving the holding are:
– sold or delivered to temporary storage, preparation or packaging stations,
– transported to producers’ organizations, or
– collected for immediate integration into an operational preparation or processing system;
(b) when, at the point of sale to the ultimate consumer, the foodstuffs are not prepackaged, are packaged at the request of the purchaser or are prepackaged for immediate sale;
(c) to packagings or containers, the largest side of which has an area of less than 10 cm$.
3. Member States may, until 31 December 1996, refrain from requiring the indication referred to in Article 1 (1) to be mentioned in the case of the glass bottles intended for re-use which are indelibly marked and which therefore bear no label, ring or collar.

Article 3
The lot shall be determined in each case by the producer, manufacturer or packager of the foodstuff in question, or the first seller established within the Community.
The indication referred to in Article 1 (1) shall be determined and affixed under the responsibility of one or other of those operators. It shall be preceded by the letter ‘L’ except in cases where it is clearly distinguishable from the other indications on the label.

Article 4
When the foodstuffs are prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter ‘L’ shall appear on the prepackaging or on a label attached thereto.
When the foodstuffs are not prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter ‘L’ shall appear on the packaging or on the container or, failing that, on the relevant commercial documents.
It shall in all cases appear in such a way as to be easily visible, clearly legible and indelible.

Article 5
When the date of minimum durability or ‘use by’ date appears on the label, the indication referred to in Article 1 (1) need not appear on the foodstuff, provided that the date consists at least of the uncoded indication of the day and the month in that order.

Article 6
This Directive shall apply without prejudice to the indications laid down by specific Community provisions.
The Commission shall publish and keep up to date a list of the provisions in question.

Article 7
Member States shall, where necessary, amend their laws, regulations or administrative provisions so as to:
– authorize trade in products complying with this Directive by not later than 20 June 1990,
– prohibit trade in products not complying with this Directive with effect from 20 June 1991, however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.
They shall forthwith inform the Commission thereof.

Article 8
This Directive is addressed to the Member States.
Done at Luxembourg, 14 June 1989.
For the Council
The President
(1) OJ No C 310, 20. 11. 1987, p. 2.
(2) OJ No C 167, 27. 6. 1988, p. 425, and OJ No C 120, 16. 5. 1989.
(3) OJ No C 95, 11. 4. 1988, p. 1.
(4) OJ No L 33, 8. 2. 1979, p. 1.
(5) See page 17 of this Official Journal.

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over the period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas trade in foodstuffs occupies a very important place in the internal market; Whereas indication of the lot to which a foodstuff belongs meets the need for better information on the identity of products; whereas it is therefore a useful source of information when foodstuffs are the subject of dispute or constitute a health hazard for consumers; Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (4), as last amended by Directive 89/395/EEC (5), contains no provisions on indication of lot identification; whereas some Member States have meanwhile adopted national measures requiring such indication; Whereas at international level there is now a general obligation to provide a reference to the manufacturing or packaging lot of prepackaged foodstuffs; whereas it is the Community’s duty to contribute to the development of international trade; Whereas it is therefore advisable to adopt rules of a general and horizontal nature in order to establish a common lot identification system; Whereas the efficiency of this system depends on its application at the various marketing stages; whereas it is nevertheless desirable to exclude certain products and operations in particular those taking place at the start of the distribution network for agricultural products; Whereas the concept of a lot implies that several sales units of a foodstuff have almost identical production, manufacture or packaging characteristics; whereas that concept therefore could not apply to bulk products or products which, owing to their individual specificity or heterogeneous nature, could not be considered as forming a homogeneous batch; Whereas, in view of the variety of identification methods used, it is up to the trader to determine the lot and to affix the corresponding indication or mark; Whereas, in order to satisfy the information requirements for which it is intended, this indication must be clearly distinguishable and recognizable as such; Whereas the date of minimum durability or ‘use by’ date, may, in conformity with Directive 79/112/EEC, serve as the lot identification, provided it is indicated precisely, HAS ADOPTED THIS DIRECTIVE:
1. This Directive concerns the indication which allows identification of the lot to which a foodstuff belongs.
2. For the purposes of this Directive, ‘lot’ means a batch of sales units of a foodstuff produced, manufactured or packaged under practically the same conditions.
1. A foodstuff may not be marketed unless it is accompanied by an indication as referred to in Article 1 (1).
2. However, paragraph 1 shall not apply:
(a) to agricultural products which, on leaving the holding are:
– sold or delivered to temporary storage, preparation or packaging stations,
– transported to producers’ organizations, or
– collected for immediate integration into an operational preparation or processing system;
(b) when, at the point of sale to the ultimate consumer, the foodstuffs are not prepackaged, are packaged at the request of the purchaser or are prepackaged for immediate sale;
(c) to packagings or containers, the largest side of which has an area of less than 10 cm$.
3. Member States may, until 31 December 1996, refrain from requiring the indication referred to in Article 1 (1) to be mentioned in the case of the glass bottles intended for re-use which are indelibly marked and which therefore bear no label, ring or collar.
The lot shall be determined in each case by the producer, manufacturer or packager of the foodstuff in question, or the first seller established within the Community.
The indication referred to in Article 1 (1) shall be determined and affixed under the responsibility of one or other of those operators. It shall be preceded by the letter ‘L’ except in cases where it is clearly distinguishable from the other indications on the label.
When the foodstuffs are prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter ‘L’ shall appear on the prepackaging or on a label attached thereto.
When the foodstuffs are not prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter ‘L’ shall appear on the packaging or on the container or, failing that, on the relevant commercial documents.
It shall in all cases appear in such a way as to be easily visible, clearly legible and indelible.
When the date of minimum durability or ‘use by’ date appears on the label, the indication referred to in Article 1 (1) need not appear on the foodstuff, provided that the date consists at least of the uncoded indication of the day and the month in that order.
This Directive shall apply without prejudice to the indications laid down by specific Community provisions.
The Commission shall publish and keep up to date a list of the provisions in question.
Member States shall, where necessary, amend their laws, regulations or administrative provisions so as to:
– authorize trade in products complying with this Directive by not later than 20 June 1990,
– prohibit trade in products not complying with this Directive with effect from 20 June 1991, however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.
They shall forthwith inform the Commission thereof.
This Directive is addressed to the Member States.
Done at Luxembourg, 14 June 1989.
For the Council
The President
(1) OJ No C 310, 20. 11. 1987, p. 2.
(2) OJ No C 167, 27. 6. 1988, p. 425, and OJ No C 120, 16. 5. 1989.
(3) OJ No C 95, 11. 4. 1988, p. 1.
(4) OJ No L 33, 8. 2. 1979, p. 1.
(5) See page 17 of this Official Journal.

Council Directive 85/7/EEC of 19 December 1984 amending a first series of Directives on the approximation of the laws of the Member States in the foodstuffs sector, as regards the involvement of the Standing Committee for Foodstuffs

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Whereas, in pursuance of the first paragraph of Article 2 of Council Decision 69/414/EEC of 13 November 1969 setting up a Standing Committee for Foodstuffs (1), the latter carries out the duties devolving upon it under provisions in the foodstuffs sector adopted by the Council, in the cases and under the conditions provided for therein; Whereas, apart from its advisory role, the Committee has the task of ensuring close cooperation between the Member States and the Commission in cases where the Council confers powers on the latter for the purpose of implementing the rules which it establishes; Whereas most of the provisions adopted by the Council have assigned to the Committee duties, in the sector to which they relate, to be carried out within a period of 18 months; Whereas the purpose of setting this time limit was to check, in legislative practice, whether the procedure for involving the Committee gave satisfaction; whereas for the same purpose the said time limit should be extended by two years, HAS ADOPTED THIS DIRECTIVE:

Article 1
In the following provisions:
1. Article 11b of the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (2), as last amended by Directive 81/20/EEC (3);
2. Article 8b of Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (4), as last amended by Directive 84/86/EEC (5);
3. Article 7 of Council Directive 70/357/EEC of 13 July 1970 on the approximation of the laws of the Member States concerning the antioxidants authorized for use in foodstuffs intended for human consumption (6), as last amended by Directive 81/962/EEC (7);
4. Article 13 of Council Directive 73/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption (8), as last amended by Directive 80/608/EEC (9);
5. Article 11 of Council Directive 74/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (10), as last amended by Directive 80/597/EEC (11);
6. Article 11 of Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (12), as last amended by Directive 80/1276/EEC (13);
7. Article 10 of Council Directive 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (14), as amended by the 1979 Act of Accession;
8. Article 10 of Council Directive 77/436/EEC of 27 June 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts (1), as amended by the 1979 Act of Accession;
9. Article 18 of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (2), as amended by the 1979 Act of Accession;
10. Article 13 of Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (3), as amended by Directive 80/1276/EEC,
the expression ‘for a period of 18 months from the date on which the matter was first referred to the Committee’ is replaced by ‘for a period of two years from the date on which the matter was first referred to the Committee after 1 January 1985’.

Article 2
This Directive is addressed to the Member States.
Done at Brussels, 19 December 1984.
For the Council
The President
(1) OJ No L 291, 19. 11. 1969, p. 9.
(2) OJ No 115, 11. 11. 1962, p. 2645/62.
(3) OJ No L 43, 14. 2. 1981, p. 11.
(4) OJ No 12, 27. 1. 1984, p. 161/64.
(5) OJ No L 40, 11. 2. 1984, p. 29.
(6) OJ No L 157, 18. 7. 1970, p. 31.
(7) OJ No L 354, 9. 12. 1981, p. 22.
(8) OJ No L 228, 16. 8. 1973, p. 23.
(9) OJ No L 170, 3. 7. 1980, p. 33.
(10) OJ No L 189, 12. 7. 1974, p. 1.
(11) OJ No L 155, 23. 6. 1980, p. 23.
(12) OJ No L 340, 9. 12. 1976, p. 19.
(13) OJ No L 375, 31. 12. 1980, p. 77.
(14) OJ No L 26, 31. 1. 1977, p. 55.
(1) OJ No L 172, 12. 7. 1977, p. 20.
(2) OJ No L 33, 8. 2. 1979, p. 1.

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission, Whereas, in pursuance of the first paragraph of Article 2 of Council Decision 69/414/EEC of 13 November 1969 setting up a Standing Committee for Foodstuffs (1), the latter carries out the duties devolving upon it under provisions in the foodstuffs sector adopted by the Council, in the cases and under the conditions provided for therein; Whereas, apart from its advisory role, the Committee has the task of ensuring close cooperation between the Member States and the Commission in cases where the Council confers powers on the latter for the purpose of implementing the rules which it establishes; Whereas most of the provisions adopted by the Council have assigned to the Committee duties, in the sector to which they relate, to be carried out within a period of 18 months; Whereas the purpose of setting this time limit was to check, in legislative practice, whether the procedure for involving the Committee gave satisfaction; whereas for the same purpose the said time limit should be extended by two years, HAS ADOPTED THIS DIRECTIVE:
In the following provisions:
1. Article 11b of the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (2), as last amended by Directive 81/20/EEC (3);
2. Article 8b of Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (4), as last amended by Directive 84/86/EEC (5);
3. Article 7 of Council Directive 70/357/EEC of 13 July 1970 on the approximation of the laws of the Member States concerning the antioxidants authorized for use in foodstuffs intended for human consumption (6), as last amended by Directive 81/962/EEC (7);
4. Article 13 of Council Directive 73/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption (8), as last amended by Directive 80/608/EEC (9);
5. Article 11 of Council Directive 74/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (10), as last amended by Directive 80/597/EEC (11);
6. Article 11 of Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (12), as last amended by Directive 80/1276/EEC (13);
7. Article 10 of Council Directive 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (14), as amended by the 1979 Act of Accession;
8. Article 10 of Council Directive 77/436/EEC of 27 June 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts (1), as amended by the 1979 Act of Accession;
9. Article 18 of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (2), as amended by the 1979 Act of Accession;
10. Article 13 of Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (3), as amended by Directive 80/1276/EEC,
the expression ‘for a period of 18 months from the date on which the matter was first referred to the Committee’ is replaced by ‘for a period of two years from the date on which the matter was first referred to the Committee after 1 January 1985’.
This Directive is addressed to the Member States.
Done at Brussels, 19 December 1984.
For the Council
The President
(1) OJ No L 291, 19. 11. 1969, p. 9.
(2) OJ No 115, 11. 11. 1962, p. 2645/62.
(3) OJ No L 43, 14. 2. 1981, p. 11.
(4) OJ No 12, 27. 1. 1984, p. 161/64.
(5) OJ No L 40, 11. 2. 1984, p. 29.
(6) OJ No L 157, 18. 7. 1970, p. 31.
(7) OJ No L 354, 9. 12. 1981, p. 22.
(8) OJ No L 228, 16. 8. 1973, p. 23.
(9) OJ No L 170, 3. 7. 1980, p. 33.
(10) OJ No L 189, 12. 7. 1974, p. 1.
(11) OJ No L 155, 23. 6. 1980, p. 23.
(12) OJ No L 340, 9. 12. 1976, p. 19.
(13) OJ No L 375, 31. 12. 1980, p. 77.
(14) OJ No L 26, 31. 1. 1977, p. 55.
(1) OJ No L 172, 12. 7. 1977, p. 20.
(2) OJ No L 33, 8. 2. 1979, p. 1.

Council Directive 81/576/EEC of 20 July 1981 amending Council Directive 77/541/EEC on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (4) lays down inter alia in Annex I requirements concerning the fitting of safety belts and restraint systems to vehicles of category M1 as defined in Annex I to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (5), as last amended by Directive 80/1267/EEC (6); Whereas in the interests of road safety the fitting of safety belts and restraint systems complying with Directive 77/541/EEC should henceforth be required for the vehicles in certain M and N categories and permitted and encouraged for vehicles in the other M and N categories by extending the scope of that Directive ; whereas such an extension has been made possible by technical progress in motor-vehicle construction; Whereas for this purpose Directive 77/541/EEC should be amended; Whereas amendment of that Directive means adapting to technical progress certain requirements in the Annexes to Directive 77/541/EEC ; whereas the entry into force of the provisions of the present Directive should be made to coincide with that of the provisions which, following adoption of the present Directive, will then be adopted in order to adapt the requirements of the Annexes to Directive 77/541/EEC to technical progress, HAS ADOPTED THIS DIRECTIVE:

Article 1
Directive 77/541/EEC shall be amended as follows: 1. Article 9 is replaced by the following:
For the purposes of this Directive, “vehicle” means any motor vehicle in categories M and N as defined in Annex I to Directive 70/156/EEC intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.”
2. In Annex I: (a) Section 3.1 is replaced by the following:
“3.1. Vehicle equipment
Any vehicle covered by Article 9, in categories M1 or N1, or category M2 (except vehicles of a permissible maximum weight exceeding 3 500 kg and those which include places specially designed for standing passengers) must be equipped with safety belts or restraint systems which satisfy the requirements of this Directive and have the following belt arrangements (with which neither non-locking locking retractors (1.8.1) or manually unlocking retractors (1.8.2) can be used).
In cases where the other vehicles covered by Article 9 are fitted with safety belts or restraint systems, these must comply with all the requirements of this Directive, with the exception of sections 3.1.1 to 3.1.3.” (1) OJ No C 87, 9.4.1980, p. 4. (2) OJ No C 265, 13.10.1980, p. 77. (3) OJ No C 230, 8.9.1980, p. 6. (4) OJ No L 220, 29.8.1977, p. 95. (5) OJ No L 42, 23.2.1970, p. 1. (6) OJ No L 375, 31.12.1980, p. 34.
(b) Section 3.1.1 is replaced by the following:
“3.1.1. for the front outboard seating positions, three-point safety belts with emergency locking retractors having multiple sensitivity (1.8.4) ; however, 3.1.1.1. for the passenger seat, automatically locking retractors (1.8.3) are permitted;
3.1.1.2. for the passenger seat of category M2 vehicles, lap-belts, whether or not fitted with retractors, are considered adequate where the windscreen is located outside the reference zone defined in Annex II to Directive 74/60/EEC.
As regards safety belts, the windscreen is considered as part of the reference zone when it is capable of entering into static contact with the test apparatus according to the method described in Annex II to Directive 74/60/EEC.”
(c) Section 3.1.3 is replaced by the following:
“3.1.3. At rear seating positions of vehicles in category M1, lap-belts or three-point belts, whether or not fitted with retractors.”
(d) Add a new section 3.1.5 as follows:
“3.1.5. Notwithstanding the foregoing provisions, on vehicles in categories N1 and M2, an emergency locking retractor of type 4N (1.8.5) may be permitted instead of a retractor of type 4 (1.8.4), where it has been shown to the satisfaction of the services responsible for the tests that the fitting of a type 4 retractor would impede the driver.”

Article 2
Member States shall bring into force the provisions necessary in order to comply with this Directive on the same date as that scheduled for the entry into force of the provisions necessary to comply with the Directive to be adopted after this Directive pursuant to Article 10 of Directive 77/541/EEC, so that the requirements of the Annexes to the latter Directive may be adapted to technical progress. They shall forthwith inform the Commission thereof.

Article 3
This Directive is addressed to the Member States.
Done at Brussels, 20 July 1981.
For the Council
The President

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (4) lays down inter alia in Annex I requirements concerning the fitting of safety belts and restraint systems to vehicles of category M1 as defined in Annex I to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type approval of motor vehicles and their trailers (5), as last amended by Directive 80/1267/EEC (6); Whereas in the interests of road safety the fitting of safety belts and restraint systems complying with Directive 77/541/EEC should henceforth be required for the vehicles in certain M and N categories and permitted and encouraged for vehicles in the other M and N categories by extending the scope of that Directive ; whereas such an extension has been made possible by technical progress in motor-vehicle construction; Whereas for this purpose Directive 77/541/EEC should be amended; Whereas amendment of that Directive means adapting to technical progress certain requirements in the Annexes to Directive 77/541/EEC ; whereas the entry into force of the provisions of the present Directive should be made to coincide with that of the provisions which, following adoption of the present Directive, will then be adopted in order to adapt the requirements of the Annexes to Directive 77/541/EEC to technical progress, HAS ADOPTED THIS DIRECTIVE:
Directive 77/541/EEC shall be amended as follows: 1. Article 9 is replaced by the following:
For the purposes of this Directive, “vehicle” means any motor vehicle in categories M and N as defined in Annex I to Directive 70/156/EEC intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.”
2. In Annex I: (a) Section 3.1 is replaced by the following:
“3.1. Vehicle equipment
Any vehicle covered by Article 9, in categories M1 or N1, or category M2 (except vehicles of a permissible maximum weight exceeding 3 500 kg and those which include places specially designed for standing passengers) must be equipped with safety belts or restraint systems which satisfy the requirements of this Directive and have the following belt arrangements (with which neither non-locking locking retractors (1.8.1) or manually unlocking retractors (1.8.2) can be used).
In cases where the other vehicles covered by Article 9 are fitted with safety belts or restraint systems, these must comply with all the requirements of this Directive, with the exception of sections 3.1.1 to 3.1.3.” (1) OJ No C 87, 9.4.1980, p. 4. (2) OJ No C 265, 13.10.1980, p. 77. (3) OJ No C 230, 8.9.1980, p. 6. (4) OJ No L 220, 29.8.1977, p. 95. (5) OJ No L 42, 23.2.1970, p. 1. (6) OJ No L 375, 31.12.1980, p. 34.
(b) Section 3.1.1 is replaced by the following:
“3.1.1. for the front outboard seating positions, three-point safety belts with emergency locking retractors having multiple sensitivity (1.8.4) ; however, 3.1.1.1. for the passenger seat, automatically locking retractors (1.8.3) are permitted;
3.1.1.2. for the passenger seat of category M2 vehicles, lap-belts, whether or not fitted with retractors, are considered adequate where the windscreen is located outside the reference zone defined in Annex II to Directive 74/60/EEC.
As regards safety belts, the windscreen is considered as part of the reference zone when it is capable of entering into static contact with the test apparatus according to the method described in Annex II to Directive 74/60/EEC.”
(c) Section 3.1.3 is replaced by the following:
“3.1.3. At rear seating positions of vehicles in category M1, lap-belts or three-point belts, whether or not fitted with retractors.”
(d) Add a new section 3.1.5 as follows:
“3.1.5. Notwithstanding the foregoing provisions, on vehicles in categories N1 and M2, an emergency locking retractor of type 4N (1.8.5) may be permitted instead of a retractor of type 4 (1.8.4), where it has been shown to the satisfaction of the services responsible for the tests that the fitting of a type 4 retractor would impede the driver.”
Member States shall bring into force the provisions necessary in order to comply with this Directive on the same date as that scheduled for the entry into force of the provisions necessary to comply with the Directive to be adopted after this Directive pursuant to Article 10 of Directive 77/541/EEC, so that the requirements of the Annexes to the latter Directive may be adapted to technical progress. They shall forthwith inform the Commission thereof.
This Directive is addressed to the Member States.
Done at Brussels, 20 July 1981.
For the Council
The President

Council Directive 81/575/EEC of 20 July 1981 amending Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (4) lays down inter alia in Annex I requirements concerning the minimum number of belt anchorages to be provided for vehicles of category M1 as defined in Annex I to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (5), as last amended by Directive 80/1267/EEC (6); Whereas in the interest of road safety the fitting of safety belts and restraint systems complying with Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (7) should henceforth be required in vehicles of certain M and N categories and permitted and encouraged for vehicles in the other M and N categories ; whereas it is therefore necessary, within the framework of EEC motor vehicle type-approval, to provide for anchorages for the different categories of vehicles ; whereas for this purpose the scope of Directive 76/115/EEC must be extended in order that manufacturers may fit such vehicles with anchorages which comply with the requirements of that Directive ; whereas such an extension has been made possible by technical progress in motor-vehicle construction; Whereas for this purpose Directive 76/115/EEC should be amended; Whereas amendment of that Directive means adapting to technical progress certain requirements in the Annexes to Directive 76/115/EEC ; whereas the entry into force of the provisions of the present Directive should be made to coincide with that of the provisions which, following adoption of the present Directive, will then be adopted in order to adapt the requirements of the Annexes to Directive 76/115/EEC to technical progress, HAS ADOPTED THIS DIRECTIVE:

Article 1
Directive 76/115/EEC shall be amended as follows: 1. Article 2 is replaced by the following:
For the purposes of this Directive, “vehicle” means any motor vehicle in categories M and N as defined in Annex I to Directive 70/156/EEC intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.”
2. In Annex I: (a) Section 4.3.1 is replaced by the following:
“4.3.1. For the front seats of vehicles in category M1, category M2 (except vehicles of a permissible maximum weight exceeding 3 500 kg and those which include places specially designed for standing passengers) and categories N1, N2 and N3, two lower belt anchorages and one upper belt anchorage must be provided. However, for front central seats, two lower belt anchorages are considered as sufficient where the windscreen is located outside the reference zone defined in Annex II to Directive 74/60/EEC. As regards the belt anchorages the windscreen is considered part (1) OJ No C 87, 9.4.1980, p. 5. (2) OJ No C 265, 13.10.1980, p. 77. (3) OJ No C 230, 8.9.1980, p. 6. (4) OJ No L 24, 30.1.1976, p. 6. (5) OJ No L 42, 23.2.1970, p. 1. (6) OJ No L 375, 31.12.1980, p. 34. (7) OJ No L 220, 29.8.1977, p. 95. of the reference zone where it is capable of entering into static contact with the test apparatus according to the method described in Annex II.”
(b) Sections 4.3.1.1 and 4.3.1.2 are deleted;
(c) Section 4.3.2 is replaced by the following:
“4.3.2. For the other outboard seats of vehicles in category M1, there must be two lower belt anchorages and one upper belt anchorage.”
(d) Section 4.3.3 is replaced by the following:
“4.3.3. For all other seats in category M1 vehicles, and for all other non-protected seats in categories other than M1 as referred to in 4.3.1, there must be a minimum of two lower belt anchorages.
For the purpose of defining “protected seat”, “protection area” means the area in front of a seat and contained: – between two horizontal planes, one through the H point and the other 400 mm above it;
– between two vertical longitudinal planes which are symmetrical in relation to the H point and are 400 mm apart;
– behind a transverse vertical plane 1 730 m from the H point.
Within any transverse vertical plane, “screen zone” means a continuous surface such that, if a sphere of 165 mm diameter is projected in a longitudinal horizontal direction through any point of the zone and through the centre of the sphere, nowhere in the protection area is there any aperture through which the sphere can be passed.
A seat is considered to be protected if the screen zones within the protection area have a combined surface area of at least 800 cm2.”
(e) Section 4.3.4 is replaced by the following:
“4.3.4. For all folding (tip-up) seats, as well as all the seats of any vehicle which are not covered by sections 4.3.1, 4.3.2 or 4.3.3, not belt anchorages are required. However, if the vehicle is fitted with anchorages for such seats, these anchorages must comply with the provisions of this Directive.”

Article 2
Member States shall bring into force the provisions necessary in order to comply with this Directive on the same date as that scheduled for the entry into force of the provisions necessary to comply with the Directive to be adopted after this Directive pursuant to Article 6 of Directive 76/115/EEC, so that the requirements of the Annexes to the latter Directive may be adapted to technical progress. They shall forthwith inform the Commission thereof.

Article 3
This Directive is addressed to the Member States.
Done at Brussels, 20 July 1981.
For the Council
The President

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to anchorages for motor-vehicle safety belts (4) lays down inter alia in Annex I requirements concerning the minimum number of belt anchorages to be provided for vehicles of category M1 as defined in Annex I to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (5), as last amended by Directive 80/1267/EEC (6); Whereas in the interest of road safety the fitting of safety belts and restraint systems complying with Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles (7) should henceforth be required in vehicles of certain M and N categories and permitted and encouraged for vehicles in the other M and N categories ; whereas it is therefore necessary, within the framework of EEC motor vehicle type-approval, to provide for anchorages for the different categories of vehicles ; whereas for this purpose the scope of Directive 76/115/EEC must be extended in order that manufacturers may fit such vehicles with anchorages which comply with the requirements of that Directive ; whereas such an extension has been made possible by technical progress in motor-vehicle construction; Whereas for this purpose Directive 76/115/EEC should be amended; Whereas amendment of that Directive means adapting to technical progress certain requirements in the Annexes to Directive 76/115/EEC ; whereas the entry into force of the provisions of the present Directive should be made to coincide with that of the provisions which, following adoption of the present Directive, will then be adopted in order to adapt the requirements of the Annexes to Directive 76/115/EEC to technical progress, HAS ADOPTED THIS DIRECTIVE:
Directive 76/115/EEC shall be amended as follows: 1. Article 2 is replaced by the following:
For the purposes of this Directive, “vehicle” means any motor vehicle in categories M and N as defined in Annex I to Directive 70/156/EEC intended for use on the road, having at least four wheels and a maximum design speed exceeding 25 km/h.”
2. In Annex I: (a) Section 4.3.1 is replaced by the following:
“4.3.1. For the front seats of vehicles in category M1, category M2 (except vehicles of a permissible maximum weight exceeding 3 500 kg and those which include places specially designed for standing passengers) and categories N1, N2 and N3, two lower belt anchorages and one upper belt anchorage must be provided. However, for front central seats, two lower belt anchorages are considered as sufficient where the windscreen is located outside the reference zone defined in Annex II to Directive 74/60/EEC. As regards the belt anchorages the windscreen is considered part (1) OJ No C 87, 9.4.1980, p. 5. (2) OJ No C 265, 13.10.1980, p. 77. (3) OJ No C 230, 8.9.1980, p. 6. (4) OJ No L 24, 30.1.1976, p. 6. (5) OJ No L 42, 23.2.1970, p. 1. (6) OJ No L 375, 31.12.1980, p. 34. (7) OJ No L 220, 29.8.1977, p. 95. of the reference zone where it is capable of entering into static contact with the test apparatus according to the method described in Annex II.”
(b) Sections 4.3.1.1 and 4.3.1.2 are deleted;
(c) Section 4.3.2 is replaced by the following:
“4.3.2. For the other outboard seats of vehicles in category M1, there must be two lower belt anchorages and one upper belt anchorage.”
(d) Section 4.3.3 is replaced by the following:
“4.3.3. For all other seats in category M1 vehicles, and for all other non-protected seats in categories other than M1 as referred to in 4.3.1, there must be a minimum of two lower belt anchorages.
For the purpose of defining “protected seat”, “protection area” means the area in front of a seat and contained: – between two horizontal planes, one through the H point and the other 400 mm above it;
– between two vertical longitudinal planes which are symmetrical in relation to the H point and are 400 mm apart;
– behind a transverse vertical plane 1 730 m from the H point.
Within any transverse vertical plane, “screen zone” means a continuous surface such that, if a sphere of 165 mm diameter is projected in a longitudinal horizontal direction through any point of the zone and through the centre of the sphere, nowhere in the protection area is there any aperture through which the sphere can be passed.
A seat is considered to be protected if the screen zones within the protection area have a combined surface area of at least 800 cm2.”
(e) Section 4.3.4 is replaced by the following:
“4.3.4. For all folding (tip-up) seats, as well as all the seats of any vehicle which are not covered by sections 4.3.1, 4.3.2 or 4.3.3, not belt anchorages are required. However, if the vehicle is fitted with anchorages for such seats, these anchorages must comply with the provisions of this Directive.”
Member States shall bring into force the provisions necessary in order to comply with this Directive on the same date as that scheduled for the entry into force of the provisions necessary to comply with the Directive to be adopted after this Directive pursuant to Article 6 of Directive 76/115/EEC, so that the requirements of the Annexes to the latter Directive may be adapted to technical progress. They shall forthwith inform the Commission thereof.
This Directive is addressed to the Member States.
Done at Brussels, 20 July 1981.
For the Council
The President

Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament; Having regard to the Opinion of the Economic and Social Committee; Whereas the provisions in force in the Member States designed to ensure safety in the use of electrical equipment used within certain voltage limits may differ, thus impeding trade; Whereas in certain Member States in respect of certain electrical equipment, the safety legislation takes the form of preventive and repressive measures by means of binding provisions; Whereas in other Member States in order to achieve the same objective, the safety legislation provides for reference to technical standards laid down by Standards Bodies ; whereas such a system offers the advantage of rapid adjustment to technical progress without neglecting safety requirements; Whereas certain Member States carry out administrative operations to approve standards ; whereas such approval neither affects the technical content of the standards in any way nor limits their conditions of use ; whereas such approval cannot therefore alter the effects, from a Community point of view, of harmonized and published standards; Whereas within the Community the free movement of electrical equipment should follow when this equipment complies with certain safety requirements recognized in all Member States ; whereas without prejudice to any other form of proof, the proof of compliance with these requirements may be established by reference to harmonized standards which incorporate these conditions ; whereas these harmonized standards should be established by common agreement by bodies to be notified by each Member State to the other Member States and to the Commission and should be publicized as widely as possible ; whereas such harmonization should for the purposes of trade eliminate the inconveniences, resulting from differences between national standards; Whereas, without prejudice to any other form of proof, the compliance of electrical equipment with the harmonized standards may be presumed from the affixing or issue of marks or certificates by the competent organizations or, in the absence thereof, from a manufacturer’s declaration of compliance ; whereas in order to facilitate the removal of barriers to trade the Member States should recognize such marks or certificates or such declaration as elements of proof ; whereas, with this end in view, the said marks or certificates should be publicized in particular by their publication in the Official Journal of the European Communities; Whereas as a transitional measure, the free movement of electrical equipment for which harmonized standards do not yet exist may be achieved by applying the safety provisions or standards already laid down by other international bodies or by one of the bodies which establish harmonized standards; Whereas it is possible that electrical equipment may be placed in free circulation even though it does not comply with the safety requirements, and whereas it is therefore desirable to lay down suitable provisions to minimize this danger; HAS ADOPTED THIS DIRECTIVE:

Article 1
For the purposes of this Directive “electrical equipment” means any equipment designed for use with a voltage rating of between 50 and 1 000 v for alternating current and between 75 and 1 500 v for direct current, other than the equipment and phenomena listed in Annex II.

Article 2
1. The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made.
2. The principal elements of the safety objectives referred to in paragraph 1 are listed in Annex I.

Article 3
The Member States shall take all appropriate measures to ensure that if electrical equipment is of such a nature as to comply with the provisions of Article 2, subject to the conditions laid down in Articles 5, 6, 7 and 8, the free movement thereof within the Community shall not be impeded for reasons of safety.

Article 4
In relation to electrical equipment the Member States shall ensure that stricter safety requirements than those laid down in Article 2 are not imposed by electricity supply bodies for connection to the grid, or for the supply of electricity to users of electrical equipment.

Article 5
The Member States shall take all appropriate measures to ensure that, in particular, electrical equipment which complies with the safety provisions of harmonized standards shall be regarded by their competent administrative authorities as complying with the provisions of Article 2, for the purposes of placing on the market and free movement as referred to in Articles 2 and 3 respectively.
Standards shall be regarded as harmonized once they are drawn up by common agreement between the bodies notified by the Member States in accordance with the procedure laid down in Article 11, and published under national procedures. The standards shall be kept up to date in the light of technological progress and the developments in good engineering practice in safety matters.
For purposes of information the list of harmonized standards and their references shall be published in the Official Journal of the European Communities.

Article 6
1. Where harmonized standards as defined in Article 5 have not yet been drawn up and published, the Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or free movement as referred to in Articles 2 and 3 respectively, their competent administrative authorities shall also regard, as complying with the provisions of Article 2, electrical equipment which complies with the safety provisions of the International Commission on the Rules for the Approval of Electrical Equipment (CEE) or of the International Electrotechnical Commission (IEC) in respect of which the publication procedure laid down in paragraphs 2 and 3 has been applied.
2. The safety provisions referred to in paragraph 1 shall be notified to the Member States by the Commission as from the entry into force of this Directive, and thereafter as and when they are published. The Commission, after consulting the Member States, shall state the provisions and in particular the variants which it recommends to be published.
3. The Member States shall inform the Commission within a period of three months of such objections as they may have to the provisions thus notified, stating the safety grounds on account of which the provisions should not be recognized.
For purposes of information those safety provisions against which no objection has been raised shall be published in the Official Journal of the European Communities.

Article 7
Where harmonized standards within the meaning of Article 5 or safety provisions published in accordance with Article 6 are not yet in existence, the Member States shall take all appropriate measures to ensure that, for the purpose of placing on the market or free movement as referred to in Articles 2 and 3 respectively, their competent administrative authorities shall also regard as complying with the provisions of Article 2, electrical equipment manufactured in accordance with the safety provisions of the standards in force in the Member State of manufacture, if it ensures a safety level equivalent to that required in their own territory.

Article 8
1. The Member States shall take all appropriate steps to ensure that their competent administrative authorities shall also allow the placing on the market or free movement, as referred to in Articles 2 and 3 respectively, of electrical equipment which, although not conforming with the harmonized standards referred to in Article 5 or the provisions of Articles 6 and 7, complies with the provisions of Article 2.
2. In the event of a challenge the manufacturer or importer may submit a report, drawn up by a body, which is notified in accordance with the procedure set out in Article 11, on the conformity of the electrical equipment with the provisions of Article 2.

Article 9
1. If, for safety reasons, a Member State prohibits the placing on the market of any electrical equipment or impedes its free movement, it shall immediately inform the other Member States concerned and the Commission, indicating the grounds for its decision and stating in particular: – whether its non-conformity with Article 2 is attributable to a shortcoming in the harmonized standards referred to in Article 5, the provisions referred to in Article 6 or the standards referred to in Article 7;
– whether its non-conformity is attributable to faulty application of such standards or publications or to failure to comply with good engineering practice as referred to in Article 2.
2. If other Member States raise objections to the decision referred to in paragraph 1, the Commission shall immediately consult the Member States concerned.
3. If an agreement has not been reached within three months from the date of notification as laid down in paragraph 1, the Commission shall obtain the opinion of one the bodies notified in accordance with the procedure laid down in Article 11 having its registered office outside the territory of the Member States concerned and which has not been involved in the procedure provided for in Article 8. The opinion shall state the extent to which the provisions of Article 2 have not been complied with.
4. The Commission shall communicate the opinion of this body to all the Member States which may, within a period of one month, make their observations known to the Commission. The Commission shall at the same time note any observations by the parties concerned on the abovementioned opinion.
5. Having taken note of these observations the Commission shall, if necessary, formulate the appropriate recommendations or opinions.

Article 10
1. Without prejudice to other methods of proof, the Member States shall take all appropriate steps to ensure that their competent administrative authorities shall accept that there is a presumption of conformity with the provisions of Articles 5, 6 and 7 where a mark has been placed on the electrical equipment denoting conformity, or where a certificate of conformity is produced or, in the absence thereof, and in particular in the case of industrial equipment, the manufacturer’s declaration of conformity.
2. The marks or certificates shall be established, separately or by common agreement, by the bodies notified in accordance with the procedure laid down in Article 11. Specimens of these marks or certificates shall be published by these bodies and, for information purposes in the Official Journal of the European Communities.

Article 11
Each Member State shall inform the other Member States and the Commission of the following: – the bodies referred to in Article 5;
– the bodies which may establish the marks and certificates in accordance with the provisions of Article 10;
– the bodies which may make a report in accordance with the provisions of Article 8 or give an opinion in accordance with the provisions of Article 9;
– the place of publication referred to in Article 5 (2);
Any amendment to the above shall be notified by each Member State to the other Member States and to the Commission.

Article 12
This Directive shall not apply to electrical equipment intended for export to third countries.

Article 13
1. The Member States shall put into force the laws, regulations and administrative provisions necessary to comply with the requirements of this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.
However, in the case of Denmark, the time limit shall be extended to five years.
2. The Member States shall communicate to the Commission the texts of the main provisions of national laws which they adopt in the field covered by this Directive.

Article 14
This Directive is addressed to the Member States.
Done at Brussels, 19 February 1973.
For the Council
The President

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament; Having regard to the Opinion of the Economic and Social Committee; Whereas the provisions in force in the Member States designed to ensure safety in the use of electrical equipment used within certain voltage limits may differ, thus impeding trade; Whereas in certain Member States in respect of certain electrical equipment, the safety legislation takes the form of preventive and repressive measures by means of binding provisions; Whereas in other Member States in order to achieve the same objective, the safety legislation provides for reference to technical standards laid down by Standards Bodies ; whereas such a system offers the advantage of rapid adjustment to technical progress without neglecting safety requirements; Whereas certain Member States carry out administrative operations to approve standards ; whereas such approval neither affects the technical content of the standards in any way nor limits their conditions of use ; whereas such approval cannot therefore alter the effects, from a Community point of view, of harmonized and published standards; Whereas within the Community the free movement of electrical equipment should follow when this equipment complies with certain safety requirements recognized in all Member States ; whereas without prejudice to any other form of proof, the proof of compliance with these requirements may be established by reference to harmonized standards which incorporate these conditions ; whereas these harmonized standards should be established by common agreement by bodies to be notified by each Member State to the other Member States and to the Commission and should be publicized as widely as possible ; whereas such harmonization should for the purposes of trade eliminate the inconveniences, resulting from differences between national standards; Whereas, without prejudice to any other form of proof, the compliance of electrical equipment with the harmonized standards may be presumed from the affixing or issue of marks or certificates by the competent organizations or, in the absence thereof, from a manufacturer’s declaration of compliance ; whereas in order to facilitate the removal of barriers to trade the Member States should recognize such marks or certificates or such declaration as elements of proof ; whereas, with this end in view, the said marks or certificates should be publicized in particular by their publication in the Official Journal of the European Communities; Whereas as a transitional measure, the free movement of electrical equipment for which harmonized standards do not yet exist may be achieved by applying the safety provisions or standards already laid down by other international bodies or by one of the bodies which establish harmonized standards; Whereas it is possible that electrical equipment may be placed in free circulation even though it does not comply with the safety requirements, and whereas it is therefore desirable to lay down suitable provisions to minimize this danger; HAS ADOPTED THIS DIRECTIVE:
For the purposes of this Directive “electrical equipment” means any equipment designed for use with a voltage rating of between 50 and 1 000 v for alternating current and between 75 and 1 500 v for direct current, other than the equipment and phenomena listed in Annex II.
1. The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made.
2. The principal elements of the safety objectives referred to in paragraph 1 are listed in Annex I.
The Member States shall take all appropriate measures to ensure that if electrical equipment is of such a nature as to comply with the provisions of Article 2, subject to the conditions laid down in Articles 5, 6, 7 and 8, the free movement thereof within the Community shall not be impeded for reasons of safety.
In relation to electrical equipment the Member States shall ensure that stricter safety requirements than those laid down in Article 2 are not imposed by electricity supply bodies for connection to the grid, or for the supply of electricity to users of electrical equipment.
The Member States shall take all appropriate measures to ensure that, in particular, electrical equipment which complies with the safety provisions of harmonized standards shall be regarded by their competent administrative authorities as complying with the provisions of Article 2, for the purposes of placing on the market and free movement as referred to in Articles 2 and 3 respectively.
Standards shall be regarded as harmonized once they are drawn up by common agreement between the bodies notified by the Member States in accordance with the procedure laid down in Article 11, and published under national procedures. The standards shall be kept up to date in the light of technological progress and the developments in good engineering practice in safety matters.
For purposes of information the list of harmonized standards and their references shall be published in the Official Journal of the European Communities.
1. Where harmonized standards as defined in Article 5 have not yet been drawn up and published, the Member States shall take all appropriate measures to ensure that, for the purposes of placing on the market or free movement as referred to in Articles 2 and 3 respectively, their competent administrative authorities shall also regard, as complying with the provisions of Article 2, electrical equipment which complies with the safety provisions of the International Commission on the Rules for the Approval of Electrical Equipment (CEE) or of the International Electrotechnical Commission (IEC) in respect of which the publication procedure laid down in paragraphs 2 and 3 has been applied.
2. The safety provisions referred to in paragraph 1 shall be notified to the Member States by the Commission as from the entry into force of this Directive, and thereafter as and when they are published. The Commission, after consulting the Member States, shall state the provisions and in particular the variants which it recommends to be published.
3. The Member States shall inform the Commission within a period of three months of such objections as they may have to the provisions thus notified, stating the safety grounds on account of which the provisions should not be recognized.
For purposes of information those safety provisions against which no objection has been raised shall be published in the Official Journal of the European Communities.
Where harmonized standards within the meaning of Article 5 or safety provisions published in accordance with Article 6 are not yet in existence, the Member States shall take all appropriate measures to ensure that, for the purpose of placing on the market or free movement as referred to in Articles 2 and 3 respectively, their competent administrative authorities shall also regard as complying with the provisions of Article 2, electrical equipment manufactured in accordance with the safety provisions of the standards in force in the Member State of manufacture, if it ensures a safety level equivalent to that required in their own territory.
1. The Member States shall take all appropriate steps to ensure that their competent administrative authorities shall also allow the placing on the market or free movement, as referred to in Articles 2 and 3 respectively, of electrical equipment which, although not conforming with the harmonized standards referred to in Article 5 or the provisions of Articles 6 and 7, complies with the provisions of Article 2.
2. In the event of a challenge the manufacturer or importer may submit a report, drawn up by a body, which is notified in accordance with the procedure set out in Article 11, on the conformity of the electrical equipment with the provisions of Article 2.
1. If, for safety reasons, a Member State prohibits the placing on the market of any electrical equipment or impedes its free movement, it shall immediately inform the other Member States concerned and the Commission, indicating the grounds for its decision and stating in particular: – whether its non-conformity with Article 2 is attributable to a shortcoming in the harmonized standards referred to in Article 5, the provisions referred to in Article 6 or the standards referred to in Article 7;
– whether its non-conformity is attributable to faulty application of such standards or publications or to failure to comply with good engineering practice as referred to in Article 2.
2. If other Member States raise objections to the decision referred to in paragraph 1, the Commission shall immediately consult the Member States concerned.
3. If an agreement has not been reached within three months from the date of notification as laid down in paragraph 1, the Commission shall obtain the opinion of one the bodies notified in accordance with the procedure laid down in Article 11 having its registered office outside the territory of the Member States concerned and which has not been involved in the procedure provided for in Article 8. The opinion shall state the extent to which the provisions of Article 2 have not been complied with.
4. The Commission shall communicate the opinion of this body to all the Member States which may, within a period of one month, make their observations known to the Commission. The Commission shall at the same time note any observations by the parties concerned on the abovementioned opinion.
5. Having taken note of these observations the Commission shall, if necessary, formulate the appropriate recommendations or opinions.
1. Without prejudice to other methods of proof, the Member States shall take all appropriate steps to ensure that their competent administrative authorities shall accept that there is a presumption of conformity with the provisions of Articles 5, 6 and 7 where a mark has been placed on the electrical equipment denoting conformity, or where a certificate of conformity is produced or, in the absence thereof, and in particular in the case of industrial equipment, the manufacturer’s declaration of conformity.
2. The marks or certificates shall be established, separately or by common agreement, by the bodies notified in accordance with the procedure laid down in Article 11. Specimens of these marks or certificates shall be published by these bodies and, for information purposes in the Official Journal of the European Communities.
Each Member State shall inform the other Member States and the Commission of the following: – the bodies referred to in Article 5;
– the bodies which may establish the marks and certificates in accordance with the provisions of Article 10;
– the bodies which may make a report in accordance with the provisions of Article 8 or give an opinion in accordance with the provisions of Article 9;
– the place of publication referred to in Article 5 (2);
Any amendment to the above shall be notified by each Member State to the other Member States and to the Commission.
This Directive shall not apply to electrical equipment intended for export to third countries.
1. The Member States shall put into force the laws, regulations and administrative provisions necessary to comply with the requirements of this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.
However, in the case of Denmark, the time limit shall be extended to five years.
2. The Member States shall communicate to the Commission the texts of the main provisions of national laws which they adopt in the field covered by this Directive.
This Directive is addressed to the Member States.
Done at Brussels, 19 February 1973.
For the Council
The President
1. General conditions a) The essential characteristics, the recognition and observance of which will ensure that electrical equipment will be used safely and in applications for which it was made, shall be marked on the equipment, or, if this is not possible, on an accompanying notice.
b) The manufacturers or brand name or trade mark should be clearly printed on the electrical equipment or, where that is not possible, on the packaging.
c) The electrical equipment, together with its component parts should be made in such a way as to ensure that it can be safely and properly assembled and connected.
d) The electrical equipment should be so designed and manufactured as to ensure that protection against the hazards set out in points 2 and 3 of this Annex is assured providing that the equipment is used in applications for which it was made and is adequately maintained.
2. Protection against hazards arising from the electrical equipment
Measures of a technical nature should be prescribed in accordance with point 1, in order to ensure: a) that persons and domestic animals are adequately protected against danger of physical injury or other harm which might be caused by electrical contact direct or indirect;
b) that temperatures, arcs or radiation which would cause a danger, are not produced;
c) that persons, domestic animals and property are adequately protected against non-electrical dangers caused by the electrical equipment which are revealed by experience;
d) that the insulation must be suitable for foreseeable conditions.
3. Protection against hazards which may be caused by external influences on the electrical equipment
Technical measures are to be laid down in accordance with point 1, in order to ensure: a) that the electrical equipment meets the expected mechanical requirements in such a way that persons, domestic animals and property are not endangered;
b) that the electrical equipment shall be resistant to non-mechanical influences in expected environmental conditions, in such a way that persons, domestic animals and property are not endangered;
c) that the electrical equipment shall not endanger persons, domestic animals and property in foreseeable conditions of overload.
Electrical equipment for use in an explosive atomosphere
Electrical equipment for radiology and medical purposes
Electrical parts for goods and passenger lifts
Electricity meters
Plugs and socket outlets for domestic use
Electric fence controllers
Radio-electrical interference
Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.

Directive (EU) 2025/2482 of the European Parliament and of the Council of 26 November 2025 amending Directive 2005/44/EC on harmonised river information services (RIS) on inland waterways in the Community

Official Journalof the European Union ENL series
2025/2482 12.12.2025
(1) Directive 2005/44/EC of the European Parliament and of the Council(3)establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union. The deployment of RIS on inland waterways supports the safety and efficiency of transport by inland waterways, and ultimately the sustainability and attractiveness of the sector, by increasing the efficiency of inland waterway transport operations.
(2) Since the entry into force of Directive 2005/44/EC, the inland waterway sector has benefited from the provision of harmonised RIS. However, the level of harmonisation between Member States varies, and the process of introducing the necessary specifications has proved to be lengthy. Additionally, the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ calls for the further development of an automated and connected multimodal mobility. Consequently, RIS should be adapted to address those new challenges. Furthermore, the Commission communication of 9 December 2020 entitled ‘Sustainable and Smart Mobility Strategy – putting European transport on track for the future’ proposes the revision of Directive 2005/44/EC as one of the measures to achieve the objective of promoting the creation of a truly smart transport system, efficient capacity allocation and traffic management. The Commission communication of 24 June 2021 set out an action plan entitled ‘NAIADES III: Boosting future-proof European inland waterway transport’, which states that in order to support the objective of inland waterways being part of a seamless system of harmonised RIS by 2030, revisions of the legal framework on RIS would aim to help close existing harmonisation and interoperability gaps with other transport modes, and contribute to improved data availability, reuse and interoperability of digital systems, in line with the Commission communication of 19 February 2020 entitled ‘A European strategy for data’. Those changes and developments, as well as the experience gained in the implementation of Directive 2005/44/EC, should be taken into account when adapting RIS.
(3) In the interest of adopting a coherent approach to interoperability in the public service sector, when implementing the electronic single-point-of-access platform for RIS (the ‘European RIS Environment’) and other solutions that fall within the scope of Directive 2005/44/EC, the principles laid down in the European Interoperability Framework (EIF), that is set out in the Commission communication of 23 March 2017 entitled ‘European Interoperability Framework – Implementation Strategy’, pursuant to Article 6 of Regulation (EU) 2024/903 of the European Parliament and of the Council(4), should be followed.
(4) Regulation (EU) 2024/1679 of the European Parliament and of the Council(5)lays down requirements for the development of the trans-European transport network (TEN-T) to achieve the smooth functioning of the internal market, and aims to ensure that the same high-quality services are available and compatible with the systems of other transport modes along that network.
(5) Given that the majority of journeys of inland waterway vessels are of an international nature, RIS should be focused on those inland waterways of Member States that form part of the TEN-T and that are directly connected to another Member State’s inland waterways that also form part of the TEN-T, and which are thus of high importance for the Union. Member States should be able to continue extending, on a voluntary basis, the RIS requirements to parts of their inland waterways network other than those that form part of the TEN-T to account for national specificities. In a cross-border context, it should also be possible for one of the Member States concerned to provide RIS. The Member States’ competent authorities should cooperate with a view to providing RIS on cross-border inland waterways.
(6) In view of Russia’s war of aggression against Ukraine, cooperation between the Union and Russia in the field of RIS is neither appropriate nor in the interest of the Union. As a consequence, cross-border cooperation on RIS with Russia is no longer a priority on the territory of the Member States.
(7) The experience gained from the application of Directive 2005/44/EC has shown that it is important to strengthen the technical specifications concerning the provision of data for navigation and voyage planning on inland waterways in order to improve the quality and timeliness of information provided to RIS users. The European Reference Data Management System (ERDMS) contains reference data and code lists necessary for the proper functioning of RIS and is set up and currently operated by the Commission. The operation of the ERDMS could be transferred to a third party in the future.
(8) The availability to RIS users, during navigation, of up-to-date and accurate information regarding the condition of the fairway and specific points like bridges, locks and inland ports is expected to improve the overall efficiency of the inland waterway sector. RIS should therefore include up-to-date exchanges of data with semi- and fully automated management of infrastructure systems of locks and movable bridges as well as with port community systems of inland ports.
(9) In order for RIS to allow for interconnection with the logistics chain, it is important that information is shared not only among the inland waterway transport users, for instance through port community systems of inland ports and smart inland waterway infrastructure systems, but also with systems and applications of other modes of transport. The maritime National Single Windows (MNSW) within the European Maritime Single Window environment (EMSWe), established by Regulation (EU) 2019/1239 of the European Parliament and of the Council(6), should enable harmonised ship reporting across the Union in maritime transport. The exchange of traffic-related information, such as arrival and departure times, would ensure interoperability, multimodality, and smooth integration of inland waterway transport (IWT) with the overall logistics chain. The electronic freight transport information (eFTI), established by Regulation (EU) 2020/1056 of the European Parliament and of the Council(7), should form the basis for the exchange of cargo information on dangerous goods and waste between RIS users where required. When necessary, RIS should enable links with, and should make information available to, digital systems and platforms of other modes of transport.
(10) The exchange of information between inland waterway vessels and inland ports, for example on availability of port installations, operating times, or vessel and cargo information, is not always optimal, thus impacting the efficiency of IWT operations. Information on the availability of alternative fuel infrastructure in inland ports is of particular importance in promoting the environmental performance of the sector. In order to simplify and streamline the exchange of such information and improve the overall efficiency of the sector, it is important that standardised interfaces be established and become part of RIS and that the necessary technical specifications are developed.
(11) The use of the European RIS Environment should streamline the provision of RIS, improve efficiency of IWT operations and reduce the burden on RIS providers and users. The European RIS Environment should support relevant services, be a central point for the exchange of RIS information within the inland waterways sector as well as with other transport modes, and therefore become the main digital backbone for the provision of RIS in the Union. Member States should designate one or more competent authorities responsible for operating the European RIS Environment. Those competent authorities are controllers, as defined in Regulation (EU) 2016/679 of the European Parliament and of the Council(8), for the purpose of operating the European RIS Environment.
(12) In order to ensure uniform conditions for the introduction of the European RIS Environment, implementing powers should be conferred on the Commission to establish the framework for the development and the functioning of the European RIS Environment. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(9).
(13) Implementing acts under this Directive should not be adopted by the Commission where the committee referred to in this Directive delivers no opinion, for example where there is no qualified majority in support of an opinion, whether positive or negative, and where the draft implementing act is not submitted to the appeal committee or where the appeal committee delivers a negative opinion. In accordance with the principle of sincere cooperation, Member States and the Commission should collaborate to swiftly set up the necessary operational characteristics, roles and procedures for the European RIS Environment.
(14) Cooperation with third countries, in particular neighbouring countries, is relevant in order to ensure connection and interoperability between the European RIS Environment and the national RIS of those third countries.
(15) The European RIS Environment should provide for the possibility for RIS users to submit feedback on the application of this Directive and ensure that such feedback is transmitted to the Member State concerned. Member States should set up a simple and accessible procedure for handling such feedback in a transparent and impartial manner. Member States’ authorities should cooperate in the handling of feedback involving cross-border elements, such as incompatible standards in reporting of vessel information, since 75 % of inland waterway transport operations includes international voyages. Analysis of the subject matter of the feedback received, as well as its frequency, makes it possible to identify the extent of compliance with this Directive, thus supporting the monitoring of implementation by identifying areas where implementation can be improved. It is therefore important that that information is collected and provided to the Commission on an annual basis.
(16) The development of technical specifications should follow a set of principles, in particular the principles set out in Annex II to this Directive, in order to ensure the proper and harmonised implementation of Directive 2005/44/EC. Those principles should outline the main elements that each RIS component should include.
(17) The requirements and technical specifications for RIS should ensure in particular that: RIS data which constitute personal data under Regulation (EU) 2016/679 can be processed solely in accordance with a comprehensive, rights-based access-control system that provides assigned functionalities; all competent authorities can have immediate access to those data in accordance with their respective regulatory competences; appropriate technical and organisational measures are implemented to ensure that the processing by electronic means of personal data can be carried out in accordance with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council(10), including for the purposes of protection against personal data breaches; and the processing of sensitive commercial information can be carried out in a way that respects the confidentiality of that information.
(18) In order to ensure the safe and optimal navigation of vessels on inland waterways, Member States should be aware of the location of all inland waterway vessels, including through the use of automatic identification systems (AIS) data. Member States should also exchange RIS-related information to increase the efficiency of RIS and reduce reporting requirements. Where the transmission and exchange of RIS-related information for those purposes entails the processing of personal data, such as the processing of names or the processing of location data when such processing enables the identification, directly or indirectly, of a person, Member States should ensure the lawfulness of the processing of those personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council(11), where applicable.
(19) In order to ensure that RIS users are supplied with the necessary information concerning navigation and voyage planning on inland waterways, and taking account of scientific and technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending the minimum data requirements set out in Annex I to Directive 2005/44/EC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as the Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(20) Where duly justified by an appropriate analysis and in the absence of pertinent and up-to-date international standards to ensure safety of navigation, or where changes in or the outcome of the decision-making process of the European committee for drawing up standards in the field of inland navigation (CESNI) would compromise Union interests, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex III to Directive 2005/44/EC in order to provide appropriate technical specifications for RIS, in line with the principles set out in Annex II to Directive 2005/44/EC and with the aim of safeguarding Union interests.
(21) The experience gained from the implementation of Directive 2005/44/EC reveals that the lengthy period for introducing and updating the technical specifications laid down therein has affected the sector’s performance. It is therefore important to change the process by which technical specifications are introduced.
(22) Directive (EU) 2016/1629 of the European Parliament and of the Council(13)introduced a process based on technical specifications developed by the CESNI. CESNI, which acts under the auspices of the Central Commission for Navigation on the Rhine (CCNR) and is open to experts from all Member States, is responsible for drawing up the technical standards in the field of inland waterway transport. Experience has shown that CESNI has developed and updated technical requirements for inland navigation vessels in an organised and timely manner. Taking into account the expertise of CESNI and the experience gained from the implementation of Directive (EU) 2016/1629, a similar approach should be applied with regard to Directive 2005/44/EC.
(23) In order to ensure a high level of safety and efficiency in inland navigation, to ensure the provision of RIS, and to take into account scientific and technical progress and other developments in the sector, the reference to the applicable technical specifications for RIS, namely the European Standard for River Information Services (ES-RIS), should form an integral part of Directive 2005/44/EC.
(24) The Committee on boatmasters’ certificates for the carriage of goods and passengers by inland waterway referred to in Article 11 of Directive 2005/44/EC has been abolished. In its place, the Inland Waterway Transport Committee, which possesses expertise in standards and technical specifications in the inland waterway sector, should assist the Commission in respect of RIS as a committee within the meaning of Regulation (EU) No 182/2011. Furthermore, this Directive introduces amendments to Articles 5 and 12 of Directive 2005/44/EC relating to the Committee procedure. Article 11 of Directive 2005/44/EC should therefore be amended to reflect those changes.
(25) For the purposes of better regulation and simplification, it should be possible for Directive 2005/44/EC to make reference to international standards without duplicating them in the Union legal framework.
(26) RIS was established in the Union in 2005, and since then considerable experience in its development and implementation has been gained by the Member States. Furthermore, the technical specifications necessary for the functioning of RIS are included in Annex III to Directive 2005/44/EC. In that regard, Article 12(2) of Directive 2005/44/EC should be deleted. In addition, by amending the scope of Directive 2005/44/EC to focus on the TEN-T, the requirement to implement RIS is applicable on the most important inland waterways, creating a reliable transport network. Article 12(3) of Directive 2005/44/EC should therefore be deleted.
(27) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of establishing a framework for the provision of RIS in the Union to lay down rules on its set up, operation and technical specifications. In accordance with Article 5(4) of the Treaty on European Union, this Directive does not go beyond what is necessary in order to achieve the objectives pursued.
(28) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 20 March 2024.
(29) Directive 2005/44/EC should therefore be amended accordingly,
(1) Article 1 is replaced by the following:‘Article 1Subject matter1.   This Directive establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union in order to support inland waterway transport with a view to enhancing its safety, efficiency and sustainability and to facilitating interfaces with other transport modes.2.   This Directive provides a framework for the establishment and further development of technical requirements, specifications and conditions to ensure harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitate continuity with traffic management services of other transport modes through the use of standardised interfaces.’;
(2) in Article 2, paragraph 1 is replaced by the following:‘1.   This Directive applies to the implementation and operation of RIS on all inland waterways and inland ports of the Member States that form part of the trans-European transport network, as specified and listed in Annexes I and II to Regulation (EU) 2024/1679 of the European Parliament and of the Council(*1), and that are directly connected to inland waterways and inland ports of another Member State that form part of the trans-European transport network, as specified and listed in those Annexes.(*1)Regulation (EU) 2024/1679 of the European Parliament and of the Council of 13 June 2024 on Union guidelines for the development of the trans-European transport network, amending Regulations (EU) 2021/1153 and (EU) No 913/2010 and repealing Regulation (EU) No 1315/2013 (OJ L, 2024/1679, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1679/oj).’;"
(3) in Article 3, the following points are added:‘(i)“trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679;(j)“European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III;(k)“port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes;(l)“smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways;(m)“European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle;(n)“inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’; ‘(i) “trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679; (j) “European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III; (k) “port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes; (l) “smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways; (m) “European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle; (n) “inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’
‘(i) “trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679;
(j) “European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III;
(k) “port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes;
(l) “smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways;
(m) “European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle;
(n) “inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’
‘(i) “trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679;
(j) “European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III;
(k) “port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes;
(l) “smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways;
(m) “European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle;
(n) “inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’
(4) Article 4 is replaced by the following:‘Article 4Setting-up of RIS1.   Member States shall take the necessary measures to implement RIS on inland waterways and inland ports falling within the scope of this Directive.2.   Member States shall develop RIS in such a way that the RIS application is efficient, expandable and interoperable so as to interact with other RIS applications and with systems for other modes of transport, while also providing interfaces to transport management systems and commercial activities.3.   In order to set up RIS, Member States shall:(a)ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;(b)ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users;(c)enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border;(d)ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;(e)ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay;(f)ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes;(g)ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2);(h)ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.The obligations referred to in this paragraph shall be fulfilled in compliance with the requirements and principles set out in Annexes I and II.4.   The competent authorities of the Member States shall establish RIS centres according to regional needs.5.   Member States shall jointly create, govern, operate, use and maintain a European RIS Environment that provides fairway-, infrastructure-, traffic-, and transport-related services, and shall provide the necessary data. The European RIS Environment shall be accessible for all RIS users and shall be the main platform for the exchange of RIS-related information. It shall contain interfaces for connections with systems of other transport modes and inland ports. Member States shall designate one or more competent authorities responsible for the operation of the European RIS Environment. The European RIS Environment shall allow for the possibility of contributions from third countries whose waterways are connected to the European inland waterway network and which are willing to cooperate and provide their network data, provided that the data are of identical quality and format to that of Member States and that they adhere to the same level of cybersecurity and data protection.6.   The Commission shall adopt implementing acts which lay down the operational characteristics, roles and procedures for the European RIS Environment and which identify its operating entity, based on the principles for RIS technical specifications set out in point 6 of Annex II, to ensure their uniform implementation throughout the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2).7.   For the use of the automatic identification systems (AIS), the Regional Arrangement on the Radiocommunication Service for Inland Waterways (RAINWAT), concluded in Bucharest on 12 April 2012, in the framework of the radio regulations of the International Telecommunication Union (ITU) shall apply.8.   Member States, in cooperation with the Union, if appropriate, shall encourage boat masters, operators, agents or owners of vessels navigating on their inland waterways and shippers or owners of goods carried on board such vessels to fully profit from the services which are made available under this Directive.9.   The Commission shall take appropriate measures to verify the interoperability, reliability, availability and safety of RIS.(*2)Regulation (EU) 2023/1804 of the European Parliament and of the Council of 13 September 2023 on the deployment of alternative fuels infrastructure, and repealing Directive 2014/94/EU (OJ L 234, 22.9.2023, p. 1, ELI:http://data.europa.eu/eli/reg/2023/1804/oj).’;" (a) ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III; (b) ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users; (c) enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border; (d) ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III; (e) ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay; (f) ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes; (g) ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2); (h) ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.
(a) ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(b) ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users;
(c) enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border;
(d) ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(e) ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay;
(f) ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes;
(g) ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2);
(h) ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.
(a) ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(b) ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users;
(c) enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border;
(d) ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(e) ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay;
(f) ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes;
(g) ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2);
(h) ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.
(5) Article 5 is replaced by the following:‘Article 5Technical specifications1.   In order to support RIS and to ensure the interoperability of services in accordance with Article 4(2), the technical specifications referred to in Annex III in line with the principles set out in Annex II shall apply and shall cover in particular the following areas:(a)electronic chart display and information system for inland navigation (inland ECDIS);(b)electronic ship reporting;(c)notices to skippers;(d)vessel tracking and tracing systems;(e)compatibility of the equipment necessary for the use of RIS;(f)operation of the European RIS Environment;(g)interconnection and exchange of information with Union data bases (ERDMS);(h)standardised interface for IT platforms of other transport modes;(i)standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems;(j)data for navigation and voyage planning on inland waterways.’; (a) electronic chart display and information system for inland navigation (inland ECDIS); (b) electronic ship reporting; (c) notices to skippers; (d) vessel tracking and tracing systems; (e) compatibility of the equipment necessary for the use of RIS; (f) operation of the European RIS Environment; (g) interconnection and exchange of information with Union data bases (ERDMS); (h) standardised interface for IT platforms of other transport modes; (i) standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems; (j) data for navigation and voyage planning on inland waterways.’
(a) electronic chart display and information system for inland navigation (inland ECDIS);
(b) electronic ship reporting;
(c) notices to skippers;
(d) vessel tracking and tracing systems;
(e) compatibility of the equipment necessary for the use of RIS;
(f) operation of the European RIS Environment;
(g) interconnection and exchange of information with Union data bases (ERDMS);
(h) standardised interface for IT platforms of other transport modes;
(i) standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems;
(j) data for navigation and voyage planning on inland waterways.’
(a) electronic chart display and information system for inland navigation (inland ECDIS);
(b) electronic ship reporting;
(c) notices to skippers;
(d) vessel tracking and tracing systems;
(e) compatibility of the equipment necessary for the use of RIS;
(f) operation of the European RIS Environment;
(g) interconnection and exchange of information with Union data bases (ERDMS);
(h) standardised interface for IT platforms of other transport modes;
(i) standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems;
(j) data for navigation and voyage planning on inland waterways.’
(6) Article 6 is replaced by the following:‘Article 6Satellite positioningFor the purposes of RIS, for which exact positioning is required, it is recommended to use satellite positioning and navigation systems, such as navigation services provided by Galileo, including the high-accuracy service and Open Service Navigation Message Authentication and the European Geostationary Navigation Overlay Service (EGNOS) referred to in Regulation (EU) 2021/696 of the European Parliament and of the Council(*3). For the purposes of applications and services relying on Earth observation data, the use of Copernicus data, information and services is recommended.(*3)Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, p. 69, ELI:http://data.europa.eu/eli/reg/2021/696/oj).’;"
(7) Article 8 is replaced by the following:‘Article 8Competent authoritiesMember States shall designate competent authorities responsible for the RIS application, for the international exchange of data, for the operation of the European RIS Environment and for the handling of feedback by RIS users. They shall notify those designated authorities to the Commission by 17 January 2029.’;
(8) the following Article is inserted:‘Article 8aFeedback mechanism1.   Each Member State shall ensure that an effective, simple and accessible procedure is in place, building, where possible, on existing structures, to handle feedback from RIS users arising from the application of this Directive.2.   The handling of feedback from RIS users shall be carried out in a manner which avoids conflicts of interest. The handling of feedback shall be impartial and transparent and shall duly respect the right to freely conduct business.3.   Feedback from RIS users shall be submitted through the European RIS Environment and be transmitted to the relevant Member States. Member States shall ensure that RIS users and other relevant stakeholders are informed of where and how to submit feedback.4.   Member States shall ensure that feedback from RIS users is handled in a timely and appropriate manner and that the information on its follow-up is provided through the European RIS Environment.5.   The European RIS Environment shall inform the Commission, on an annual basis, of the amount of feedback received and of the way that the feedback was handled.’;
(9) Article 9 is replaced by the following:‘Article 9Rules on privacy, security of information and processing of personal data1.   Member States shall take the necessary technical and organisational measures in accordance with applicable Union and national law in order to protect RIS information and records against untoward events or misuse, including improper access, alteration or loss, and to ensure the confidentiality of commercial and other sensitive information exchanged pursuant to this Directive.2.   Data that constitute personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679 of the European Parliament and of the Council(*4)may be processed on the basis of this Directive only insofar as such processing is necessary for the operation of RIS applications, with a view to ensuring harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitating standardised interfaces with traffic management services of other transport modes.(*4)Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI:http://data.europa.eu/eli/reg/2016/679/oj).’;"
(10) Article 10 is replaced by the following:‘Article 10Delegated powers1.   The Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex I, by updating and revising the minimum data requirements, taking into account the experience gained from the application of this Directive, and the technical progress in developing RIS technologies and applications.2.   In the absence of pertinent and up-to-date technical specifications, or when technical specifications developed by the European committee for drawing up standards in the field of inland navigation (CESNI) do not comply with any of the applicable requirements set out in the Annex II, or where changes in the decision-making process of CESNI or in other elements of the standard would compromise Union interests, and where duly justified by an appropriate analysis, the Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex III to provide appropriate technical specifications based on the principles set out in Annex II.’;
(11) Article 10a is amended as follows:(a)paragraph 2 is replaced by the following:‘2.   The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’;(b)paragraph 6 is replaced by the following:‘6.   A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’; (a) paragraph 2 is replaced by the following:‘2.   The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’; (b) paragraph 6 is replaced by the following:‘6.   A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;
(a) paragraph 2 is replaced by the following:‘2.   The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’;
(b) paragraph 6 is replaced by the following:‘6.   A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;
(a) paragraph 2 is replaced by the following:‘2.   The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’;
(b) paragraph 6 is replaced by the following:‘6.   A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;
(12) Article 11 is replaced by the following:‘Article 11Committee procedure1.   The Commission shall be assisted by the Inland Waterway Transport Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council(*5).2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.(*5)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13, ELI:http://data.europa.eu/eli/reg/2011/182/oj).’;"
(13) in Article 12, paragraphs 2 and 3 are deleted;
(14) the following article is inserted:‘Article 12aMonitoringThe Commission shall monitor the setting up of RIS in the Union and shall report to the European Parliament and to the Council by 3 January 2034. The report shall include an analysis of the impact of this Directive on the level of integration of inland waterway transport in the overall logistics chain and shall examine the potential for new digital tools to increase efficiency throughout the TEN-T inland waterway network.’;
(15) Annex I to Directive 2005/44/EC is replaced by the text set out in Annex I to this Directive;
(16) Annex II to Directive 2005/44/EC is replaced by the text set out in Annex II to this Directive;
(17) the text set out in Annex III to this Directive is added as Annex III to Directive 2005/44/EC.
(a) waterway axis with kilometre indication;
(b) restrictions for vessels or convoys in terms of length, width, draught and air draught;
(c) operation times of restricting structures, in particular locks and bridges;
(d) predicted waiting times at bridges, locks and inland ports, in real time when available;
(e) location of ports and transhipment sites;
(f) reference data for water level gauges relevant to navigation;
(g) location and, when available, current availability of alternative fuels infrastructure, including shore-side electricity supply.
(a) the indication of technical requirements for the planning, implementing and operational use of services and related systems;
(b) the RIS architecture and organisation;
(c) recommendations for vessels to participate in RIS, for individual services and for the stepwise development of RIS.
(a) compatibility with the maritime electronic chart display and information system (maritime ECDIS) in order to facilitate traffic of inland waterway vessels in mixed traffic zones of the estuaries and sea-river traffic;
(b) the specification of minimum requirements for inland ECDIS equipment as well as the minimum content of electronic navigational charts with a view to the safety of navigation, in particular:(i)a high level of reliability and availability of the inland ECDIS equipment used;(ii)the robustness of the inland ECDIS equipment in order to withstand the environmental conditions typically prevailing on board a vessel without any degradation in quality or reliability;(iii)the inclusion in the electronic navigational chart of all kinds of geographical objects, for example boundaries of the fairway, shoreline constructions, and beacons, that are needed for safe navigation;(iv)the monitoring of the electronic chart with overlaid radar image when used for conning the vessel; (i) a high level of reliability and availability of the inland ECDIS equipment used; (ii) the robustness of the inland ECDIS equipment in order to withstand the environmental conditions typically prevailing on board a vessel without any degradation in quality or reliability; (iii) the inclusion in the electronic navigational chart of all kinds of geographical objects, for example boundaries of the fairway, shoreline constructions, and beacons, that are needed for safe navigation; (iv) the monitoring of the electronic chart with overlaid radar image when used for conning the vessel;
(i) a high level of reliability and availability of the inland ECDIS equipment used;
(ii) the robustness of the inland ECDIS equipment in order to withstand the environmental conditions typically prevailing on board a vessel without any degradation in quality or reliability;
(iii) the inclusion in the electronic navigational chart of all kinds of geographical objects, for example boundaries of the fairway, shoreline constructions, and beacons, that are needed for safe navigation;
(iv) the monitoring of the electronic chart with overlaid radar image when used for conning the vessel;
(i) a high level of reliability and availability of the inland ECDIS equipment used;
(ii) the robustness of the inland ECDIS equipment in order to withstand the environmental conditions typically prevailing on board a vessel without any degradation in quality or reliability;
(iii) the inclusion in the electronic navigational chart of all kinds of geographical objects, for example boundaries of the fairway, shoreline constructions, and beacons, that are needed for safe navigation;
(iv) the monitoring of the electronic chart with overlaid radar image when used for conning the vessel;
(c) the integration of up-to-date depth information on the fairway in the electronic navigational chart and display of such information in relation to a predefined or the actual water level;
(d) the integration of additional information, for example of parties other than the competent authorities, in the electronic navigational chart and display of such information in the inland ECDIS without affecting the information that is needed for safe navigation;
(e) the availability of electronic navigational charts to RIS users;
(f) the availability of the data for electronic navigational charts to all manufacturers of applications, when appropriate against a reasonable cost-related charge;
(g) the integration of up-to-date information on the waiting times at locks, bridges and inland ports and display of such information in the inland ECDIS without affecting the information that is needed for safe navigation.
(a) the facilitation of the electronic data exchange between the competent authorities of the Member States, between participants in inland as well as maritime navigation and in multi-modal transport where inland navigation is involved;
(b) the use of a standardised transport notification message for ship-to-authority, authority-to-ship and authority-to-authority messaging in order to achieve compatibility with maritime navigation;
(c) the use of internationally accepted code lists and classifications, possibly complemented by additional inland navigation needs;
(d) the use of a unique European vessel identification number.
(a) a standardised data structure using predefined text modules and encoded to a high extent in order to enable automatic translation of the most important content into other languages and to facilitate the integration of notices to skippers into voyage planning systems;
(b) the compatibility of the standardised data structure with the data structure of inland ECDIS to facilitate integration of notices to skippers in inland ECDIS;
(c) an alignment with technical specifications for navigation and voyage planning on inland waterways to ensure coherence of provided information.
(a) the specification of the requirements concerning systems and of standard messages as well as procedures so that they can be provided in an automated way;
(b) the differentiation between systems suited to requirements of tactical traffic information and systems suited to requirements of strategic traffic information, both with regard to positioning accuracy and required update rate;
(c) the description of the relevant technical systems for vessel tracking and tracing such as Inland AIS (inland automatic identification system);
(d) compatibility of data formats with the maritime AIS system.
(a) acting as a single digital window for inland navigation;
(b) a harmonised, single point of access for up-to-date and, if possible, real-time information on fairway conditions for safe and sustainable navigation, voyage planning and port operations along the TEN-T;
(c) enabling multi-modality transport chains while providing an adequate level of data protection;
(d) high level of data accuracy for seamless data exchange among relevant RIS users along the TEN-T (within and outside the Union);
(e) user-friendly interface with serviceable, useful and practical functionalities such as the ability to save and store profiles;
(f) harmonised, single point of reporting in accordance with the “once-only” principle, also for international voyages;
(g) link with other systems using information, communication, navigation or positioning/localisation technologies in order to manage infrastructure, mobility and traffic on the TEN-T effectively and to provide value-added services to citizens and operators, including systems for safe, secure, environmentally sound and capacity-efficient use of the TEN-T;
(h) collect and report anonymised and aggregate usage data that can be used for the monitoring of the implementation of RIS, including at least the number of RIS users, data availability in the European RIS Environment, connection and the number of exchanges with other digital systems or platforms;
(i) ensure cybersecurity.
(a) build on the functionalities provided by the European RIS Environment;
(b) the facilitation of the electronic data exchange between RIS technologies and the databases and systems in use by other modes of transport, through appropriate data links and interfaces;
(c) the specification of the requirements concerning other digital systems or platforms as well as procedures for automated data exchange;
(d) the real-time exchange of information in particular for time-critical data;
(e) ensuring the secure exchange of information in accordance with a comprehensive rights-based access-control system;
(f) anticipate a system exchange framework that will allow for future developments and links with additional systems as required, including exchanges with the future European Mobility Data Space and any other system that is designed to promote innovations in multimodality transport.
(a) provision of up-to-date information at regular intervals and at least when significant changes in the fairway situation take place that can impact the navigation;
(b) cover at least the following information:(i)predicted waiting times at locks, (movable) bridges, inland ports;(ii)data on the European waterway network required for navigation and voyage planning on inland waterways and covering at least the minimum data requirements set out in Annex I;(iii)water level, the least sounded depth, the vertical clearance, the barrage status if blocking navigation, the regime, the forecast water level, the least sounded predicted depth;(iv)ice situation and the related navigability or other extreme weather warnings;(v)operating hours of locks, (movable) bridges, inland ports. (i) predicted waiting times at locks, (movable) bridges, inland ports; (ii) data on the European waterway network required for navigation and voyage planning on inland waterways and covering at least the minimum data requirements set out in Annex I; (iii) water level, the least sounded depth, the vertical clearance, the barrage status if blocking navigation, the regime, the forecast water level, the least sounded predicted depth; (iv) ice situation and the related navigability or other extreme weather warnings; (v) operating hours of locks, (movable) bridges, inland ports.
(i) predicted waiting times at locks, (movable) bridges, inland ports;
(ii) data on the European waterway network required for navigation and voyage planning on inland waterways and covering at least the minimum data requirements set out in Annex I;
(iii) water level, the least sounded depth, the vertical clearance, the barrage status if blocking navigation, the regime, the forecast water level, the least sounded predicted depth;
(iv) ice situation and the related navigability or other extreme weather warnings;
(v) operating hours of locks, (movable) bridges, inland ports.
(i) predicted waiting times at locks, (movable) bridges, inland ports;
(ii) data on the European waterway network required for navigation and voyage planning on inland waterways and covering at least the minimum data requirements set out in Annex I;
(iii) water level, the least sounded depth, the vertical clearance, the barrage status if blocking navigation, the regime, the forecast water level, the least sounded predicted depth;
(iv) ice situation and the related navigability or other extreme weather warnings;
(v) operating hours of locks, (movable) bridges, inland ports.
(c) provision of information through inland ECDIS, notices to skippers and the European RIS Environment as appropriate.’.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure(2),
(1) Directive 2005/44/EC of the European Parliament and of the Council(3)establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union. The deployment of RIS on inland waterways supports the safety and efficiency of transport by inland waterways, and ultimately the sustainability and attractiveness of the sector, by increasing the efficiency of inland waterway transport operations.
(2) Since the entry into force of Directive 2005/44/EC, the inland waterway sector has benefited from the provision of harmonised RIS. However, the level of harmonisation between Member States varies, and the process of introducing the necessary specifications has proved to be lengthy. Additionally, the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ calls for the further development of an automated and connected multimodal mobility. Consequently, RIS should be adapted to address those new challenges. Furthermore, the Commission communication of 9 December 2020 entitled ‘Sustainable and Smart Mobility Strategy – putting European transport on track for the future’ proposes the revision of Directive 2005/44/EC as one of the measures to achieve the objective of promoting the creation of a truly smart transport system, efficient capacity allocation and traffic management. The Commission communication of 24 June 2021 set out an action plan entitled ‘NAIADES III: Boosting future-proof European inland waterway transport’, which states that in order to support the objective of inland waterways being part of a seamless system of harmonised RIS by 2030, revisions of the legal framework on RIS would aim to help close existing harmonisation and interoperability gaps with other transport modes, and contribute to improved data availability, reuse and interoperability of digital systems, in line with the Commission communication of 19 February 2020 entitled ‘A European strategy for data’. Those changes and developments, as well as the experience gained in the implementation of Directive 2005/44/EC, should be taken into account when adapting RIS.
(3) In the interest of adopting a coherent approach to interoperability in the public service sector, when implementing the electronic single-point-of-access platform for RIS (the ‘European RIS Environment’) and other solutions that fall within the scope of Directive 2005/44/EC, the principles laid down in the European Interoperability Framework (EIF), that is set out in the Commission communication of 23 March 2017 entitled ‘European Interoperability Framework – Implementation Strategy’, pursuant to Article 6 of Regulation (EU) 2024/903 of the European Parliament and of the Council(4), should be followed.
(4) Regulation (EU) 2024/1679 of the European Parliament and of the Council(5)lays down requirements for the development of the trans-European transport network (TEN-T) to achieve the smooth functioning of the internal market, and aims to ensure that the same high-quality services are available and compatible with the systems of other transport modes along that network.
(5) Given that the majority of journeys of inland waterway vessels are of an international nature, RIS should be focused on those inland waterways of Member States that form part of the TEN-T and that are directly connected to another Member State’s inland waterways that also form part of the TEN-T, and which are thus of high importance for the Union. Member States should be able to continue extending, on a voluntary basis, the RIS requirements to parts of their inland waterways network other than those that form part of the TEN-T to account for national specificities. In a cross-border context, it should also be possible for one of the Member States concerned to provide RIS. The Member States’ competent authorities should cooperate with a view to providing RIS on cross-border inland waterways.
(6) In view of Russia’s war of aggression against Ukraine, cooperation between the Union and Russia in the field of RIS is neither appropriate nor in the interest of the Union. As a consequence, cross-border cooperation on RIS with Russia is no longer a priority on the territory of the Member States.
(7) The experience gained from the application of Directive 2005/44/EC has shown that it is important to strengthen the technical specifications concerning the provision of data for navigation and voyage planning on inland waterways in order to improve the quality and timeliness of information provided to RIS users. The European Reference Data Management System (ERDMS) contains reference data and code lists necessary for the proper functioning of RIS and is set up and currently operated by the Commission. The operation of the ERDMS could be transferred to a third party in the future.
(8) The availability to RIS users, during navigation, of up-to-date and accurate information regarding the condition of the fairway and specific points like bridges, locks and inland ports is expected to improve the overall efficiency of the inland waterway sector. RIS should therefore include up-to-date exchanges of data with semi- and fully automated management of infrastructure systems of locks and movable bridges as well as with port community systems of inland ports.
(9) In order for RIS to allow for interconnection with the logistics chain, it is important that information is shared not only among the inland waterway transport users, for instance through port community systems of inland ports and smart inland waterway infrastructure systems, but also with systems and applications of other modes of transport. The maritime National Single Windows (MNSW) within the European Maritime Single Window environment (EMSWe), established by Regulation (EU) 2019/1239 of the European Parliament and of the Council(6), should enable harmonised ship reporting across the Union in maritime transport. The exchange of traffic-related information, such as arrival and departure times, would ensure interoperability, multimodality, and smooth integration of inland waterway transport (IWT) with the overall logistics chain. The electronic freight transport information (eFTI), established by Regulation (EU) 2020/1056 of the European Parliament and of the Council(7), should form the basis for the exchange of cargo information on dangerous goods and waste between RIS users where required. When necessary, RIS should enable links with, and should make information available to, digital systems and platforms of other modes of transport.
(10) The exchange of information between inland waterway vessels and inland ports, for example on availability of port installations, operating times, or vessel and cargo information, is not always optimal, thus impacting the efficiency of IWT operations. Information on the availability of alternative fuel infrastructure in inland ports is of particular importance in promoting the environmental performance of the sector. In order to simplify and streamline the exchange of such information and improve the overall efficiency of the sector, it is important that standardised interfaces be established and become part of RIS and that the necessary technical specifications are developed.
(11) The use of the European RIS Environment should streamline the provision of RIS, improve efficiency of IWT operations and reduce the burden on RIS providers and users. The European RIS Environment should support relevant services, be a central point for the exchange of RIS information within the inland waterways sector as well as with other transport modes, and therefore become the main digital backbone for the provision of RIS in the Union. Member States should designate one or more competent authorities responsible for operating the European RIS Environment. Those competent authorities are controllers, as defined in Regulation (EU) 2016/679 of the European Parliament and of the Council(8), for the purpose of operating the European RIS Environment.
(12) In order to ensure uniform conditions for the introduction of the European RIS Environment, implementing powers should be conferred on the Commission to establish the framework for the development and the functioning of the European RIS Environment. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(9).
(13) Implementing acts under this Directive should not be adopted by the Commission where the committee referred to in this Directive delivers no opinion, for example where there is no qualified majority in support of an opinion, whether positive or negative, and where the draft implementing act is not submitted to the appeal committee or where the appeal committee delivers a negative opinion. In accordance with the principle of sincere cooperation, Member States and the Commission should collaborate to swiftly set up the necessary operational characteristics, roles and procedures for the European RIS Environment.
(14) Cooperation with third countries, in particular neighbouring countries, is relevant in order to ensure connection and interoperability between the European RIS Environment and the national RIS of those third countries.
(15) The European RIS Environment should provide for the possibility for RIS users to submit feedback on the application of this Directive and ensure that such feedback is transmitted to the Member State concerned. Member States should set up a simple and accessible procedure for handling such feedback in a transparent and impartial manner. Member States’ authorities should cooperate in the handling of feedback involving cross-border elements, such as incompatible standards in reporting of vessel information, since 75 % of inland waterway transport operations includes international voyages. Analysis of the subject matter of the feedback received, as well as its frequency, makes it possible to identify the extent of compliance with this Directive, thus supporting the monitoring of implementation by identifying areas where implementation can be improved. It is therefore important that that information is collected and provided to the Commission on an annual basis.
(16) The development of technical specifications should follow a set of principles, in particular the principles set out in Annex II to this Directive, in order to ensure the proper and harmonised implementation of Directive 2005/44/EC. Those principles should outline the main elements that each RIS component should include.
(17) The requirements and technical specifications for RIS should ensure in particular that: RIS data which constitute personal data under Regulation (EU) 2016/679 can be processed solely in accordance with a comprehensive, rights-based access-control system that provides assigned functionalities; all competent authorities can have immediate access to those data in accordance with their respective regulatory competences; appropriate technical and organisational measures are implemented to ensure that the processing by electronic means of personal data can be carried out in accordance with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council(10), including for the purposes of protection against personal data breaches; and the processing of sensitive commercial information can be carried out in a way that respects the confidentiality of that information.
(18) In order to ensure the safe and optimal navigation of vessels on inland waterways, Member States should be aware of the location of all inland waterway vessels, including through the use of automatic identification systems (AIS) data. Member States should also exchange RIS-related information to increase the efficiency of RIS and reduce reporting requirements. Where the transmission and exchange of RIS-related information for those purposes entails the processing of personal data, such as the processing of names or the processing of location data when such processing enables the identification, directly or indirectly, of a person, Member States should ensure the lawfulness of the processing of those personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council(11), where applicable.
(19) In order to ensure that RIS users are supplied with the necessary information concerning navigation and voyage planning on inland waterways, and taking account of scientific and technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending the minimum data requirements set out in Annex I to Directive 2005/44/EC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as the Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(20) Where duly justified by an appropriate analysis and in the absence of pertinent and up-to-date international standards to ensure safety of navigation, or where changes in or the outcome of the decision-making process of the European committee for drawing up standards in the field of inland navigation (CESNI) would compromise Union interests, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex III to Directive 2005/44/EC in order to provide appropriate technical specifications for RIS, in line with the principles set out in Annex II to Directive 2005/44/EC and with the aim of safeguarding Union interests.
(21) The experience gained from the implementation of Directive 2005/44/EC reveals that the lengthy period for introducing and updating the technical specifications laid down therein has affected the sector’s performance. It is therefore important to change the process by which technical specifications are introduced.
(22) Directive (EU) 2016/1629 of the European Parliament and of the Council(13)introduced a process based on technical specifications developed by the CESNI. CESNI, which acts under the auspices of the Central Commission for Navigation on the Rhine (CCNR) and is open to experts from all Member States, is responsible for drawing up the technical standards in the field of inland waterway transport. Experience has shown that CESNI has developed and updated technical requirements for inland navigation vessels in an organised and timely manner. Taking into account the expertise of CESNI and the experience gained from the implementation of Directive (EU) 2016/1629, a similar approach should be applied with regard to Directive 2005/44/EC.
(23) In order to ensure a high level of safety and efficiency in inland navigation, to ensure the provision of RIS, and to take into account scientific and technical progress and other developments in the sector, the reference to the applicable technical specifications for RIS, namely the European Standard for River Information Services (ES-RIS), should form an integral part of Directive 2005/44/EC.
(24) The Committee on boatmasters’ certificates for the carriage of goods and passengers by inland waterway referred to in Article 11 of Directive 2005/44/EC has been abolished. In its place, the Inland Waterway Transport Committee, which possesses expertise in standards and technical specifications in the inland waterway sector, should assist the Commission in respect of RIS as a committee within the meaning of Regulation (EU) No 182/2011. Furthermore, this Directive introduces amendments to Articles 5 and 12 of Directive 2005/44/EC relating to the Committee procedure. Article 11 of Directive 2005/44/EC should therefore be amended to reflect those changes.
(25) For the purposes of better regulation and simplification, it should be possible for Directive 2005/44/EC to make reference to international standards without duplicating them in the Union legal framework.
(26) RIS was established in the Union in 2005, and since then considerable experience in its development and implementation has been gained by the Member States. Furthermore, the technical specifications necessary for the functioning of RIS are included in Annex III to Directive 2005/44/EC. In that regard, Article 12(2) of Directive 2005/44/EC should be deleted. In addition, by amending the scope of Directive 2005/44/EC to focus on the TEN-T, the requirement to implement RIS is applicable on the most important inland waterways, creating a reliable transport network. Article 12(3) of Directive 2005/44/EC should therefore be deleted.
(27) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of establishing a framework for the provision of RIS in the Union to lay down rules on its set up, operation and technical specifications. In accordance with Article 5(4) of the Treaty on European Union, this Directive does not go beyond what is necessary in order to achieve the objectives pursued.
(28) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 20 March 2024.
(29) Directive 2005/44/EC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 2005/44/EC
Article 1
Directive 2005/44/EC is amended as follows:
(1)
Article 1 is replaced by the following:
1. This Directive establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union in order to support inland waterway transport with a view to enhancing its safety, efficiency and sustainability and to facilitating interfaces with other transport modes.
2. This Directive provides a framework for the establishment and further development of technical requirements, specifications and conditions to ensure harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitate continuity with traffic management services of other transport modes through the use of standardised interfaces.’
(2)
in Article 2, paragraph 1 is replaced by the following:
‘1. This Directive applies to the implementation and operation of RIS on all inland waterways and inland ports of the Member States that form part of the trans-European transport network, as specified and listed in Annexes I and II to Regulation (EU) 2024/1679 of the European Parliament and of the Council(*1), and that are directly connected to inland waterways and inland ports of another Member State that form part of the trans-European transport network, as specified and listed in those Annexes.
(3)
in Article 3, the following points are added:
‘(i)
“trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679;
(j)
“European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III;
(k)
“port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes;
(l)
“smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways;
(m)
“European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle;
(n)
“inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’
;
(4)
Article 4 is replaced by the following:
1. Member States shall take the necessary measures to implement RIS on inland waterways and inland ports falling within the scope of this Directive.
2. Member States shall develop RIS in such a way that the RIS application is efficient, expandable and interoperable so as to interact with other RIS applications and with systems for other modes of transport, while also providing interfaces to transport management systems and commercial activities.
3. In order to set up RIS, Member States shall:
(a)
ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(b)
ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users;
(c)
enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border;
(d)
ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(e)
ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay;
(f)
ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes;
(g)
ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2);
(h)
ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.
The obligations referred to in this paragraph shall be fulfilled in compliance with the requirements and principles set out in Annexes I and II.
4. The competent authorities of the Member States shall establish RIS centres according to regional needs.
5. Member States shall jointly create, govern, operate, use and maintain a European RIS Environment that provides fairway-, infrastructure-, traffic-, and transport-related services, and shall provide the necessary data. The European RIS Environment shall be accessible for all RIS users and shall be the main platform for the exchange of RIS-related information. It shall contain interfaces for connections with systems of other transport modes and inland ports. Member States shall designate one or more competent authorities responsible for the operation of the European RIS Environment. The European RIS Environment shall allow for the possibility of contributions from third countries whose waterways are connected to the European inland waterway network and which are willing to cooperate and provide their network data, provided that the data are of identical quality and format to that of Member States and that they adhere to the same level of cybersecurity and data protection.
6. The Commission shall adopt implementing acts which lay down the operational characteristics, roles and procedures for the European RIS Environment and which identify its operating entity, based on the principles for RIS technical specifications set out in point 6 of Annex II, to ensure their uniform implementation throughout the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2).
7. For the use of the automatic identification systems (AIS), the Regional Arrangement on the Radiocommunication Service for Inland Waterways (RAINWAT), concluded in Bucharest on 12 April 2012, in the framework of the radio regulations of the International Telecommunication Union (ITU) shall apply.
8. Member States, in cooperation with the Union, if appropriate, shall encourage boat masters, operators, agents or owners of vessels navigating on their inland waterways and shippers or owners of goods carried on board such vessels to fully profit from the services which are made available under this Directive.
9. The Commission shall take appropriate measures to verify the interoperability, reliability, availability and safety of RIS.
(5)
Article 5 is replaced by the following:
1. In order to support RIS and to ensure the interoperability of services in accordance with Article 4(2), the technical specifications referred to in Annex III in line with the principles set out in Annex II shall apply and shall cover in particular the following areas:
(a)
electronic chart display and information system for inland navigation (inland ECDIS);
(b)
electronic ship reporting;
(c)
notices to skippers;
(d)
vessel tracking and tracing systems;
(e)
compatibility of the equipment necessary for the use of RIS;
(f)
operation of the European RIS Environment;
(g)
interconnection and exchange of information with Union data bases (ERDMS);
(h)
standardised interface for IT platforms of other transport modes;
(i)
standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems;
(j)
data for navigation and voyage planning on inland waterways.’
(6)
Article 6 is replaced by the following:
For the purposes of RIS, for which exact positioning is required, it is recommended to use satellite positioning and navigation systems, such as navigation services provided by Galileo, including the high-accuracy service and Open Service Navigation Message Authentication and the European Geostationary Navigation Overlay Service (EGNOS) referred to in Regulation (EU) 2021/696 of the European Parliament and of the Council(*3). For the purposes of applications and services relying on Earth observation data, the use of Copernicus data, information and services is recommended.
(7)
Article 8 is replaced by the following:
Member States shall designate competent authorities responsible for the RIS application, for the international exchange of data, for the operation of the European RIS Environment and for the handling of feedback by RIS users. They shall notify those designated authorities to the Commission by 17 January 2029.’
(8)
the following Article is inserted:
1. Each Member State shall ensure that an effective, simple and accessible procedure is in place, building, where possible, on existing structures, to handle feedback from RIS users arising from the application of this Directive.
2. The handling of feedback from RIS users shall be carried out in a manner which avoids conflicts of interest. The handling of feedback shall be impartial and transparent and shall duly respect the right to freely conduct business.
3. Feedback from RIS users shall be submitted through the European RIS Environment and be transmitted to the relevant Member States. Member States shall ensure that RIS users and other relevant stakeholders are informed of where and how to submit feedback.
4. Member States shall ensure that feedback from RIS users is handled in a timely and appropriate manner and that the information on its follow-up is provided through the European RIS Environment.
5. The European RIS Environment shall inform the Commission, on an annual basis, of the amount of feedback received and of the way that the feedback was handled.’
(9)
Article 9 is replaced by the following:
1. Member States shall take the necessary technical and organisational measures in accordance with applicable Union and national law in order to protect RIS information and records against untoward events or misuse, including improper access, alteration or loss, and to ensure the confidentiality of commercial and other sensitive information exchanged pursuant to this Directive.
2. Data that constitute personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679 of the European Parliament and of the Council(*4)may be processed on the basis of this Directive only insofar as such processing is necessary for the operation of RIS applications, with a view to ensuring harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitating standardised interfaces with traffic management services of other transport modes.
(10)
Article 10 is replaced by the following:
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex I, by updating and revising the minimum data requirements, taking into account the experience gained from the application of this Directive, and the technical progress in developing RIS technologies and applications.
2. In the absence of pertinent and up-to-date technical specifications, or when technical specifications developed by the European committee for drawing up standards in the field of inland navigation (CESNI) do not comply with any of the applicable requirements set out in the Annex II, or where changes in the decision-making process of CESNI or in other elements of the standard would compromise Union interests, and where duly justified by an appropriate analysis, the Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex III to provide appropriate technical specifications based on the principles set out in Annex II.’
(11)
Article 10a is amended as follows:
(a)
paragraph 2 is replaced by the following:
‘2. The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’
(b)
paragraph 6 is replaced by the following:
‘6. A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’
(12)
Article 11 is replaced by the following:
1. The Commission shall be assisted by the Inland Waterway Transport Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council(*5).
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
(13)
in Article 12, paragraphs 2 and 3 are deleted;
(14)
the following article is inserted:
The Commission shall monitor the setting up of RIS in the Union and shall report to the European Parliament and to the Council by 3 January 2034. The report shall include an analysis of the impact of this Directive on the level of integration of inland waterway transport in the overall logistics chain and shall examine the potential for new digital tools to increase efficiency throughout the TEN-T inland waterway network.’
(15)
Annex I to Directive 2005/44/EC is replaced by the text set out in Annex I to this Directive;
(16)
Annex II to Directive 2005/44/EC is replaced by the text set out in Annex II to this Directive;
(17)
the text set out in Annex III to this Directive is added as Annex III to Directive 2005/44/EC.

Transposition
Article 2
1. Member States which have inland waterways and inland ports falling within the scope of this Directive shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 January 2029. They shall immediately inform the Commission thereof.
2. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
3. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.

Entry into force
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Addressees
Article 4
This Directive is addressed to the Member States which have inland waterways falling within the scope of Article 2 of Directive 2005/44/EC.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure(2),
(1) Directive 2005/44/EC of the European Parliament and of the Council(3)establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union. The deployment of RIS on inland waterways supports the safety and efficiency of transport by inland waterways, and ultimately the sustainability and attractiveness of the sector, by increasing the efficiency of inland waterway transport operations.
(2) Since the entry into force of Directive 2005/44/EC, the inland waterway sector has benefited from the provision of harmonised RIS. However, the level of harmonisation between Member States varies, and the process of introducing the necessary specifications has proved to be lengthy. Additionally, the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ calls for the further development of an automated and connected multimodal mobility. Consequently, RIS should be adapted to address those new challenges. Furthermore, the Commission communication of 9 December 2020 entitled ‘Sustainable and Smart Mobility Strategy – putting European transport on track for the future’ proposes the revision of Directive 2005/44/EC as one of the measures to achieve the objective of promoting the creation of a truly smart transport system, efficient capacity allocation and traffic management. The Commission communication of 24 June 2021 set out an action plan entitled ‘NAIADES III: Boosting future-proof European inland waterway transport’, which states that in order to support the objective of inland waterways being part of a seamless system of harmonised RIS by 2030, revisions of the legal framework on RIS would aim to help close existing harmonisation and interoperability gaps with other transport modes, and contribute to improved data availability, reuse and interoperability of digital systems, in line with the Commission communication of 19 February 2020 entitled ‘A European strategy for data’. Those changes and developments, as well as the experience gained in the implementation of Directive 2005/44/EC, should be taken into account when adapting RIS.
(3) In the interest of adopting a coherent approach to interoperability in the public service sector, when implementing the electronic single-point-of-access platform for RIS (the ‘European RIS Environment’) and other solutions that fall within the scope of Directive 2005/44/EC, the principles laid down in the European Interoperability Framework (EIF), that is set out in the Commission communication of 23 March 2017 entitled ‘European Interoperability Framework – Implementation Strategy’, pursuant to Article 6 of Regulation (EU) 2024/903 of the European Parliament and of the Council(4), should be followed.
(4) Regulation (EU) 2024/1679 of the European Parliament and of the Council(5)lays down requirements for the development of the trans-European transport network (TEN-T) to achieve the smooth functioning of the internal market, and aims to ensure that the same high-quality services are available and compatible with the systems of other transport modes along that network.
(5) Given that the majority of journeys of inland waterway vessels are of an international nature, RIS should be focused on those inland waterways of Member States that form part of the TEN-T and that are directly connected to another Member State’s inland waterways that also form part of the TEN-T, and which are thus of high importance for the Union. Member States should be able to continue extending, on a voluntary basis, the RIS requirements to parts of their inland waterways network other than those that form part of the TEN-T to account for national specificities. In a cross-border context, it should also be possible for one of the Member States concerned to provide RIS. The Member States’ competent authorities should cooperate with a view to providing RIS on cross-border inland waterways.
(6) In view of Russia’s war of aggression against Ukraine, cooperation between the Union and Russia in the field of RIS is neither appropriate nor in the interest of the Union. As a consequence, cross-border cooperation on RIS with Russia is no longer a priority on the territory of the Member States.
(7) The experience gained from the application of Directive 2005/44/EC has shown that it is important to strengthen the technical specifications concerning the provision of data for navigation and voyage planning on inland waterways in order to improve the quality and timeliness of information provided to RIS users. The European Reference Data Management System (ERDMS) contains reference data and code lists necessary for the proper functioning of RIS and is set up and currently operated by the Commission. The operation of the ERDMS could be transferred to a third party in the future.
(8) The availability to RIS users, during navigation, of up-to-date and accurate information regarding the condition of the fairway and specific points like bridges, locks and inland ports is expected to improve the overall efficiency of the inland waterway sector. RIS should therefore include up-to-date exchanges of data with semi- and fully automated management of infrastructure systems of locks and movable bridges as well as with port community systems of inland ports.
(9) In order for RIS to allow for interconnection with the logistics chain, it is important that information is shared not only among the inland waterway transport users, for instance through port community systems of inland ports and smart inland waterway infrastructure systems, but also with systems and applications of other modes of transport. The maritime National Single Windows (MNSW) within the European Maritime Single Window environment (EMSWe), established by Regulation (EU) 2019/1239 of the European Parliament and of the Council(6), should enable harmonised ship reporting across the Union in maritime transport. The exchange of traffic-related information, such as arrival and departure times, would ensure interoperability, multimodality, and smooth integration of inland waterway transport (IWT) with the overall logistics chain. The electronic freight transport information (eFTI), established by Regulation (EU) 2020/1056 of the European Parliament and of the Council(7), should form the basis for the exchange of cargo information on dangerous goods and waste between RIS users where required. When necessary, RIS should enable links with, and should make information available to, digital systems and platforms of other modes of transport.
(10) The exchange of information between inland waterway vessels and inland ports, for example on availability of port installations, operating times, or vessel and cargo information, is not always optimal, thus impacting the efficiency of IWT operations. Information on the availability of alternative fuel infrastructure in inland ports is of particular importance in promoting the environmental performance of the sector. In order to simplify and streamline the exchange of such information and improve the overall efficiency of the sector, it is important that standardised interfaces be established and become part of RIS and that the necessary technical specifications are developed.
(11) The use of the European RIS Environment should streamline the provision of RIS, improve efficiency of IWT operations and reduce the burden on RIS providers and users. The European RIS Environment should support relevant services, be a central point for the exchange of RIS information within the inland waterways sector as well as with other transport modes, and therefore become the main digital backbone for the provision of RIS in the Union. Member States should designate one or more competent authorities responsible for operating the European RIS Environment. Those competent authorities are controllers, as defined in Regulation (EU) 2016/679 of the European Parliament and of the Council(8), for the purpose of operating the European RIS Environment.
(12) In order to ensure uniform conditions for the introduction of the European RIS Environment, implementing powers should be conferred on the Commission to establish the framework for the development and the functioning of the European RIS Environment. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(9).
(13) Implementing acts under this Directive should not be adopted by the Commission where the committee referred to in this Directive delivers no opinion, for example where there is no qualified majority in support of an opinion, whether positive or negative, and where the draft implementing act is not submitted to the appeal committee or where the appeal committee delivers a negative opinion. In accordance with the principle of sincere cooperation, Member States and the Commission should collaborate to swiftly set up the necessary operational characteristics, roles and procedures for the European RIS Environment.
(14) Cooperation with third countries, in particular neighbouring countries, is relevant in order to ensure connection and interoperability between the European RIS Environment and the national RIS of those third countries.
(15) The European RIS Environment should provide for the possibility for RIS users to submit feedback on the application of this Directive and ensure that such feedback is transmitted to the Member State concerned. Member States should set up a simple and accessible procedure for handling such feedback in a transparent and impartial manner. Member States’ authorities should cooperate in the handling of feedback involving cross-border elements, such as incompatible standards in reporting of vessel information, since 75 % of inland waterway transport operations includes international voyages. Analysis of the subject matter of the feedback received, as well as its frequency, makes it possible to identify the extent of compliance with this Directive, thus supporting the monitoring of implementation by identifying areas where implementation can be improved. It is therefore important that that information is collected and provided to the Commission on an annual basis.
(16) The development of technical specifications should follow a set of principles, in particular the principles set out in Annex II to this Directive, in order to ensure the proper and harmonised implementation of Directive 2005/44/EC. Those principles should outline the main elements that each RIS component should include.
(17) The requirements and technical specifications for RIS should ensure in particular that: RIS data which constitute personal data under Regulation (EU) 2016/679 can be processed solely in accordance with a comprehensive, rights-based access-control system that provides assigned functionalities; all competent authorities can have immediate access to those data in accordance with their respective regulatory competences; appropriate technical and organisational measures are implemented to ensure that the processing by electronic means of personal data can be carried out in accordance with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council(10), including for the purposes of protection against personal data breaches; and the processing of sensitive commercial information can be carried out in a way that respects the confidentiality of that information.
(18) In order to ensure the safe and optimal navigation of vessels on inland waterways, Member States should be aware of the location of all inland waterway vessels, including through the use of automatic identification systems (AIS) data. Member States should also exchange RIS-related information to increase the efficiency of RIS and reduce reporting requirements. Where the transmission and exchange of RIS-related information for those purposes entails the processing of personal data, such as the processing of names or the processing of location data when such processing enables the identification, directly or indirectly, of a person, Member States should ensure the lawfulness of the processing of those personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council(11), where applicable.
(19) In order to ensure that RIS users are supplied with the necessary information concerning navigation and voyage planning on inland waterways, and taking account of scientific and technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amending the minimum data requirements set out in Annex I to Directive 2005/44/EC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as the Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(20) Where duly justified by an appropriate analysis and in the absence of pertinent and up-to-date international standards to ensure safety of navigation, or where changes in or the outcome of the decision-making process of the European committee for drawing up standards in the field of inland navigation (CESNI) would compromise Union interests, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex III to Directive 2005/44/EC in order to provide appropriate technical specifications for RIS, in line with the principles set out in Annex II to Directive 2005/44/EC and with the aim of safeguarding Union interests.
(21) The experience gained from the implementation of Directive 2005/44/EC reveals that the lengthy period for introducing and updating the technical specifications laid down therein has affected the sector’s performance. It is therefore important to change the process by which technical specifications are introduced.
(22) Directive (EU) 2016/1629 of the European Parliament and of the Council(13)introduced a process based on technical specifications developed by the CESNI. CESNI, which acts under the auspices of the Central Commission for Navigation on the Rhine (CCNR) and is open to experts from all Member States, is responsible for drawing up the technical standards in the field of inland waterway transport. Experience has shown that CESNI has developed and updated technical requirements for inland navigation vessels in an organised and timely manner. Taking into account the expertise of CESNI and the experience gained from the implementation of Directive (EU) 2016/1629, a similar approach should be applied with regard to Directive 2005/44/EC.
(23) In order to ensure a high level of safety and efficiency in inland navigation, to ensure the provision of RIS, and to take into account scientific and technical progress and other developments in the sector, the reference to the applicable technical specifications for RIS, namely the European Standard for River Information Services (ES-RIS), should form an integral part of Directive 2005/44/EC.
(24) The Committee on boatmasters’ certificates for the carriage of goods and passengers by inland waterway referred to in Article 11 of Directive 2005/44/EC has been abolished. In its place, the Inland Waterway Transport Committee, which possesses expertise in standards and technical specifications in the inland waterway sector, should assist the Commission in respect of RIS as a committee within the meaning of Regulation (EU) No 182/2011. Furthermore, this Directive introduces amendments to Articles 5 and 12 of Directive 2005/44/EC relating to the Committee procedure. Article 11 of Directive 2005/44/EC should therefore be amended to reflect those changes.
(25) For the purposes of better regulation and simplification, it should be possible for Directive 2005/44/EC to make reference to international standards without duplicating them in the Union legal framework.
(26) RIS was established in the Union in 2005, and since then considerable experience in its development and implementation has been gained by the Member States. Furthermore, the technical specifications necessary for the functioning of RIS are included in Annex III to Directive 2005/44/EC. In that regard, Article 12(2) of Directive 2005/44/EC should be deleted. In addition, by amending the scope of Directive 2005/44/EC to focus on the TEN-T, the requirement to implement RIS is applicable on the most important inland waterways, creating a reliable transport network. Article 12(3) of Directive 2005/44/EC should therefore be deleted.
(27) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of establishing a framework for the provision of RIS in the Union to lay down rules on its set up, operation and technical specifications. In accordance with Article 5(4) of the Treaty on European Union, this Directive does not go beyond what is necessary in order to achieve the objectives pursued.
(28) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 20 March 2024.
(29) Directive 2005/44/EC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 2005/44/EC

Directive 2005/44/EC is amended as follows:
(1)
Article 1 is replaced by the following:
1. This Directive establishes a framework for the deployment and use of harmonised river information services (RIS) in the Union in order to support inland waterway transport with a view to enhancing its safety, efficiency and sustainability and to facilitating interfaces with other transport modes.
2. This Directive provides a framework for the establishment and further development of technical requirements, specifications and conditions to ensure harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitate continuity with traffic management services of other transport modes through the use of standardised interfaces.’
(2)
in Article 2, paragraph 1 is replaced by the following:
‘1. This Directive applies to the implementation and operation of RIS on all inland waterways and inland ports of the Member States that form part of the trans-European transport network, as specified and listed in Annexes I and II to Regulation (EU) 2024/1679 of the European Parliament and of the Council(*1), and that are directly connected to inland waterways and inland ports of another Member State that form part of the trans-European transport network, as specified and listed in those Annexes.
(3)
in Article 3, the following points are added:
‘(i)
“trans-European transport network” or “TEN-T” means inland waterways as specified in the maps set out in Annex I to Regulation (EU) 2024/1679;
(j)
“European Reference Data Management System” or “ERDMS” means a single point of access repository (library) of reference data and code lists that are used by IT applications in inland waterway transport operated under the authority of the Commission; it does not include the network data provided by the Member State in accordance with Annexes I and III;
(k)
“port community system” means an electronic platform for the exchange of information between public and private stakeholders to ensure smooth port and logistics processes;
(l)
“smart inland waterway infrastructure system” means an electronic platform that supports semi- and fully automated management of inland waterway transport infrastructure in locks and movable bridges in the TEN-T and is operated by the public management authorities of inland waterways;
(m)
“European RIS Environment” means an electronic single-point-of-access platform based on national RIS information that provides technical and operational services for RIS users and contains links to electronic reporting according to the “once-only” principle;
(n)
“inland port” means an inland waterway port of the TEN-T core network or TEN-T comprehensive network, as listed and categorised in Annex II to Regulation (EU) 2024/1679.’
;
(4)
Article 4 is replaced by the following:
1. Member States shall take the necessary measures to implement RIS on inland waterways and inland ports falling within the scope of this Directive.
2. Member States shall develop RIS in such a way that the RIS application is efficient, expandable and interoperable so as to interact with other RIS applications and with systems for other modes of transport, while also providing interfaces to transport management systems and commercial activities.
3. In order to set up RIS, Member States shall:
(a)
ensure that all relevant data for navigation and voyage planning on inland waterways are supplied to RIS users; those network data, as set out in Annex I, shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(b)
ensure that for all their inland waterways and inland ports of the TEN-T, in addition to the data referred to in point (a), electronic navigational charts suitable for navigational purposes are available to RIS users;
(c)
enable, as far as ship reporting is required by national or international regulations, the competent authorities to receive electronic ship reports of all required data from ships; in cross-border transport, those data shall be made available in full to the competent authorities of the neighbouring Member State before arrival of the vessels at the border;
(d)
ensure that notices to skippers, including on water level or maximum allowable draught, and ice reports of their inland waterways are provided as standardised, encoded and downloadable messages; the standardised message shall contain at least the information necessary for safe navigation and the notices to skippers shall be kept up-to-date and provided at least in an accessible common electronic format in accordance with Annex III;
(e)
ensure that the network data in the European RIS Environment are kept up to date by supplying all the necessary network data in accordance with Annexes I and III without delay;
(f)
ensure, when available, that at least traffic related information is made available through interfaces following the technical specifications laid down in accordance with point 7 of Annex II, where applicable, to electronic information exchange environments established by Union law and used in other transport modes;
(g)
ensure that standardised interfaces in accordance with Annexes II and III to this Directive are made available to the port community systems of inland ports, including, when available, up-to-date information on the availability of berths and of alternative fuel infrastructure, and in particular the installations required pursuant to Article 10 of Regulation (EU) 2023/1804 of the European Parliament and of the Council(*2);
(h)
ensure that standardised interfaces in accordance with Annexes II and III are made available to other smart inland waterways infrastructure systems for the purpose of managing inland waterway traffic.
The obligations referred to in this paragraph shall be fulfilled in compliance with the requirements and principles set out in Annexes I and II.
4. The competent authorities of the Member States shall establish RIS centres according to regional needs.
5. Member States shall jointly create, govern, operate, use and maintain a European RIS Environment that provides fairway-, infrastructure-, traffic-, and transport-related services, and shall provide the necessary data. The European RIS Environment shall be accessible for all RIS users and shall be the main platform for the exchange of RIS-related information. It shall contain interfaces for connections with systems of other transport modes and inland ports. Member States shall designate one or more competent authorities responsible for the operation of the European RIS Environment. The European RIS Environment shall allow for the possibility of contributions from third countries whose waterways are connected to the European inland waterway network and which are willing to cooperate and provide their network data, provided that the data are of identical quality and format to that of Member States and that they adhere to the same level of cybersecurity and data protection.
6. The Commission shall adopt implementing acts which lay down the operational characteristics, roles and procedures for the European RIS Environment and which identify its operating entity, based on the principles for RIS technical specifications set out in point 6 of Annex II, to ensure their uniform implementation throughout the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2).
7. For the use of the automatic identification systems (AIS), the Regional Arrangement on the Radiocommunication Service for Inland Waterways (RAINWAT), concluded in Bucharest on 12 April 2012, in the framework of the radio regulations of the International Telecommunication Union (ITU) shall apply.
8. Member States, in cooperation with the Union, if appropriate, shall encourage boat masters, operators, agents or owners of vessels navigating on their inland waterways and shippers or owners of goods carried on board such vessels to fully profit from the services which are made available under this Directive.
9. The Commission shall take appropriate measures to verify the interoperability, reliability, availability and safety of RIS.
(5)
Article 5 is replaced by the following:
1. In order to support RIS and to ensure the interoperability of services in accordance with Article 4(2), the technical specifications referred to in Annex III in line with the principles set out in Annex II shall apply and shall cover in particular the following areas:
(a)
electronic chart display and information system for inland navigation (inland ECDIS);
(b)
electronic ship reporting;
(c)
notices to skippers;
(d)
vessel tracking and tracing systems;
(e)
compatibility of the equipment necessary for the use of RIS;
(f)
operation of the European RIS Environment;
(g)
interconnection and exchange of information with Union data bases (ERDMS);
(h)
standardised interface for IT platforms of other transport modes;
(i)
standardised interface between the European RIS Environment and port community systems of inland ports and between the European RIS Environment and smart inland waterway infrastructure systems;
(j)
data for navigation and voyage planning on inland waterways.’
(6)
Article 6 is replaced by the following:
For the purposes of RIS, for which exact positioning is required, it is recommended to use satellite positioning and navigation systems, such as navigation services provided by Galileo, including the high-accuracy service and Open Service Navigation Message Authentication and the European Geostationary Navigation Overlay Service (EGNOS) referred to in Regulation (EU) 2021/696 of the European Parliament and of the Council(*3). For the purposes of applications and services relying on Earth observation data, the use of Copernicus data, information and services is recommended.
(7)
Article 8 is replaced by the following:
Member States shall designate competent authorities responsible for the RIS application, for the international exchange of data, for the operation of the European RIS Environment and for the handling of feedback by RIS users. They shall notify those designated authorities to the Commission by 17 January 2029.’
(8)
the following Article is inserted:
1. Each Member State shall ensure that an effective, simple and accessible procedure is in place, building, where possible, on existing structures, to handle feedback from RIS users arising from the application of this Directive.
2. The handling of feedback from RIS users shall be carried out in a manner which avoids conflicts of interest. The handling of feedback shall be impartial and transparent and shall duly respect the right to freely conduct business.
3. Feedback from RIS users shall be submitted through the European RIS Environment and be transmitted to the relevant Member States. Member States shall ensure that RIS users and other relevant stakeholders are informed of where and how to submit feedback.
4. Member States shall ensure that feedback from RIS users is handled in a timely and appropriate manner and that the information on its follow-up is provided through the European RIS Environment.
5. The European RIS Environment shall inform the Commission, on an annual basis, of the amount of feedback received and of the way that the feedback was handled.’
(9)
Article 9 is replaced by the following:
1. Member States shall take the necessary technical and organisational measures in accordance with applicable Union and national law in order to protect RIS information and records against untoward events or misuse, including improper access, alteration or loss, and to ensure the confidentiality of commercial and other sensitive information exchanged pursuant to this Directive.
2. Data that constitute personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679 of the European Parliament and of the Council(*4)may be processed on the basis of this Directive only insofar as such processing is necessary for the operation of RIS applications, with a view to ensuring harmonised, interoperable and accessible RIS on inland waterways in the Union and to facilitating standardised interfaces with traffic management services of other transport modes.
(10)
Article 10 is replaced by the following:
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex I, by updating and revising the minimum data requirements, taking into account the experience gained from the application of this Directive, and the technical progress in developing RIS technologies and applications.
2. In the absence of pertinent and up-to-date technical specifications, or when technical specifications developed by the European committee for drawing up standards in the field of inland navigation (CESNI) do not comply with any of the applicable requirements set out in the Annex II, or where changes in the decision-making process of CESNI or in other elements of the standard would compromise Union interests, and where duly justified by an appropriate analysis, the Commission shall be empowered to adopt delegated acts in accordance with Article 10a to amend Annex III to provide appropriate technical specifications based on the principles set out in Annex II.’
(11)
Article 10a is amended as follows:
(a)
paragraph 2 is replaced by the following:
‘2. The power to adopt delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years from 1 January 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.’
(b)
paragraph 6 is replaced by the following:
‘6. A delegated act adopted pursuant to Article 10 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’
(12)
Article 11 is replaced by the following:
1. The Commission shall be assisted by the Inland Waterway Transport Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council(*5).
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
(13)
in Article 12, paragraphs 2 and 3 are deleted;
(14)
the following article is inserted:
The Commission shall monitor the setting up of RIS in the Union and shall report to the European Parliament and to the Council by 3 January 2034. The report shall include an analysis of the impact of this Directive on the level of integration of inland waterway transport in the overall logistics chain and shall examine the potential for new digital tools to increase efficiency throughout the TEN-T inland waterway network.’
(15)
Annex I to Directive 2005/44/EC is replaced by the text set out in Annex I to this Directive;
(16)
Annex II to Directive 2005/44/EC is replaced by the text set out in Annex II to this Directive;
(17)
the text set out in Annex III to this Directive is added as Annex III to Directive 2005/44/EC.

Transposition

1. Member States which have inland waterways and inland ports falling within the scope of this Directive shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 January 2029. They shall immediately inform the Commission thereof.
2. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
3. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Addressees

This Directive is addressed to the Member States which have inland waterways falling within the scope of Article 2 of Directive 2005/44/EC.
ANNEX I
‘ANNEX I
MINIMUM DATA REQUIREMENTS
As referred to in Article 4(3), point (a), in particular the following data shall be supplied:
(a) waterway axis with kilometre indication;
(b) restrictions for vessels or convoys in terms of length, width, draught and air draught;
(c) operation times of restricting structures, in particular locks and bridges;
(d) predicted waiting times at bridges, locks and inland ports, in real time when available;
(e) location of ports and transhipment sites;
(f) reference data for water level gauges relevant to navigation;
(g) location and, when available, current availability of alternative fuels infrastructure, including shore-side electricity supply.
The information provided shall be kept up-to-date and, when available, reflect the real-time situation.’.
ANNEX II
‘ANNEX II
PRINCIPLES FOR RIS TECHNICAL SPECIFICATIONS 1. General principles
The RIS technical specifications shall respect the following general principles:
(a) the indication of technical requirements for the planning, implementing and operational use of services and related systems;
(b) the RIS architecture and organisation;
(c) recommendations for vessels to participate in RIS, for individual services and for the stepwise development of RIS. 2. Electronic chart display and information system for inland navigation (inland ECDIS)
The technical specifications to be established in accordance with Article 5 for an electronic chart display and information system for inland navigation (inland ECDIS) shall respect the following principles:
(a) compatibility with the maritime electronic chart display and information system (maritime ECDIS) in order to facilitate traffic of inland waterway vessels in mixed traffic zones of the estuaries and sea-river traffic;
(b) the specification of minimum requirements for inland ECDIS equipment as well as the minimum content of electronic navigational charts with a view to the safety of navigation, in particular:
(i) a high level of reliability and availability of the inland ECDIS equipment used;
(ii) the robustness of the inland ECDIS equipment in order to withstand the environmental conditions typically prevailing on board a vessel without any degradation in quality or reliability;
(iii) the inclusion in the electronic navigational chart of all kinds of geographical objects, for example boundaries of the fairway, shoreline constructions, and beacons, that are needed for safe navigation;
(iv) the monitoring of the electronic chart with overlaid radar image when used for conning the vessel;
(c) the integration of up-to-date depth information on the fairway in the electronic navigational chart and display of such information in relation to a predefined or the actual water level;
(d) the integration of additional information, for example of parties other than the competent authorities, in the electronic navigational chart and display of such information in the inland ECDIS without affecting the information that is needed for safe navigation;
(e) the availability of electronic navigational charts to RIS users;
(f) the availability of the data for electronic navigational charts to all manufacturers of applications, when appropriate against a reasonable cost-related charge;
(g) the integration of up-to-date information on the waiting times at locks, bridges and inland ports and display of such information in the inland ECDIS without affecting the information that is needed for safe navigation. 3. Electronic ship reporting
The technical specifications for electronic ship reporting in inland navigation in accordance with Article 5 shall respect the following principles:
(a) the facilitation of the electronic data exchange between the competent authorities of the Member States, between participants in inland as well as maritime navigation and in multi-modal transport where inland navigation is involved;
(b) the use of a standardised transport notification message for ship-to-authority, authority-to-ship and authority-to-authority messaging in order to achieve compatibility with maritime navigation;
(c) the use of internationally accepted code lists and classifications, possibly complemented by additional inland navigation needs;
(d) the use of a unique European vessel identification number. 4. Notices to skippers
The technical specifications for notices to skippers in accordance with Article 5, in particular regarding fairway information, traffic information and traffic management as well as voyage planning on inland waterways, shall respect the following principles:
(a) a standardised data structure using predefined text modules and encoded to a high extent in order to enable automatic translation of the most important content into other languages and to facilitate the integration of notices to skippers into voyage planning systems;
(b) the compatibility of the standardised data structure with the data structure of inland ECDIS to facilitate integration of notices to skippers in inland ECDIS;
(c) an alignment with technical specifications for navigation and voyage planning on inland waterways to ensure coherence of provided information. 5. Vessel tracking and tracing systems
The technical specifications for vessel tracking and tracing systems in accordance with Article 5 shall respect the following principles:
(a) the specification of the requirements concerning systems and of standard messages as well as procedures so that they can be provided in an automated way;
(b) the differentiation between systems suited to requirements of tactical traffic information and systems suited to requirements of strategic traffic information, both with regard to positioning accuracy and required update rate;
(c) the description of the relevant technical systems for vessel tracking and tracing such as Inland AIS (inland automatic identification system);
(d) compatibility of data formats with the maritime AIS system. 6. Operational principles of the European RIS Environment
The technical specifications of the European RIS Environment in accordance with Article 5 shall respect the following principles:
(a) acting as a single digital window for inland navigation;
(b) a harmonised, single point of access for up-to-date and, if possible, real-time information on fairway conditions for safe and sustainable navigation, voyage planning and port operations along the TEN-T;
(c) enabling multi-modality transport chains while providing an adequate level of data protection;
(d) high level of data accuracy for seamless data exchange among relevant RIS users along the TEN-T (within and outside the Union);
(e) user-friendly interface with serviceable, useful and practical functionalities such as the ability to save and store profiles;
(f) harmonised, single point of reporting in accordance with the “once-only” principle, also for international voyages;
(g) link with other systems using information, communication, navigation or positioning/localisation technologies in order to manage infrastructure, mobility and traffic on the TEN-T effectively and to provide value-added services to citizens and operators, including systems for safe, secure, environmentally sound and capacity-efficient use of the TEN-T;
(h) collect and report anonymised and aggregate usage data that can be used for the monitoring of the implementation of RIS, including at least the number of RIS users, data availability in the European RIS Environment, connection and the number of exchanges with other digital systems or platforms;
(i) ensure cybersecurity. 7. Availability of data for other digital systems or platforms
The technical specifications for exchange of data with other digital systems or platforms, in accordance with Article 5, shall respect the following principles:
(a) build on the functionalities provided by the European RIS Environment;
(b) the facilitation of the electronic data exchange between RIS technologies and the databases and systems in use by other modes of transport, through appropriate data links and interfaces;
(c) the specification of the requirements concerning other digital systems or platforms as well as procedures for automated data exchange;
(d) the real-time exchange of information in particular for time-critical data;
(e) ensuring the secure exchange of information in accordance with a comprehensive rights-based access-control system;
(f) anticipate a system exchange framework that will allow for future developments and links with additional systems as required, including exchanges with the future European Mobility Data Space and any other system that is designed to promote innovations in multimodality transport. 8. Data for navigation and voyage planning on inland waterways
The technical specifications for data for navigation and voyage planning on inland waterways in accordance with Article 5 shall respect the following principles:
(a) provision of up-to-date information at regular intervals and at least when significant changes in the fairway situation take place that can impact the navigation;
(b) cover at least the following information:
(i) predicted waiting times at locks, (movable) bridges, inland ports;
(ii) data on the European waterway network required for navigation and voyage planning on inland waterways and covering at least the minimum data requirements set out in Annex I;
(iii) water level, the least sounded depth, the vertical clearance, the barrage status if blocking navigation, the regime, the forecast water level, the least sounded predicted depth;
(iv) ice situation and the related navigability or other extreme weather warnings;
(v) operating hours of locks, (movable) bridges, inland ports.
(c) provision of information through inland ECDIS, notices to skippers and the European RIS Environment as appropriate.’.
ANNEX III
‘ANNEX III
TECHNICAL SPECIFICATIONS FOR RIS
The technical specifications applicable to RIS shall be those set out in the latest edition of the European Standard for River Information Services (ES-RIS) adopted by CESNI.’.

Directive (EU) 2025/2456 of the European Parliament and of the Council of 26 November 2025 amending Directive 2011/65/EU as regards the reattribution of scientific and technical tasks to the European Chemicals Agency (Text with EEA relevance)

Official Journalof the European Union ENL series
2025/2456 12.12.2025
(1) The communication of the Commission of 11 December 2019 on the European Green Deal sets as an objective that chemical safety assessments should move towards a ‘one substance, one assessment’ approach, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making and increase consistency and predictability of scientific decisions and opinions. The communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union law needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve the quality and coherence of safety assessments across Union law, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing the administrative burden, thereby ensuring that businesses can adapt efficiently to evolving regulatory frameworks.
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency (the ‘Agency’) is necessary in order to align processes and levels of scientific scrutiny and digitalisation with the current standards and processes of the Agency. The reattribution of such tasks is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one substance, one assessment’ approach. Moreover, digitalisation and streamlining of processes will reduce the duplication of efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
(3) The amendment of Directive 2011/65/EU of the European Parliament and of the Council(3)aims to expand the tasks, workload and remit of scientific committees of the Agency. In order to provide adequate expertise and support, and thorough scientific evaluations, appropriate and stable resources and governance of the scientific committees should be ensured. In this respect, it is appropriate to provide for a review clause to ensure that the Commission take account of any future regulatory developments relating to the governance of the scientific committees of the Agency in order, if necessary, to revise Directive 2011/65/EU accordingly.
(4) Directive 2011/65/EU contains two procedures relating to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions and the review of substances to be added to the list of restricted substances. There is a need to increase transparency by setting detailed procedural steps for the process of reviewing substances for potential inclusion in the list of restricted substances.
(5) Data and information held by the Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(4)can be usefully deployed for the assessment of potential substance restrictions and for the assessment of applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies and make the best use of available expertise and resources.
(6) To ensure consistency between the evaluation of economic operators’ applications for granting, renewing or revoking an exemption pursuant to Article 5 of the Directive 2011/65/EU, and to make the best use of existing chemicals-related expertise, the technical evaluation to assess the justification of such exemption applications should be carried out by the Agency and its committees in close coordination with the Commission.
(7) The information submitted in the confidential version of an exemption application should be subject to an assessment by the Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
(8) Most exemption applications are expected to require the expertise of the Committee for Socioeconomic Analysis set up pursuant to Regulation (EC) No 1907/2006. The Commission should consult Members States’ representatives when adopting guidelines on the involvement of the Committee for Risk Assessment.
(9) To ensure that the restriction process of Directive 2011/65/EU is consistent with the restriction processes under other legal acts related to chemicals, and in particular the substance restriction process laid down in Regulation (EC) No 1907/2006, Directive 2011/65/EU should be amended in order to formally assign the Agency a role in the restriction process. In light of experience gained while carrying out substance reviews, it is essential for the quality of the related technical assessment and for enabling synergies, to make use of information and tools being used in the context of assessments for chemical restrictions under Regulation (EC) No 1907/2006.
(10) The list of restricted substances referred to in Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is appropriate for such reviews to take place at least every 4 years, taking into account market developments, technical and scientific progress, that restriction dossiers can be submitted by Member States at any time and that horizontal restriction measures can be initiated and adopted under Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 of the European Parliament and of the Council(5)or other Union law concerning sustainability criteria for hazardous substances and chemicals.
(11) The Agency can develop guidance concerning the Annex to Directive 2011/65/EU introduced by this Directive. In addition, where relevant, reference can be made to the existing guidance concerning Annex XV to Regulation (EC) No 1907/2006 in respect of the specific aim of Directive 2011/65/EU and the criteria laid down in Article 6(1) of that Directive.
(12) The two procedures described under Article 5 and Article 6 of Directive 2011/65/EU are applicable at Union level. National provisions should not deviate from those Articles.
(13) In order to ensure that this Directive is consistent with any future amendment of Regulation (EC) No 1907/2006, and with other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether further amendments of Directive 2011/65/EU are necessary in order to amend the rules concerning the adaptation of the Annexes to that Directive to scientific and technical progress and the rules concerning the amendment of the list of restricted substances in Annex II to that Directive. Where appropriate, the Commission should propose amendments to Directive 2011/65/EU in future proposals concerning sustainability criteria for hazardous substances and chemicals or in other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals.
(14) For amending procedural provisions under Directive 2011/65/EU, it is necessary to provide for a transitional period of 20 months to allow for appropriate resource allocation and task assignment in respect of the Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
(15) Directive 2011/65/EU should therefore be amended accordingly,
(1) Article 5 is amended as follows:(a)paragraphs 3 and 4 are replaced by the following:‘3.   An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.4.   The Agency shall:(a)acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;(b)upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;(c)verify that the application contains all the elements set out in Annex V;(d)if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application.(e)make the application and any supplementary information supplied by the applicant available to Member States;(f)make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;(g)invite interested parties to submit information within 3 months of making the application available in accordance with point (f).If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’;(b)the following paragraph is inserted:‘4a.   Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:(a)shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;(b)shall assess whether the criteria in Article 5(1), point (a), are met;(c)shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;(d)may request the applicant or third parties to submit, within a specified period, additional information;(e)upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;(f)shall adopt their final opinions, taking into account the comments from the applicant.Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’;(c)paragraph 5 is replaced by the following:‘5.   An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’;(d)paragraph 8 is replaced by the following:‘8.   The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’;(e)the following paragraph is added:‘9.   The Commission shall publish guidelines to facilitate the harmonised application of this Article.’; (a) paragraphs 3 and 4 are replaced by the following:‘3.   An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.4.   The Agency shall:(a)acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;(b)upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;(c)verify that the application contains all the elements set out in Annex V;(d)if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application.(e)make the application and any supplementary information supplied by the applicant available to Member States;(f)make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;(g)invite interested parties to submit information within 3 months of making the application available in accordance with point (f).If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’; (a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application; (b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs; (c) verify that the application contains all the elements set out in Annex V; (d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application. (e) make the application and any supplementary information supplied by the applicant available to Member States; (f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete; (g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f). (b) the following paragraph is inserted:‘4a.   Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:(a)shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;(b)shall assess whether the criteria in Article 5(1), point (a), are met;(c)shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;(d)may request the applicant or third parties to submit, within a specified period, additional information;(e)upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;(f)shall adopt their final opinions, taking into account the comments from the applicant.Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’; (a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency; (b) shall assess whether the criteria in Article 5(1), point (a), are met; (c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption; (d) may request the applicant or third parties to submit, within a specified period, additional information; (e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication; (f) shall adopt their final opinions, taking into account the comments from the applicant. (c) paragraph 5 is replaced by the following:‘5.   An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’; (d) paragraph 8 is replaced by the following:‘8.   The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’; (e) the following paragraph is added:‘9.   The Commission shall publish guidelines to facilitate the harmonised application of this Article.’;
(a) paragraphs 3 and 4 are replaced by the following:‘3.   An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.4.   The Agency shall:(a)acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;(b)upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;(c)verify that the application contains all the elements set out in Annex V;(d)if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application.(e)make the application and any supplementary information supplied by the applicant available to Member States;(f)make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;(g)invite interested parties to submit information within 3 months of making the application available in accordance with point (f).If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’; (a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application; (b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs; (c) verify that the application contains all the elements set out in Annex V; (d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application. (e) make the application and any supplementary information supplied by the applicant available to Member States; (f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete; (g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
(a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;
(b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;
(c) verify that the application contains all the elements set out in Annex V;
(d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application.
(i) request the applicant to complete the application; and
(ii) set an appropriate time limit of maximum 60 days for completion of the application.
(e) make the application and any supplementary information supplied by the applicant available to Member States;
(f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;
(g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
(b) the following paragraph is inserted:‘4a.   Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:(a)shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;(b)shall assess whether the criteria in Article 5(1), point (a), are met;(c)shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;(d)may request the applicant or third parties to submit, within a specified period, additional information;(e)upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;(f)shall adopt their final opinions, taking into account the comments from the applicant.Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’; (a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency; (b) shall assess whether the criteria in Article 5(1), point (a), are met; (c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption; (d) may request the applicant or third parties to submit, within a specified period, additional information; (e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication; (f) shall adopt their final opinions, taking into account the comments from the applicant.
(a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;
(b) shall assess whether the criteria in Article 5(1), point (a), are met;
(c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;
(d) may request the applicant or third parties to submit, within a specified period, additional information;
(e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;
(f) shall adopt their final opinions, taking into account the comments from the applicant.
(c) paragraph 5 is replaced by the following:‘5.   An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’;
(d) paragraph 8 is replaced by the following:‘8.   The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’;
(e) the following paragraph is added:‘9.   The Commission shall publish guidelines to facilitate the harmonised application of this Article.’;
(a) paragraphs 3 and 4 are replaced by the following:‘3.   An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.4.   The Agency shall:(a)acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;(b)upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;(c)verify that the application contains all the elements set out in Annex V;(d)if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application.(e)make the application and any supplementary information supplied by the applicant available to Member States;(f)make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;(g)invite interested parties to submit information within 3 months of making the application available in accordance with point (f).If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’; (a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application; (b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs; (c) verify that the application contains all the elements set out in Annex V; (d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application. (e) make the application and any supplementary information supplied by the applicant available to Member States; (f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete; (g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
(a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;
(b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;
(c) verify that the application contains all the elements set out in Annex V;
(d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application.
(i) request the applicant to complete the application; and
(ii) set an appropriate time limit of maximum 60 days for completion of the application.
(e) make the application and any supplementary information supplied by the applicant available to Member States;
(f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;
(g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
(a) acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;
(b) upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;
(c) verify that the application contains all the elements set out in Annex V;
(d) if necessary and within 45 days of receipt of the application:(i)request the applicant to complete the application; and(ii)set an appropriate time limit of maximum 60 days for completion of the application. (i) request the applicant to complete the application; and (ii) set an appropriate time limit of maximum 60 days for completion of the application.
(i) request the applicant to complete the application; and
(ii) set an appropriate time limit of maximum 60 days for completion of the application.
(i) request the applicant to complete the application; and
(ii) set an appropriate time limit of maximum 60 days for completion of the application.
(e) make the application and any supplementary information supplied by the applicant available to Member States;
(f) make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;
(g) invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
(b) the following paragraph is inserted:‘4a.   Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:(a)shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;(b)shall assess whether the criteria in Article 5(1), point (a), are met;(c)shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;(d)may request the applicant or third parties to submit, within a specified period, additional information;(e)upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;(f)shall adopt their final opinions, taking into account the comments from the applicant.Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’; (a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency; (b) shall assess whether the criteria in Article 5(1), point (a), are met; (c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption; (d) may request the applicant or third parties to submit, within a specified period, additional information; (e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication; (f) shall adopt their final opinions, taking into account the comments from the applicant.
(a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;
(b) shall assess whether the criteria in Article 5(1), point (a), are met;
(c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;
(d) may request the applicant or third parties to submit, within a specified period, additional information;
(e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;
(f) shall adopt their final opinions, taking into account the comments from the applicant.
(a) shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;
(b) shall assess whether the criteria in Article 5(1), point (a), are met;
(c) shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;
(d) may request the applicant or third parties to submit, within a specified period, additional information;
(e) upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;
(f) shall adopt their final opinions, taking into account the comments from the applicant.
(c) paragraph 5 is replaced by the following:‘5.   An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’;
(d) paragraph 8 is replaced by the following:‘8.   The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’;
(e) the following paragraph is added:‘9.   The Commission shall publish guidelines to facilitate the harmonised application of this Article.’;
(2) Article 6 is amended as follows:(a)paragraph 1 is amended as follows:(i)the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;(ii)the fourth subparagraph is deleted.(b)paragraph 2 is replaced by the following:‘2.   The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’; (a) paragraph 1 is amended as follows:(i)the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;(ii)the fourth subparagraph is deleted. (i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’; (ii) the fourth subparagraph is deleted. (b) paragraph 2 is replaced by the following:‘2.   The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’;
(a) paragraph 1 is amended as follows:(i)the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;(ii)the fourth subparagraph is deleted. (i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’; (ii) the fourth subparagraph is deleted.
(i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;
(ii) the fourth subparagraph is deleted.
(b) paragraph 2 is replaced by the following:‘2.   The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’;
(a) paragraph 1 is amended as follows:(i)the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;(ii)the fourth subparagraph is deleted. (i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’; (ii) the fourth subparagraph is deleted.
(i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;
(ii) the fourth subparagraph is deleted.
(i) the first subparagraph is replaced by the following:‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’;
(ii) the fourth subparagraph is deleted.
(b) paragraph 2 is replaced by the following:‘2.   The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’;
(3) the following Articles are inserted:‘Article 6aInitiation of a procedure for review and amendment of the list of restricted substances1.   Within 12 months of receipt of the request from the Commission as referred to in Article 6(2), first subparagraph, the Agency shall prepare a restriction dossier in accordance with Article 6(2), and shall propose restrictions in order to initiate the procedure for review and amendment of the list of restricted substances (the “restriction process”).2.   Where a Member State intends to prepare a restriction dossier, it shall notify the Agency at least 12 months in advance of the submission of that restriction dossier. If the restriction dossier demonstrates that action on a Union-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in order to initiate the restriction process.3.   The Agency shall, without delay, make available to the public on its website the intention of the Commission or the Member State to initiate the restriction process.4.   The Agency shall establish and maintain a list of substances for which a restriction dossier is intended or is being prepared by either the Agency or a Member State for the purposes of a proposed restriction.5.   The Agency shall consult the Committee for Risk Assessment and the Committee for Socioeconomic Analysis. The Committees shall verify whether the restriction dossier submitted meets requirements referred to in Article 6(2).Within 30 days of receipt of the restriction dossier, the Committees shall inform the Agency or the Member State proposing restrictions whether the dossier meets the requirements referred to in Article 6(2). If the dossier does not meet those requirements, the Committees shall provide the Agency or the Member State with the reasons therefor, in writing, within 45 days of receipt of that dossier. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Article shall be terminated.6.   Where the restriction dossier meets the requirements referred to in Article 6(2), the Agency shall make it publicly available without delay, clearly indicating the date of publication. The Agency shall invite all interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations to submit, individually or jointly, within 4 months of the date of the publication of the dossier, the following:(a)comments on the restriction dossier and the proposed restrictions;(b)a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.The socioeconomic analysis referred to in the first subparagraph, point (b), shall meet the requirements set out in Annex XVI to Regulation (EC) No 1907/2006 that relate to the criteria set out in Article 6(1) of this Directive.Article 6bOpinion of the Agency’s Committees1.   Within 12 months of the date of publication referred to in Article 6a(6), the Committee for Risk Assessment shall adopt an opinion as to whether the restriction is appropriate in reducing the detrimental effects and exposure referred to in Article 6(1). That opinion shall take account of the restriction dossier prepared by the Agency, at the request of the Commission, or by the Member State, and the comments of interested parties submitted pursuant to Article 6a(6), point (a).2.   Within 15 months of the date of publication referred to in Article 6a(6), the Committee for Socioeconomic Analysis shall adopt an opinion on the proposed restrictions, based on its consideration of the relevant parts of the dossier and the of socioeconomic impact of the proposed restrictions, taking account of any existing analysis or information submitted pursuant to Article 6a(6), point (b).Prior to adopting its opinion, the Committee for Socioeconomic Analysis shall prepare a draft of that opinion and shall submit it to the Agency.3.   The Agency shall publish the draft opinion of the Committee for Socioeconomic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication.4.   The Committee for Socioeconomic Analysis shall adopt its opinion without delay, taking into account the comments of interested parties submitted in accordance with Article 6a(6), point (a), and paragraph 3 of this Article.5.   Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions proposed, the Agency shall postpone the deadline for the opinion of the Committee for Socioeconomic Analysis by a maximum of 90 days.6.   For the purpose of adopting opinions pursuant to this Article, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.Article 6cSubmission of an opinion to the Commission1.   The Agency shall submit to the Commission, without delay, the opinions of the Committees for Risk Assessment and Socioeconomic Analysis adopted pursuant to Article 6b. Where the opinions of the Committees for Risk Assessment and Socioeconomic Analysis diverge significantly from the proposed restrictions, the Agency shall submit an explanatory note to the Commission providing a detailed explanation of the reasons for those divergences. If one or both of the Committees do not adopt an opinion by the deadlines set in Article 6b(1) and (2), the Agency shall inform the Commission accordingly, stating the reasons.2.   The Agency shall publish the opinions of the Committees for Risk Assessment and Socioeconomic Analysis on its website without delay.3.   The Agency shall, on request, provide the Commission or Member State with all documents and evidence submitted to or considered by it.’; (a) comments on the restriction dossier and the proposed restrictions; (b) a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.
(a) comments on the restriction dossier and the proposed restrictions;
(b) a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.
(a) comments on the restriction dossier and the proposed restrictions;
(b) a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.
(4) Article 20 is amended as follows:(a)paragraph 1 is replaced by the following:‘1.   The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’;(b)the following paragraph is inserted:‘1a.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).(*1)OJ L 123, 12.5.2016, p. 1, ELI:http://data.europa.eu/eli/agree_interinstit/2016/512/oj.’;" (a) paragraph 1 is replaced by the following:‘1.   The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’; (b) the following paragraph is inserted:‘1a.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).(*1)OJ L 123, 12.5.2016, p. 1, ELI:http://data.europa.eu/eli/agree_interinstit/2016/512/oj.’;"
(a) paragraph 1 is replaced by the following:‘1.   The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’;
(b) the following paragraph is inserted:‘1a.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).(*1)OJ L 123, 12.5.2016, p. 1, ELI:http://data.europa.eu/eli/agree_interinstit/2016/512/oj.’;"
(a) paragraph 1 is replaced by the following:‘1.   The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’;
(b) the following paragraph is inserted:‘1a.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).(*1)OJ L 123, 12.5.2016, p. 1, ELI:http://data.europa.eu/eli/agree_interinstit/2016/512/oj.’;"
(5) In Article 24, the following paragraph is added:‘3.   Taking due account of any regulatory developments concerning the status of the resources and of the governance of the scientific committees of the Agency, the Commission shall monitor the situation regarding the tasks, workload and remit of the scientific committees, and, where necessary, present a legislative proposal to amend this Directive accordingly.’;
(6) In Annex V, the following paragraph is added:‘In cases referred to in the first paragraph, point (h), the applicant shall submit a non-confidential version of the application.’;
(7) The text set out in the Annex to this Directive is added as Annex Va.
(1) the identity of the substance or substances;
(2) a precise and clear wording of the entry of the proposed restriction in Annex II;
(3) references and scientific evidence for such restriction;
(4) information on the use of the substance or the group of similar substances in the EEE;
(5) information on detrimental effects and exposure in particular during waste EEE management operations;
(6) information on possible substitutes and other alternatives, their availability and reliability;
(7) a justification for considering a Union-wide restriction to be the most appropriate measure;
(8) a socioeconomic assessment.’.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the ordinary legislative procedure(2),
(1) The communication of the Commission of 11 December 2019 on the European Green Deal sets as an objective that chemical safety assessments should move towards a ‘one substance, one assessment’ approach, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making and increase consistency and predictability of scientific decisions and opinions. The communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union law needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve the quality and coherence of safety assessments across Union law, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing the administrative burden, thereby ensuring that businesses can adapt efficiently to evolving regulatory frameworks.
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency (the ‘Agency’) is necessary in order to align processes and levels of scientific scrutiny and digitalisation with the current standards and processes of the Agency. The reattribution of such tasks is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one substance, one assessment’ approach. Moreover, digitalisation and streamlining of processes will reduce the duplication of efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
(3) The amendment of Directive 2011/65/EU of the European Parliament and of the Council(3)aims to expand the tasks, workload and remit of scientific committees of the Agency. In order to provide adequate expertise and support, and thorough scientific evaluations, appropriate and stable resources and governance of the scientific committees should be ensured. In this respect, it is appropriate to provide for a review clause to ensure that the Commission take account of any future regulatory developments relating to the governance of the scientific committees of the Agency in order, if necessary, to revise Directive 2011/65/EU accordingly.
(4) Directive 2011/65/EU contains two procedures relating to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions and the review of substances to be added to the list of restricted substances. There is a need to increase transparency by setting detailed procedural steps for the process of reviewing substances for potential inclusion in the list of restricted substances.
(5) Data and information held by the Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(4)can be usefully deployed for the assessment of potential substance restrictions and for the assessment of applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies and make the best use of available expertise and resources.
(6) To ensure consistency between the evaluation of economic operators’ applications for granting, renewing or revoking an exemption pursuant to Article 5 of the Directive 2011/65/EU, and to make the best use of existing chemicals-related expertise, the technical evaluation to assess the justification of such exemption applications should be carried out by the Agency and its committees in close coordination with the Commission.
(7) The information submitted in the confidential version of an exemption application should be subject to an assessment by the Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
(8) Most exemption applications are expected to require the expertise of the Committee for Socioeconomic Analysis set up pursuant to Regulation (EC) No 1907/2006. The Commission should consult Members States’ representatives when adopting guidelines on the involvement of the Committee for Risk Assessment.
(9) To ensure that the restriction process of Directive 2011/65/EU is consistent with the restriction processes under other legal acts related to chemicals, and in particular the substance restriction process laid down in Regulation (EC) No 1907/2006, Directive 2011/65/EU should be amended in order to formally assign the Agency a role in the restriction process. In light of experience gained while carrying out substance reviews, it is essential for the quality of the related technical assessment and for enabling synergies, to make use of information and tools being used in the context of assessments for chemical restrictions under Regulation (EC) No 1907/2006.
(10) The list of restricted substances referred to in Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is appropriate for such reviews to take place at least every 4 years, taking into account market developments, technical and scientific progress, that restriction dossiers can be submitted by Member States at any time and that horizontal restriction measures can be initiated and adopted under Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 of the European Parliament and of the Council(5)or other Union law concerning sustainability criteria for hazardous substances and chemicals.
(11) The Agency can develop guidance concerning the Annex to Directive 2011/65/EU introduced by this Directive. In addition, where relevant, reference can be made to the existing guidance concerning Annex XV to Regulation (EC) No 1907/2006 in respect of the specific aim of Directive 2011/65/EU and the criteria laid down in Article 6(1) of that Directive.
(12) The two procedures described under Article 5 and Article 6 of Directive 2011/65/EU are applicable at Union level. National provisions should not deviate from those Articles.
(13) In order to ensure that this Directive is consistent with any future amendment of Regulation (EC) No 1907/2006, and with other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether further amendments of Directive 2011/65/EU are necessary in order to amend the rules concerning the adaptation of the Annexes to that Directive to scientific and technical progress and the rules concerning the amendment of the list of restricted substances in Annex II to that Directive. Where appropriate, the Commission should propose amendments to Directive 2011/65/EU in future proposals concerning sustainability criteria for hazardous substances and chemicals or in other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals.
(14) For amending procedural provisions under Directive 2011/65/EU, it is necessary to provide for a transitional period of 20 months to allow for appropriate resource allocation and task assignment in respect of the Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
(15) Directive 2011/65/EU should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 2011/65/EU
Article 1
Directive 2011/65/EU is amended as follows:
(1)
Article 5 is amended as follows:
(a)
paragraphs 3 and 4 are replaced by the following:
‘3. An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.
4. The Agency shall:
(a)
acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;
(b)
upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;
(c)
verify that the application contains all the elements set out in Annex V;
(d)
if necessary and within 45 days of receipt of the application:
(i)
request the applicant to complete the application; and
(ii)
set an appropriate time limit of maximum 60 days for completion of the application.
(e)
make the application and any supplementary information supplied by the applicant available to Member States;
(f)
make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;
(g)
invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.
The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.
If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’
(b)
the following paragraph is inserted:
‘4a. Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.
The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:
(a)
shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;
(b)
shall assess whether the criteria in Article 5(1), point (a), are met;
(c)
shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;
(d)
may request the applicant or third parties to submit, within a specified period, additional information;
(e)
upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;
(f)
shall adopt their final opinions, taking into account the comments from the applicant.
Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).
The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.
The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.
For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’
(c)
paragraph 5 is replaced by the following:
‘5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’
(d)
paragraph 8 is replaced by the following:
‘8. The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’
(e)
the following paragraph is added:
‘9. The Commission shall publish guidelines to facilitate the harmonised application of this Article.’
(2)
Article 6 is amended as follows:
(a)
paragraph 1 is amended as follows:
(i)
the first subparagraph is replaced by the following:
‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’
(ii)
the fourth subparagraph is deleted.
(b)
paragraph 2 is replaced by the following:
‘2. The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.
Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’
(3)
the following Articles are inserted:
1. Within 12 months of receipt of the request from the Commission as referred to in Article 6(2), first subparagraph, the Agency shall prepare a restriction dossier in accordance with Article 6(2), and shall propose restrictions in order to initiate the procedure for review and amendment of the list of restricted substances (the “restriction process”).
2. Where a Member State intends to prepare a restriction dossier, it shall notify the Agency at least 12 months in advance of the submission of that restriction dossier. If the restriction dossier demonstrates that action on a Union-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in order to initiate the restriction process.
3. The Agency shall, without delay, make available to the public on its website the intention of the Commission or the Member State to initiate the restriction process.
4. The Agency shall establish and maintain a list of substances for which a restriction dossier is intended or is being prepared by either the Agency or a Member State for the purposes of a proposed restriction.
5. The Agency shall consult the Committee for Risk Assessment and the Committee for Socioeconomic Analysis. The Committees shall verify whether the restriction dossier submitted meets requirements referred to in Article 6(2).
Within 30 days of receipt of the restriction dossier, the Committees shall inform the Agency or the Member State proposing restrictions whether the dossier meets the requirements referred to in Article 6(2). If the dossier does not meet those requirements, the Committees shall provide the Agency or the Member State with the reasons therefor, in writing, within 45 days of receipt of that dossier. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Article shall be terminated.
6. Where the restriction dossier meets the requirements referred to in Article 6(2), the Agency shall make it publicly available without delay, clearly indicating the date of publication. The Agency shall invite all interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations to submit, individually or jointly, within 4 months of the date of the publication of the dossier, the following:
(a)
comments on the restriction dossier and the proposed restrictions;
(b)
a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.
The socioeconomic analysis referred to in the first subparagraph, point (b), shall meet the requirements set out in Annex XVI to Regulation (EC) No 1907/2006 that relate to the criteria set out in Article 6(1) of this Directive.
1. Within 12 months of the date of publication referred to in Article 6a(6), the Committee for Risk Assessment shall adopt an opinion as to whether the restriction is appropriate in reducing the detrimental effects and exposure referred to in Article 6(1). That opinion shall take account of the restriction dossier prepared by the Agency, at the request of the Commission, or by the Member State, and the comments of interested parties submitted pursuant to Article 6a(6), point (a).
2. Within 15 months of the date of publication referred to in Article 6a(6), the Committee for Socioeconomic Analysis shall adopt an opinion on the proposed restrictions, based on its consideration of the relevant parts of the dossier and the of socioeconomic impact of the proposed restrictions, taking account of any existing analysis or information submitted pursuant to Article 6a(6), point (b).
Prior to adopting its opinion, the Committee for Socioeconomic Analysis shall prepare a draft of that opinion and shall submit it to the Agency.
3. The Agency shall publish the draft opinion of the Committee for Socioeconomic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication.
4. The Committee for Socioeconomic Analysis shall adopt its opinion without delay, taking into account the comments of interested parties submitted in accordance with Article 6a(6), point (a), and paragraph 3 of this Article.
5. Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions proposed, the Agency shall postpone the deadline for the opinion of the Committee for Socioeconomic Analysis by a maximum of 90 days.
6. For the purpose of adopting opinions pursuant to this Article, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.
1. The Agency shall submit to the Commission, without delay, the opinions of the Committees for Risk Assessment and Socioeconomic Analysis adopted pursuant to Article 6b. Where the opinions of the Committees for Risk Assessment and Socioeconomic Analysis diverge significantly from the proposed restrictions, the Agency shall submit an explanatory note to the Commission providing a detailed explanation of the reasons for those divergences. If one or both of the Committees do not adopt an opinion by the deadlines set in Article 6b(1) and (2), the Agency shall inform the Commission accordingly, stating the reasons.
2. The Agency shall publish the opinions of the Committees for Risk Assessment and Socioeconomic Analysis on its website without delay.
3. The Agency shall, on request, provide the Commission or Member State with all documents and evidence submitted to or considered by it.’
(4)
Article 20 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’
(b)
the following paragraph is inserted:
‘1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).
(5)
In Article 24, the following paragraph is added:
‘3. Taking due account of any regulatory developments concerning the status of the resources and of the governance of the scientific committees of the Agency, the Commission shall monitor the situation regarding the tasks, workload and remit of the scientific committees, and, where necessary, present a legislative proposal to amend this Directive accordingly.’
(6)
In Annex V, the following paragraph is added:
‘In cases referred to in the first paragraph, point (h), the applicant shall submit a non-confidential version of the application.’
(7)
The text set out in the Annex to this Directive is added as Annex Va.

Application
Article 2
This Directive shall apply from 13 August 2027.

Entry into force
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Addressees
Article 4
This Directive is addressed to the Member States.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the ordinary legislative procedure(2),
(1) The communication of the Commission of 11 December 2019 on the European Green Deal sets as an objective that chemical safety assessments should move towards a ‘one substance, one assessment’ approach, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making and increase consistency and predictability of scientific decisions and opinions. The communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union law needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve the quality and coherence of safety assessments across Union law, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing the administrative burden, thereby ensuring that businesses can adapt efficiently to evolving regulatory frameworks.
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency (the ‘Agency’) is necessary in order to align processes and levels of scientific scrutiny and digitalisation with the current standards and processes of the Agency. The reattribution of such tasks is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one substance, one assessment’ approach. Moreover, digitalisation and streamlining of processes will reduce the duplication of efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
(3) The amendment of Directive 2011/65/EU of the European Parliament and of the Council(3)aims to expand the tasks, workload and remit of scientific committees of the Agency. In order to provide adequate expertise and support, and thorough scientific evaluations, appropriate and stable resources and governance of the scientific committees should be ensured. In this respect, it is appropriate to provide for a review clause to ensure that the Commission take account of any future regulatory developments relating to the governance of the scientific committees of the Agency in order, if necessary, to revise Directive 2011/65/EU accordingly.
(4) Directive 2011/65/EU contains two procedures relating to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions and the review of substances to be added to the list of restricted substances. There is a need to increase transparency by setting detailed procedural steps for the process of reviewing substances for potential inclusion in the list of restricted substances.
(5) Data and information held by the Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(4)can be usefully deployed for the assessment of potential substance restrictions and for the assessment of applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies and make the best use of available expertise and resources.
(6) To ensure consistency between the evaluation of economic operators’ applications for granting, renewing or revoking an exemption pursuant to Article 5 of the Directive 2011/65/EU, and to make the best use of existing chemicals-related expertise, the technical evaluation to assess the justification of such exemption applications should be carried out by the Agency and its committees in close coordination with the Commission.
(7) The information submitted in the confidential version of an exemption application should be subject to an assessment by the Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
(8) Most exemption applications are expected to require the expertise of the Committee for Socioeconomic Analysis set up pursuant to Regulation (EC) No 1907/2006. The Commission should consult Members States’ representatives when adopting guidelines on the involvement of the Committee for Risk Assessment.
(9) To ensure that the restriction process of Directive 2011/65/EU is consistent with the restriction processes under other legal acts related to chemicals, and in particular the substance restriction process laid down in Regulation (EC) No 1907/2006, Directive 2011/65/EU should be amended in order to formally assign the Agency a role in the restriction process. In light of experience gained while carrying out substance reviews, it is essential for the quality of the related technical assessment and for enabling synergies, to make use of information and tools being used in the context of assessments for chemical restrictions under Regulation (EC) No 1907/2006.
(10) The list of restricted substances referred to in Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is appropriate for such reviews to take place at least every 4 years, taking into account market developments, technical and scientific progress, that restriction dossiers can be submitted by Member States at any time and that horizontal restriction measures can be initiated and adopted under Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 of the European Parliament and of the Council(5)or other Union law concerning sustainability criteria for hazardous substances and chemicals.
(11) The Agency can develop guidance concerning the Annex to Directive 2011/65/EU introduced by this Directive. In addition, where relevant, reference can be made to the existing guidance concerning Annex XV to Regulation (EC) No 1907/2006 in respect of the specific aim of Directive 2011/65/EU and the criteria laid down in Article 6(1) of that Directive.
(12) The two procedures described under Article 5 and Article 6 of Directive 2011/65/EU are applicable at Union level. National provisions should not deviate from those Articles.
(13) In order to ensure that this Directive is consistent with any future amendment of Regulation (EC) No 1907/2006, and with other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether further amendments of Directive 2011/65/EU are necessary in order to amend the rules concerning the adaptation of the Annexes to that Directive to scientific and technical progress and the rules concerning the amendment of the list of restricted substances in Annex II to that Directive. Where appropriate, the Commission should propose amendments to Directive 2011/65/EU in future proposals concerning sustainability criteria for hazardous substances and chemicals or in other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals.
(14) For amending procedural provisions under Directive 2011/65/EU, it is necessary to provide for a transitional period of 20 months to allow for appropriate resource allocation and task assignment in respect of the Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
(15) Directive 2011/65/EU should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 2011/65/EU

Directive 2011/65/EU is amended as follows:
(1)
Article 5 is amended as follows:
(a)
paragraphs 3 and 4 are replaced by the following:
‘3. An application for granting, renewing or revoking an exemption shall be made to the European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 1907/2006 (the “Agency”) in accordance with Annex V.
4. The Agency shall:
(a)
acknowledge receipt of an application within 15 days of its receipt, stating the date of receipt of the application;
(b)
upon receipt of an application, notify the Commission of the application and keep it informed of any of the procedural steps under points (c) to (g) and the second, third and fourth subparagraphs;
(c)
verify that the application contains all the elements set out in Annex V;
(d)
if necessary and within 45 days of receipt of the application:
(i)
request the applicant to complete the application; and
(ii)
set an appropriate time limit of maximum 60 days for completion of the application.
(e)
make the application and any supplementary information supplied by the applicant available to Member States;
(f)
make available to the public a summary and a non-confidential version of the application on the Agency’s website, as well as the date on which it considers the application to be complete;
(g)
invite interested parties to submit information within 3 months of making the application available in accordance with point (f).
If the volume and the complexity of the application is such that the Agency cannot comply with the 45 day time limit referred to in the first subparagraph, point (d), the Agency shall inform the applicant of any extension of the time limit and of the reasons therefor, as soon as possible, and in any case before the end of that time limit.
The Agency may extend the 60 day time limit referred to in the first subparagraph, point (d)(ii), if the volume and the complexity of the application is such that that time limit cannot be complied with and provided that the applicant submits a reasoned request for an extension before the expiry of the 60 day time limit. The Agency shall decide on such extension within 5 working days of the request.
If the applicant does not complete the application, in accordance with Annex V, with the elements identified as missing by the Agency, within the time limit set in accordance with the first subparagraph, point (d)(ii), and the second and third subparagraphs, of this Article, the Agency shall reject the application. The Agency shall establish and communicate to the applicant without delay the date when the application is considered complete.’
(b)
the following paragraph is inserted:
‘4a. Once the Agency considers the application to be complete, it shall request the opinion of the Committee for Socioeconomic Analysis, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 (the “Committee for Socioeconomic Analysis”). The Agency shall also request the opinion of the Committee for Risk Assessment, set up pursuant to Article 76(1), point (c), of Regulation (EC) No 1907/2006 (the “Committee for Risk Assessment”), in the case of an application for a new exemption, or where otherwise considered appropriate.
The Committee for Socioeconomic Analysis and, where relevant, the Committee for Risk Assessment:
(a)
shall draw up draft opinions within 9 months of the date the application is considered complete by the Agency;
(b)
shall assess whether the criteria in Article 5(1), point (a), are met;
(c)
shall provide clear guidance to the Commission on granting, renewing or revoking an exemption;
(d)
may request the applicant or third parties to submit, within a specified period, additional information;
(e)
upon adopting the draft opinions, shall communicate those draft opinions to the applicant and allow the applicant the opportunity to comment within 4 weeks of that communication;
(f)
shall adopt their final opinions, taking into account the comments from the applicant.
Each Committee shall take into account any information submitted by third parties in accordance with the second subparagraph, point (d).
The Agency shall send the final opinions of the Committees to the Commission within 12 months of the date on which the Agency considers the application to be complete.
The Agency shall identify which parts of those opinions, including any attachments thereto are to be made publicly available on its website. The Agency shall make those parts, and any requests made in accordance with the second subparagraph, point (d), available to the public on its website.
For the purpose of adopting opinions pursuant to this paragraph, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.’
(c)
paragraph 5 is replaced by the following:
‘5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within 9 months of receipt of the opinions from the Agency pursuant to paragraph 4a, fourth subparagraph. The existing exemption shall remain valid until a decision on the application for renewal is adopted by the Commission.’
(d)
paragraph 8 is replaced by the following:
‘8. The Agency shall, in agreement with the Commission, establish a harmonised format for the applications as referred to in paragraph 3 as well as comprehensive guidelines for such applications, taking into account the situation of SMEs. Any application to the Agency shall be made using that harmonised format and submission tools made available by the Agency.’
(e)
the following paragraph is added:
‘9. The Commission shall publish guidelines to facilitate the harmonised application of this Article.’
(2)
Article 6 is amended as follows:
(a)
paragraph 1 is amended as follows:
(i)
the first subparagraph is replaced by the following:
‘With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 4 years on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.’
(ii)
the fourth subparagraph is deleted.
(b)
paragraph 2 is replaced by the following:
‘2. The review and amendment of the list of restricted substances, or a group of similar substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
In preparing restriction dossiers, the Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legal acts covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To that end, other bodies established under Union law and carrying out similar tasks shall, on request, provide information to the Agency or Member State concerned.
Restriction dossiers shall comply with the requirements set out in paragraph 1 of this Article, and shall, in addition, contain the information set out in Annex Va.’
(3)
the following Articles are inserted:
1. Within 12 months of receipt of the request from the Commission as referred to in Article 6(2), first subparagraph, the Agency shall prepare a restriction dossier in accordance with Article 6(2), and shall propose restrictions in order to initiate the procedure for review and amendment of the list of restricted substances (the “restriction process”).
2. Where a Member State intends to prepare a restriction dossier, it shall notify the Agency at least 12 months in advance of the submission of that restriction dossier. If the restriction dossier demonstrates that action on a Union-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in order to initiate the restriction process.
3. The Agency shall, without delay, make available to the public on its website the intention of the Commission or the Member State to initiate the restriction process.
4. The Agency shall establish and maintain a list of substances for which a restriction dossier is intended or is being prepared by either the Agency or a Member State for the purposes of a proposed restriction.
5. The Agency shall consult the Committee for Risk Assessment and the Committee for Socioeconomic Analysis. The Committees shall verify whether the restriction dossier submitted meets requirements referred to in Article 6(2).
Within 30 days of receipt of the restriction dossier, the Committees shall inform the Agency or the Member State proposing restrictions whether the dossier meets the requirements referred to in Article 6(2). If the dossier does not meet those requirements, the Committees shall provide the Agency or the Member State with the reasons therefor, in writing, within 45 days of receipt of that dossier. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Article shall be terminated.
6. Where the restriction dossier meets the requirements referred to in Article 6(2), the Agency shall make it publicly available without delay, clearly indicating the date of publication. The Agency shall invite all interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations to submit, individually or jointly, within 4 months of the date of the publication of the dossier, the following:
(a)
comments on the restriction dossier and the proposed restrictions;
(b)
a socioeconomic analysis, including an analysis of possible substitutes and other alternatives, or information relevant to the examination of the advantages and disadvantages of one of the proposed restrictions.
The socioeconomic analysis referred to in the first subparagraph, point (b), shall meet the requirements set out in Annex XVI to Regulation (EC) No 1907/2006 that relate to the criteria set out in Article 6(1) of this Directive.
1. Within 12 months of the date of publication referred to in Article 6a(6), the Committee for Risk Assessment shall adopt an opinion as to whether the restriction is appropriate in reducing the detrimental effects and exposure referred to in Article 6(1). That opinion shall take account of the restriction dossier prepared by the Agency, at the request of the Commission, or by the Member State, and the comments of interested parties submitted pursuant to Article 6a(6), point (a).
2. Within 15 months of the date of publication referred to in Article 6a(6), the Committee for Socioeconomic Analysis shall adopt an opinion on the proposed restrictions, based on its consideration of the relevant parts of the dossier and the of socioeconomic impact of the proposed restrictions, taking account of any existing analysis or information submitted pursuant to Article 6a(6), point (b).
Prior to adopting its opinion, the Committee for Socioeconomic Analysis shall prepare a draft of that opinion and shall submit it to the Agency.
3. The Agency shall publish the draft opinion of the Committee for Socioeconomic Analysis on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication.
4. The Committee for Socioeconomic Analysis shall adopt its opinion without delay, taking into account the comments of interested parties submitted in accordance with Article 6a(6), point (a), and paragraph 3 of this Article.
5. Where the opinion of the Committee for Risk Assessment diverges significantly from the restrictions proposed, the Agency shall postpone the deadline for the opinion of the Committee for Socioeconomic Analysis by a maximum of 90 days.
6. For the purpose of adopting opinions pursuant to this Article, Article 87 of Regulation (EC) No 1907/2006 shall applymutatis mutandis.
1. The Agency shall submit to the Commission, without delay, the opinions of the Committees for Risk Assessment and Socioeconomic Analysis adopted pursuant to Article 6b. Where the opinions of the Committees for Risk Assessment and Socioeconomic Analysis diverge significantly from the proposed restrictions, the Agency shall submit an explanatory note to the Commission providing a detailed explanation of the reasons for those divergences. If one or both of the Committees do not adopt an opinion by the deadlines set in Article 6b(1) and (2), the Agency shall inform the Commission accordingly, stating the reasons.
2. The Agency shall publish the opinions of the Committees for Risk Assessment and Socioeconomic Analysis on its website without delay.
3. The Agency shall, on request, provide the Commission or Member State with all documents and evidence submitted to or considered by it.’
(4)
Article 20 is amended as follows:
(a)
paragraph 1 is replaced by the following:
‘1. The power to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21.’
(b)
the following paragraph is inserted:
‘1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(*1).
(5)
In Article 24, the following paragraph is added:
‘3. Taking due account of any regulatory developments concerning the status of the resources and of the governance of the scientific committees of the Agency, the Commission shall monitor the situation regarding the tasks, workload and remit of the scientific committees, and, where necessary, present a legislative proposal to amend this Directive accordingly.’
(6)
In Annex V, the following paragraph is added:
‘In cases referred to in the first paragraph, point (h), the applicant shall submit a non-confidential version of the application.’
(7)
The text set out in the Annex to this Directive is added as Annex Va.

Application

This Directive shall apply from 13 August 2027.

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Addressees

This Directive is addressed to the Member States.
ANNEX
‘ANNEX Va
Dossiers for restriction proposals
The proposals to review and amend the list of restricted substances, or a group of similar substances, in Annex II shall contain at least the following information:
(1) the identity of the substance or substances;
(2) a precise and clear wording of the entry of the proposed restriction in Annex II;
(3) references and scientific evidence for such restriction;
(4) information on the use of the substance or the group of similar substances in the EEE;
(5) information on detrimental effects and exposure in particular during waste EEE management operations;
(6) information on possible substitutes and other alternatives, their availability and reliability;
(7) a justification for considering a Union-wide restriction to be the most appropriate measure;
(8) a socioeconomic assessment.’.

Commission Delegated Directive (EU) 2025/2364 of 8 September 2025 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as an alloying element in steel, aluminium and copper

Official Journalof the European Union ENL series
2025/2364 21.11.2025
(1) Article 4(1) of Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex III to that Directive.
(2) The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The maximum tolerated concentration value is 0,1 % by weight of lead in homogenous materials.
(4) Commission Delegated Directive (EU) 2018/739(2)granted an exemption for the use of lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight and in batch hot dip galvanised steel components containing up to 0,2 % lead by weight, as set out in point 6(a)-I of Annex III to Directive 2011/65/EU. That exemption covers categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(a) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(5) Commission Delegated Directive (EU) 2018/740(3)granted exemptions for the use of lead as an alloying element in aluminium containing up to 0,4 % lead by weight either for machining purposes or for recycling of lead-bearing aluminium scrap. The exemptions are set out in points 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU. Those exemptions cover categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(b) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(6) Commission Delegated Directive (EU) 2018/741(4)granted an exemption for the use of copper alloy containing up to 4 % lead by weight for all categories, as set out in point 6(c) of Annex III to Directive 2011/65/EU.
(7) On 17 January 2020 and 20 January 2020, the Commission received two applications for renewing the exemptions set out in points 6(a) and 6(a)-I of Annex III to Directive 2011/65/EU in light of scientific and technical progress, in particular with regard to its scope. On 2 December 2019 and 17 January 2020, the Commission received two applications for renewing the exemption set out in points 6(b), 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU and on 15 January 2020 and 16 January 2020, the Commission received two applications for renewing the exemption set out in point 6(c) of Annex III to Directive 2011/65/EU.
(8) For the exemptions set out in points 6(a), 6(b) and 6(c) of Annex III to Directive 2011/65/EU, the electrical and electronic equipment category 8 ‘in vitro diagnostic medical devices’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2023 and the categories 9 ‘industrial monitoring and control instruments’ and 11 ‘other electrical and electronic equipment not covered by any of the categories’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2024. On 20 January 2023, two renewal applications were received for each exemption set out in points 6(a) and 6(b) of Annex III to Directive 2011/65/EU and specifically regarding those three categories. In accordance with Article 5(5), second subparagraph, of Directive 2011/65/EU, their submission extended the validity of the existing exemptions until a decision on the renewal applications is taken.
(9) In order to evaluate the applications received, a technical and scientific assessment study was carried out and finalised in 2022(5). A further study focussing on the categories for which a renewal was requested at a later stage was carried out and finalised in 2024(6). The evaluations included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.
(10) The evaluation of the requested exemption renewal concluded that, regarding the exemption set out in point 6(a)-I of Annex III to Directive 2011/65/EU, lead is still necessary in steel to achieve certain machining properties. A substitution or elimination in batch hot dip galvanised steel is currently not technically feasible nor economically viable. However, both technical applications can be split between points 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, to allow a more dedicated examination in the next review.
(11) In order to provide sufficient time to substitute lead in steel and to avoid negative impacts, which outweigh the benefits of a substitution, it is appropriate to grant a short-term validity period for those applications, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. As regards points 6(a), 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, it is appropriate to set one expiry date for all categories listed in Annex I of that Directive.
(12) The exemption set out in point 6(a) of Annex III to Directive 2011/65/EU should expire 12 months after the date of the decision on the renewal application, in accordance with Article 5(6) of that Directive.
(13) As regards the exemption set out in point 6(b)-I of Annex III to Directive 2011/65/EU concerning lead in aluminium stemming from lead-bearing aluminium scrap recycling, it was found that the lead concentration can further be reduced to 0,3 % by weight in aluminium. That should be set out in a new point, specifying that such aluminium is a casted alloy.
(14) The use of intentionally added lead in aluminium for machining purposes is no more needed for electrical and electronic equipment. Reliable substitutes for lead in aluminium exist on the market. The last application area relying on such an exemption is expected to be replaced by alternatives by 2025. In accordance with Article 5(6) of Directive 2011/65/EU, the maximum transition period of 18 months should be set to allow individual market participants in the industry to adapt.
(15) It was found that the use of aluminium alloys containing lead with lead concentration below 0,4 % by weight requires redesign and requalification of electrical and electronic equipment falling under category 9 ‘industrial monitoring and control instruments’ and open-scope category 11 ‘other electrical and electronic equipment’, which requires more time for compliance when compared to other categories referred to in Annex I to Directive 2011/65/EU. Therefore, longer validity periods should be considered for those two categories.
(16) As regards point 6(c) of Annex III to Directive 2011/65/EU concerning copper alloys containing up to 4 % lead by weight, it was not possible during the scientific and technical assessment to identify and define application areas that no longer require the exemption, despite many indications that lead could be successfully substituted in certain applications. Since substitutes are not sufficiently reliable, an extension of the exemption should be granted. In view of the technical evaluation, it is appropriate to set one expiry date for all categories listed in Annex I to Directive 2011/65/EU.
(17) The inclusion of materials and components of electrical and electronic equipment should not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council(7). Pursuant to point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006, lead is restricted in articles and their accessible parts with the aim of minimising children’s lead exposure from articles supplied to the general public. Lead in those articles or accessible parts is restricted to not more than 0,05 % by weight if those components may be placed in the mouth of children. To ensure compliance with the protection level established by Regulation (EC) No 1907/2006, the approved exemption entries should be marked with a footnote, which further restricts the applications in accordance with point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006.
(18) Directive 2011/65/EU should therefore be amended accordingly,
‘6(a) Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0,35 % lead by weight Expires on 11 december 2026
6(a)-I Lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight(*1) Expires on 30 June 2027 for all categories.
6(a)-II Lead as an alloying element in batch hot-dip galvanised steel components containing up to 0,2 % lead by weight(*1) Expires on 30 June 2027 for all categories.
6(b) Lead as an alloying element in aluminium containing up to 0,4 % lead by weight Expires on 11 June 2027
6(b)-I Lead as an alloying element in aluminium containing up to 0,4 % lead by weight, provided it stems from lead-bearing aluminium scrap recycling(*1) Expires on 11 december 2026 for categories 1-7, 10.Expires on 30 June 2027 for categories 9 industrial monitoring and control instruments, and 11.
6(b)-II Lead as an alloying element in aluminium for machining purposes with a lead content up to 0,4 % by weight(*1) Expires on 11 June 2027 for categories 1-7, 10.Expires on 30 June 2027 for categories 9 industrial monitoring and control instruments and 11 (*).
6(b)-III Lead as an alloying element in aluminium casting alloys containing up to 0,3 % lead by weight provided it stems from lead-bearing aluminium scrap recycling(*1) Expires on 30 June 2027 for categories 1-8, 9 other than industrial monitoring and control instruments, and 10.
6(c) Copper alloy containing up to 4 % lead by weight(*1) Expires on 30 June 2027.
— the rate of lead release from such an EEE or any accessible part, whether coated or uncoated, does not exceed 0,05 μg/cm2per hour (equivalent to 0,05 μg/g/h),
— for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the EEE.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(1), and in particular Article 5(1), point (a) and (b), thereof,
(1) Article 4(1) of Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex III to that Directive.
(2) The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The maximum tolerated concentration value is 0,1 % by weight of lead in homogenous materials.
(4) Commission Delegated Directive (EU) 2018/739(2)granted an exemption for the use of lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight and in batch hot dip galvanised steel components containing up to 0,2 % lead by weight, as set out in point 6(a)-I of Annex III to Directive 2011/65/EU. That exemption covers categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(a) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(5) Commission Delegated Directive (EU) 2018/740(3)granted exemptions for the use of lead as an alloying element in aluminium containing up to 0,4 % lead by weight either for machining purposes or for recycling of lead-bearing aluminium scrap. The exemptions are set out in points 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU. Those exemptions cover categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(b) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(6) Commission Delegated Directive (EU) 2018/741(4)granted an exemption for the use of copper alloy containing up to 4 % lead by weight for all categories, as set out in point 6(c) of Annex III to Directive 2011/65/EU.
(7) On 17 January 2020 and 20 January 2020, the Commission received two applications for renewing the exemptions set out in points 6(a) and 6(a)-I of Annex III to Directive 2011/65/EU in light of scientific and technical progress, in particular with regard to its scope. On 2 December 2019 and 17 January 2020, the Commission received two applications for renewing the exemption set out in points 6(b), 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU and on 15 January 2020 and 16 January 2020, the Commission received two applications for renewing the exemption set out in point 6(c) of Annex III to Directive 2011/65/EU.
(8) For the exemptions set out in points 6(a), 6(b) and 6(c) of Annex III to Directive 2011/65/EU, the electrical and electronic equipment category 8 ‘in vitro diagnostic medical devices’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2023 and the categories 9 ‘industrial monitoring and control instruments’ and 11 ‘other electrical and electronic equipment not covered by any of the categories’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2024. On 20 January 2023, two renewal applications were received for each exemption set out in points 6(a) and 6(b) of Annex III to Directive 2011/65/EU and specifically regarding those three categories. In accordance with Article 5(5), second subparagraph, of Directive 2011/65/EU, their submission extended the validity of the existing exemptions until a decision on the renewal applications is taken.
(9) In order to evaluate the applications received, a technical and scientific assessment study was carried out and finalised in 2022(5). A further study focussing on the categories for which a renewal was requested at a later stage was carried out and finalised in 2024(6). The evaluations included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.
(10) The evaluation of the requested exemption renewal concluded that, regarding the exemption set out in point 6(a)-I of Annex III to Directive 2011/65/EU, lead is still necessary in steel to achieve certain machining properties. A substitution or elimination in batch hot dip galvanised steel is currently not technically feasible nor economically viable. However, both technical applications can be split between points 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, to allow a more dedicated examination in the next review.
(11) In order to provide sufficient time to substitute lead in steel and to avoid negative impacts, which outweigh the benefits of a substitution, it is appropriate to grant a short-term validity period for those applications, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. As regards points 6(a), 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, it is appropriate to set one expiry date for all categories listed in Annex I of that Directive.
(12) The exemption set out in point 6(a) of Annex III to Directive 2011/65/EU should expire 12 months after the date of the decision on the renewal application, in accordance with Article 5(6) of that Directive.
(13) As regards the exemption set out in point 6(b)-I of Annex III to Directive 2011/65/EU concerning lead in aluminium stemming from lead-bearing aluminium scrap recycling, it was found that the lead concentration can further be reduced to 0,3 % by weight in aluminium. That should be set out in a new point, specifying that such aluminium is a casted alloy.
(14) The use of intentionally added lead in aluminium for machining purposes is no more needed for electrical and electronic equipment. Reliable substitutes for lead in aluminium exist on the market. The last application area relying on such an exemption is expected to be replaced by alternatives by 2025. In accordance with Article 5(6) of Directive 2011/65/EU, the maximum transition period of 18 months should be set to allow individual market participants in the industry to adapt.
(15) It was found that the use of aluminium alloys containing lead with lead concentration below 0,4 % by weight requires redesign and requalification of electrical and electronic equipment falling under category 9 ‘industrial monitoring and control instruments’ and open-scope category 11 ‘other electrical and electronic equipment’, which requires more time for compliance when compared to other categories referred to in Annex I to Directive 2011/65/EU. Therefore, longer validity periods should be considered for those two categories.
(16) As regards point 6(c) of Annex III to Directive 2011/65/EU concerning copper alloys containing up to 4 % lead by weight, it was not possible during the scientific and technical assessment to identify and define application areas that no longer require the exemption, despite many indications that lead could be successfully substituted in certain applications. Since substitutes are not sufficiently reliable, an extension of the exemption should be granted. In view of the technical evaluation, it is appropriate to set one expiry date for all categories listed in Annex I to Directive 2011/65/EU.
(17) The inclusion of materials and components of electrical and electronic equipment should not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council(7). Pursuant to point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006, lead is restricted in articles and their accessible parts with the aim of minimising children’s lead exposure from articles supplied to the general public. Lead in those articles or accessible parts is restricted to not more than 0,05 % by weight if those components may be placed in the mouth of children. To ensure compliance with the protection level established by Regulation (EC) No 1907/2006, the approved exemption entries should be marked with a footnote, which further restricts the applications in accordance with point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006.
(18) Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex III to Directive 2011/65/EU is amended in accordance with the Annex to this Directive.

Article 2
1. Member States shall adopt and publish, by 30 June 2026 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 July 2026.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3
This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment(1), and in particular Article 5(1), point (a) and (b), thereof,
(1) Article 4(1) of Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex III to that Directive.
(2) The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.
(3) Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The maximum tolerated concentration value is 0,1 % by weight of lead in homogenous materials.
(4) Commission Delegated Directive (EU) 2018/739(2)granted an exemption for the use of lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight and in batch hot dip galvanised steel components containing up to 0,2 % lead by weight, as set out in point 6(a)-I of Annex III to Directive 2011/65/EU. That exemption covers categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(a) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(5) Commission Delegated Directive (EU) 2018/740(3)granted exemptions for the use of lead as an alloying element in aluminium containing up to 0,4 % lead by weight either for machining purposes or for recycling of lead-bearing aluminium scrap. The exemptions are set out in points 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU. Those exemptions cover categories 1 to 7 and category 10 of electrical and electronic equipment, listed in Annex I to Directive 2011/65/EU. The application of the exemption set out in point 6(b) of Annex III to that Directive was limited to electrical and electronic equipment categories 8, 9 and 11.
(6) Commission Delegated Directive (EU) 2018/741(4)granted an exemption for the use of copper alloy containing up to 4 % lead by weight for all categories, as set out in point 6(c) of Annex III to Directive 2011/65/EU.
(7) On 17 January 2020 and 20 January 2020, the Commission received two applications for renewing the exemptions set out in points 6(a) and 6(a)-I of Annex III to Directive 2011/65/EU in light of scientific and technical progress, in particular with regard to its scope. On 2 December 2019 and 17 January 2020, the Commission received two applications for renewing the exemption set out in points 6(b), 6(b)-I and 6(b)-II of Annex III to Directive 2011/65/EU and on 15 January 2020 and 16 January 2020, the Commission received two applications for renewing the exemption set out in point 6(c) of Annex III to Directive 2011/65/EU.
(8) For the exemptions set out in points 6(a), 6(b) and 6(c) of Annex III to Directive 2011/65/EU, the electrical and electronic equipment category 8 ‘in vitro diagnostic medical devices’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2023 and the categories 9 ‘industrial monitoring and control instruments’ and 11 ‘other electrical and electronic equipment not covered by any of the categories’, referred to in Annex I to Directive 2011/65/EU, were to expire on 21 July 2024. On 20 January 2023, two renewal applications were received for each exemption set out in points 6(a) and 6(b) of Annex III to Directive 2011/65/EU and specifically regarding those three categories. In accordance with Article 5(5), second subparagraph, of Directive 2011/65/EU, their submission extended the validity of the existing exemptions until a decision on the renewal applications is taken.
(9) In order to evaluate the applications received, a technical and scientific assessment study was carried out and finalised in 2022(5). A further study focussing on the categories for which a renewal was requested at a later stage was carried out and finalised in 2024(6). The evaluations included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.
(10) The evaluation of the requested exemption renewal concluded that, regarding the exemption set out in point 6(a)-I of Annex III to Directive 2011/65/EU, lead is still necessary in steel to achieve certain machining properties. A substitution or elimination in batch hot dip galvanised steel is currently not technically feasible nor economically viable. However, both technical applications can be split between points 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, to allow a more dedicated examination in the next review.
(11) In order to provide sufficient time to substitute lead in steel and to avoid negative impacts, which outweigh the benefits of a substitution, it is appropriate to grant a short-term validity period for those applications, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. As regards points 6(a), 6(a)-I and 6(a)-II of Annex III to Directive 2011/65/EU, it is appropriate to set one expiry date for all categories listed in Annex I of that Directive.
(12) The exemption set out in point 6(a) of Annex III to Directive 2011/65/EU should expire 12 months after the date of the decision on the renewal application, in accordance with Article 5(6) of that Directive.
(13) As regards the exemption set out in point 6(b)-I of Annex III to Directive 2011/65/EU concerning lead in aluminium stemming from lead-bearing aluminium scrap recycling, it was found that the lead concentration can further be reduced to 0,3 % by weight in aluminium. That should be set out in a new point, specifying that such aluminium is a casted alloy.
(14) The use of intentionally added lead in aluminium for machining purposes is no more needed for electrical and electronic equipment. Reliable substitutes for lead in aluminium exist on the market. The last application area relying on such an exemption is expected to be replaced by alternatives by 2025. In accordance with Article 5(6) of Directive 2011/65/EU, the maximum transition period of 18 months should be set to allow individual market participants in the industry to adapt.
(15) It was found that the use of aluminium alloys containing lead with lead concentration below 0,4 % by weight requires redesign and requalification of electrical and electronic equipment falling under category 9 ‘industrial monitoring and control instruments’ and open-scope category 11 ‘other electrical and electronic equipment’, which requires more time for compliance when compared to other categories referred to in Annex I to Directive 2011/65/EU. Therefore, longer validity periods should be considered for those two categories.
(16) As regards point 6(c) of Annex III to Directive 2011/65/EU concerning copper alloys containing up to 4 % lead by weight, it was not possible during the scientific and technical assessment to identify and define application areas that no longer require the exemption, despite many indications that lead could be successfully substituted in certain applications. Since substitutes are not sufficiently reliable, an extension of the exemption should be granted. In view of the technical evaluation, it is appropriate to set one expiry date for all categories listed in Annex I to Directive 2011/65/EU.
(17) The inclusion of materials and components of electrical and electronic equipment should not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council(7). Pursuant to point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006, lead is restricted in articles and their accessible parts with the aim of minimising children’s lead exposure from articles supplied to the general public. Lead in those articles or accessible parts is restricted to not more than 0,05 % by weight if those components may be placed in the mouth of children. To ensure compliance with the protection level established by Regulation (EC) No 1907/2006, the approved exemption entries should be marked with a footnote, which further restricts the applications in accordance with point 7 of the restriction set out in point 63 of Annex XVII to Regulation (EC) No 1907/2006.
(18) Directive 2011/65/EU should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE:
Annex III to Directive 2011/65/EU is amended in accordance with the Annex to this Directive.
1. Member States shall adopt and publish, by 30 June 2026 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
They shall apply those provisions from 1 July 2026.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEXIn Annex III to Directive 2011/65/EU, points 6(a), 6(a)-I, 6(b), 6(b)-I, 6(b)-II and 6(c) are replaced by the following:

‘6(a) Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0,35 % lead by weight
Expires on 11 december 2026
6(a)-I
Lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight (*1)
Expires on 30 June 2027 for all categories.
6(a)-II
Lead as an alloying element in batch hot-dip galvanised steel components containing up to 0,2 % lead by weight (*1)
Expires on 30 June 2027 for all categories.
6(b) Lead as an alloying element in aluminium containing up to 0,4 % lead by weight
Expires on 11 June 2027
6(b)-I
Lead as an alloying element in aluminium containing up to 0,4 % lead by weight, provided it stems from lead-bearing aluminium scrap recycling (*1)
Expires on 11 december 2026 for categories 1-7, 10. Expires on 30 June 2027 for categories 9 industrial monitoring and control instruments, and 11. 6(b)-II
Lead as an alloying element in aluminium for machining purposes with a lead content up to 0,4 % by weight (*1)
Expires on 11 June 2027 for categories 1-7, 10. Expires on 30 June 2027 for categories 9 industrial monitoring and control instruments and 11 (*).
6(b)-III
Lead as an alloying element in aluminium casting alloys containing up to 0,3 % lead by weight provided it stems from lead-bearing aluminium scrap recycling (*1)
Expires on 30 June 2027 for categories 1-8, 9 other than industrial monitoring and control instruments, and 10. 6(c) Copper alloy containing up to 4 % lead by weight (*1)
Expires on 30 June 2027.
(*1) The exemption shall not cover EEE for supply to the general public where the EEE or accessible part thereof may, during normal or foreseeable conditions of use, be placed in the mouth by children. However, the exemption shall apply where the following can be both demonstrated:
— | the rate of lead release from such an EEE or any accessible part, whether coated or uncoated, does not exceed 0,05 μg/cm2per hour (equivalent to 0,05 μg/g/h),
— | for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the EEE.For the purpose of this footnote, it is considered that an EEE or accessible part of an EEE may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size.’.