Pending: 32010L0019

20.3.2010 EN Official Journal of the European Union L 72/17
(1) Council Directive 91/226/EEC of 27 March 1991 on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers(2)is one of the separate directives in the context of the EC type-approval procedure established under Directive 2007/46/EC. The provisions of Directive 2007/46/EC relating to systems, components and separate technical units for vehicles therefore apply to Directive 91/226/EEC.
(2) In view of the mandatory application of the EC type-approval procedure to all vehicle categories covered by Directive 2007/46/EC, it is necessary to provide harmonised requirements with regard to spray suppression for all vehicle categories covered by Directive 91/226/EEC. Furthermore, it is necessary to clarify that those requirements are not mandatory for off-road vehicles. Finally, in view of the experience gained, it is necessary to adapt Directive 91/226/EEC and, consequently, Annex IV to Directive 2007/46/EC to technical progress.
(3) Directives 91/226/EEC and 2007/46/EC should therefore be amended accordingly.
(4) The measures provided for in this Directive are in accordance with the opinion of the Technical Committee — Motor Vehicles,
1. the list of Annexes and Annexes I, II and III are amended in accordance with Annex I to this Directive;
2. the unnumbered Annex entitled ‘Figures’ is replaced by the text set out in Annex II to this Directive.
‘43 Spray suppression systems Directive 91/226/EEC L 103, 23.4.1991, p. 5 X X X X X X X’
(a) the title relating to Appendix 3 of Annex II is replaced by the following:‘Information document for EC component type-approval’;
(b) the title relating to Annex III is replaced by the following:‘Annex III:Requirements relating to the EC type approval of a vehicle with regard to the fitting of spray suppression systemsAppendix 1:Information document for EC vehicle type-approvalAppendix 2:Model for EC vehicle type-approval certificate’; ‘Annex III : Requirements relating to the EC type approval of a vehicle with regard to the fitting of spray suppression systemsAppendix 1:Information document for EC vehicle type-approvalAppendix 2:Model for EC vehicle type-approval certificate’; Appendix 1 : Information document for EC vehicle type-approval Appendix 2 : Model for EC vehicle type-approval certificate’;
‘Annex III : Requirements relating to the EC type approval of a vehicle with regard to the fitting of spray suppression systemsAppendix 1:Information document for EC vehicle type-approvalAppendix 2:Model for EC vehicle type-approval certificate’; Appendix 1 : Information document for EC vehicle type-approval Appendix 2 : Model for EC vehicle type-approval certificate’;
Appendix 1 : Information document for EC vehicle type-approval
Appendix 2 : Model for EC vehicle type-approval certificate’;
‘Annex III : Requirements relating to the EC type approval of a vehicle with regard to the fitting of spray suppression systemsAppendix 1:Information document for EC vehicle type-approvalAppendix 2:Model for EC vehicle type-approval certificate’; Appendix 1 : Information document for EC vehicle type-approval Appendix 2 : Model for EC vehicle type-approval certificate’;
Appendix 1 : Information document for EC vehicle type-approval
Appendix 2 : Model for EC vehicle type-approval certificate’;
Appendix 1 : Information document for EC vehicle type-approval
Appendix 2 : Model for EC vehicle type-approval certificate’;
(c) the line ‘FIGURES: (1 to 9)’ is replaced by the following:‘Annex V:Figures 1 to 9’. ‘Annex V : Figures 1 to 9’.
‘Annex V : Figures 1 to 9’.
‘Annex V : Figures 1 to 9’.
(a) points 9, 10 and 11 are replaced by the following:‘9.Retractable axle“Retractable axle” means an axle as defined in Annex I point 2.15 to Directive 97/27/EC.10.Unladen vehicle“Unladen vehicle” means a vehicle in running order as defined in point 2.6 of Annex I to Directive 2007/46/EC of the European Parliament and of the Council(*1).11.Tread“Tread” is the part of the tyre as defined in point 2.8 of Annex II to Directive 92/23/EEC.(*1)OJ L 263, 9.10.2007, p. 1.’;"
(b) the following points 13, 14 and 15 are added:‘13.Semitrailer towing vehicle“Semitrailer towing vehicle” means a towing vehicle as defined in point 2.1.1.2.2 of Annex I to Directive 97/27/EC.14.Technically permissible maximum laden mass“Technically permissible maximum laden mass” means the maximum mass of the vehicle as defined in point 2.6 of Annex I to Directive 97/27/EC.15.Type of vehicle“Type of vehicle” means, in relation to spray suppression complete, incomplete or completed vehicles, which do not differ with respect to the following aspects:—type of spray suppression device (installed on the vehicle),—manufacturer’s spray suppression system type designation.’ — type of spray suppression device (installed on the vehicle), — manufacturer’s spray suppression system type designation.’
— type of spray suppression device (installed on the vehicle),
— manufacturer’s spray suppression system type designation.’
— type of spray suppression device (installed on the vehicle),
— manufacturer’s spray suppression system type designation.’
(a) points 2 to 3.4.3 are replaced by the following:‘2.Application for EC component type-approval2.1.   The application for EC component type-approval pursuant to Article 7 of Directive 2007/46/EC of a type of spray-suppression device shall be submitted by the manufacturer.2.2.   A model for the information document is set out in Appendix 3.2.3.   The following shall be submitted to the technical service responsible for conducting the type-approval tests:Four samples: three of which for tests and a fourth to be kept by the laboratory for any subsequent verification. The test laboratory may require further samples.2.4.   MarkingsEach sample must be clearly and indelibly marked with the trade name or mark and an indication of the type and include a space that is large enough for the EC component type-approval mark.3.Granting of EC component type-approval3.1.   If the relevant requirements are satisfied, EC type-approval pursuant to Article 10 of Directive 2007/46/EC shall be granted.3.2.   A model for the EC type-approval certificate is set out in Appendix 4.3.3.   An approval number in accordance with Annex VII to Directive 2007/46/EC shall be assigned to each type of spray-suppression device approved. The same Member State shall not assign the same number to another type of spray-suppression device.3.4.   Any spray-suppression device in conformity with a type approved pursuant to this Directive shall bear an EC component type-approval mark, so affixed as to be indelible and easily legible even when the device is fitted to the vehicle.3.5.   A symbol “A” for devices of the energy-absorption type or “S” for devices of the air/water separator type shall be added to the approval mark in accordance with point 1.3 of the Appendix of Annex VII to Directive 2007/46/EC.’;
(b) Appendices 1 to 4 are replaced by the following:‘Appendix 1Tests on spray-suppression devices of the energy-absorber type1.PrincipleThe aim of this test is to quantify the ability of a device to retain the water directed against it by a series of jets. The test assembly is intended to reproduce the conditions under which the device is to function when fitted to a vehicle as regards the volume and speed of the water thrown up from the ground by the tyre tread.2.EquipmentSee Figure 8 in Annex V for a description of the test assembly.3.Test conditions3.1.The tests must be carried out in a closed room with a still-air environment.3.2.The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.3.3.De-ionized water is to be used.3.4.The test pieces must be prepared for each test by wetting.4.Procedure4.1.Secure a 500 (+ 0/– 5) mm wide 750 mm high sample of the equipment to be tested to the vertical plate of the testing equipment, making sure that the sample lies well within the limits of the collector, and that no obstacle is able to deflect the water, either before or after its impact.4.2.Set the water flow rate at 0,675 (+/– 0,01) l/s and direct at least 90 l, at most 120 l on to the sample from a horizontal distance of 500 (+/– 2) mm (Figure 8 of Annex V).4.3.Allow the water to trickle from the sample into the collector. Calculate the percentage of water collected versus the quantity of water sprayed.4.4.Carry out the test five times on the sample according to points 4.2 and 4.3. Calculate the average percentage of the series of five tests.5.Results5.1.The average percentage calculated in point 4.4 must be 70 % or higher.5.2.If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated.If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 % and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.5.3.Test whether the vertical position of the device influences the results obtained. If it is the case, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentage of water collected; the requirements of point 5.2 remain in force.The mean of the individual results shall then be taken to give the average percentage. this average percentage must be 70 or higher.‘Appendix 2Test on spray-suppression devices of the air/water separator type1.PrincipleThis test is intended to determine the effectiveness of a porous material intended to retain the water with which it has been sprayed by means of a pressurised air/water pulveriser.The equipment used for the test must simulate the conditions to which the material would be submitted, with regard to the volume and speed of the water sprays produced by the tyres, if it were fitted to a vehicle.2.EquipmentSee figure 9 in Annex v for a description of the test assembly.3.Test conditions3.1.The tests must be carried out in a closed room with a still-air environment.3.2.The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.3.3.De-ionized water must be used.3.4.The test pieces must be prepared for each test by wetting4.Procedure4.1.Secure a 305 × 100 mm sample vertically in the test assembly, check that there is no space between the sample and the upper curved plate and that the tray is properly in position. Fill the pulveriser tank with 1 ± 0,005 litres of water and place this as described in the diagram.4.2.The pulveriser must be regulated as follows:pressure (at pulveriser): 5 bar + 10 %/– 0 %flowrate: 1 litre/minute ± 5 secondspulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.4.3.Pulverise until there is no more water mist and note the time taken. Let the water flow out of the sample on to the tray for 60 seconds and measure the volume of water collected. Measure the quantity of water left in the pulveriser tank. Calculate the percentage by volume of water collected versus the volume of water pulverised.4.4.Carry out the test five times and calculate the average percentage of the quantity collected. Check before each test that the tray, pulveriser tank and measuring vessel are dry.5.Results5.1.The average percentage calculated in point 4.4 must be 85 % or higher.5.2.If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated. If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 %, and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.5.3.Where the vertical position of the device influences the results obtained, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentages of water collected; the requirements of point 5.2 remain in force.The requirement of point 5.1 remains in force in order to give the results of each test.‘Appendix 3Information document No … relating to the EC component type-approval of spray suppression devices (Directive 91/226/EEC)The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.0.   GENERAL0.1.Make (trade name of manufacturer):0.2.Type:0.5.Name and address of manufacturer:0.7.In the case of components and separate technical units, location and method of affixing of the EC approval mark:0.8.Address(es) of assembly plant(s):1.   DESCRIPTION OF THE DEVICE1.1.A technical description of the spray-suppression device indicating its physical operating principle and the relevant test to which it must be subject:1.2.The materials used:1.3.Drawing(s) in sufficient detail and to an appropriate scale to enable this (or these) to be identified. The drawing must show the space intended for the EEC component type-approval mark:DateSigned‘Appendix 4Text of imageMODEL(maximum format: A4 (210 × 297 mm))EC TYPE-APPROVAL CERTIFICATEStamp of type-approval authorityCommunication concerning:EC type approvalExtension of EC type approvalRefusal of EC type approvalWithdrawal of EC type approvalof a type of a vehicle/component/separate technical unit (1) with regard to Directive 91/226/EEC, as last amended by Commission Directive 2010/19/EU (2)Type-approval number:Reason for extension:SECTION I0.1. Make (trade name of manufacturer):0.2. Type:0.3. Means of identification of type if marked on the vehicle/component/separate technical unit (1) (3)0.3.1. Location of that marking:0.4. Category of vehicle (4)0.5. Name and address of manufacturer:0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:0.8. Address(es) of assembly plant(s):SECTION II1. Additional information (where applicable): see Addendum2. Technical service responsible for carrying out the tests:3. Date of test report:4. Number of test report:5. Remarks (if any): see Addendum6. Place:7. Date:8. Signature:9. The index to the information package lodged with the approval authority, which may be obtained on request, is attached.(1) Delete where not applicable.(2) OJ L 72, 20.3.2010, p. 17.(3) If the means of identification type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).(4) As defined in Annex II A to Directive 2007/46/EC.‘Addendumto EC type-approval certificate No … concerning the component type-approval of spray suppression devices with regard to Directive 91/226/EEC as last amended by Directive 2010/19/EU1.   Additional information1.1.Operating principle of device: energy-absorption/air/water separator(1):1.2.Characteristics of spray-suppression devices (brief description, trademark or name, number(s):5.Remarks (if any): 3.1. The tests must be carried out in a closed room with a still-air environment. 3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C. 3.3. De-ionized water is to be used. 3.4. The test pieces must be prepared for each test by wetting. 4.1. Secure a 500 (+ 0/– 5) mm wide 750 mm high sample of the equipment to be tested to the vertical plate of the testing equipment, making sure that the sample lies well within the limits of the collector, and that no obstacle is able to deflect the water, either before or after its impact. 4.2. Set the water flow rate at 0,675 (+/– 0,01) l/s and direct at least 90 l, at most 120 l on to the sample from a horizontal distance of 500 (+/– 2) mm (Figure 8 of Annex V). 4.3. Allow the water to trickle from the sample into the collector. Calculate the percentage of water collected versus the quantity of water sprayed. 4.4. Carry out the test five times on the sample according to points 4.2 and 4.3. Calculate the average percentage of the series of five tests. 5.1. The average percentage calculated in point 4.4 must be 70 % or higher. 5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated.If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 % and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused. 5.3. Test whether the vertical position of the device influences the results obtained. If it is the case, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentage of water collected; the requirements of point 5.2 remain in force.The mean of the individual results shall then be taken to give the average percentage. this average percentage must be 70 or higher. 3.1. The tests must be carried out in a closed room with a still-air environment. 3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C. 3.3. De-ionized water must be used. 3.4. The test pieces must be prepared for each test by wetting 4.1. Secure a 305 × 100 mm sample vertically in the test assembly, check that there is no space between the sample and the upper curved plate and that the tray is properly in position. Fill the pulveriser tank with 1 ± 0,005 litres of water and place this as described in the diagram. 4.2. The pulveriser must be regulated as follows:pressure (at pulveriser): 5 bar + 10 %/– 0 %flowrate: 1 litre/minute ± 5 secondspulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter. pressure (at pulveriser): 5 bar + 10 %/– 0 % flowrate: 1 litre/minute ± 5 seconds pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter. 4.3. Pulverise until there is no more water mist and note the time taken. Let the water flow out of the sample on to the tray for 60 seconds and measure the volume of water collected. Measure the quantity of water left in the pulveriser tank. Calculate the percentage by volume of water collected versus the volume of water pulverised. 4.4. Carry out the test five times and calculate the average percentage of the quantity collected. Check before each test that the tray, pulveriser tank and measuring vessel are dry. 5.1. The average percentage calculated in point 4.4 must be 85 % or higher. 5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated. If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 %, and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused. 5.3. Where the vertical position of the device influences the results obtained, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentages of water collected; the requirements of point 5.2 remain in force.The requirement of point 5.1 remains in force in order to give the results of each test. 0.1. Make (trade name of manufacturer): 0.2. Type: 0.5. Name and address of manufacturer: 0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark: 0.8. Address(es) of assembly plant(s): 1.1. A technical description of the spray-suppression device indicating its physical operating principle and the relevant test to which it must be subject: 1.2. The materials used: 1.3. Drawing(s) in sufficient detail and to an appropriate scale to enable this (or these) to be identified. The drawing must show the space intended for the EEC component type-approval mark:DateSigned 1.1. Operating principle of device: energy-absorption/air/water separator(1): 1.2. Characteristics of spray-suppression devices (brief description, trademark or name, number(s): 5. Remarks (if any):
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water is to be used.
3.4. The test pieces must be prepared for each test by wetting.
4.1. Secure a 500 (+ 0/– 5) mm wide 750 mm high sample of the equipment to be tested to the vertical plate of the testing equipment, making sure that the sample lies well within the limits of the collector, and that no obstacle is able to deflect the water, either before or after its impact.
4.2. Set the water flow rate at 0,675 (+/– 0,01) l/s and direct at least 90 l, at most 120 l on to the sample from a horizontal distance of 500 (+/– 2) mm (Figure 8 of Annex V).
4.3. Allow the water to trickle from the sample into the collector. Calculate the percentage of water collected versus the quantity of water sprayed.
4.4. Carry out the test five times on the sample according to points 4.2 and 4.3. Calculate the average percentage of the series of five tests.
5.1. The average percentage calculated in point 4.4 must be 70 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated.If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 % and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Test whether the vertical position of the device influences the results obtained. If it is the case, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentage of water collected; the requirements of point 5.2 remain in force.The mean of the individual results shall then be taken to give the average percentage. this average percentage must be 70 or higher.
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water must be used.
3.4. The test pieces must be prepared for each test by wetting
4.1. Secure a 305 × 100 mm sample vertically in the test assembly, check that there is no space between the sample and the upper curved plate and that the tray is properly in position. Fill the pulveriser tank with 1 ± 0,005 litres of water and place this as described in the diagram.
4.2. The pulveriser must be regulated as follows:pressure (at pulveriser): 5 bar + 10 %/– 0 %flowrate: 1 litre/minute ± 5 secondspulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter. pressure (at pulveriser): 5 bar + 10 %/– 0 % flowrate: 1 litre/minute ± 5 seconds pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
pressure (at pulveriser): 5 bar + 10 %/– 0 %
flowrate: 1 litre/minute ± 5 seconds
pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
4.3. Pulverise until there is no more water mist and note the time taken. Let the water flow out of the sample on to the tray for 60 seconds and measure the volume of water collected. Measure the quantity of water left in the pulveriser tank. Calculate the percentage by volume of water collected versus the volume of water pulverised.
4.4. Carry out the test five times and calculate the average percentage of the quantity collected. Check before each test that the tray, pulveriser tank and measuring vessel are dry.
5.1. The average percentage calculated in point 4.4 must be 85 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated. If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 %, and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Where the vertical position of the device influences the results obtained, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentages of water collected; the requirements of point 5.2 remain in force.The requirement of point 5.1 remains in force in order to give the results of each test.
0.1. Make (trade name of manufacturer):
0.2. Type:
0.5. Name and address of manufacturer:
0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:
0.8. Address(es) of assembly plant(s):
1.1. A technical description of the spray-suppression device indicating its physical operating principle and the relevant test to which it must be subject:
1.2. The materials used:
1.3. Drawing(s) in sufficient detail and to an appropriate scale to enable this (or these) to be identified. The drawing must show the space intended for the EEC component type-approval mark:DateSigned
1.1. Operating principle of device: energy-absorption/air/water separator(1):
1.2. Characteristics of spray-suppression devices (brief description, trademark or name, number(s):
5. Remarks (if any):
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water is to be used.
3.4. The test pieces must be prepared for each test by wetting.
4.1. Secure a 500 (+ 0/– 5) mm wide 750 mm high sample of the equipment to be tested to the vertical plate of the testing equipment, making sure that the sample lies well within the limits of the collector, and that no obstacle is able to deflect the water, either before or after its impact.
4.2. Set the water flow rate at 0,675 (+/– 0,01) l/s and direct at least 90 l, at most 120 l on to the sample from a horizontal distance of 500 (+/– 2) mm (Figure 8 of Annex V).
4.3. Allow the water to trickle from the sample into the collector. Calculate the percentage of water collected versus the quantity of water sprayed.
4.4. Carry out the test five times on the sample according to points 4.2 and 4.3. Calculate the average percentage of the series of five tests.
5.1. The average percentage calculated in point 4.4 must be 70 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated.If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 % and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Test whether the vertical position of the device influences the results obtained. If it is the case, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentage of water collected; the requirements of point 5.2 remain in force.The mean of the individual results shall then be taken to give the average percentage. this average percentage must be 70 or higher.
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water must be used.
3.4. The test pieces must be prepared for each test by wetting
4.1. Secure a 305 × 100 mm sample vertically in the test assembly, check that there is no space between the sample and the upper curved plate and that the tray is properly in position. Fill the pulveriser tank with 1 ± 0,005 litres of water and place this as described in the diagram.
4.2. The pulveriser must be regulated as follows:pressure (at pulveriser): 5 bar + 10 %/– 0 %flowrate: 1 litre/minute ± 5 secondspulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter. pressure (at pulveriser): 5 bar + 10 %/– 0 % flowrate: 1 litre/minute ± 5 seconds pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
pressure (at pulveriser): 5 bar + 10 %/– 0 %
flowrate: 1 litre/minute ± 5 seconds
pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
pressure (at pulveriser): 5 bar + 10 %/– 0 %
flowrate: 1 litre/minute ± 5 seconds
pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
4.3. Pulverise until there is no more water mist and note the time taken. Let the water flow out of the sample on to the tray for 60 seconds and measure the volume of water collected. Measure the quantity of water left in the pulveriser tank. Calculate the percentage by volume of water collected versus the volume of water pulverised.
4.4. Carry out the test five times and calculate the average percentage of the quantity collected. Check before each test that the tray, pulveriser tank and measuring vessel are dry.
5.1. The average percentage calculated in point 4.4 must be 85 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated. If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 %, and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Where the vertical position of the device influences the results obtained, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentages of water collected; the requirements of point 5.2 remain in force.The requirement of point 5.1 remains in force in order to give the results of each test.
0.1. Make (trade name of manufacturer):
0.2. Type:
0.5. Name and address of manufacturer:
0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:
0.8. Address(es) of assembly plant(s):
1.1. A technical description of the spray-suppression device indicating its physical operating principle and the relevant test to which it must be subject:
1.2. The materials used:
1.3. Drawing(s) in sufficient detail and to an appropriate scale to enable this (or these) to be identified. The drawing must show the space intended for the EEC component type-approval mark:DateSigned
1.1. Operating principle of device: energy-absorption/air/water separator(1):
1.2. Characteristics of spray-suppression devices (brief description, trademark or name, number(s):
5. Remarks (if any):
(a) points 0.1 and 0.2 are replaced by the following:‘SCOPE0.1.Category N and O vehicles, with the exception of off-road vehicles as defined in Annex II to Directive 2007/46/EC, shall be constructed and/or fitted with spray suppression systems in such a way as to meet the requirements laid down in this Annex. In case of chassis/cab vehicles, these requirements may only be applied to the wheels covered by the cab.For vehicles of category N1 and N2 with a permissible maximum laden mass not exceeding 7,5 tonnes, the requirements of Directive 78/549/EEC(*2)may be applied as alternative to the requirements of this Directive at the request of the manufacturer.0.2.The requirements of this Annex relating to spray-suppression devices, as defined in point 4 of Annex I, are not mandatory for categories N, O1and O2vehicles with a permissible maximum laden mass not exceeding 7,5 tonnes, chassis/cab vehicles, unbodied vehicles or vehicles on which the presence of spray-suppression devices would be incompatible with their use. However, if such devices are fitted to those vehicles, they must conform to the requirements of this Directive.(*2)OJ L 168, 26.6.1978, p. 45.’;" 0.1. Category N and O vehicles, with the exception of off-road vehicles as defined in Annex II to Directive 2007/46/EC, shall be constructed and/or fitted with spray suppression systems in such a way as to meet the requirements laid down in this Annex. In case of chassis/cab vehicles, these requirements may only be applied to the wheels covered by the cab.For vehicles of category N1 and N2 with a permissible maximum laden mass not exceeding 7,5 tonnes, the requirements of Directive 78/549/EEC(*2)may be applied as alternative to the requirements of this Directive at the request of the manufacturer. 0.2. The requirements of this Annex relating to spray-suppression devices, as defined in point 4 of Annex I, are not mandatory for categories N, O1and O2vehicles with a permissible maximum laden mass not exceeding 7,5 tonnes, chassis/cab vehicles, unbodied vehicles or vehicles on which the presence of spray-suppression devices would be incompatible with their use. However, if such devices are fitted to those vehicles, they must conform to the requirements of this Directive.
0.1. Category N and O vehicles, with the exception of off-road vehicles as defined in Annex II to Directive 2007/46/EC, shall be constructed and/or fitted with spray suppression systems in such a way as to meet the requirements laid down in this Annex. In case of chassis/cab vehicles, these requirements may only be applied to the wheels covered by the cab.For vehicles of category N1 and N2 with a permissible maximum laden mass not exceeding 7,5 tonnes, the requirements of Directive 78/549/EEC(*2)may be applied as alternative to the requirements of this Directive at the request of the manufacturer.
0.2. The requirements of this Annex relating to spray-suppression devices, as defined in point 4 of Annex I, are not mandatory for categories N, O1and O2vehicles with a permissible maximum laden mass not exceeding 7,5 tonnes, chassis/cab vehicles, unbodied vehicles or vehicles on which the presence of spray-suppression devices would be incompatible with their use. However, if such devices are fitted to those vehicles, they must conform to the requirements of this Directive.
0.1. Category N and O vehicles, with the exception of off-road vehicles as defined in Annex II to Directive 2007/46/EC, shall be constructed and/or fitted with spray suppression systems in such a way as to meet the requirements laid down in this Annex. In case of chassis/cab vehicles, these requirements may only be applied to the wheels covered by the cab.For vehicles of category N1 and N2 with a permissible maximum laden mass not exceeding 7,5 tonnes, the requirements of Directive 78/549/EEC(*2)may be applied as alternative to the requirements of this Directive at the request of the manufacturer.
0.2. The requirements of this Annex relating to spray-suppression devices, as defined in point 4 of Annex I, are not mandatory for categories N, O1and O2vehicles with a permissible maximum laden mass not exceeding 7,5 tonnes, chassis/cab vehicles, unbodied vehicles or vehicles on which the presence of spray-suppression devices would be incompatible with their use. However, if such devices are fitted to those vehicles, they must conform to the requirements of this Directive.
(b) point 4 is replaced by the following:‘4.Position of outer valanceThe distance “c” between the longitudinal plane tangential to the outer tyre wall, apart from any tyre bulge near the ground, and the inner edge of the valance must not exceed 100 mm (Figures 1a and 1b of Annex V).’;
(c) points 4.1 and 4.2 are deleted;
(d) point 7.1.1 is replaced by the following:‘7.1.1.The mudguards must cover the zone immediately above, ahead and behind the tyre or tyres in the following manner:(a)in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;(b)in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;(c)the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’; ‘7.1.1. The mudguards must cover the zone immediately above, ahead and behind the tyre or tyres in the following manner:(a)in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;(b)in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;(c)the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’; (a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel; (b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle; (c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
‘7.1.1. The mudguards must cover the zone immediately above, ahead and behind the tyre or tyres in the following manner:(a)in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;(b)in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;(c)the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’; (a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel; (b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle; (c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
(a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;
(b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;
(c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
‘7.1.1. The mudguards must cover the zone immediately above, ahead and behind the tyre or tyres in the following manner:(a)in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;(b)in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;(c)the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’; (a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel; (b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle; (c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
(a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;
(b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;
(c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
(a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;
(b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;
(c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
(e) point 7.1.3 is replaced by the following:‘7.1.3.If the mudguards are made up of several components, when fitted, they must not incorporate any aperture enabling spray to exit while the vehicle is in motion. This requirement is deemed to be met if, when the vehicle is either laden or unladen, any radial jet running outwards from the wheel centre over the entire width of the tyre running surface and within the range covered by the mudguard always strikes against a part of the spray suppression system.’; ‘7.1.3. If the mudguards are made up of several components, when fitted, they must not incorporate any aperture enabling spray to exit while the vehicle is in motion. This requirement is deemed to be met if, when the vehicle is either laden or unladen, any radial jet running outwards from the wheel centre over the entire width of the tyre running surface and within the range covered by the mudguard always strikes against a part of the spray suppression system.’;
‘7.1.3. If the mudguards are made up of several components, when fitted, they must not incorporate any aperture enabling spray to exit while the vehicle is in motion. This requirement is deemed to be met if, when the vehicle is either laden or unladen, any radial jet running outwards from the wheel centre over the entire width of the tyre running surface and within the range covered by the mudguard always strikes against a part of the spray suppression system.’;
‘7.1.3. If the mudguards are made up of several components, when fitted, they must not incorporate any aperture enabling spray to exit while the vehicle is in motion. This requirement is deemed to be met if, when the vehicle is either laden or unladen, any radial jet running outwards from the wheel centre over the entire width of the tyre running surface and within the range covered by the mudguard always strikes against a part of the spray suppression system.’;
(f) points 7.2.1, 7.2.2 and 7.2.3 are replaced by the following:‘7.2.1.In the case of single axles, the lower edge of the outer valance may not be situated beyond the following distances and radii, as measured from the centre of the wheel, except at the lowest extremities that may be rounded (Figure 2 of Annex V).Air suspension:(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A)Rv≤ 1,5 R(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A)Rv≤ 1,25 RMechanical suspension(a)general case } Rv≤ 1,8 R(b)non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.7.2.2.In the case of multiple axles the requirements laid down in point 7.2.1 do not apply between the vertical transversal planes passing through the centre of the first and the last axles where the outer valance may be straight in order to ensure the continuity of the spray suppression system. (Figure 4 of Annex V).7.2.3.The distance between the uppermost and the lowermost points of the spray suppression system (mudguard and outer valance) measured in any cross section perpendicular to the mudguard (see figures 1b and 2 in Annex V) must extend to not less than 45 mm at all points behind a vertical line passing through the centre of the wheel or the first wheel in the case of multiple axles. This dimension may be gradually reduced in front of this line.’; ‘7.2.1. In the case of single axles, the lower edge of the outer valance may not be situated beyond the following distances and radii, as measured from the centre of the wheel, except at the lowest extremities that may be rounded (Figure 2 of Annex V).Air suspension:(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A)Rv≤ 1,5 R(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A)Rv≤ 1,25 RMechanical suspension(a)general case } Rv≤ 1,8 R(b)non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated. (a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R (b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R (a) general case } Rv≤ 1,8 R (b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated. 7.2.2. In the case of multiple axles the requirements laid down in point 7.2.1 do not apply between the vertical transversal planes passing through the centre of the first and the last axles where the outer valance may be straight in order to ensure the continuity of the spray suppression system. (Figure 4 of Annex V). 7.2.3. The distance between the uppermost and the lowermost points of the spray suppression system (mudguard and outer valance) measured in any cross section perpendicular to the mudguard (see figures 1b and 2 in Annex V) must extend to not less than 45 mm at all points behind a vertical line passing through the centre of the wheel or the first wheel in the case of multiple axles. This dimension may be gradually reduced in front of this line.’;
‘7.2.1. In the case of single axles, the lower edge of the outer valance may not be situated beyond the following distances and radii, as measured from the centre of the wheel, except at the lowest extremities that may be rounded (Figure 2 of Annex V).Air suspension:(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A)Rv≤ 1,5 R(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A)Rv≤ 1,25 RMechanical suspension(a)general case } Rv≤ 1,8 R(b)non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated. (a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R (b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R (a) general case } Rv≤ 1,8 R (b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R
(a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A)
From the front edge (towards the front of the vehicle) (tip C)
To the rear edge (towards the rear of the vehicle) (tip A)
(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R
(b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A)
From the front edge (tip C)
To the rear edge (tip A)
(a) general case } Rv≤ 1,8 R
(b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
7.2.2. In the case of multiple axles the requirements laid down in point 7.2.1 do not apply between the vertical transversal planes passing through the centre of the first and the last axles where the outer valance may be straight in order to ensure the continuity of the spray suppression system. (Figure 4 of Annex V).
7.2.3. The distance between the uppermost and the lowermost points of the spray suppression system (mudguard and outer valance) measured in any cross section perpendicular to the mudguard (see figures 1b and 2 in Annex V) must extend to not less than 45 mm at all points behind a vertical line passing through the centre of the wheel or the first wheel in the case of multiple axles. This dimension may be gradually reduced in front of this line.’;
‘7.2.1. In the case of single axles, the lower edge of the outer valance may not be situated beyond the following distances and radii, as measured from the centre of the wheel, except at the lowest extremities that may be rounded (Figure 2 of Annex V).Air suspension:(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A)Rv≤ 1,5 R(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A)Rv≤ 1,25 RMechanical suspension(a)general case } Rv≤ 1,8 R(b)non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated. (a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R (b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R (a) general case } Rv≤ 1,8 R (b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R
(a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A)
From the front edge (towards the front of the vehicle) (tip C)
To the rear edge (towards the rear of the vehicle) (tip A)
(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R
(b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A)
From the front edge (tip C)
To the rear edge (tip A)
(a) general case } Rv≤ 1,8 R
(b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
(a)Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) (a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A) Rv≤ 1,5 R
(a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A)
From the front edge (towards the front of the vehicle) (tip C)
To the rear edge (towards the rear of the vehicle) (tip A)
(b)Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) (b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A) Rv≤ 1,25 R
(b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A)
From the front edge (tip C)
To the rear edge (tip A)
(a) Axles fitted with steered wheels or self-steering wheels:From the front edge (towards the front of the vehicle) (tip C)To the rear edge (towards the rear of the vehicle) (tip A) From the front edge (towards the front of the vehicle) (tip C) To the rear edge (towards the rear of the vehicle) (tip A)
From the front edge (towards the front of the vehicle) (tip C)
To the rear edge (towards the rear of the vehicle) (tip A)
From the front edge (towards the front of the vehicle) (tip C)
To the rear edge (towards the rear of the vehicle) (tip A)
(b) Axles fitted with non-steered wheels:From the front edge (tip C)To the rear edge (tip A) From the front edge (tip C) To the rear edge (tip A)
From the front edge (tip C)
To the rear edge (tip A)
From the front edge (tip C)
To the rear edge (tip A)
(a) general case } Rv≤ 1,8 R
(b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv≤ 1,5 Rwhere R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
7.2.2. In the case of multiple axles the requirements laid down in point 7.2.1 do not apply between the vertical transversal planes passing through the centre of the first and the last axles where the outer valance may be straight in order to ensure the continuity of the spray suppression system. (Figure 4 of Annex V).
7.2.3. The distance between the uppermost and the lowermost points of the spray suppression system (mudguard and outer valance) measured in any cross section perpendicular to the mudguard (see figures 1b and 2 in Annex V) must extend to not less than 45 mm at all points behind a vertical line passing through the centre of the wheel or the first wheel in the case of multiple axles. This dimension may be gradually reduced in front of this line.’;
(g) the following points 7.2.5 and 7.2.6 are inserted:‘7.2.5.The requirements of points 7.2.3 and 7.2.4 may not be respected locally when the valance is composed by different elements with relative movement.7.2.6.Tractors for semi-trailers with a low chassis (defined in point 6.20 of standard ISO 612 of 1978), namely those which may have a coupling pin height in relation to the ground equal to or less than 1 100 mm, may be designed in such a way as to be exempted from the requirements of points 7.1.1.a, 7.1.3 and 7.2.4. In this regard, mudguards and valances may not cover the area immediately above the tyres of the rear axles, when these tractors are coupled to a semi-trailer, in order to avoid the spray-suppression system being destroyed. However, the mudguards and valances of these vehicles must conform to the requirements of the above points, in sectors more than 60° from the vertical line passing through the centre of the wheel, in front and behind these tyres.Those vehicles must therefore be designed in such a way as to meet the requirements set out in the first paragraph when they are operated without a semi-trailer.In order to be able to meet those requirements, mudguards and valances may, for example, comprise a removable part.’; ‘7.2.5. The requirements of points 7.2.3 and 7.2.4 may not be respected locally when the valance is composed by different elements with relative movement. 7.2.6. Tractors for semi-trailers with a low chassis (defined in point 6.20 of standard ISO 612 of 1978), namely those which may have a coupling pin height in relation to the ground equal to or less than 1 100 mm, may be designed in such a way as to be exempted from the requirements of points 7.1.1.a, 7.1.3 and 7.2.4. In this regard, mudguards and valances may not cover the area immediately above the tyres of the rear axles, when these tractors are coupled to a semi-trailer, in order to avoid the spray-suppression system being destroyed. However, the mudguards and valances of these vehicles must conform to the requirements of the above points, in sectors more than 60° from the vertical line passing through the centre of the wheel, in front and behind these tyres.Those vehicles must therefore be designed in such a way as to meet the requirements set out in the first paragraph when they are operated without a semi-trailer.In order to be able to meet those requirements, mudguards and valances may, for example, comprise a removable part.’;
‘7.2.5. The requirements of points 7.2.3 and 7.2.4 may not be respected locally when the valance is composed by different elements with relative movement.
7.2.6. Tractors for semi-trailers with a low chassis (defined in point 6.20 of standard ISO 612 of 1978), namely those which may have a coupling pin height in relation to the ground equal to or less than 1 100 mm, may be designed in such a way as to be exempted from the requirements of points 7.1.1.a, 7.1.3 and 7.2.4. In this regard, mudguards and valances may not cover the area immediately above the tyres of the rear axles, when these tractors are coupled to a semi-trailer, in order to avoid the spray-suppression system being destroyed. However, the mudguards and valances of these vehicles must conform to the requirements of the above points, in sectors more than 60° from the vertical line passing through the centre of the wheel, in front and behind these tyres.Those vehicles must therefore be designed in such a way as to meet the requirements set out in the first paragraph when they are operated without a semi-trailer.In order to be able to meet those requirements, mudguards and valances may, for example, comprise a removable part.’;
‘7.2.5. The requirements of points 7.2.3 and 7.2.4 may not be respected locally when the valance is composed by different elements with relative movement.
7.2.6. Tractors for semi-trailers with a low chassis (defined in point 6.20 of standard ISO 612 of 1978), namely those which may have a coupling pin height in relation to the ground equal to or less than 1 100 mm, may be designed in such a way as to be exempted from the requirements of points 7.1.1.a, 7.1.3 and 7.2.4. In this regard, mudguards and valances may not cover the area immediately above the tyres of the rear axles, when these tractors are coupled to a semi-trailer, in order to avoid the spray-suppression system being destroyed. However, the mudguards and valances of these vehicles must conform to the requirements of the above points, in sectors more than 60° from the vertical line passing through the centre of the wheel, in front and behind these tyres.Those vehicles must therefore be designed in such a way as to meet the requirements set out in the first paragraph when they are operated without a semi-trailer.In order to be able to meet those requirements, mudguards and valances may, for example, comprise a removable part.’;
(h) point 7.3.1 is replaced by the following:‘7.3.1.The width of the flap must fulfil the requirement for “q” in point 7.1.1(c), except where the flap is within the mudguards, in which case it must be at least equal in width to the tread of the tyre.The width of the part of the rain flaps positioned beneath the mudguard must satisfy the condition laid down in this paragraph with a tolerance of 10 mm at each side.’; ‘7.3.1. The width of the flap must fulfil the requirement for “q” in point 7.1.1(c), except where the flap is within the mudguards, in which case it must be at least equal in width to the tread of the tyre.The width of the part of the rain flaps positioned beneath the mudguard must satisfy the condition laid down in this paragraph with a tolerance of 10 mm at each side.’;
‘7.3.1. The width of the flap must fulfil the requirement for “q” in point 7.1.1(c), except where the flap is within the mudguards, in which case it must be at least equal in width to the tread of the tyre.The width of the part of the rain flaps positioned beneath the mudguard must satisfy the condition laid down in this paragraph with a tolerance of 10 mm at each side.’;
‘7.3.1. The width of the flap must fulfil the requirement for “q” in point 7.1.1(c), except where the flap is within the mudguards, in which case it must be at least equal in width to the tread of the tyre.The width of the part of the rain flaps positioned beneath the mudguard must satisfy the condition laid down in this paragraph with a tolerance of 10 mm at each side.’;
(i) point 7.3.3 is replaced by the following:‘7.3.3.The maximum height of the bottom edge must not exceed 200 mm (Figure 3 of Annex V).This distance is increased to 300 mm in the case of the last axle where the radial distance of the lower edge of the outer valancing, Rv, does not exceed the dimensions of the radius of the tyres fitted to the wheels on that axle.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’; ‘7.3.3. The maximum height of the bottom edge must not exceed 200 mm (Figure 3 of Annex V).This distance is increased to 300 mm in the case of the last axle where the radial distance of the lower edge of the outer valancing, Rv, does not exceed the dimensions of the radius of the tyres fitted to the wheels on that axle.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
‘7.3.3. The maximum height of the bottom edge must not exceed 200 mm (Figure 3 of Annex V).This distance is increased to 300 mm in the case of the last axle where the radial distance of the lower edge of the outer valancing, Rv, does not exceed the dimensions of the radius of the tyres fitted to the wheels on that axle.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
‘7.3.3. The maximum height of the bottom edge must not exceed 200 mm (Figure 3 of Annex V).This distance is increased to 300 mm in the case of the last axle where the radial distance of the lower edge of the outer valancing, Rv, does not exceed the dimensions of the radius of the tyres fitted to the wheels on that axle.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
(j) in point 7.3.5, the reference to ‘Figure 4b’ is replaced by a reference to ‘Figure 4 of Annex V’;
(k) point 9.3.2.1 is replaced by the following:‘9.3.2.1.The lower edge of the spray-suppression device must be not more than 200 mm from the ground.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’; ‘9.3.2.1. The lower edge of the spray-suppression device must be not more than 200 mm from the ground.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
‘9.3.2.1. The lower edge of the spray-suppression device must be not more than 200 mm from the ground.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
‘9.3.2.1. The lower edge of the spray-suppression device must be not more than 200 mm from the ground.The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
(l) the following point 10 is added:‘10.In the case of multiple axles, the spray-suppression system of one axle, which is not the furthest back, may not need to cover the entire width of the tread of the tyre when there is, locally, the possibility of interference between the spray-suppression system and the structure of the axles or of the suspension or of the undercarriage.’; ‘10. In the case of multiple axles, the spray-suppression system of one axle, which is not the furthest back, may not need to cover the entire width of the tread of the tyre when there is, locally, the possibility of interference between the spray-suppression system and the structure of the axles or of the suspension or of the undercarriage.’;
‘10. In the case of multiple axles, the spray-suppression system of one axle, which is not the furthest back, may not need to cover the entire width of the tread of the tyre when there is, locally, the possibility of interference between the spray-suppression system and the structure of the axles or of the suspension or of the undercarriage.’;
‘10. In the case of multiple axles, the spray-suppression system of one axle, which is not the furthest back, may not need to cover the entire width of the tread of the tyre when there is, locally, the possibility of interference between the spray-suppression system and the structure of the axles or of the suspension or of the undercarriage.’;
(m) the Appendix is deleted;
(n) the following Appendices 1 and 2 are added:‘Appendix 1INFORMATION DOCUMENT No … RELATING TO EC TYPE-APPROVAL OF A VEHICLE WITH RESPECT TO THE FITTING OF SPRAY-SUPPRESSION SYSTEMS (DIRECTIVE 91/226/EEC, AS LAST AMENDED BY DIRECTIVE 2010/19/EU)(*3)(For the Explanatory notes please refer to Annex I to Directive 2007/46/EC)The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.0.   GENERAL0.1.   Make (trade name of manufacturer):0.2.   Type:0.2.1.Commercial name(s) (if available):0.3.   Means of identification of type, if marked on the vehicle (b)0.3.1.Location of that marking:0.4.   Category of vehicle (c):0.5.   Name and address of manufacturer:0.8.   Address(es) of assembly plant(s):1.   GENERAL CONSTRUCTION CHARACTERISTICS OF THE VEHICLE1.1.   Photographs and/or drawings of a representative vehicle:1.3.   Number of axles and wheels:1.3.1.Number and position of axles with twin wheels:1.3.2.Number and position of steered axles2.   MASSES AND DIMENSIONS (f) (g)(in kg and mm) (Refer to drawing where applicable)2.1.   Wheelbase(s) (fully loaded) (g) (l):2.6.   Mass in running order (maximum and minimum for each variant)Mass of the vehicle with bodywork and, in the case of a towing vehicle of category other than M1, with coupling device, if fitted by manufacturer, in running order, or mass of the chassis or chassis with cab, without bodywork and/or coupling device if the manufacturer does not fit the bodywork and/or coupling device (including liquids, tools, spare wheel, if fitted, and driver and, for buses and coaches, a crew member if there is a crew seat in the vehicle) (h) (maximum and minimum for each variant):2.6.1.Distribution of this mass among the axles and, in the case of a semi-trailer or centre-axle trailer, load on the coupling point (maximum and minimum for each variant):2.8.   Technically permissible maximum laden mass stated by the manufacturer (i) (3):9.   BODYWORK9.20.   Spray-suppression system9.20.0.Presence: yes/no/incomplete (1)9.20.1.Brief description of the vehicle with regard to its spray-suppression system and the constituent components:9.20.2.Detailed drawings of the spray-suppression system and its position on the vehicle showing the dimensions specified in the Figures in Annex V to Directive 91/226/EEC and taking account of the extremes of tyre/wheel combinations:9.20.3.Approval number(s) of spray-suppression device(s), if available:Date, File‘Appendix 2Text of imageMODEL(maximum format: A4 (210 × 297 mm))EC TYPE-APPROVAL CERTIFICATEStamp of type-approval authorityCommunication concerning:EC type approval (1)Extension of EC type approval (1)Refusal of EC type approval (1)Withdrawal of EC type approval (1)of a type of a vehicle/component/separate technical unit with regard to Directive 91/226/EEC, as last amended by Directive 2010/19/EU (1)Type-approval number:Reason for extension:SECTION I0.1. Make (trade name of manufacturer):0.2. Type:0.3. Means of identification of type if marked on the vehicle/component/separate technical unit (1) (2)0.3.1. Location of that marking:0.4. Category of vehicle (2) (3)0.5. Name and address of manufacturer:0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:0.8. Address(es) of assembly plant(s):SECTION II1. Additional information (where applicable): See Addendum2. Technical service responsible for carrying out the tests:3. Date of test report:4. Number of test report:5. Remarks (if any): See Addendum6. Place:7. Date:8. Signature:9. The index to the information package lodged with the approval authority, which may be obtained on request, is attached.(1) Delete where not applicable.(2) If the means of identification type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).(3) As defined in Annex II A to Directive 2007/46/EC.‘AddendumTO EC TYPE-APPROVAL CERTIFICATE No … CONCERNING THE TYPE APPROVAL OF A VEHICLE WITH REGARD TO DIRECTIVE 91/226/EEC AS LAST AMENDED BY DIRECTIVE 2010/19/EU1.   Additional information1.1.Characteristics of the spray-suppression devices (type, brief description, trade mark or name, component type-approval number(s):5.   Remarks (if any): 0.2.1. Commercial name(s) (if available): 0.3.1. Location of that marking: 1.3.1. Number and position of axles with twin wheels: 1.3.2. Number and position of steered axles 2.6.1. Distribution of this mass among the axles and, in the case of a semi-trailer or centre-axle trailer, load on the coupling point (maximum and minimum for each variant): 9.20.0. Presence: yes/no/incomplete (1) 9.20.1. Brief description of the vehicle with regard to its spray-suppression system and the constituent components: 9.20.2. Detailed drawings of the spray-suppression system and its position on the vehicle showing the dimensions specified in the Figures in Annex V to Directive 91/226/EEC and taking account of the extremes of tyre/wheel combinations: 9.20.3. Approval number(s) of spray-suppression device(s), if available: 1.1. Characteristics of the spray-suppression devices (type, brief description, trade mark or name, component type-approval number(s):
0.2.1. Commercial name(s) (if available):
0.3.1. Location of that marking:
1.3.1. Number and position of axles with twin wheels:
1.3.2. Number and position of steered axles
2.6.1. Distribution of this mass among the axles and, in the case of a semi-trailer or centre-axle trailer, load on the coupling point (maximum and minimum for each variant):
9.20.0. Presence: yes/no/incomplete (1)
9.20.1. Brief description of the vehicle with regard to its spray-suppression system and the constituent components:
9.20.2. Detailed drawings of the spray-suppression system and its position on the vehicle showing the dimensions specified in the Figures in Annex V to Directive 91/226/EEC and taking account of the extremes of tyre/wheel combinations:
9.20.3. Approval number(s) of spray-suppression device(s), if available:
1.1. Characteristics of the spray-suppression devices (type, brief description, trade mark or name, component type-approval number(s):
0.2.1. Commercial name(s) (if available):
0.3.1. Location of that marking:
1.3.1. Number and position of axles with twin wheels:
1.3.2. Number and position of steered axles
2.6.1. Distribution of this mass among the axles and, in the case of a semi-trailer or centre-axle trailer, load on the coupling point (maximum and minimum for each variant):
9.20.0. Presence: yes/no/incomplete (1)
9.20.1. Brief description of the vehicle with regard to its spray-suppression system and the constituent components:
9.20.2. Detailed drawings of the spray-suppression system and its position on the vehicle showing the dimensions specified in the Figures in Annex V to Directive 91/226/EEC and taking account of the extremes of tyre/wheel combinations:
9.20.3. Approval number(s) of spray-suppression device(s), if available:
1.1. Characteristics of the spray-suppression devices (type, brief description, trade mark or name, component type-approval number(s):
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive)(1), and in particular Article 39(2) thereof,
(1) Council Directive 91/226/EEC of 27 March 1991 on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers(2)is one of the separate directives in the context of the EC type-approval procedure established under Directive 2007/46/EC. The provisions of Directive 2007/46/EC relating to systems, components and separate technical units for vehicles therefore apply to Directive 91/226/EEC.
(2) In view of the mandatory application of the EC type-approval procedure to all vehicle categories covered by Directive 2007/46/EC, it is necessary to provide harmonised requirements with regard to spray suppression for all vehicle categories covered by Directive 91/226/EEC. Furthermore, it is necessary to clarify that those requirements are not mandatory for off-road vehicles. Finally, in view of the experience gained, it is necessary to adapt Directive 91/226/EEC and, consequently, Annex IV to Directive 2007/46/EC to technical progress.
(3) Directives 91/226/EEC and 2007/46/EC should therefore be amended accordingly.
(4) The measures provided for in this Directive are in accordance with the opinion of the Technical Committee — Motor Vehicles,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Directive 91/226/EEC shall be amended as follows:
1.
the list of Annexes and Annexes I, II and III are amended in accordance with Annex I to this Directive;
2.
the unnumbered Annex entitled ‘Figures’ is replaced by the text set out in Annex II to this Directive.

Article 2
Item 43 of Annex IV and Annex XI, Appendices 2 and 4 to Directive 2007/46/EC shall be replaced by the following:

Article 3
1. With effect from 9 April 2011 Member States shall not, on grounds related to spray suppression, refuse to grant an EC or national type-approval to a vehicle and a component complying with the requirements laid down in Directive 91/226/EEC as amended by this Directive.
2. With effect from 9 April 2011 Member States shall, on grounds related to spray suppression, refuse to grant an EC or national type-approval to a vehicle and a component not complying with the requirements laid down in Directive 91/226/EEC as amended by this Directive.
3. When applying for EC whole vehicle type-approval under Directive 2007/46/EC, vehicle types which were granted a national or EC type-approval covering spray-suppression, shall not have to comply with the spray-suppression requirements set out in Directive 91/226/EEC.

Article 4
1. Member States shall adopt and publish, by 8 April 2011 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 9 April 2011.
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 5
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Article 6
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 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive)(1), and in particular Article 39(2) thereof,
(1) Council Directive 91/226/EEC of 27 March 1991 on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers(2)is one of the separate directives in the context of the EC type-approval procedure established under Directive 2007/46/EC. The provisions of Directive 2007/46/EC relating to systems, components and separate technical units for vehicles therefore apply to Directive 91/226/EEC.
(2) In view of the mandatory application of the EC type-approval procedure to all vehicle categories covered by Directive 2007/46/EC, it is necessary to provide harmonised requirements with regard to spray suppression for all vehicle categories covered by Directive 91/226/EEC. Furthermore, it is necessary to clarify that those requirements are not mandatory for off-road vehicles. Finally, in view of the experience gained, it is necessary to adapt Directive 91/226/EEC and, consequently, Annex IV to Directive 2007/46/EC to technical progress.
(3) Directives 91/226/EEC and 2007/46/EC should therefore be amended accordingly.
(4) The measures provided for in this Directive are in accordance with the opinion of the Technical Committee — Motor Vehicles,
HAS ADOPTED THIS DIRECTIVE:
Directive 91/226/EEC shall be amended as follows:
1.
the list of Annexes and Annexes I, II and III are amended in accordance with Annex I to this Directive;
2.
the unnumbered Annex entitled ‘Figures’ is replaced by the text set out in Annex II to this Directive.
Item 43 of Annex IV and Annex XI, Appendices 2 and 4 to Directive 2007/46/EC shall be replaced by the following:
1. With effect from 9 April 2011 Member States shall not, on grounds related to spray suppression, refuse to grant an EC or national type-approval to a vehicle and a component complying with the requirements laid down in Directive 91/226/EEC as amended by this Directive.
2. With effect from 9 April 2011 Member States shall, on grounds related to spray suppression, refuse to grant an EC or national type-approval to a vehicle and a component not complying with the requirements laid down in Directive 91/226/EEC as amended by this Directive.
3. When applying for EC whole vehicle type-approval under Directive 2007/46/EC, vehicle types which were granted a national or EC type-approval covering spray-suppression, shall not have to comply with the spray-suppression requirements set out in Directive 91/226/EEC.
1. Member States shall adopt and publish, by 8 April 2011 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 9 April 2011.
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 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX I 1.
The list of Annexes to Directive 91/226/EEC is amended as follows:
(a) the title relating to Appendix 3 of Annex II is replaced by the following:
‘Information document for EC component type-approval’;
(b) the title relating to Annex III is replaced by the following:
‘Annex III
:
Requirements relating to the EC type approval of a vehicle with regard to the fitting of spray suppression systems
Appendix 1
:
Information document for EC vehicle type-approval
Appendix 2
:
Model for EC vehicle type-approval certificate’;
(c) the line ‘FIGURES: (1 to 9)’ is replaced by the following:
‘Annex V
:
Figures 1 to 9’.
2.
Annex I to Directive 91/226/EEC is amended as follows:
(a) points 9, 10 and 11 are replaced by the following:
‘9. Retractable axle
“Retractable axle” means an axle as defined in Annex I point 2.15 to Directive 97/27/EC. 10. Unladen vehicle
“Unladen vehicle” means a vehicle in running order as defined in point 2.6 of Annex I to Directive 2007/46/EC of the European Parliament and of the Council (*1). 11. Tread
“Tread” is the part of the tyre as defined in point 2.8 of Annex II to Directive 92/23/EEC.
(*1)
OJ L 263, 9.10.2007, p. 1.’;”

(b) the following points 13, 14 and 15 are added:
‘13. Semitrailer towing vehicle
“Semitrailer towing vehicle” means a towing vehicle as defined in point 2.1.1.2.2 of Annex I to Directive 97/27/EC. 14. Technically permissible maximum laden mass
“Technically permissible maximum laden mass” means the maximum mass of the vehicle as defined in point 2.6 of Annex I to Directive 97/27/EC. 15. Type of vehicle
“Type of vehicle” means, in relation to spray suppression complete, incomplete or completed vehicles, which do not differ with respect to the following aspects:
—
type of spray suppression device (installed on the vehicle),
—
manufacturer’s spray suppression system type designation.’

3.
Annex II to Directive 91/226/EEC is amended as follows:
(a) points 2 to 3.4.3 are replaced by the following:
‘2. Application for EC component type-approval
2.1. The application for EC component type-approval pursuant to Article 7 of Directive 2007/46/EC of a type of spray-suppression device shall be submitted by the manufacturer.
2.2. A model for the information document is set out in Appendix 3. 2.3. The following shall be submitted to the technical service responsible for conducting the type-approval tests:
Four samples: three of which for tests and a fourth to be kept by the laboratory for any subsequent verification. The test laboratory may require further samples.
2.4. Markings
Each sample must be clearly and indelibly marked with the trade name or mark and an indication of the type and include a space that is large enough for the EC component type-approval mark. 3. Granting of EC component type-approval
3.1. If the relevant requirements are satisfied, EC type-approval pursuant to Article 10 of Directive 2007/46/EC shall be granted.
3.2. A model for the EC type-approval certificate is set out in Appendix 4. 3.3. An approval number in accordance with Annex VII to Directive 2007/46/EC shall be assigned to each type of spray-suppression device approved. The same Member State shall not assign the same number to another type of spray-suppression device.
3.4. Any spray-suppression device in conformity with a type approved pursuant to this Directive shall bear an EC component type-approval mark, so affixed as to be indelible and easily legible even when the device is fitted to the vehicle.
3.5. A symbol “A” for devices of the energy-absorption type or “S” for devices of the air/water separator type shall be added to the approval mark in accordance with point 1.3 of the Appendix of Annex VII to Directive 2007/46/EC.’;
(b) Appendices 1 to 4 are replaced by the following:
‘Appendix 1
Tests on spray-suppression devices of the energy-absorber type 1. Principle
The aim of this test is to quantify the ability of a device to retain the water directed against it by a series of jets. The test assembly is intended to reproduce the conditions under which the device is to function when fitted to a vehicle as regards the volume and speed of the water thrown up from the ground by the tyre tread. 2. Equipment
See Figure 8 in Annex V for a description of the test assembly. 3. Test conditions
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water is to be used.
3.4. The test pieces must be prepared for each test by wetting. 4. Procedure
4.1. Secure a 500 (+ 0/– 5) mm wide 750 mm high sample of the equipment to be tested to the vertical plate of the testing equipment, making sure that the sample lies well within the limits of the collector, and that no obstacle is able to deflect the water, either before or after its impact.
4.2. Set the water flow rate at 0,675 (+/– 0,01) l/s and direct at least 90 l, at most 120 l on to the sample from a horizontal distance of 500 (+/– 2) mm (Figure 8 of Annex V).
4.3. Allow the water to trickle from the sample into the collector. Calculate the percentage of water collected versus the quantity of water sprayed.
4.4. Carry out the test five times on the sample according to points 4.2 and 4.3. Calculate the average percentage of the series of five tests. 5. Results
5.1. The average percentage calculated in point 4.4 must be 70 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated.
If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 % and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Test whether the vertical position of the device influences the results obtained. If it is the case, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentage of water collected; the requirements of point 5.2 remain in force.
The mean of the individual results shall then be taken to give the average percentage. this average percentage must be 70 or higher.
‘Appendix 2
Test on spray-suppression devices of the air/water separator type 1. Principle
This test is intended to determine the effectiveness of a porous material intended to retain the water with which it has been sprayed by means of a pressurised air/water pulveriser.
The equipment used for the test must simulate the conditions to which the material would be submitted, with regard to the volume and speed of the water sprays produced by the tyres, if it were fitted to a vehicle. 2. Equipment
See figure 9 in Annex v for a description of the test assembly. 3. Test conditions
3.1. The tests must be carried out in a closed room with a still-air environment.
3.2. The ambient temperature and the temperature of the test pieces must be 21 (± 3) °C.
3.3. De-ionized water must be used.
3.4. The test pieces must be prepared for each test by wetting 4. Procedure
4.1. Secure a 305 × 100 mm sample vertically in the test assembly, check that there is no space between the sample and the upper curved plate and that the tray is properly in position. Fill the pulveriser tank with 1 ± 0,005 litres of water and place this as described in the diagram.
4.2. The pulveriser must be regulated as follows:
pressure (at pulveriser): 5 bar + 10 %/– 0 %
flowrate: 1 litre/minute ± 5 seconds
pulverisation: circular, 50 ± 5 mm in diameter at 200 ± 5 mm from the sample, nozzle 5 ± 0,1 mm in diameter.
4.3. Pulverise until there is no more water mist and note the time taken. Let the water flow out of the sample on to the tray for 60 seconds and measure the volume of water collected. Measure the quantity of water left in the pulveriser tank. Calculate the percentage by volume of water collected versus the volume of water pulverised.
4.4. Carry out the test five times and calculate the average percentage of the quantity collected. Check before each test that the tray, pulveriser tank and measuring vessel are dry. 5. Results
5.1. The average percentage calculated in point 4.4 must be 85 % or higher.
5.2. If within a series of five tests the highest and lowest percentages of water collected depart from the average percentage by more than 5 %, the series of five tests must be repeated. If within a second series of five tests the highest and lowest percentages of water recovered again depart from the average percentage by more than 5 %, and if the lower value does not satisfy the requirements of point 5.1, type-approval shall be refused.
5.3. Where the vertical position of the device influences the results obtained, the procedure described in points 4.1 to 4.4 must be repeated in the positions giving the highest and lowest percentages of water collected; the requirements of point 5.2 remain in force.
The requirement of point 5.1 remains in force in order to give the results of each test.
‘Appendix 3
Information document No … relating to the EC component type-approval of spray suppression devices (Directive 91/226/EEC)
The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.
If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied. 0. GENERAL
0.1. Make (trade name of manufacturer):
0.2. Type:
0.5. Name and address of manufacturer:
0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:
0.8. Address(es) of assembly plant(s): 1. DESCRIPTION OF THE DEVICE
1.1. A technical description of the spray-suppression device indicating its physical operating principle and the relevant test to which it must be subject:
1.2. The materials used:
1.3. Drawing(s) in sufficient detail and to an appropriate scale to enable this (or these) to be identified. The drawing must show the space intended for the EEC component type-approval mark:
Date
Signed
‘Appendix 4
Text of image
MODEL
(maximum format: A4 (210 × 297 mm))
EC TYPE-APPROVAL CERTIFICATE
Stamp of type-approval authority
Communication concerning:
EC type approval
Extension of EC type approval
Refusal of EC type approval
Withdrawal of EC type approval
of a type of a vehicle/component/separate technical unit (1) with regard to Directive 91/226/EEC, as last amended by Commission Directive 2010/19/EU (2) Type-approval number:
Reason for extension:
SECTION I
0.1. Make (trade name of manufacturer):
0.2. Type:
0.3. Means of identification of type if marked on the vehicle/component/separate technical unit (1) (3) 0.3.1. Location of that marking:
0.4. Category of vehicle (4) 0.5. Name and address of manufacturer:
0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:
0.8. Address(es) of assembly plant(s):
SECTION II 1. Additional information (where applicable): see Addendum 2. Technical service responsible for carrying out the tests: 3. Date of test report: 4. Number of test report: 5. Remarks (if any): see Addendum 6. Place: 7. Date: 8. Signature: 9. The index to the information package lodged with the approval authority, which may be obtained on request, is attached.
(1) Delete where not applicable.
(2) OJ L 72, 20.3.2010, p. 17. (3) If the means of identification type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).
(4) As defined in Annex II A to Directive 2007/46/EC.
‘Addendum
to EC type-approval certificate No … concerning the component type-approval of spray suppression devices with regard to Directive 91/226/EEC as last amended by Directive 2010/19/EU 1. Additional information
1.1. Operating principle of device: energy-absorption/air/water separator (1):
1.2. Characteristics of spray-suppression devices (brief description, trademark or name, number(s): 5. Remarks (if any):
4.
Annex III to Directive 91/226/EEC is amended as follows:
(a) points 0.1 and 0.2 are replaced by the following:
‘SCOPE
0.1. Category N and O vehicles, with the exception of off-road vehicles as defined in Annex II to Directive 2007/46/EC, shall be constructed and/or fitted with spray suppression systems in such a way as to meet the requirements laid down in this Annex. In case of chassis/cab vehicles, these requirements may only be applied to the wheels covered by the cab.
For vehicles of category N1 and N2 with a permissible maximum laden mass not exceeding 7,5 tonnes, the requirements of Directive 78/549/EEC (*2) may be applied as alternative to the requirements of this Directive at the request of the manufacturer.
0.2. The requirements of this Annex relating to spray-suppression devices, as defined in point 4 of Annex I, are not mandatory for categories N, O1 and O2 vehicles with a permissible maximum laden mass not exceeding 7,5 tonnes, chassis/cab vehicles, unbodied vehicles or vehicles on which the presence of spray-suppression devices would be incompatible with their use. However, if such devices are fitted to those vehicles, they must conform to the requirements of this Directive.
(*2)
OJ L 168, 26.6.1978, p. 45.’;”

(b) point 4 is replaced by the following:
‘4. Position of outer valance
The distance “c” between the longitudinal plane tangential to the outer tyre wall, apart from any tyre bulge near the ground, and the inner edge of the valance must not exceed 100 mm (Figures 1a and 1b of Annex V).’;
(c) points 4.1 and 4.2 are deleted;
(d) point 7.1.1 is replaced by the following:
‘7.1.1. The mudguards must cover the zone immediately above, ahead and behind the tyre or tyres in the following manner:
(a) in the case of a single or multiple axle, the forward edge (C) must extend forwards to reach a line O-Z where θ (theta) is no more than 45° above the horizontal.
The rearmost edge (Figure 2 of Annex V) must extend downwards in such a way as not to be more than 100 mm above a horizontal line passing through the centre of the wheel;
(b) in the case of multiple axles the angle θ relates only to the foremost axle and the requirement relating to the height of the rearmost edge applies only to the rearmost axle;
(c) the mudguard must possess a total width “q” (Figure 1a of Annex V) at least adequate to cover the width of the tyre “b” or the entire width of two tyres “t” in the case of twin wheels, account being taken of the extremes for the tyre/wheel unit specified by the manufacturer. Dimensions “b” and “t” shall be measured at hub height, excluding any markings, ribs, protective bands, etc., on the tyre walls.’;
(e) point 7.1.3 is replaced by the following:
‘7.1.3. If the mudguards are made up of several components, when fitted, they must not incorporate any aperture enabling spray to exit while the vehicle is in motion. This requirement is deemed to be met if, when the vehicle is either laden or unladen, any radial jet running outwards from the wheel centre over the entire width of the tyre running surface and within the range covered by the mudguard always strikes against a part of the spray suppression system.’;
(f) points 7.2.1, 7.2.2 and 7.2.3 are replaced by the following:
‘7.2.1. In the case of single axles, the lower edge of the outer valance may not be situated beyond the following distances and radii, as measured from the centre of the wheel, except at the lowest extremities that may be rounded (Figure 2 of Annex V).
Air suspension:
(a) Axles fitted with steered wheels or self-steering wheels:

From the front edge (towards the front of the vehicle) (tip C)

To the rear edge (towards the rear of the vehicle) (tip A)
Rv ≤ 1,5 R
(b) Axles fitted with non-steered wheels:

From the front edge (tip C)

To the rear edge (tip A)
Rv ≤ 1,25 R
Mechanical suspension
(a) general case } Rv ≤ 1,8 R
(b) non-steered wheels for vehicles with a technically permissible laden mass more than 7,5 t } Rv ≤ 1,5 R
where R is the radius of the tyre fitted to the vehicle, and Rv the distance, expressed as a radius, at which the lower edge of the outer valance is situated.
7.2.2. In the case of multiple axles the requirements laid down in point 7.2.1 do not apply between the vertical transversal planes passing through the centre of the first and the last axles where the outer valance may be straight in order to ensure the continuity of the spray suppression system. (Figure 4 of Annex V).
7.2.3. The distance between the uppermost and the lowermost points of the spray suppression system (mudguard and outer valance) measured in any cross section perpendicular to the mudguard (see figures 1b and 2 in Annex V) must extend to not less than 45 mm at all points behind a vertical line passing through the centre of the wheel or the first wheel in the case of multiple axles. This dimension may be gradually reduced in front of this line.’;
(g) the following points 7.2.5 and 7.2.6 are inserted:
‘7.2.5. The requirements of points 7.2.3 and 7.2.4 may not be respected locally when the valance is composed by different elements with relative movement.
7.2.6. Tractors for semi-trailers with a low chassis (defined in point 6.20 of standard ISO 612 of 1978), namely those which may have a coupling pin height in relation to the ground equal to or less than 1 100 mm, may be designed in such a way as to be exempted from the requirements of points 7.1.1.a, 7.1.3 and 7.2.4. In this regard, mudguards and valances may not cover the area immediately above the tyres of the rear axles, when these tractors are coupled to a semi-trailer, in order to avoid the spray-suppression system being destroyed. However, the mudguards and valances of these vehicles must conform to the requirements of the above points, in sectors more than 60° from the vertical line passing through the centre of the wheel, in front and behind these tyres.
Those vehicles must therefore be designed in such a way as to meet the requirements set out in the first paragraph when they are operated without a semi-trailer.
In order to be able to meet those requirements, mudguards and valances may, for example, comprise a removable part.’;
(h) point 7.3.1 is replaced by the following:
‘7.3.1. The width of the flap must fulfil the requirement for “q” in point 7.1.1(c), except where the flap is within the mudguards, in which case it must be at least equal in width to the tread of the tyre.
The width of the part of the rain flaps positioned beneath the mudguard must satisfy the condition laid down in this paragraph with a tolerance of 10 mm at each side.’;
(i) point 7.3.3 is replaced by the following:
‘7.3.3. The maximum height of the bottom edge must not exceed 200 mm (Figure 3 of Annex V).
This distance is increased to 300 mm in the case of the last axle where the radial distance of the lower edge of the outer valancing, Rv, does not exceed the dimensions of the radius of the tyres fitted to the wheels on that axle.
The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
(j) in point 7.3.5, the reference to ‘Figure 4b’ is replaced by a reference to ‘Figure 4 of Annex V’;
(k) point 9.3.2.1 is replaced by the following:
‘9.3.2.1. The lower edge of the spray-suppression device must be not more than 200 mm from the ground.
The maximum height of the bottom edge of the rain flap in relation to the ground, may be raised to 300 mm if the manufacturer deems it technically appropriate with regard to the suspension characteristics.’;
(l) the following point 10 is added:
‘10. In the case of multiple axles, the spray-suppression system of one axle, which is not the furthest back, may not need to cover the entire width of the tread of the tyre when there is, locally, the possibility of interference between the spray-suppression system and the structure of the axles or of the suspension or of the undercarriage.’;
(m) the Appendix is deleted;
(n) the following Appendices 1 and 2 are added:
‘Appendix 1
INFORMATION DOCUMENT No … RELATING TO EC TYPE-APPROVAL OF A VEHICLE WITH RESPECT TO THE FITTING OF SPRAY-SUPPRESSION SYSTEMS (DIRECTIVE 91/226/EEC, AS LAST AMENDED BY DIRECTIVE 2010/19/EU) (*3)
(For the Explanatory notes please refer to Annex I to Directive 2007/46/EC)
The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.
If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied. 0. GENERAL
0.1. Make (trade name of manufacturer):
0.2. Type:
0.2.1. Commercial name(s) (if available):
0.3. Means of identification of type, if marked on the vehicle (b) 0.3.1. Location of that marking:
0.4. Category of vehicle (c):
0.5. Name and address of manufacturer:
0.8. Address(es) of assembly plant(s): 1. GENERAL CONSTRUCTION CHARACTERISTICS OF THE VEHICLE
1.1. Photographs and/or drawings of a representative vehicle:
1.3. Number of axles and wheels:
1.3.1. Number and position of axles with twin wheels:
1.3.2. Number and position of steered axles 2. MASSES AND DIMENSIONS (f) (g) (in kg and mm) (Refer to drawing where applicable)
2.1. Wheelbase(s) (fully loaded) (g) (l):
2.6. Mass in running order (maximum and minimum for each variant)
Mass of the vehicle with bodywork and, in the case of a towing vehicle of category other than M1, with coupling device, if fitted by manufacturer, in running order, or mass of the chassis or chassis with cab, without bodywork and/or coupling device if the manufacturer does not fit the bodywork and/or coupling device (including liquids, tools, spare wheel, if fitted, and driver and, for buses and coaches, a crew member if there is a crew seat in the vehicle) (h) (maximum and minimum for each variant):
2.6.1. Distribution of this mass among the axles and, in the case of a semi-trailer or centre-axle trailer, load on the coupling point (maximum and minimum for each variant):
2.8. Technically permissible maximum laden mass stated by the manufacturer (i) (3): 9. BODYWORK
9.20. Spray-suppression system
9.20.0. Presence: yes/no/incomplete (1) 9.20.1. Brief description of the vehicle with regard to its spray-suppression system and the constituent components:
9.20.2. Detailed drawings of the spray-suppression system and its position on the vehicle showing the dimensions specified in the Figures in Annex V to Directive 91/226/EEC and taking account of the extremes of tyre/wheel combinations:
9.20.3. Approval number(s) of spray-suppression device(s), if available:
Date, File
‘Appendix 2
Text of image
MODEL
(maximum format: A4 (210 × 297 mm))
EC TYPE-APPROVAL CERTIFICATE
Stamp of type-approval authority
Communication concerning:
EC type approval (1) Extension of EC type approval (1) Refusal of EC type approval (1) Withdrawal of EC type approval (1) of a type of a vehicle/component/separate technical unit with regard to Directive 91/226/EEC, as last amended by Directive 2010/19/EU (1) Type-approval number:
Reason for extension:
SECTION I
0.1. Make (trade name of manufacturer):
0.2. Type:
0.3. Means of identification of type if marked on the vehicle/component/separate technical unit (1) (2) 0.3.1. Location of that marking:
0.4. Category of vehicle (2) (3) 0.5. Name and address of manufacturer:
0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:
0.8. Address(es) of assembly plant(s):
SECTION II 1. Additional information (where applicable): See Addendum 2. Technical service responsible for carrying out the tests: 3. Date of test report: 4. Number of test report: 5. Remarks (if any): See Addendum 6. Place: 7. Date: 8. Signature: 9. The index to the information package lodged with the approval authority, which may be obtained on request, is attached.
(1) Delete where not applicable.
(2) If the means of identification type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: “?” (e.g. ABC??123??).
(3) As defined in Annex II A to Directive 2007/46/EC.
‘Addendum
TO EC TYPE-APPROVAL CERTIFICATE No … CONCERNING THE TYPE APPROVAL OF A VEHICLE WITH REGARD TO DIRECTIVE 91/226/EEC AS LAST AMENDED BY DIRECTIVE 2010/19/EU 1. Additional information
1.1. Characteristics of the spray-suppression devices (type, brief description, trade mark or name, component type-approval number(s): 5. Remarks (if any):

(*1)
OJ L 263, 9.10.2007, p. 1.’;
(*2)
OJ L 168, 26.6.1978, p. 45.’;’
(1) Delete where not applicable.
(*3) For vehicles of category N1 and those of category N2 with a technically permissible maximum laden mass not exceeding 7,5 tons using the derogation of point 0.1 of Annex III to this Directive, the information document set out in Annex II to Directive 78/549/EEC may be used.

ANNEX II
‘ANNEX V
FIGURES
Figure 1a
Width (q) of mudguard (a) and position of valance (j) Figure 1b
Example of measurement of the outer valance
Figure 2
Dimensions of mudguard and outer valance
Note
Figure 3
Position of mudguard and rain flap
Figure 4
Diagram showing assembly of a spray-suppression system (mudguard, rain flap, outer valance) incorporating spray-suppression devices (energy absorbers) for multiple axles
Figure 5
Diagram showing assembly of a spray-suppression system incorporating spray-suppression devices (energy absorbers) for axles fitted with non-steered or self-steering wheels
(Annex III — items 6.2 and 8)
Figure 6
Diagram showing assembly of a spray-suppression system incorporating spray-suppression devices fitted with air/water separators for axles fitted with steered, self-steering or non-steered wheels
Note
Figure 7
Diagram showing assembly of a spray-suppression system incorporating spray-suppression devices (mudguard, rain flap, outer valance) for multiple axles where the distance between the tyres does not exceed 300 mm
Note
Figure 8
Test assembly for energy absorption spray-suppression devices
(Annex II, Appendix 1)
Note
Figure 9
Test assembly for air/water separator spray-suppression devices
(Annex II, Appendix 2)
’

Pending: 32010L0017

10.3.2010 EN Official Journal of the European Union L 60/17
(1) Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included malathion. By Commission Decision 2007/389/EC(4)it was decided not to include malathion in Annex I to Directive 91/414/EEC.
(2) Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I(5).
(3) The application was submitted to the United Kingdom, replacing Finland which had originally been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance is the same as was the subject of Decision 2007/389/EC while the initially supported use on apples has been replaced by strawberry and the application rate has been lowered. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
(4) The United Kingdom evaluated the new information and data submitted by the notifier and prepared an additional report in February 2009.
(5) The additional report was peer reviewed by the Member States and the EFSA and presented to the Commission on 17 July 2009 in the format of the EFSA Scientific Report for malathion(6). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2010 in the format of the Commission review report for malathion.
(6) The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that lead to the non-inclusion. Those concerns were in particular the presence in the technical material of varying levels of isomalathion, an impurity that contributes significantly to the toxicity profile of malathion and the genotoxicity of which cannot be excluded. Because of this fact it was impossible to assess the risk to operators, workers and bystanders. Moreover, information on the effects of certain toxicologically relevant metabolites was insufficient, and it had, hence, not been demonstrated that the estimated exposure of consumers resulting from the acute and chronic intake of edible crops is acceptable.
(7) New data and information were submitted by the notifier in the new dossier and a new assessment was performed, as included in the additional report and in the EFSA conclusions. Those new data show that the genotoxicity of malathion containing not more than 2 g/kg isomalathion can be ruled out. It has therefore been possible to determine acceptable levels of exposure of operators, workers and bystanders. Use by non-professionals could, however, raise concerns, as it cannot be assumed that these have recourse to the adequate personal protective equipment. As a consequence, such use should not be authorised.
(8) Without prejudice to those conclusions, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information as regards consumer intakes, the acute and long-term risk assessment for insectivorous birds, and on the quantification of the different potency of malaoxon and malathion, before authorisations are granted. As regards the consumer exposure, the information currently available allows nonetheless to conclude that the risk is acceptable, given the large margin of safety that exists.
(9) Consequently, the additional data and information provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.
(10) It has appeared from the various examinations made that plant protection products containing malathion may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include malathion in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(11) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
No Common Name,Identification Numbers IUPAC Name Purity(1) Entry into force Expiration of inclusion Specific provisions
‘MalathionCAS No: 121-75-5CIPAC No: 12 diethyl (dimethoxyphosphinothioylthio)succinateorS-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioateracemate ≥ 950 g/kgImpurities:Isomalathion: not more than 2 g/kg 1 May 2010 PART AOnly uses as insecticide may be authorised. Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to:—the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;—the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;—the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.Where appropriate, conditions of authorisation shall include further risk mitigation measures.The Member States concerned shall ensure that the notifier presents to the Commission:—information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;—information on the quantification of the different potency of malaoxon and malathion.’ — the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment; — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; — the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure. — information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds; — information on the quantification of the different potency of malaoxon and malathion.’
— the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;
— the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;
— the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.
— information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;
— information on the quantification of the different potency of malaoxon and malathion.’
— the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;
— the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;
— the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.
— information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;
— information on the quantification of the different potency of malaoxon and malathion.’
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included malathion. By Commission Decision 2007/389/EC(4)it was decided not to include malathion in Annex I to Directive 91/414/EEC.
(2) Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I(5).
(3) The application was submitted to the United Kingdom, replacing Finland which had originally been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance is the same as was the subject of Decision 2007/389/EC while the initially supported use on apples has been replaced by strawberry and the application rate has been lowered. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
(4) The United Kingdom evaluated the new information and data submitted by the notifier and prepared an additional report in February 2009.
(5) The additional report was peer reviewed by the Member States and the EFSA and presented to the Commission on 17 July 2009 in the format of the EFSA Scientific Report for malathion(6). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2010 in the format of the Commission review report for malathion.
(6) The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that lead to the non-inclusion. Those concerns were in particular the presence in the technical material of varying levels of isomalathion, an impurity that contributes significantly to the toxicity profile of malathion and the genotoxicity of which cannot be excluded. Because of this fact it was impossible to assess the risk to operators, workers and bystanders. Moreover, information on the effects of certain toxicologically relevant metabolites was insufficient, and it had, hence, not been demonstrated that the estimated exposure of consumers resulting from the acute and chronic intake of edible crops is acceptable.
(7) New data and information were submitted by the notifier in the new dossier and a new assessment was performed, as included in the additional report and in the EFSA conclusions. Those new data show that the genotoxicity of malathion containing not more than 2 g/kg isomalathion can be ruled out. It has therefore been possible to determine acceptable levels of exposure of operators, workers and bystanders. Use by non-professionals could, however, raise concerns, as it cannot be assumed that these have recourse to the adequate personal protective equipment. As a consequence, such use should not be authorised.
(8) Without prejudice to those conclusions, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information as regards consumer intakes, the acute and long-term risk assessment for insectivorous birds, and on the quantification of the different potency of malaoxon and malathion, before authorisations are granted. As regards the consumer exposure, the information currently available allows nonetheless to conclude that the risk is acceptable, given the large margin of safety that exists.
(9) Consequently, the additional data and information provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.
(10) It has appeared from the various examinations made that plant protection products containing malathion may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include malathion in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(11) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
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.

Article 3
This Directive shall enter into force on 1 May 2010.

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 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) Commission Regulations (EC) No 451/2000(2)and (EC) No 703/2001(3)lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included malathion. By Commission Decision 2007/389/EC(4)it was decided not to include malathion in Annex I to Directive 91/414/EEC.
(2) Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I(5).
(3) The application was submitted to the United Kingdom, replacing Finland which had originally been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance is the same as was the subject of Decision 2007/389/EC while the initially supported use on apples has been replaced by strawberry and the application rate has been lowered. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
(4) The United Kingdom evaluated the new information and data submitted by the notifier and prepared an additional report in February 2009.
(5) The additional report was peer reviewed by the Member States and the EFSA and presented to the Commission on 17 July 2009 in the format of the EFSA Scientific Report for malathion(6). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2010 in the format of the Commission review report for malathion.
(6) The new assessment by the rapporteur Member State and the new conclusion by the EFSA concentrated on the concerns that lead to the non-inclusion. Those concerns were in particular the presence in the technical material of varying levels of isomalathion, an impurity that contributes significantly to the toxicity profile of malathion and the genotoxicity of which cannot be excluded. Because of this fact it was impossible to assess the risk to operators, workers and bystanders. Moreover, information on the effects of certain toxicologically relevant metabolites was insufficient, and it had, hence, not been demonstrated that the estimated exposure of consumers resulting from the acute and chronic intake of edible crops is acceptable.
(7) New data and information were submitted by the notifier in the new dossier and a new assessment was performed, as included in the additional report and in the EFSA conclusions. Those new data show that the genotoxicity of malathion containing not more than 2 g/kg isomalathion can be ruled out. It has therefore been possible to determine acceptable levels of exposure of operators, workers and bystanders. Use by non-professionals could, however, raise concerns, as it cannot be assumed that these have recourse to the adequate personal protective equipment. As a consequence, such use should not be authorised.
(8) Without prejudice to those conclusions, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information as regards consumer intakes, the acute and long-term risk assessment for insectivorous birds, and on the quantification of the different potency of malaoxon and malathion, before authorisations are granted. As regards the consumer exposure, the information currently available allows nonetheless to conclude that the risk is acceptable, given the large margin of safety that exists.
(9) Consequently, the additional data and information provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.
(10) It has appeared from the various examinations made that plant protection products containing malathion may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include malathion in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(11) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
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.
This Directive shall enter into force on 1 May 2010.
This Directive is addressed to the Member States.
ANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

No
Common Name,
Identification Numbers
IUPAC Name
Purity (1) Entry into force
Expiration of inclusion
Specific provisions

‘Malathion
CAS No: 121-75-5
CIPAC No: 12
diethyl (dimethoxyphosphinothioylthio)succinate
or
S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate
racemate
≥ 950 g/kg
Impurities:
Isomalathion: not more than 2 g/kg
1 May 2010

PART A
Only uses as insecticide may be authorised. Authorisations shall be limited to professional users.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
—
the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;
—
the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;
—
the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.
Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.
Where appropriate, conditions of authorisation shall include further risk mitigation measures.
The Member States concerned shall ensure that the notifier presents to the Commission:
—
information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;
—
information on the quantification of the different potency of malaoxon and malathion.’

(1) Further details on identity and specification of active substance are provided in the review report.

Pending: 32010L0015

9.3.2010 EN Official Journal of the European Union L 58/5
(1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.
(4) It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.
(6) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(7) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
(a) in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b) in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
No Common Name, Identification Numbers IUPAC Name Purity(1) Entry into force Expiration of inclusion Specific provisions
‘303 FluopicolideCAS No239110-15-7CIPAC No787 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide ≥ 970 g/kgThe impurity toluene must not exceed 3 g/kg in the technical material. 1 June 2010 31 May 2020 PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.In this overall assessment, Member States must pay particular attention to:—the protection of aquatic organisms,—the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,—to the risk to operators during application,—the potential for long range transport via air.Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.’ — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air.
— the protection of aquatic organisms,
— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
— to the risk to operators during application,
— the potential for long range transport via air.
— the protection of aquatic organisms,
— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
— to the risk to operators during application,
— the potential for long range transport via air.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.
(4) It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.
(6) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(7) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2
Member States shall adopt and publish by 30 November 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 December 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fluopicolide as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to fluopicolide are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing fluopicolide as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fluopicolide. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b)
in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4
This Directive shall enter into force on 1 June 2010.

Article 5
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 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.
(4) It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.
(6) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(7) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall adopt and publish by 30 November 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 December 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fluopicolide as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to fluopicolide are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing fluopicolide as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fluopicolide. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b)
in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
This Directive shall enter into force on 1 June 2010.
This Directive is addressed to the Member States.
ANNEXIn Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

No
Common Name, Identification Numbers
IUPAC Name
Purity (1) Entry into force
Expiration of inclusion
Specific provisions
‘303
Fluopicolide
CAS No
239110-15-7
CIPAC No 787
2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide
≥ 970 g/kg
The impurity toluene must not exceed 3 g/kg in the technical material.
1 June 2010
31 May 2020
PART A
Only uses as fungicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
In this overall assessment, Member States must pay particular attention to:
—
the protection of aquatic organisms,
—
the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
—
to the risk to operators during application,
—
the potential for long range transport via air.
Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.
The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.’

(1) Further details on identity and specification of active substances are provided in the review report.

Pending: 32010L0014

4.3.2010 EN Official Journal of the European Union L 53/7
(1) In accordance with Article 6(2) of Directive 91/414/EEC France received on 9 May 2006 an application from Elicityl SA for the inclusion of the active substance heptamaloxyloglucan in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 26 July 2007.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for heptamaloxyloglucan on 17 July 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for heptamaloxyloglucan.
(4) It has appeared from the various examinations made that plant protection products containing heptamaloxyloglucan may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include heptamaloxyloglucan in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing heptamaloxyloglucan to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(6) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
(a) in the case of a product containing heptamaloxyloglucan as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b) in the case of a product containing heptamaloxyloglucan as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
No Common name, Identification numbers IUPAC name Purity(1) Entry into force Expiration of inclusion Specific provisions
‘304 HeptamaloxyloglucanCAS No870721-81-6CIPAC NoNot available Full IUPAC name in footnote(*1)Xyl p: xylopyranosylGlc p: glucopyranosylFuc p: fucopyranosylGal p: galactopyranosylGlc-ol: glucitol Xyl p: xylopyranosyl Glc p: glucopyranosyl Fuc p: fucopyranosyl Gal p: galactopyranosyl Glc-ol: glucitol ≥ 780 g/kgThe impurity Patulin must not exceed 50 μg/kg in the technical material. 1 June 2010 31 May 2020 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
Xyl p: xylopyranosyl
Glc p: glucopyranosyl
Fuc p: fucopyranosyl
Gal p: galactopyranosyl
Glc-ol: glucitol
Xyl p: xylopyranosyl
Glc p: glucopyranosyl
Fuc p: fucopyranosyl
Gal p: galactopyranosyl
Glc-ol: glucitol
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) In accordance with Article 6(2) of Directive 91/414/EEC France received on 9 May 2006 an application from Elicityl SA for the inclusion of the active substance heptamaloxyloglucan in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 26 July 2007.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for heptamaloxyloglucan on 17 July 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for heptamaloxyloglucan.
(4) It has appeared from the various examinations made that plant protection products containing heptamaloxyloglucan may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include heptamaloxyloglucan in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing heptamaloxyloglucan to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(6) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2
Member States shall adopt and publish by 30 November 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 December 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing heptamaloxyloglucan as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to heptamaloxyloglucan are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing heptamaloxyloglucan as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning heptamaloxyloglucan. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing heptamaloxyloglucan as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b)
in the case of a product containing heptamaloxyloglucan as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4
This Directive shall enter into force on 1 June 2010.

Article 5
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 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) In accordance with Article 6(2) of Directive 91/414/EEC France received on 9 May 2006 an application from Elicityl SA for the inclusion of the active substance heptamaloxyloglucan in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/EC(2)confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
(2) For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 26 July 2007.
(3) The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for heptamaloxyloglucan on 17 July 2009(3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for heptamaloxyloglucan.
(4) It has appeared from the various examinations made that plant protection products containing heptamaloxyloglucan may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include heptamaloxyloglucan in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
(5) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing heptamaloxyloglucan to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(6) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall adopt and publish by 30 November 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 December 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing heptamaloxyloglucan as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to heptamaloxyloglucan are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing heptamaloxyloglucan as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning heptamaloxyloglucan. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing heptamaloxyloglucan as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or
(b)
in the case of a product containing heptamaloxyloglucan as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
This Directive shall enter into force on 1 June 2010.
This Directive is addressed to the Member States.
ANNEXIn Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

No | Common name, Identification numbers | IUPAC name | Purity(1) | Entry into force | Expiration of inclusion | Specific provisions
‘304 | HeptamaloxyloglucanCAS No870721-81-6CIPAC NoNot available | Full IUPAC name in footnote(*1)Xyl p: xylopyranosylGlc p: glucopyranosylFuc p: fucopyranosylGal p: galactopyranosylGlc-ol: glucitol | | Xyl p: xylopyranosyl | | Glc p: glucopyranosyl | | Fuc p: fucopyranosyl | | Gal p: galactopyranosyl | | Glc-ol: glucitol | ≥ 780 g/kgThe impurity Patulin must not exceed 50 μg/kg in the technical material. | 1 June 2010 | 31 May 2020 | PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
| Xyl p: xylopyranosyl
| Glc p: glucopyranosyl
| Fuc p: fucopyranosyl
| Gal p: galactopyranosyl
| Glc-ol: glucitol
(*1)

’

(1) Further details on identity and specification of active substances are provided in the review report.

Pending: 32010L0001

12.1.2010 EN Official Journal of the European Union L 7/17
(1) Directive 2000/29/EC provides for certain zones to be recognised as protected zones.
(2) By Commission Regulation (EC) No 690/2008 of 4 July 2008 recognising protected zones exposed to particular plant health risks in the Community(2)certain parts of the Veneto region in Italy were recognised as a protected zone with respect to the harmful organismErwinia amylovora(Burr.) Winsl.et al. until 31 March 2010.
(3) Following observations regarding the presence of that harmful organism in certain parts of the Veneto region made by the Commission during an inspection in Italy from 31 August to 11 September 2009, Italy informed the Commission on 23 October 2009 of the results of the latest survey carried out in the Veneto region for the presence of that harmful organism in September and October 2009. The results of this latest survey show that in the province of Venice there are 14 places, in which that harmful organism has been occurring for a period of at least the last three successive years in spite of the eradication measures taken by the Italian authorities. Consequently, those measures have proved to be ineffective.
(4) The latest survey results were discussed during the meeting of the Standing Committee on Plant Health on 19-20 October 2009. It was concluded thatErwinia amylovora(Burr.) Winsl.et al. has to be considered as established in the province of Venice. That province should therefore no longer be included in the lists in Annexes II, III and IV to Directive 2000/29/EC as a protected zone in respect of that harmful organism.
(5) From the Swiss legislation on plant protection, it appears that the Cantons of Fribourg and Vaud are no longer recognised as a protected zone forErwinia amylovora(Burr.) Winsl.et al. in Switzerland as of 15 November 2009. The derogation allowing certain imports from those regions into certain protected zones under special requirements should therefore be deleted and Part B of Annex IV to Directive 2000/29/EC should be amended accordingly.
(6) Annexes II, III and IV to Directive 2000/29/EC should therefore be amended accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
1. in point 2 of heading (b) of Part B of Annex II, the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
2. part B of Annex III is amended as follows:(a)in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;(b)in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (a) in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (b) in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(a) in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(a) in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
3. part B of Annex IV is amended as follows:(a)point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;(b)point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. (a) point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (b) point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. (i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(a) point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. (i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’;
‘(b) originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(a) point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; (i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(i) in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; ‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
‘(c) the plants originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. (i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’; (ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’;
‘(b) originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(i) in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; ‘(b) originate in the Canton of Valais in Switzerland, or’;
‘(b) originate in the Canton of Valais in Switzerland, or’;
‘(b) originate in the Canton of Valais in Switzerland, or’;
(ii) the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,
After consulting the Member States concerned,
(1) Directive 2000/29/EC provides for certain zones to be recognised as protected zones.
(2) By Commission Regulation (EC) No 690/2008 of 4 July 2008 recognising protected zones exposed to particular plant health risks in the Community(2)certain parts of the Veneto region in Italy were recognised as a protected zone with respect to the harmful organismErwinia amylovora(Burr.) Winsl.et al. until 31 March 2010.
(3) Following observations regarding the presence of that harmful organism in certain parts of the Veneto region made by the Commission during an inspection in Italy from 31 August to 11 September 2009, Italy informed the Commission on 23 October 2009 of the results of the latest survey carried out in the Veneto region for the presence of that harmful organism in September and October 2009. The results of this latest survey show that in the province of Venice there are 14 places, in which that harmful organism has been occurring for a period of at least the last three successive years in spite of the eradication measures taken by the Italian authorities. Consequently, those measures have proved to be ineffective.
(4) The latest survey results were discussed during the meeting of the Standing Committee on Plant Health on 19-20 October 2009. It was concluded thatErwinia amylovora(Burr.) Winsl.et al. has to be considered as established in the province of Venice. That province should therefore no longer be included in the lists in Annexes II, III and IV to Directive 2000/29/EC as a protected zone in respect of that harmful organism.
(5) From the Swiss legislation on plant protection, it appears that the Cantons of Fribourg and Vaud are no longer recognised as a protected zone forErwinia amylovora(Burr.) Winsl.et al. in Switzerland as of 15 November 2009. The derogation allowing certain imports from those regions into certain protected zones under special requirements should therefore be deleted and Part B of Annex IV to Directive 2000/29/EC should be amended accordingly.
(6) Annexes II, III and IV to Directive 2000/29/EC should therefore be amended accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annexes II, III and IV to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.

Transposition
Article 2
Member States shall adopt and publish, by 28 February 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 March 2010.
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.

Article 3
This Directive shall enter into force on the day following 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 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,
After consulting the Member States concerned,
(1) Directive 2000/29/EC provides for certain zones to be recognised as protected zones.
(2) By Commission Regulation (EC) No 690/2008 of 4 July 2008 recognising protected zones exposed to particular plant health risks in the Community(2)certain parts of the Veneto region in Italy were recognised as a protected zone with respect to the harmful organismErwinia amylovora(Burr.) Winsl.et al. until 31 March 2010.
(3) Following observations regarding the presence of that harmful organism in certain parts of the Veneto region made by the Commission during an inspection in Italy from 31 August to 11 September 2009, Italy informed the Commission on 23 October 2009 of the results of the latest survey carried out in the Veneto region for the presence of that harmful organism in September and October 2009. The results of this latest survey show that in the province of Venice there are 14 places, in which that harmful organism has been occurring for a period of at least the last three successive years in spite of the eradication measures taken by the Italian authorities. Consequently, those measures have proved to be ineffective.
(4) The latest survey results were discussed during the meeting of the Standing Committee on Plant Health on 19-20 October 2009. It was concluded thatErwinia amylovora(Burr.) Winsl.et al. has to be considered as established in the province of Venice. That province should therefore no longer be included in the lists in Annexes II, III and IV to Directive 2000/29/EC as a protected zone in respect of that harmful organism.
(5) From the Swiss legislation on plant protection, it appears that the Cantons of Fribourg and Vaud are no longer recognised as a protected zone forErwinia amylovora(Burr.) Winsl.et al. in Switzerland as of 15 November 2009. The derogation allowing certain imports from those regions into certain protected zones under special requirements should therefore be deleted and Part B of Annex IV to Directive 2000/29/EC should be amended accordingly.
(6) Annexes II, III and IV to Directive 2000/29/EC should therefore be amended accordingly.
(7) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
HAS ADOPTED THIS DIRECTIVE:
Annexes II, III and IV to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.

Transposition

Member States shall adopt and publish, by 28 February 2010 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 and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 March 2010.
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.
This Directive shall enter into force on the day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEXAnnexes II, III and IV to Directive 2000/29/EC are amended as follows:

1. | in point 2 of heading (b) of Part B of Annex II, the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
2. | part B of Annex III is amended as follows:(a)in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;(b)in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; | (a) | in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; | (b) | in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(a) | in point 1, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) | in point 2, the text in the second column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
3. | part B of Annex IV is amended as follows:(a)point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;(b)point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. | (a) | point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; | (i) | in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; | ‘(c) | the plants originate in the Canton of Valais in Switzerland, or’; | (ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; | (b) | point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. | (i) | in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; | ‘(b) | originate in the Canton of Valais in Switzerland, or’; | (ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(a) | point 21 is amended as follows:(i)in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’; | (i) | in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; | ‘(c) | the plants originate in the Canton of Valais in Switzerland, or’; | (ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(i) | in the second column, special requirements, point (c) is replaced by the following:‘(c)the plants originate in the Canton of Valais in Switzerland, or’; | ‘(c) | the plants originate in the Canton of Valais in Switzerland, or’;
‘(c) | the plants originate in the Canton of Valais in Switzerland, or’;
(ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;
(b) | point 21.3 is amended as follows:(i)in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’;(ii)the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’. | (i) | in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; | ‘(b) | originate in the Canton of Valais in Switzerland, or’; | (ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.
(i) | in the second column, special requirements, point (b) is replaced by the following:‘(b)originate in the Canton of Valais in Switzerland, or’; | ‘(b) | originate in the Canton of Valais in Switzerland, or’;
‘(b) | originate in the Canton of Valais in Switzerland, or’;
(ii) | the text in the third column, protected zone(s), is replaced by the following:‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d’Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Castelbaldo, Barbona, Boara Pisani, Masi, Piacenza d’Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’.

Pending: 32009L0164

23.12.2009 EN Official Journal of the European Union L 344/41
(1) The substance Verbena oil (Lippia citriodoraKunth.) is currently banned for use in cosmetic products, being listed in Annex II to Directive 76/768/EEC, under reference number 450. The ban of this substance was introduced on the basis of an opinion of May 2000 of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), subsequently replaced by the ‘Scientific Committee on Consumer Products (SCCP)’ by Commission Decision 2004/210/EC(2), and later by the ‘Scientific Committee on Consumer Safety (SCCS)’ by Commission Decision 2008/721/EC(3). The SCCNFP recommended the prohibition of Verbena (Lippia citriodoraKunth.) essential oils and derivatives, e.g. concrete and absolute, when used as a fragrance ingredient, based on the sensitising potential.
(2) However, the SCCNFP later concluded in an opinion issued in 2001 that Verbena absolute obtained fromLippia citriodoraKunth. should not be used such that the level in the finished cosmetic products exceeds 0,2 %. It is therefore appropriate to include Verbena absolute (Lippia citriodoraKunth.) together with its respective restriction in Annex III, Part 1 to Directive 76/768/EEC. It is also appropriate to amend reference number 450 of Annex II in order to specify that the substances Verbena essential oils (Lippia citriodoraKunth.) and derivatives other than absolute are prohibited when used as a fragrance ingredient.
(3) Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress(4)included several allyl esters containing allyl alcohol as impurity in Annex III, Part 1 to Directive 76/768/EEC. The substance allyl phenethyl ether may contain allyl alcohol as impurity as well. For this substance, the SCCNFP issued an opinion in 2000 recommending an upper limit of 0,1 % of allyl alcohol as impurity.
(4) In the light of the SCCNFP opinion, as well as for consistency reasons, it is appropriate to include in Annex III, Part 1 to Directive 76/768/EEC the substance allyl phenethyl ether together with its respective restriction.
(5) The group of substances Terpene terpenoids sinpine is currently regulated under reference number 130 in Annex III, Part 1 to Directive 76/768/EEC. However, the word ‘sinpine’ is a trade name and should therefore be deleted from the designation of that group of substances.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) In view of a smooth transition from existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
1. In Annex II, reference number 450, ‘Verbena oil (Lippia citriodoraKunth.) (CAS No 8024-12-2), when used as a fragrance ingredient’ is replaced by ‘Verbena essential oils (Lippia citriodoraKunth.) and derivatives other than absolute (CAS No 8024-12-2), when used as a fragrance ingredient’.
2. Part 1 of Annex III is amended as follows:(a)the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’(b)the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2  %’(c)in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’. (a) the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’ (b) the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2  %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’ (c) in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’.
(a) the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’
(b) the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2  %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’
(c) in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’.
(a) the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘151a Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 Level of free allyl alcohol in the ether should be less than 0,1 %’
(b) the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2  %’ Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘X Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 0,2  %’
(c) in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Safety,
(1) The substance Verbena oil (Lippia citriodoraKunth.) is currently banned for use in cosmetic products, being listed in Annex II to Directive 76/768/EEC, under reference number 450. The ban of this substance was introduced on the basis of an opinion of May 2000 of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), subsequently replaced by the ‘Scientific Committee on Consumer Products (SCCP)’ by Commission Decision 2004/210/EC(2), and later by the ‘Scientific Committee on Consumer Safety (SCCS)’ by Commission Decision 2008/721/EC(3). The SCCNFP recommended the prohibition of Verbena (Lippia citriodoraKunth.) essential oils and derivatives, e.g. concrete and absolute, when used as a fragrance ingredient, based on the sensitising potential.
(2) However, the SCCNFP later concluded in an opinion issued in 2001 that Verbena absolute obtained fromLippia citriodoraKunth. should not be used such that the level in the finished cosmetic products exceeds 0,2 %. It is therefore appropriate to include Verbena absolute (Lippia citriodoraKunth.) together with its respective restriction in Annex III, Part 1 to Directive 76/768/EEC. It is also appropriate to amend reference number 450 of Annex II in order to specify that the substances Verbena essential oils (Lippia citriodoraKunth.) and derivatives other than absolute are prohibited when used as a fragrance ingredient.
(3) Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress(4)included several allyl esters containing allyl alcohol as impurity in Annex III, Part 1 to Directive 76/768/EEC. The substance allyl phenethyl ether may contain allyl alcohol as impurity as well. For this substance, the SCCNFP issued an opinion in 2000 recommending an upper limit of 0,1 % of allyl alcohol as impurity.
(4) In the light of the SCCNFP opinion, as well as for consistency reasons, it is appropriate to include in Annex III, Part 1 to Directive 76/768/EEC the substance allyl phenethyl ether together with its respective restriction.
(5) The group of substances Terpene terpenoids sinpine is currently regulated under reference number 130 in Annex III, Part 1 to Directive 76/768/EEC. However, the word ‘sinpine’ is a trade name and should therefore be deleted from the designation of that group of substances.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) In view of a smooth transition from existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.

Article 2
Member States shall take all necessary measures to ensure that, as from 15 February 2011, no cosmetic products which fail to comply with this Directive are placed on the market by Union manufacturers or by importers established within the Union.
Member States shall take all necessary measures to ensure that, as from 15 August 2011, no cosmetic products which fail to comply with this Directive are sold or disposed of to the final consumer in the Union.

Article 3
1. Member States shall adopt and publish, by 15 August 2010 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 15 February 2011.
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 4
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Article 5
This Directive is addressed to the Member States.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Safety,
(1) The substance Verbena oil (Lippia citriodoraKunth.) is currently banned for use in cosmetic products, being listed in Annex II to Directive 76/768/EEC, under reference number 450. The ban of this substance was introduced on the basis of an opinion of May 2000 of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), subsequently replaced by the ‘Scientific Committee on Consumer Products (SCCP)’ by Commission Decision 2004/210/EC(2), and later by the ‘Scientific Committee on Consumer Safety (SCCS)’ by Commission Decision 2008/721/EC(3). The SCCNFP recommended the prohibition of Verbena (Lippia citriodoraKunth.) essential oils and derivatives, e.g. concrete and absolute, when used as a fragrance ingredient, based on the sensitising potential.
(2) However, the SCCNFP later concluded in an opinion issued in 2001 that Verbena absolute obtained fromLippia citriodoraKunth. should not be used such that the level in the finished cosmetic products exceeds 0,2 %. It is therefore appropriate to include Verbena absolute (Lippia citriodoraKunth.) together with its respective restriction in Annex III, Part 1 to Directive 76/768/EEC. It is also appropriate to amend reference number 450 of Annex II in order to specify that the substances Verbena essential oils (Lippia citriodoraKunth.) and derivatives other than absolute are prohibited when used as a fragrance ingredient.
(3) Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress(4)included several allyl esters containing allyl alcohol as impurity in Annex III, Part 1 to Directive 76/768/EEC. The substance allyl phenethyl ether may contain allyl alcohol as impurity as well. For this substance, the SCCNFP issued an opinion in 2000 recommending an upper limit of 0,1 % of allyl alcohol as impurity.
(4) In the light of the SCCNFP opinion, as well as for consistency reasons, it is appropriate to include in Annex III, Part 1 to Directive 76/768/EEC the substance allyl phenethyl ether together with its respective restriction.
(5) The group of substances Terpene terpenoids sinpine is currently regulated under reference number 130 in Annex III, Part 1 to Directive 76/768/EEC. However, the word ‘sinpine’ is a trade name and should therefore be deleted from the designation of that group of substances.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) In view of a smooth transition from existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:
Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Member States shall take all necessary measures to ensure that, as from 15 February 2011, no cosmetic products which fail to comply with this Directive are placed on the market by Union manufacturers or by importers established within the Union.
Member States shall take all necessary measures to ensure that, as from 15 August 2011, no cosmetic products which fail to comply with this Directive are sold or disposed of to the final consumer in the Union.
1. Member States shall adopt and publish, by 15 August 2010 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 15 February 2011.
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 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEXDirective 76/768/EEC is amended as follows:

1. | In Annex II, reference number 450, ‘Verbena oil (Lippia citriodoraKunth.) (CAS No 8024-12-2), when used as a fragrance ingredient’ is replaced by ‘Verbena essential oils (Lippia citriodoraKunth.) and derivatives other than absolute (CAS No 8024-12-2), when used as a fragrance ingredient’.
2. | Part 1 of Annex III is amended as follows:(a)the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’(b)the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2 %’(c)in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’. | (a) | the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’ | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘151a | Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 | | | Level of free allyl alcohol in the ether should be less than 0,1 %’ | | (b) | the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2 %’ | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘X | Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 | | 0,2 %’ | | | (c) | in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’.
(a) | the following entry is inserted after the entry with reference number 151:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘151aAllyl phenethyl etherCAS No 14289-65-7EC No 238-212-2Level of free allyl alcohol in the ether should be less than 0,1 %’ | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘151a | Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 | | | Level of free allyl alcohol in the ether should be less than 0,1 %’ |
Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label
Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements
a | b | c | d | e | f
‘151a | Allyl phenethyl etherCAS No 14289-65-7EC No 238-212-2 | | | Level of free allyl alcohol in the ether should be less than 0,1 %’ |
(b) | the following entry is added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘XVerbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-20,2 %’ | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘X | Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 | | 0,2 %’ | |
Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label
Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements
a | b | c | d | e | f
‘X | Verbena absolute(Lippia citriodoraKunth.)CAS No 8024-12-2 | | 0,2 %’ | |
(c) | in column ‘b’ of the entry relating to reference number 130, the words ‘Terpene terpenoids sinpine’ are replaced by ‘Terpenes and terpenoids’.

Pending: 32009L0157

10.12.2009 EN Official Journal of the European Union L 323/1
(1) Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding animals of the bovine species(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Cattle production occupies a very important place in Community agriculture, and satisfactory results depend to a large extent on the use of pure-bred breeding animals.
(3) Disparities between Member States as regards breeds and standards hinder intra-Community trade. If these disparities are to be removed, thereby increasing agricultural productivity in this sector, intra-Community trade in all pure-bred breeding animals should be liberalised.
(4) It should be possible for the Member States to insist on pedigree certificates drawn up in accordance with a Community procedure being presented.
(5) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).
(6) This Directive is without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B,
(a) ‘pure-bred breeding animal of the bovine species’ means any bovine animal, including buffalo, the parents and grandparents of which are entered or registered in a herd-book of the same breed, and which is itself either entered or registered and eligible for entry in such a herd-book;
(b) ‘herd-book’ means any book, register, file or data medium:(i)which is maintained by a breeders' organisation or association officially recognised by a Member State in which the breeders' organisation or association was constituted, or by an official department of the Member State concerned; and(ii)in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors. (i) which is maintained by a breeders' organisation or association officially recognised by a Member State in which the breeders' organisation or association was constituted, or by an official department of the Member State concerned; and (ii) in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.
(i) which is maintained by a breeders' organisation or association officially recognised by a Member State in which the breeders' organisation or association was constituted, or by an official department of the Member State concerned; and
(ii) in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.
(i) which is maintained by a breeders' organisation or association officially recognised by a Member State in which the breeders' organisation or association was constituted, or by an official department of the Member State concerned; and
(ii) in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.
(a) intra-Community trade in pure-bred breeding animals of the bovine species;
(b) intra-Community trade in the semen, ova and embryos of pure-bred breeding animals of the bovine species;
(c) the establishment of herd-books, provided that they comply with the requirements laid down pursuant to Article 6;
(d) the recognition of organisations or associations which maintain herd-books, in accordance with Article 6; and
(e) subject to Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species(6), intra-Community trade in bulls used for artificial insemination.
(a) performance monitoring methods and methods for assessing cattle's genetic value;
(b) the criteria governing the recognition of breeders' organisations and associations;
(c) the criteria governing the establishment of herd-books;
(d) the criteria governing entry in herd-books;
(e) the particulars to be shown on the pedigree certificate.
Council Directive 77/504/EEC(OJ L 206, 12.8.1977, p. 8)
Council Directive 79/268/EEC(OJ L 62, 13.3.1979, p. 5)
1979 Act of Accession, Annex I, Point II.A.65 and Point II.E.6(OJ L 291, 19.11.1979, p. 64andp. 85)
Council Directive 85/586/EEC(OJ L 372, 31.12.1985, p. 44) only Article 4
Council Regulation (EEC) No 3768/85(OJ L 362, 31.12.1985, p. 8) only Annex, point 46
Council Directive 91/174/EEC(OJ L 85, 5.4.1991, p. 37) only Article 3
Council Directive 94/28/EC(OJ L 178, 12.7.1994, p. 66) only Article 11
1994 Act of Accession, Annex I, Point V.F.I.A.60(OJ C 241, 29.8.1994, p. 155)
Council Regulation (EC) No 807/2003(OJ L 122, 16.5.2003, p. 36) only Annex III, point 23
Council Directive 2008/73/EC(OJ L 219, 14.8.2008, p. 40) only Article 2
Directive Time-limit for transposition
77/504/EEC 1 January 1979, with the exception of Article 7.Relating to Article 7, as regards each of the points which it covers, on the same dates as those on which the Member States comply with the provisions applicable in intra-Community trade, and in particular the decisions that are successively adopted pursuant to Article 6.
85/586/EEC 1 January 1986
91/174/EEC 31 December 1991
94/28/EC 1 July 1995
2008/73/EC 1 January 2010
Directive 77/504/EEC This Directive
Article 1(a) Article 1(a)
Article 1(b), first and second indents Article 1(b)(i) and (ii)
Article 2, first paragraph, first to fifth indents Article 2(a) to (e)
Article 2, second paragraph —
Article 3 —
Article 4 Article 3
Article 4a Article 4
Article 5 Article 5
Article 6(1), first to fifth indents Article 6(a) to (e)
Article 6(2) —
Article 8(1) and (2) Article 7(1) and (2)
Article 8(3) —
— Article 8
Article 9 —
— Article 9
— Article 10
Article 10 Article 11
— Annex I
— Annex II
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Parliament(1),
Having regard to the opinion of the European Economic and Social Committee(2),
(1) Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding animals of the bovine species(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Cattle production occupies a very important place in Community agriculture, and satisfactory results depend to a large extent on the use of pure-bred breeding animals.
(3) Disparities between Member States as regards breeds and standards hinder intra-Community trade. If these disparities are to be removed, thereby increasing agricultural productivity in this sector, intra-Community trade in all pure-bred breeding animals should be liberalised.
(4) It should be possible for the Member States to insist on pedigree certificates drawn up in accordance with a Community procedure being presented.
(5) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).
(6) This Directive is without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B,
HAS ADOPTED THIS DIRECTIVE:

Article 1
For the purposes of this Directive, the following definitions shall apply:
(a)
‘pure-bred breeding animal of the bovine species’ means any bovine animal, including buffalo, the parents and grandparents of which are entered or registered in a herd-book of the same breed, and which is itself either entered or registered and eligible for entry in such a herd-book;
(b)
‘herd-book’ means any book, register, file or data medium:
(i)
which is maintained by a breeders’ organisation or association officially recognised by a Member State in which the breeders’ organisation or association was constituted, or by an official department of the Member State concerned; and
(ii)
in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.

Article 2
The Member States shall ensure that the following shall not be prohibited, restricted or impeded on zootechnical grounds:
(a)
intra-Community trade in pure-bred breeding animals of the bovine species;
(b)
intra-Community trade in the semen, ova and embryos of pure-bred breeding animals of the bovine species;
(c)
the establishment of herd-books, provided that they comply with the requirements laid down pursuant to Article 6;
(d)
the recognition of organisations or associations which maintain herd-books, in accordance with Article 6; and
(e)
subject to Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species(6), intra-Community trade in bulls used for artificial insemination.

Article 3
Breeders’ organisations or associations officially recognised by a Member State may not oppose the entry in their herd-books of pure-bred breeding animals of the bovine species from other Member States provided that they satisfy the requirements laid down in accordance with Article 6.

Article 4
1. Member States shall draw up and keep up-to-date a list of bodies as referred to in Article 1(b) (i) which are officially recognised for the purpose of maintaining or establishing herd-books, and make it available to the other Member States and to the public.
2. Detailed rules for the uniform application of paragraph 1 may be adopted in accordance with the procedure referred to in Article 7(2).

Article 5
Member States may require that pure-bred breeding animals of the bovine species and the semen or ova and embryos from such animals shall be accompanied, in intra-Community trade, by a pedigree certificate which complies with a specimen drawn up in accordance with the procedure referred to in Article 7(2), particularly with regard to zootechnical performance.

Article 6
The following shall be determined in accordance with the procedure referred to in Article 7(2):
(a)
performance monitoring methods and methods for assessing cattle’s genetic value;
(b)
the criteria governing the recognition of breeders’ organisations and associations;
(c)
the criteria governing the establishment of herd-books;
(d)
the criteria governing entry in herd-books;
(e)
the particulars to be shown on the pedigree certificate.

Article 7
1. The Commission shall be assisted by the Standing Committee on Zootechnics established by Council Decision 77/505/EEC of 25 July 1977 setting up a Standing Committee on Zootechnics(7).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 8
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

Article 9
Directive 77/504/EEC, as amended by the acts listed in Annex I, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.

Article 10
This Directive shall enter into force on the twentieth day following its publication in theOfficial Journal of the European Union.
It shall apply from 2 January 2010.

Article 11
This Directive is addressed to the Member States.

THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Parliament(1),
Having regard to the opinion of the European Economic and Social Committee(2),
(1) Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding animals of the bovine species(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Cattle production occupies a very important place in Community agriculture, and satisfactory results depend to a large extent on the use of pure-bred breeding animals.
(3) Disparities between Member States as regards breeds and standards hinder intra-Community trade. If these disparities are to be removed, thereby increasing agricultural productivity in this sector, intra-Community trade in all pure-bred breeding animals should be liberalised.
(4) It should be possible for the Member States to insist on pedigree certificates drawn up in accordance with a Community procedure being presented.
(5) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).
(6) This Directive is without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B,
HAS ADOPTED THIS DIRECTIVE:
For the purposes of this Directive, the following definitions shall apply:
(a)
‘pure-bred breeding animal of the bovine species’ means any bovine animal, including buffalo, the parents and grandparents of which are entered or registered in a herd-book of the same breed, and which is itself either entered or registered and eligible for entry in such a herd-book;
(b)
‘herd-book’ means any book, register, file or data medium:
(i)
which is maintained by a breeders’ organisation or association officially recognised by a Member State in which the breeders’ organisation or association was constituted, or by an official department of the Member State concerned; and
(ii)
in which pure-bred breeding animals of a given breed of the bovine species are entered or registered with mention of their ancestors.
The Member States shall ensure that the following shall not be prohibited, restricted or impeded on zootechnical grounds:
(a)
intra-Community trade in pure-bred breeding animals of the bovine species;
(b)
intra-Community trade in the semen, ova and embryos of pure-bred breeding animals of the bovine species;
(c)
the establishment of herd-books, provided that they comply with the requirements laid down pursuant to Article 6;
(d)
the recognition of organisations or associations which maintain herd-books, in accordance with Article 6; and
(e)
subject to Council Directive 87/328/EEC of 18 June 1987 on the acceptance for breeding purposes of pure-bred breeding animals of the bovine species(6), intra-Community trade in bulls used for artificial insemination.
Breeders’ organisations or associations officially recognised by a Member State may not oppose the entry in their herd-books of pure-bred breeding animals of the bovine species from other Member States provided that they satisfy the requirements laid down in accordance with Article 6.
1. Member States shall draw up and keep up-to-date a list of bodies as referred to in Article 1(b) (i) which are officially recognised for the purpose of maintaining or establishing herd-books, and make it available to the other Member States and to the public.
2. Detailed rules for the uniform application of paragraph 1 may be adopted in accordance with the procedure referred to in Article 7(2).
Member States may require that pure-bred breeding animals of the bovine species and the semen or ova and embryos from such animals shall be accompanied, in intra-Community trade, by a pedigree certificate which complies with a specimen drawn up in accordance with the procedure referred to in Article 7(2), particularly with regard to zootechnical performance.
The following shall be determined in accordance with the procedure referred to in Article 7(2):
(a)
performance monitoring methods and methods for assessing cattle’s genetic value;
(b)
the criteria governing the recognition of breeders’ organisations and associations;
(c)
the criteria governing the establishment of herd-books;
(d)
the criteria governing entry in herd-books;
(e)
the particulars to be shown on the pedigree certificate.
1. The Commission shall be assisted by the Standing Committee on Zootechnics established by Council Decision 77/505/EEC of 25 July 1977 setting up a Standing Committee on Zootechnics(7).
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Directive 77/504/EEC, as amended by the acts listed in Annex I, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
This Directive shall enter into force on the twentieth day following its publication in theOfficial Journal of the European Union.
It shall apply from 2 January 2010.
This Directive is addressed to the Member States.

Part A

ANNEX IRepealed Directive with list of its successive amendments(referred to in Article 9)
Council Directive 77/504/EEC(OJ L 206, 12.8.1977, p. 8) |
Council Directive 79/268/EEC(OJ L 62, 13.3.1979, p. 5) |
1979 Act of Accession, Annex I, Point II.A.65 and Point II.E.6(OJ L 291, 19.11.1979, p. 64andp. 85) |
Council Directive 85/586/EEC(OJ L 372, 31.12.1985, p. 44) | only Article 4
Council Regulation (EEC) No 3768/85(OJ L 362, 31.12.1985, p. 8) | only Annex, point 46
Council Directive 91/174/EEC(OJ L 85, 5.4.1991, p. 37) | only Article 3
Council Directive 94/28/EC(OJ L 178, 12.7.1994, p. 66) | only Article 11
1994 Act of Accession, Annex I, Point V.F.I.A.60(OJ C 241, 29.8.1994, p. 155) |
Council Regulation (EC) No 807/2003(OJ L 122, 16.5.2003, p. 36) | only Annex III, point 23
Council Directive 2008/73/EC(OJ L 219, 14.8.2008, p. 40) | only Article 2
Part B
List of time-limits for transposition into national law(referred to in Article 9)
Directive | Time-limit for transposition
77/504/EEC | 1 January 1979, with the exception of Article 7.Relating to Article 7, as regards each of the points which it covers, on the same dates as those on which the Member States comply with the provisions applicable in intra-Community trade, and in particular the decisions that are successively adopted pursuant to Article 6.
85/586/EEC | 1 January 1986
91/174/EEC | 31 December 1991
94/28/EC | 1 July 1995
2008/73/EC | 1 January 2010
ANNEX II
Correlation Table

Directive 77/504/EEC | This Directive
Article 1(a) | Article 1(a)
Article 1(b), first and second indents | Article 1(b)(i) and (ii)
Article 2, first paragraph, first to fifth indents | Article 2(a) to (e)
Article 2, second paragraph | —
Article 3 | —
Article 4 | Article 3
Article 4a | Article 4
Article 5 | Article 5
Article 6(1), first to fifth indents | Article 6(a) to (e)
Article 6(2) | —
Article 8(1) and (2) | Article 7(1) and (2)
Article 8(3) | —
— | Article 8
Article 9 | —
— | Article 9
— | Article 10
Article 10 | Article 11
— | Annex I
— | Annex II

Pending: 32009L0149

28.11.2009 EN Official Journal of the European Union L 313/65
(1) Article 5(2) of Directive 2004/49/EC, as corrected, provides for the possibility to revise Annex I to the said Directive in order to include common definitions of the Common Safety Indicators (CSIs) and methods to calculate accident costs.
(2) In accordance with Article 5(1) of Directive 2004/49/EC information on CSIs is to be collected to facilitate the assessment of the achievement of the Common Safety Targets (CSTs). In conformity with Article 7(3) of the said Directive, the CSTs should be accompanied by an assessment of the economic impact in terms of societal acceptance of risk. The main purpose of CSIs should be to measure safety performance and to facilitate the economic impact assessment of CSTs. Therefore, it is necessary to move from indicators related to costs of all accidents borne by railways to indicators related to the economic impact of accidents on society.
(3) Attributing monetary values to improved safety should be seen in the context of limited budget resources of public policy actions. Therefore, in order to select initiatives that ensure an efficient allocation of resources, it becomes necessary to prioritise across the different actions.
(4) Article 9 of Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European Railway Agency (Agency Regulation)(2)mandates the Agency to set up a network with the national authorities responsible for safety and the national authorities responsible for the investigations in order to define the content of the CSIs listed in Annex I to Directive 2004/49/EC. In response to this mandate, on 29 September 2008 the Agency delivered its recommendation on the revision of Annex I to Directive 2004/49/EC: common definitions for the CSIs and methods to calculate the economic impact of accidents (ERA/REC/SAF/02-2008).
(5) Annex I to Directive 2004/49/EC should therefore be amended.
(6) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 21 of Directive 96/48/EC,
1.1. Total and relative (to train-kilometres) number of significant accidents and a break-down on the following types of accidents:—collisions of trains, including collisions with obstacles within the clearance gauge,—derailments of trains,—level crossing accidents, including accidents involving pedestrians at level crossings,—accidents to persons caused by rolling stock in motion, with the exception of suicides,—fires in rolling stock,—others.Each significant accident shall be reported under the type of the primary accident, even if the consequences of the secondary accident are more severe, e.g. a fire following a derailment. — collisions of trains, including collisions with obstacles within the clearance gauge, — derailments of trains, — level crossing accidents, including accidents involving pedestrians at level crossings, — accidents to persons caused by rolling stock in motion, with the exception of suicides, — fires in rolling stock, — others.
— collisions of trains, including collisions with obstacles within the clearance gauge,
— derailments of trains,
— level crossing accidents, including accidents involving pedestrians at level crossings,
— accidents to persons caused by rolling stock in motion, with the exception of suicides,
— fires in rolling stock,
— others.
— collisions of trains, including collisions with obstacles within the clearance gauge,
— derailments of trains,
— level crossing accidents, including accidents involving pedestrians at level crossings,
— accidents to persons caused by rolling stock in motion, with the exception of suicides,
— fires in rolling stock,
— others.
1.2. Total and relative (to train-kilometres) number of persons seriously injured and killed by type of accident divided into the following categories:—passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres),—employees including the staff of contractors,—level crossing users,—unauthorised persons on railway premises,—others. — passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres), — employees including the staff of contractors, — level crossing users, — unauthorised persons on railway premises, — others.
— passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres),
— employees including the staff of contractors,
— level crossing users,
— unauthorised persons on railway premises,
— others.
— passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres),
— employees including the staff of contractors,
— level crossing users,
— unauthorised persons on railway premises,
— others.
— accidents involving at least one railway vehicle transporting dangerous goods, as defined by the Appendix,
— number of such accidents in which dangerous goods are released.
— broken rails,
— track buckles,
— wrong-side signalling failures,
— signals passed at danger,
— broken wheels and axles on rolling stock in service.
— number of deaths and serious injuries multiplied by the Value of Preventing a Casualty (VPC),
— cost of damages to environment,
— cost of material damages to rolling stock or infrastructure,
— cost of delays as a consequence of accidents.
6.1. Percentage of tracks with Automatic Train Protection (ATP) in operation, percentage of train-kilometres using operational ATP systems.
6.2. Number of level crossings (total, per line kilometre and track kilometre) by the following eight types:(a)active level crossings with:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection,(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning.(b)passive level crossings. (a) active level crossings with:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection,(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection, (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning. (b) passive level crossings.
(a) active level crossings with:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection,(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection, (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection,
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
(b) passive level crossings.
(a) active level crossings with:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection,(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection, (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection,
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection,
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
(b) passive level crossings.
1.1. “significant accident” means any accident involving at least one rail vehicle in motion, resulting in at least one killed or seriously injured person, or in significant damage to stock, track, other installations or environment, or extensive disruptions to traffic. Accidents in workshops, warehouses and depots are excluded.
1.2. “significant damage to stock, track, other installations or environment” means damage that is equivalent to EUR 150 000 or more.
1.3. “extensive disruptions to traffic” means that train services on a main railway line are suspended for six hours or more.
1.4. “train” means one or more railway vehicles hauled by one or more locomotives or railcars, or one railcar travelling alone, running under a given number or specific designation from an initial fixed point to a terminal fixed point. A light engine, i.e. a locomotive travelling on its own, is considered to be a train.
1.5. “collision of trains, including collisions with obstacles within the clearance gauge” means a front to front, front to end or a side collision between a part of a train and a part of another train, or with:(i)shunting rolling stock,(ii)objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user). (i) shunting rolling stock, (ii) objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user).
(i) shunting rolling stock,
(ii) objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user).
(i) shunting rolling stock,
(ii) objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user).
1.6. “train derailment” means any case in which at least one wheel of a train leaves the rails.
1.7. “level crossing accidents” means accidents at level crossings involving at least one railway vehicle and one or more crossing vehicles, other crossing users such as pedestrians or other objects temporarily present on or near the track if lost by a crossing vehicle/user.
1.8. “accidents to persons caused by rolling stock in motion” means accidents to one or more persons who are either hit by a railway vehicle or by an object attached to, or that has become detached from, the vehicle. Persons who fall from railway vehicles are included, as well as persons who fall or are hit by loose objects when travelling on board vehicles.
1.9. “fires in rolling stock” means fires and explosions that occur in railway vehicles (including their load) when they are running between the departure station and the destination, including when stopped at the departure station, the destination or intermediate stops, as well as during re-marshalling operations.
1.10. “other types of accidents” means all accidents other than those already mentioned (train collisions, train derailments, at level crossing, to persons caused by rolling stock in motion and fires in rolling stock).
1.11. “passenger” means any person, excluding members of the train crew, who makes a trip by rail. For accident statistics, passengers trying to embark/disembark onto/from a moving train are included.
1.12. “employees (staff of contractors and self-employed contractors are included)” means any person whose employment is in connection with a railway and is at work at the time of the accident. It includes the crew of the train and persons handling rolling stock and infrastructure installations.
1.13. “level crossing users” means all persons using a level crossing to cross the railway line by any mean of transport or by foot.
1.14. “unauthorised persons on railway premises” means any person present on railway premises where such presence is forbidden, with the exception of level crossing users.
1.15. “others (third parties)” means all persons not defined as “passengers”, “employees including the staff of contractors”, “level crossing users” or “unauthorised persons on railway premises”.
1.16. “deaths (killed person)” means any person killed immediately or dying within 30 days as a result of an accident, excluding suicides.
1.17. “injuries (seriously injured person)” means any person injured who was hospitalised for more than 24 hours as a result of an accident, excluding attempted suicides.
2.1. “accident involving the transport of dangerous goods” means any accident or incident that is subject to reporting in accordance with RID(2)/ADR section 1.8.5.
2.2. “dangerous goods” means those substances and articles the carriage of which is prohibited by RID, or authorised only under the conditions prescribed therein.
3.1. “suicide” means an act to deliberately injure oneself resulting in death, as recorded and classified by the competent national authority.
4.1. “broken rails” means any rail which is separated in two or more pieces, or any rail from which a piece of metal becomes detached, causing a gap of more than 50 mm in length and more than 10 mm in depth on the running surface.
4.2. “track buckles” means faults related to the continuum and the geometry of track, requiring track obstruction or immediate reduction of permitted speed to maintain safety.
4.3. “wrong side signalling failure” means any failure of a signalling system (either to infrastructure or to rolling stock), resulting in signalling information less restrictive than that demanded.
4.4. “Signal Passed at Danger (SPAD)” means any occasion when any part of a train proceeds beyond its authorised movement.Unauthorised movement means to pass:—a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational,—the end of a safety related movement authority provided in an ATCS or ATP system,—a point communicated by verbal or written authorisation laid down in regulations,—stop boards (buffer stops are not included) or hand signals.Cases in which vehicles without any traction unit attached or a train that is unattended run away past a signal at danger are not included. Cases in which, for any reason, the signal is not turned to danger in time to allow the driver to stop the train before the signal are not included.National Safety Authorities may report separately on the four indexes and shall report at least an aggregate indicator containing data on all four items. — a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational, — the end of a safety related movement authority provided in an ATCS or ATP system, — a point communicated by verbal or written authorisation laid down in regulations, — stop boards (buffer stops are not included) or hand signals.
— a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational,
— the end of a safety related movement authority provided in an ATCS or ATP system,
— a point communicated by verbal or written authorisation laid down in regulations,
— stop boards (buffer stops are not included) or hand signals.
— a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational,
— the end of a safety related movement authority provided in an ATCS or ATP system,
— a point communicated by verbal or written authorisation laid down in regulations,
— stop boards (buffer stops are not included) or hand signals.
4.5. “broken wheels and broken axles” means a break affecting the essential parts of the wheel or the axle and creating a risk of accident (derailment or collision).
5.1. The Value of Preventing a Casualty (VPC) is composed of:1.Value of safetyper se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied.2.Direct and indirect economic costs: cost values appraised in the Member State, composed of:—medical and rehabilitation cost,—legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,—production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred. 1. Value of safetyper se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied. 2. Direct and indirect economic costs: cost values appraised in the Member State, composed of:—medical and rehabilitation cost,—legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,—production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred. — medical and rehabilitation cost, — legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance, — production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
1. Value of safetyper se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied.
2. Direct and indirect economic costs: cost values appraised in the Member State, composed of:—medical and rehabilitation cost,—legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,—production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred. — medical and rehabilitation cost, — legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance, — production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
— medical and rehabilitation cost,
— legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,
— production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
1. Value of safetyper se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied.
2. Direct and indirect economic costs: cost values appraised in the Member State, composed of:—medical and rehabilitation cost,—legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,—production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred. — medical and rehabilitation cost, — legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance, — production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
— medical and rehabilitation cost,
— legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,
— production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
— medical and rehabilitation cost,
— legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,
— production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
5.2. Common principles to appraise the value of safetyper seand direct/indirect economic costs:For the value of safetyper se, the assessment of whether available estimates are appropriate or not shall be based on the following considerations:—estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods,—the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population,—method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.Direct and indirect economic costs shall be appraised on the basis of the real costs borne by society. — estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods, — the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population, — method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.
— estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods,
— the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population,
— method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.
— estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods,
— the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population,
— method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.
5.3. “Cost of damage to environment” means costs that are to be met by Railway Undertakings/Infrastructure Managers, appraised on the basis of their experience, in order to restore the damaged area to its state before the railway accident.
5.4. “Cost of material damage to rolling stock or infrastructure” means the cost of providing new rolling stock or infrastructure, with the same functionalities and technical parameters as that damaged beyond repair, and the cost of restoring repairable rolling stock or infrastructure to its state before the accident. Both are to be estimated by Railway Undertakings/Infrastructure Managers on the basis of their experience. Also includes costs related to leasing rolling stock, as a consequence of non availability due to damaged vehicles.
5.5. “Cost of delays as a consequence of accidents” means the monetary value of delays incurred by users of rail transport (passengers and freight customers) as a consequence of accidents, calculated by the following model:VT= monetary value of travel time savingsValue of time for a passenger of a train (an hour)VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]VT measured in EUR per passenger per hourValue of time for a freight train (an hour)VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]VT is measured in EUR per freight tonne per hourAverage tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)CM= Cost of 1 minute of delay of a trainPassenger trainCMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)Freight trainCMF= K2* (VTF/60)Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.Cost of delays of an accident = CMP*(Minutes of delay of passenger trains) + CMF*(Minutes of delay of freight trains) Value of time for a passenger of a train (an hour)VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]VT measured in EUR per passenger per hour VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year] VT measured in EUR per passenger per hour Value of time for a freight train (an hour)VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]VT is measured in EUR per freight tonne per hourAverage tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km) VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)] VT is measured in EUR per freight tonne per hour Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km) Passenger trainCMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]Average number of passengers per train in one year = (Passenger-Km)/(Train-Km) CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)] Average number of passengers per train in one year = (Passenger-Km)/(Train-Km) Freight trainCMF= K2* (VTF/60)Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time. CMF= K2* (VTF/60) Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
Value of time for a passenger of a train (an hour)VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]VT measured in EUR per passenger per hour VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year] VT measured in EUR per passenger per hour
VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]
VT measured in EUR per passenger per hour
Value of time for a freight train (an hour)VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]VT is measured in EUR per freight tonne per hourAverage tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km) VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)] VT is measured in EUR per freight tonne per hour Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]
VT is measured in EUR per freight tonne per hour
Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
Passenger trainCMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]Average number of passengers per train in one year = (Passenger-Km)/(Train-Km) CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)] Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]
Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
Freight trainCMF= K2* (VTF/60)Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time. CMF= K2* (VTF/60) Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
CMF= K2* (VTF/60)
Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
Value of time for a passenger of a train (an hour)VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]VT measured in EUR per passenger per hour VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year] VT measured in EUR per passenger per hour
VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]
VT measured in EUR per passenger per hour
VTP= [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]
VT measured in EUR per passenger per hour
Value of time for a freight train (an hour)VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]VT is measured in EUR per freight tonne per hourAverage tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km) VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)] VT is measured in EUR per freight tonne per hour Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]
VT is measured in EUR per freight tonne per hour
Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
VTF= [VT of freight trains]*[(Tonne-Km)/(Train-Km)]
VT is measured in EUR per freight tonne per hour
Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
Passenger trainCMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]Average number of passengers per train in one year = (Passenger-Km)/(Train-Km) CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)] Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]
Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
CMP= K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]
Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
Freight trainCMF= K2* (VTF/60)Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time. CMF= K2* (VTF/60) Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
CMF= K2* (VTF/60)
Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
CMF= K2* (VTF/60)
Factors K1and K2are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
— real delays on the railway lines where accidents occurred,
— real delays or, if not possible, estimated delays on the other affected lines.
6.1. “Automatic Train Protection (ATP)” means a system that enforces obedience to signals and speed restrictions by speed supervision, including automatic stop at signals.
6.2. “level crossing” means any level intersection between the railway and a passage, as recognised by the infrastructure manager and open to public or private users. Passages between platforms within stations are excluded, as well as passages over tracks for the sole use of employees.
6.3. “passage” means any public or private road, street or highway, including footpaths and bicycle paths, or other route provided for the passage of people, animals, vehicles or machinery.
6.4. “active level crossing” means a level crossing where the crossing users are protected from or warned of the approaching train by the activation of devices when it is unsafe for the user to traverse the crossing.—Protection by the use of physical devices:—half or full barriers,—gates.—Warning by the use of fixed equipment at level crossings:—visible devices: lights,—audible devices: bells, horns, klaxons, etc.,—physical devices, e.g. vibration due to road bumps.Active level crossings are classified as:1.“Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.These level crossings are classified as:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.2.“Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.These level crossings are classified as:(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. — Protection by the use of physical devices:—half or full barriers,—gates. — half or full barriers, — gates. — Warning by the use of fixed equipment at level crossings:—visible devices: lights,—audible devices: bells, horns, klaxons, etc.,—physical devices, e.g. vibration due to road bumps. — visible devices: lights, — audible devices: bells, horns, klaxons, etc., — physical devices, e.g. vibration due to road bumps. 1. “Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.These level crossings are classified as:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection. 2. “Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.These level crossings are classified as:(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning.
— Protection by the use of physical devices:—half or full barriers,—gates. — half or full barriers, — gates.
— half or full barriers,
— gates.
— Warning by the use of fixed equipment at level crossings:—visible devices: lights,—audible devices: bells, horns, klaxons, etc.,—physical devices, e.g. vibration due to road bumps. — visible devices: lights, — audible devices: bells, horns, klaxons, etc., — physical devices, e.g. vibration due to road bumps.
— visible devices: lights,
— audible devices: bells, horns, klaxons, etc.,
— physical devices, e.g. vibration due to road bumps.
1. “Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.These level crossings are classified as:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.
2. “Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.These level crossings are classified as:(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning.
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
— Protection by the use of physical devices:—half or full barriers,—gates. — half or full barriers, — gates.
— half or full barriers,
— gates.
— half or full barriers,
— gates.
— Warning by the use of fixed equipment at level crossings:—visible devices: lights,—audible devices: bells, horns, klaxons, etc.,—physical devices, e.g. vibration due to road bumps. — visible devices: lights, — audible devices: bells, horns, klaxons, etc., — physical devices, e.g. vibration due to road bumps.
— visible devices: lights,
— audible devices: bells, horns, klaxons, etc.,
— physical devices, e.g. vibration due to road bumps.
— visible devices: lights,
— audible devices: bells, horns, klaxons, etc.,
— physical devices, e.g. vibration due to road bumps.
1. “Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.These level crossings are classified as:(i)automatic user-side warning,(ii)automatic user-side protection,(iii)automatic user-side protection and warning,(iv)automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection. (i) automatic user-side warning, (ii) automatic user-side protection, (iii) automatic user-side protection and warning, (iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection.“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection.
2. “Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.These level crossings are classified as:(v)manual user-side warning,(vi)manual user-side protection,(vii)manual user-side protection and warning. (v) manual user-side warning, (vi) manual user-side protection, (vii) manual user-side protection and warning.
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
6.5. “Passive level crossing” means a level crossing without any form of warning system and/or protection activated when it is unsafe for the user to traverse the crossing.
7.1. “audit” means a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
8.1. “train-km” means the unit of measure representing the movement of a train over one kilometre. The distance used is the distance actually run, if available, otherwise the standard network distance between the origin and destination shall be used. Only the distance on the national territory of the reporting country shall be taken into account.
8.2. “passenger-km” means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre. Only the distance on the national territory of the reporting country shall be taken into account.
8.3. “line km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. For multiple-track railway lines, only the distance between origin and destination is to be counted.
8.4. “track km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. Each track of a multiple-track railway line is to be counted.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety of the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive)(1), and in particular Article 5(2) thereof,
Having regard to the recommendation of the European Railway Agency (ERA/REC/SAF/02-2008) of 29 September 2008,
(1) Article 5(2) of Directive 2004/49/EC, as corrected, provides for the possibility to revise Annex I to the said Directive in order to include common definitions of the Common Safety Indicators (CSIs) and methods to calculate accident costs.
(2) In accordance with Article 5(1) of Directive 2004/49/EC information on CSIs is to be collected to facilitate the assessment of the achievement of the Common Safety Targets (CSTs). In conformity with Article 7(3) of the said Directive, the CSTs should be accompanied by an assessment of the economic impact in terms of societal acceptance of risk. The main purpose of CSIs should be to measure safety performance and to facilitate the economic impact assessment of CSTs. Therefore, it is necessary to move from indicators related to costs of all accidents borne by railways to indicators related to the economic impact of accidents on society.
(3) Attributing monetary values to improved safety should be seen in the context of limited budget resources of public policy actions. Therefore, in order to select initiatives that ensure an efficient allocation of resources, it becomes necessary to prioritise across the different actions.
(4) Article 9 of Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European Railway Agency (Agency Regulation)(2)mandates the Agency to set up a network with the national authorities responsible for safety and the national authorities responsible for the investigations in order to define the content of the CSIs listed in Annex I to Directive 2004/49/EC. In response to this mandate, on 29 September 2008 the Agency delivered its recommendation on the revision of Annex I to Directive 2004/49/EC: common definitions for the CSIs and methods to calculate the economic impact of accidents (ERA/REC/SAF/02-2008).
(5) Annex I to Directive 2004/49/EC should therefore be amended.
(6) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 21 of Directive 96/48/EC,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 2004/49/EC is replaced by the text in the Annex to this Directive.

Article 2
1. Member States shall adopt and publish, by 18 June 2010 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 and a correlation table between those provisions and this Directive.
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 20 days after its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety of the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive)(1), and in particular Article 5(2) thereof,
Having regard to the recommendation of the European Railway Agency (ERA/REC/SAF/02-2008) of 29 September 2008,
(1) Article 5(2) of Directive 2004/49/EC, as corrected, provides for the possibility to revise Annex I to the said Directive in order to include common definitions of the Common Safety Indicators (CSIs) and methods to calculate accident costs.
(2) In accordance with Article 5(1) of Directive 2004/49/EC information on CSIs is to be collected to facilitate the assessment of the achievement of the Common Safety Targets (CSTs). In conformity with Article 7(3) of the said Directive, the CSTs should be accompanied by an assessment of the economic impact in terms of societal acceptance of risk. The main purpose of CSIs should be to measure safety performance and to facilitate the economic impact assessment of CSTs. Therefore, it is necessary to move from indicators related to costs of all accidents borne by railways to indicators related to the economic impact of accidents on society.
(3) Attributing monetary values to improved safety should be seen in the context of limited budget resources of public policy actions. Therefore, in order to select initiatives that ensure an efficient allocation of resources, it becomes necessary to prioritise across the different actions.
(4) Article 9 of Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European Railway Agency (Agency Regulation)(2)mandates the Agency to set up a network with the national authorities responsible for safety and the national authorities responsible for the investigations in order to define the content of the CSIs listed in Annex I to Directive 2004/49/EC. In response to this mandate, on 29 September 2008 the Agency delivered its recommendation on the revision of Annex I to Directive 2004/49/EC: common definitions for the CSIs and methods to calculate the economic impact of accidents (ERA/REC/SAF/02-2008).
(5) Annex I to Directive 2004/49/EC should therefore be amended.
(6) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 21 of Directive 96/48/EC,
HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 2004/49/EC is replaced by the text in the Annex to this Directive.
1. Member States shall adopt and publish, by 18 June 2010 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 and a correlation table between those provisions and this Directive.
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 20 days after its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX
‘ANNEX I
COMMON SAFETY INDICATORS
Common safety indicators shall be reported annually by the safety authorities. The first reporting period shall be 2010. Indicators relating to activities referred to in Article 2(2), (a) and (b), should be accounted for separately, if they are submitted.
If new facts or errors are discovered after the submission of the report the indicators for one particular year shall be amended or corrected by the safety authority at the first convenient opportunity and at the latest in the next annual report.
For indicators relating to accidents under heading 1, Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics (1) shall be applied as far as the information is available. 1. Indicators relating to accidents
1.1. Total and relative (to train-kilometres) number of significant accidents and a break-down on the following types of accidents:
—
collisions of trains, including collisions with obstacles within the clearance gauge,
—
derailments of trains,
—
level crossing accidents, including accidents involving pedestrians at level crossings,
—
accidents to persons caused by rolling stock in motion, with the exception of suicides,
—
fires in rolling stock,
—
others.
Each significant accident shall be reported under the type of the primary accident, even if the consequences of the secondary accident are more severe, e.g. a fire following a derailment.
1.2. Total and relative (to train-kilometres) number of persons seriously injured and killed by type of accident divided into the following categories:
—
passengers (also in relation to total number of passenger-kilometres and passenger train-kilometres),
—
employees including the staff of contractors,
—
level crossing users,
—
unauthorised persons on railway premises,
—
others. 2. Indicators relating to dangerous goods
Total and relative (to train-kilometres) number of accidents involving the transport of dangerous goods divided into the following categories:
—
accidents involving at least one railway vehicle transporting dangerous goods, as defined by the Appendix,
—
number of such accidents in which dangerous goods are released. 3. Indicators relating to suicides
Total and relative (to train-kilometres) number of suicides. 4. Indicators relating to precursors of accidents
Total and relative (to train-kilometres) number of:
—
broken rails,
—
track buckles,
—
wrong-side signalling failures,
—
signals passed at danger,
—
broken wheels and axles on rolling stock in service.
All precursors are to be reported, both resulting and not resulting in accidents. Precursors resulting in an accident shall be reported under the CSIs on precursors; the accidents that occurred, if significant, shall be reported under the CSIs on accidents referred to in heading 1. 5. Indicators to calculate the economic impact of accidents
Total in euro and relative (to train-kilometres):
—
number of deaths and serious injuries multiplied by the Value of Preventing a Casualty (VPC),
—
cost of damages to environment,
—
cost of material damages to rolling stock or infrastructure,
—
cost of delays as a consequence of accidents.
Safety authorities shall report either the economic impact of all accidents, or the economic impact of significant accidents only. This choice shall be clearly indicated in the annual report referred to in Article 18. The VPC is the value society attributes to the prevention of a casualty and as such shall not form a reference for compensation between parties involved in accidents. 6. Indicators relating to technical safety of infrastructure and its implementation
6.1. Percentage of tracks with Automatic Train Protection (ATP) in operation, percentage of train-kilometres using operational ATP systems.
6.2. Number of level crossings (total, per line kilometre and track kilometre) by the following eight types:
(a) active level crossings with:
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection,
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
(b) passive level crossings. 7. Indicators relating to the management of safety
Internal audits accomplished by infrastructure managers and railway undertakings as set out in the documentation of the safety management system. Total number of audits accomplished and the number as a percentage of audits required (and/or planned). 8. Definitions
Common definitions for the CSIs and methods to calculate the economic impact of accidents are laid down in the Appendix.
Appendix
Common definitions for the CSIs and methods to calculate the economic impact of accidents 1. Indicators relating to accidents
1.1. “significant accident” means any accident involving at least one rail vehicle in motion, resulting in at least one killed or seriously injured person, or in significant damage to stock, track, other installations or environment, or extensive disruptions to traffic. Accidents in workshops, warehouses and depots are excluded.
1.2. “significant damage to stock, track, other installations or environment” means damage that is equivalent to EUR 150 000 or more.
1.3. “extensive disruptions to traffic” means that train services on a main railway line are suspended for six hours or more.
1.4. “train” means one or more railway vehicles hauled by one or more locomotives or railcars, or one railcar travelling alone, running under a given number or specific designation from an initial fixed point to a terminal fixed point. A light engine, i.e. a locomotive travelling on its own, is considered to be a train.
1.5. “collision of trains, including collisions with obstacles within the clearance gauge” means a front to front, front to end or a side collision between a part of a train and a part of another train, or with:
(i) shunting rolling stock,
(ii) objects fixed or temporarily present on or near the track (except at level crossings if lost by a crossing vehicle or user).
1.6. “train derailment” means any case in which at least one wheel of a train leaves the rails.
1.7. “level crossing accidents” means accidents at level crossings involving at least one railway vehicle and one or more crossing vehicles, other crossing users such as pedestrians or other objects temporarily present on or near the track if lost by a crossing vehicle/user.
1.8. “accidents to persons caused by rolling stock in motion” means accidents to one or more persons who are either hit by a railway vehicle or by an object attached to, or that has become detached from, the vehicle. Persons who fall from railway vehicles are included, as well as persons who fall or are hit by loose objects when travelling on board vehicles.
1.9. “fires in rolling stock” means fires and explosions that occur in railway vehicles (including their load) when they are running between the departure station and the destination, including when stopped at the departure station, the destination or intermediate stops, as well as during re-marshalling operations.
1.10. “other types of accidents” means all accidents other than those already mentioned (train collisions, train derailments, at level crossing, to persons caused by rolling stock in motion and fires in rolling stock).
1.11. “passenger” means any person, excluding members of the train crew, who makes a trip by rail. For accident statistics, passengers trying to embark/disembark onto/from a moving train are included.
1.12. “employees (staff of contractors and self-employed contractors are included)” means any person whose employment is in connection with a railway and is at work at the time of the accident. It includes the crew of the train and persons handling rolling stock and infrastructure installations.
1.13. “level crossing users” means all persons using a level crossing to cross the railway line by any mean of transport or by foot.
1.14. “unauthorised persons on railway premises” means any person present on railway premises where such presence is forbidden, with the exception of level crossing users.
1.15. “others (third parties)” means all persons not defined as “passengers”, “employees including the staff of contractors”, “level crossing users” or “unauthorised persons on railway premises”.
1.16. “deaths (killed person)” means any person killed immediately or dying within 30 days as a result of an accident, excluding suicides.
1.17. “injuries (seriously injured person)” means any person injured who was hospitalised for more than 24 hours as a result of an accident, excluding attempted suicides. 2. Indicators relating to dangerous goods
2.1. “accident involving the transport of dangerous goods” means any accident or incident that is subject to reporting in accordance with RID (2)/ADR section 1.8.5. 2.2. “dangerous goods” means those substances and articles the carriage of which is prohibited by RID, or authorised only under the conditions prescribed therein. 3. Indicators relating to suicides
3.1. “suicide” means an act to deliberately injure oneself resulting in death, as recorded and classified by the competent national authority. 4. Indicators relating to precursors of accidents
4.1. “broken rails” means any rail which is separated in two or more pieces, or any rail from which a piece of metal becomes detached, causing a gap of more than 50 mm in length and more than 10 mm in depth on the running surface.
4.2. “track buckles” means faults related to the continuum and the geometry of track, requiring track obstruction or immediate reduction of permitted speed to maintain safety.
4.3. “wrong side signalling failure” means any failure of a signalling system (either to infrastructure or to rolling stock), resulting in signalling information less restrictive than that demanded.
4.4. “Signal Passed at Danger (SPAD)” means any occasion when any part of a train proceeds beyond its authorised movement.
Unauthorised movement means to pass:
—
a trackside colour light signal or semaphore at danger, order to STOP, where an Automatic Train Control System (ATCS) or ATP system is not operational,
—
the end of a safety related movement authority provided in an ATCS or ATP system,
—
a point communicated by verbal or written authorisation laid down in regulations,
—
stop boards (buffer stops are not included) or hand signals.
Cases in which vehicles without any traction unit attached or a train that is unattended run away past a signal at danger are not included. Cases in which, for any reason, the signal is not turned to danger in time to allow the driver to stop the train before the signal are not included.
National Safety Authorities may report separately on the four indexes and shall report at least an aggregate indicator containing data on all four items.
4.5. “broken wheels and broken axles” means a break affecting the essential parts of the wheel or the axle and creating a risk of accident (derailment or collision). 5. Common methodologies to calculate the economic impact of accidents
5.1. The Value of Preventing a Casualty (VPC) is composed of: 1. Value of safety per se: Willingness to Pay (WTP) values based on stated preference studies carried out in the Member State for which they are applied. 2. Direct and indirect economic costs: cost values appraised in the Member State, composed of:
—
medical and rehabilitation cost,
—
legal court cost, cost for police, private crash investigations, the emergency service and administrative costs of insurance,
—
production losses: value to society of goods and services that could have been produced by the person if the accident had not occurred.
5.2. Common principles to appraise the value of safety per se and direct/indirect economic costs:
For the value of safety per se, the assessment of whether available estimates are appropriate or not shall be based on the following considerations:
—
estimates shall relate to a system for valuation of mortality risk reduction in the transport sector and follow a WTP approach according to stated preference methods,
—
the respondent sample used for the values shall be representative of the population concerned. In particular, the sample has to reflect the age/income distribution along with other relevant socio-economic/demographic characteristics of the population,
—
method for eliciting WTP values: survey design shall be such that questions are clear/meaningful to respondents.
Direct and indirect economic costs shall be appraised on the basis of the real costs borne by society.
5.3. “Cost of damage to environment” means costs that are to be met by Railway Undertakings/Infrastructure Managers, appraised on the basis of their experience, in order to restore the damaged area to its state before the railway accident.
5.4. “Cost of material damage to rolling stock or infrastructure” means the cost of providing new rolling stock or infrastructure, with the same functionalities and technical parameters as that damaged beyond repair, and the cost of restoring repairable rolling stock or infrastructure to its state before the accident. Both are to be estimated by Railway Undertakings/Infrastructure Managers on the basis of their experience. Also includes costs related to leasing rolling stock, as a consequence of non availability due to damaged vehicles.
5.5. “Cost of delays as a consequence of accidents” means the monetary value of delays incurred by users of rail transport (passengers and freight customers) as a consequence of accidents, calculated by the following model:
VT= monetary value of travel time savings
Value of time for a passenger of a train (an hour)
VTP = [VT of work passengers]*[Average percentage of work passengers per year] + [VT of non-work passengers]*[Average percentage of non-work passengers per year]
VT measured in EUR per passenger per hour
Value of time for a freight train (an hour)
VTF = [VT of freight trains]*[(Tonne-Km)/(Train-Km)]
VT is measured in EUR per freight tonne per hour
Average tonnes of goods transported per train in one year = (Tonne-Km)/(Train-Km)
CM
= Cost of 1 minute of delay of a train
Passenger train
CMP = K1*(VTP/60)*[(Passenger-Km)/(Train-Km)]
Average number of passengers per train in one year = (Passenger-Km)/(Train-Km)
Freight train
CMF = K2* (VTF/60)
Factors K1 and K2 are between the value of time and the value of delay, as estimated by stated preference studies, to take into account that the time lost as a result of delays is perceived significantly more negatively than normal travel time.
Cost of delays of an accident = CMP*(Minutes of delay of passenger trains) + CMF*(Minutes of delay of freight trains)
Scope of the model
Cost of delays is to be calculated for all accidents, both significant and non-significant.
Delays are to be calculated as follows:
—
real delays on the railway lines where accidents occurred,
—
real delays or, if not possible, estimated delays on the other affected lines. 6. Indicators relating to technical safety of infrastructure and its implementation
6.1. “Automatic Train Protection (ATP)” means a system that enforces obedience to signals and speed restrictions by speed supervision, including automatic stop at signals.
6.2. “level crossing” means any level intersection between the railway and a passage, as recognised by the infrastructure manager and open to public or private users. Passages between platforms within stations are excluded, as well as passages over tracks for the sole use of employees.
6.3. “passage” means any public or private road, street or highway, including footpaths and bicycle paths, or other route provided for the passage of people, animals, vehicles or machinery.
6.4. “active level crossing” means a level crossing where the crossing users are protected from or warned of the approaching train by the activation of devices when it is unsafe for the user to traverse the crossing.
—
Protection by the use of physical devices:
—
half or full barriers,
—
gates.
—
Warning by the use of fixed equipment at level crossings:
—
visible devices: lights,
—
audible devices: bells, horns, klaxons, etc.,
—
physical devices, e.g. vibration due to road bumps.
Active level crossings are classified as: 1. “Level crossing with crossing-user-side automatic protection and/or warning” means a level crossing where the crossing protection and/or warning are activated by the approaching train.
These level crossings are classified as:
(i) automatic user-side warning,
(ii) automatic user-side protection,
(iii) automatic user-side protection and warning,
(iv) automatic user-side protection and warning, and rail-side protection.
“Rail-side protection” means a signal or other train protection system that only permits a train to proceed if the level crossing is user-side protected and free from incursion; the latter by means of surveillance and/or obstacle detection. 2. “Level crossing with crossing-user-side manual protection and/or warning” means a level crossing where protection and/or warning is manually activated and there is not an interlocked railway signal showing, to the train, a running aspect only when protection and/or warning of level crossing are activated.
These level crossings are classified as:
(v) manual user-side warning,
(vi) manual user-side protection,
(vii) manual user-side protection and warning.
6.5. “Passive level crossing” means a level crossing without any form of warning system and/or protection activated when it is unsafe for the user to traverse the crossing. 7. Indicators relating to the management of safety
7.1. “audit” means a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. 8. Definitions of the scaling bases
8.1. “train-km” means the unit of measure representing the movement of a train over one kilometre. The distance used is the distance actually run, if available, otherwise the standard network distance between the origin and destination shall be used. Only the distance on the national territory of the reporting country shall be taken into account.
8.2. “passenger-km” means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre. Only the distance on the national territory of the reporting country shall be taken into account.
8.3. “line km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. For multiple-track railway lines, only the distance between origin and destination is to be counted.
8.4. “track km” means the length measured in kilometres of the railway network in Member States, whose scope is laid down in Article 2. Each track of a multiple-track railway line is to be counted.
’

(1)
OJ L 14, 21.1.2003, p. 1.
(2) RID, Regulations concerning the International Carriage of Dangerous Goods by Rail, as adopted under Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

Pending: 32009L0143

4.12.2009 EN Official Journal of the European Union L 318/23
(1) Under Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2)the responsible official bodies in the Member States may only delegate the tasks provided for in that Directive, including laboratory testing, to a legal person which under its officially approved constitution is charged exclusively with specific public functions.
(2) The laboratory tests which have to be carried out in the framework of Directive 2000/29/EC are of a highly technical nature and concern different scientific fields. Such tests require a wide range of different and expensive technical facilities and highly specialised laboratory staff capable of adapting to the rapid development of diagnostic methodology. The number of tests to be carried out has been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.
(3) For these reasons it is appropriate to provide that the numerous and diverse laboratory tests required under Directive 2000/29/EC may, in addition to legal persons which are exclusively charged with specific public functions, be delegated to legal persons not fulfilling this requirement, such as universities, research institutes or private laboratories in any legal form recognised in the Member State in accordance with their national legislation, provided that they satisfy certain conditions.
(4) It is appropriate that the responsible official bodies verify that the legal persons, to which the execution of the laboratory testing is delegated, can assure quality. They should for example be impartial, free of conflict of interest and able to ensure reliable results and protection of confidential information.
(5) At the same time it is appropriate to allow legal persons carrying out delegated tasks in accordance with Directive 2000/29/EC to use their laboratories for testing activities which do not form part of their specific public functions.
(6) The issue of an appropriate diagnostic infrastructure is one of the issues addressed in the ongoing evaluation of the plant health legislation. However, without prejudice to the outcome of the review, it is appropriate in the short term to modify the requirements on the delegation of laboratory testing to existing needs.
(7) The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC should therefore be amended accordingly.
(8) In accordance with point 34 of the Interinstitutional agreement on better law-making(3), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public,
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Parliament(1),
(1) Under Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2)the responsible official bodies in the Member States may only delegate the tasks provided for in that Directive, including laboratory testing, to a legal person which under its officially approved constitution is charged exclusively with specific public functions.
(2) The laboratory tests which have to be carried out in the framework of Directive 2000/29/EC are of a highly technical nature and concern different scientific fields. Such tests require a wide range of different and expensive technical facilities and highly specialised laboratory staff capable of adapting to the rapid development of diagnostic methodology. The number of tests to be carried out has been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.
(3) For these reasons it is appropriate to provide that the numerous and diverse laboratory tests required under Directive 2000/29/EC may, in addition to legal persons which are exclusively charged with specific public functions, be delegated to legal persons not fulfilling this requirement, such as universities, research institutes or private laboratories in any legal form recognised in the Member State in accordance with their national legislation, provided that they satisfy certain conditions.
(4) It is appropriate that the responsible official bodies verify that the legal persons, to which the execution of the laboratory testing is delegated, can assure quality. They should for example be impartial, free of conflict of interest and able to ensure reliable results and protection of confidential information.
(5) At the same time it is appropriate to allow legal persons carrying out delegated tasks in accordance with Directive 2000/29/EC to use their laboratories for testing activities which do not form part of their specific public functions.
(6) The issue of an appropriate diagnostic infrastructure is one of the issues addressed in the ongoing evaluation of the plant health legislation. However, without prejudice to the outcome of the review, it is appropriate in the short term to modify the requirements on the delegation of laboratory testing to existing needs.
(7) The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC should therefore be amended accordingly.
(8) In accordance with point 34 of the Interinstitutional agreement on better law-making(3), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public,
HAS ADOPTED THIS DIRECTIVE:

Article 1
The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC shall be replaced by the following:
‘The responsible official bodies in a Member State may, in accordance with national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to a legal person, whether governed by public or private law, provided that such person, and its members, has no personal interest in the outcome of the measure it takes.
The responsible official bodies in the Member States shall ensure that the legal person referred to in the second subparagraph is, under its officially approved constitution, charged exclusively with specific public functions, with the exception of laboratory testing which such legal person may perform even where the laboratory testing does not form part of its specific public functions.
Notwithstanding the third subparagraph, the responsible official bodies in a Member State may delegate the laboratory testing provided for in this Directive to a legal person which does not comply with that provision.
The laboratory testing may only be delegated if the responsible official body ensures throughout the time of the delegation that the legal person to which it delegates laboratory testing can assure impartiality, quality and protection of confidential information, and that no conflict of interest exists between the exercise of the tasks delegated to it and its other activities.’

Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2011. They shall forthwith inform the Commission thereof.
When they are adopted by Member States, those measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Article 3
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Parliament(1),
(1) Under Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(2)the responsible official bodies in the Member States may only delegate the tasks provided for in that Directive, including laboratory testing, to a legal person which under its officially approved constitution is charged exclusively with specific public functions.
(2) The laboratory tests which have to be carried out in the framework of Directive 2000/29/EC are of a highly technical nature and concern different scientific fields. Such tests require a wide range of different and expensive technical facilities and highly specialised laboratory staff capable of adapting to the rapid development of diagnostic methodology. The number of tests to be carried out has been growing over recent years. As a result, it has grown increasingly difficult to find legal persons fulfilling all the necessary requirements.
(3) For these reasons it is appropriate to provide that the numerous and diverse laboratory tests required under Directive 2000/29/EC may, in addition to legal persons which are exclusively charged with specific public functions, be delegated to legal persons not fulfilling this requirement, such as universities, research institutes or private laboratories in any legal form recognised in the Member State in accordance with their national legislation, provided that they satisfy certain conditions.
(4) It is appropriate that the responsible official bodies verify that the legal persons, to which the execution of the laboratory testing is delegated, can assure quality. They should for example be impartial, free of conflict of interest and able to ensure reliable results and protection of confidential information.
(5) At the same time it is appropriate to allow legal persons carrying out delegated tasks in accordance with Directive 2000/29/EC to use their laboratories for testing activities which do not form part of their specific public functions.
(6) The issue of an appropriate diagnostic infrastructure is one of the issues addressed in the ongoing evaluation of the plant health legislation. However, without prejudice to the outcome of the review, it is appropriate in the short term to modify the requirements on the delegation of laboratory testing to existing needs.
(7) The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC should therefore be amended accordingly.
(8) In accordance with point 34 of the Interinstitutional agreement on better law-making(3), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public,
HAS ADOPTED THIS DIRECTIVE:
The second subparagraph of Article 2(1)(g) of Directive 2000/29/EC shall be replaced by the following:
‘The responsible official bodies in a Member State may, in accordance with national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to a legal person, whether governed by public or private law, provided that such person, and its members, has no personal interest in the outcome of the measure it takes.
The responsible official bodies in the Member States shall ensure that the legal person referred to in the second subparagraph is, under its officially approved constitution, charged exclusively with specific public functions, with the exception of laboratory testing which such legal person may perform even where the laboratory testing does not form part of its specific public functions.
Notwithstanding the third subparagraph, the responsible official bodies in a Member State may delegate the laboratory testing provided for in this Directive to a legal person which does not comply with that provision.
The laboratory testing may only be delegated if the responsible official body ensures throughout the time of the delegation that the legal person to which it delegates laboratory testing can assure impartiality, quality and protection of confidential information, and that no conflict of interest exists between the exercise of the tasks delegated to it and its other activities.’
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2011. They shall forthwith inform the Commission thereof.
When they are adopted by Member States, those measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.