Commission Implementing Decision (EU) 2025/2343 of 19 November 2025 on refusing protection in the Union of the Appellation of Origin ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) registered in the International Register of Appellations of Origin and Geographical Indications of the Geneva Act (notified under document C(2025)7686)

Official Journalof the European Union ENL series
2025/2343 21.11.2025
(1) In accordance with Article 5(1) and (2) of the 2015 Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications(2)(the ‘Geneva Act’), the Competent Authorities of each Contracting Party to the Geneva Act may file applications for international registration of an appellation of origin (AO) or geographical indication with the International Bureau of the World Intellectual Property Organization (WIPO), which registers it in the International Register in accordance with Article 6 of the Geneva Act. In accordance with Article 9 of the Geneva Act, the other Contracting Parties are to protect registered AOs and geographical indications on their territories within their own legal system subject to any refusal, renunciation, invalidation or cancellation.
(2) In accordance with Article 6(4) of the Geneva Act, on 17 April 2025, the International Bureau of WIPO (thereinafter ‘the International Bureau’) notified the Commission that the name ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), applied by the Russian Federation, had been recorded as AO in the International Register of Appellations of Origin and Geographical Indications under the Geneva Act. The name designates lace, lace curtains, lace bedspreads, lace napkins, lace tablecloths, lace runners, lace towels, lace collars, lace inserts, lace vests, lace blouses, lace shirtfronts, lace kerchiefs, lace cuffs, lace mantles, lace pelerines, lace scarves, lace ties, lace stoles, lace capes, lace gloves, lace apron dresses, lace shawls, lace suits, lace jabots, and lace bookmarks from the city of Vologda, Vologodsky District, Vologda Region of the Russian Federation.
(3) Since there is no protection at Union level for geographical indications designating crafts products to date, the international registration of the AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) was not published. In accordance with Article 4(1) of Regulation (EU) 2019/1753, only the international registration notified by the International Bureau relating to products in respect of which protection at Union level of geographical indications is provided are to be published in theOfficial Journal of the European Unionto enable possible opposition to be lodged. Regulation (EU) 2023/2411 of the European Parliament and of the Council(3), providing for protection of geographical indications designating craft and industrial products will become applicable from 1 December 2025 in order to provide that registrations of craft and industrial geographical indications from third countries notified by WIPO are published in theOfficial Journal of the European Unionand assessed with a view to granting protection.
(4) Therefore, in accordance with Article 7(2) of Regulation (EU) 2019/1753, the protection in the Union of the name ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), designating lace products, registered as AO in the International Register under the Geneva Act should be refused.
(5) In addition, in accordance with Article 5s(1) of Council Regulation (EU) No 833/2014(4), competent institutions under Union law, including the Commission, are not allowed to accept new applications for registration of geographical indications filed by Russian nationals or natural persons residing in Russia or by legal persons established in Russia.
(6) Furthermore, in accordance with Article 5s(4) of Regulation (EU) No 833/2014, the Union, when acting under the Convention Establishing the World Intellectual Property Organization, is obliged to use best efforts to ensure that WIPO or intellectual property offices constituted under Union law do not accept new applications for intellectual property rights by any Russian nationals or natural persons residing in Russia, or by legal persons, entities or bodies established in Russia.
(7) As AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) has been notified to the Union for protection following its registration in the International Register, it is not possible to ensure that WIPO will not accept new applications for intellectual property rights by any Russian nationals or natural persons residing in Russia, or by legal persons, entities or bodies established in Russia. However, the protection sought for intellectual property rights, and in particular geographical indications, related to Russia should not be granted in the Union.
(8) As long as such restrictive measures against the applications and the protection of intellectual property rights concerning any Russian nationals or natural persons residing in Russia, or legal persons, entities or bodies established in Russia, are in force, the Commission should act in a way to stop the granting of any such protection of AO or geographical indication.
(9) Since several Member States, namely, Czechia, France, Hungary, Portugal and Slovakia are contracting parties to the Geneva Act, and considering the lack of competence of Member States to decide on national protection of an AO due to the fact that it is exclusive Union competence since the Union’s accession to the Geneva Act in 2019, it is necessary to clarify that the refusal to ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) applies to the whole territory of the Union. Furthermore, given the exclusive competence of the Union on the matter and the role the Commission exercises within the Geneva Act, of competent authority for the Union and for those Member States that are contracting parties to the Geneva Act, such refusal should be notified to WIPO on behalf of the Union and on behalf of Czechia, France, Hungary, Portugal and Slovakia.
(10) Although they are not competent to adopt decisions on the national protection of the AOs registered under the Geneva Act, in order to ensure consistency in protection of those AOs throughout the territory of the Union, Bulgaria and Italy, being signatories of the Lisbon Agreement, but not having yet acceded to the Geneva Act, should notify WIPO of the refusal of the protection of the AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), if they accede to the Geneva Act, within one year from that accession.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1753 of the European Parliament and of the Council of 23 October 2019 on the action of the Union following its accession to the Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications (1), and in particular Article 7(2) thereof,
Whereas:
(1) In accordance with Article 5(1) and (2) of the 2015 Geneva Act of the Lisbon Agreement on Appellations of Origin and Geographical Indications (2) (the ‘Geneva Act’), the Competent Authorities of each Contracting Party to the Geneva Act may file applications for international registration of an appellation of origin (AO) or geographical indication with the International Bureau of the World Intellectual Property Organization (WIPO), which registers it in the International Register in accordance with Article 6 of the Geneva Act. In accordance with Article 9 of the Geneva Act, the other Contracting Parties are to protect registered AOs and geographical indications on their territories within their own legal system subject to any refusal, renunciation, invalidation or cancellation.
(2) In accordance with Article 6(4) of the Geneva Act, on 17 April 2025, the International Bureau of WIPO (thereinafter ‘the International Bureau’) notified the Commission that the name ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), applied by the Russian Federation, had been recorded as AO in the International Register of Appellations of Origin and Geographical Indications under the Geneva Act. The name designates lace, lace curtains, lace bedspreads, lace napkins, lace tablecloths, lace runners, lace towels, lace collars, lace inserts, lace vests, lace blouses, lace shirtfronts, lace kerchiefs, lace cuffs, lace mantles, lace pelerines, lace scarves, lace ties, lace stoles, lace capes, lace gloves, lace apron dresses, lace shawls, lace suits, lace jabots, and lace bookmarks from the city of Vologda, Vologodsky District, Vologda Region of the Russian Federation.
(3) Since there is no protection at Union level for geographical indications designating crafts products to date, the international registration of the AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) was not published. In accordance with Article 4(1) of Regulation (EU) 2019/1753, only the international registration notified by the International Bureau relating to products in respect of which protection at Union level of geographical indications is provided are to be published in the Official Journal of the European Union to enable possible opposition to be lodged. Regulation (EU) 2023/2411 of the European Parliament and of the Council (3), providing for protection of geographical indications designating craft and industrial products will become applicable from 1 December 2025 in order to provide that registrations of craft and industrial geographical indications from third countries notified by WIPO are published in the Official Journal of the European Union and assessed with a view to granting protection.
(4) Therefore, in accordance with Article 7(2) of Regulation (EU) 2019/1753, the protection in the Union of the name ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), designating lace products, registered as AO in the International Register under the Geneva Act should be refused.
(5) In addition, in accordance with Article 5s(1) of Council Regulation (EU) No 833/2014 (4), competent institutions under Union law, including the Commission, are not allowed to accept new applications for registration of geographical indications filed by Russian nationals or natural persons residing in Russia or by legal persons established in Russia.
(6) Furthermore, in accordance with Article 5s(4) of Regulation (EU) No 833/2014, the Union, when acting under the Convention Establishing the World Intellectual Property Organization, is obliged to use best efforts to ensure that WIPO or intellectual property offices constituted under Union law do not accept new applications for intellectual property rights by any Russian nationals or natural persons residing in Russia, or by legal persons, entities or bodies established in Russia.
(7) As AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) has been notified to the Union for protection following its registration in the International Register, it is not possible to ensure that WIPO will not accept new applications for intellectual property rights by any Russian nationals or natural persons residing in Russia, or by legal persons, entities or bodies established in Russia. However, the protection sought for intellectual property rights, and in particular geographical indications, related to Russia should not be granted in the Union.
(8) As long as such restrictive measures against the applications and the protection of intellectual property rights concerning any Russian nationals or natural persons residing in Russia, or legal persons, entities or bodies established in Russia, are in force, the Commission should act in a way to stop the granting of any such protection of AO or geographical indication.
(9) Since several Member States, namely, Czechia, France, Hungary, Portugal and Slovakia are contracting parties to the Geneva Act, and considering the lack of competence of Member States to decide on national protection of an AO due to the fact that it is exclusive Union competence since the Union’s accession to the Geneva Act in 2019, it is necessary to clarify that the refusal to ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) applies to the whole territory of the Union. Furthermore, given the exclusive competence of the Union on the matter and the role the Commission exercises within the Geneva Act, of competent authority for the Union and for those Member States that are contracting parties to the Geneva Act, such refusal should be notified to WIPO on behalf of the Union and on behalf of Czechia, France, Hungary, Portugal and Slovakia.
(10) Although they are not competent to adopt decisions on the national protection of the AOs registered under the Geneva Act, in order to ensure consistency in protection of those AOs throughout the territory of the Union, Bulgaria and Italy, being signatories of the Lisbon Agreement, but not having yet acceded to the Geneva Act, should notify WIPO of the refusal of the protection of the AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), if they accede to the Geneva Act, within one year from that accession.
HAS ADOPTED THIS DECISION:
The protection of the name ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO), which is registered as an Appellation of Origin (AO) in the International Register, is hereby refused in the Union.
The refusal of protection referred to in Article 1 applies to the entire territory of the Union. It shall be notified to the World Intellectual Property Organization (WIPO) on behalf of the Union and also on behalf of Czechia, France, Hungary, Portugal and Slovakia as contracting parties to the Geneva Act.
Bulgaria and Italy shall notify WIPO of the refusal of protection concerning the AO ВОЛОГОДСКОЕ КРУЖЕВО (VOLOGODSKOE KRUZHEVO) within one year from their accession to the Geneva Act.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union. It shall be notified to the World Intellectual Property Organization.

Commission Implementing Decision (EU) 2025/2323 of 11 November 2025 pursuant to Article 11 of Regulation (EU) 2024/1351 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2323 14.11.2025
(1) Under Regulation (EU) 2024/1351, the Commission is to determine every year the Member States under migratory pressure, at risk of migratory pressure or facing a significant migratory situation. By 15 October 2025, and every year after, the Commission is to adopt the European Annual Asylum and Migration Report and adopt a decision determining those Member States.
(2) In order to determine whether a particular Member State is under migratory pressure, risk of migratory pressure, or facing a significant migratory situation, the Commission has carried out an assessment based on the European Annual Asylum and Migration Report(2)and the elements listed in Article 9 and Article 10 of that Regulation. For that purpose, the Commission developed a methodology that considers that pressure is relative to the creation of disproportionate obligations in a Member State taking into account the overall migratory situation in the Union. This methodologywas discussed thoroughly with the Member States. To determine what constitutes disproportionate obligations, the methodology compares each Member State’s situation to the overall situation in the Union(3).
(3) The assessment considers a 12-month period, from 1 July 2024 to 30 June 2025, to identify Member States under migratory pressure and Member States at risk of migratory pressure in accordance with Article 9(1) of Regulation (EU) 2024/1351 and with the definition of ‘migratory pressure’ in Article 2(24) of that Regulation. In accordance with the definition of ‘significant migratory situation’ in Article 2(25) of Regulation (EU) 2024/1351, in order to consider the cumulative effect of current and previous annual arrivals of third-country nationals or stateless persons, the assessment of a significant migratory situation considers the period between 1 July 2020 to 30 June 2025.
(4) During the reporting period from 1 July 2024 to 30 June 2025, illegal border crossings at the Union’s external border decreased by 35 %, showing that the overall migratory situation in the Union continues to improve. Applications for international protection and unauthorised movements also show decreasing trends by 21 % and 25 % respectively, a stable trend already observed since 2024.
(5) During the reporting period from 1 July 2024 to 30 June 2025, based on the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, when all the relevant quantitative and qualitative data and information are aggregated and assessed in relation to the overall situation in the Union, the assessment concludes that Greece and Cyprus are under migratory pressure. The assessment also concludes that Italy and Spain are under migratory pressure because of a large number of arrivals due to disembarkations following search and rescue (‘SAR’) operations.
(6) During the reporting period from 1 July 2024 to 30 June 2025, in Greece, while trends remained overall stable compared to the previous 12-month period, the country faced disproportionate obligations in relation to the overall situation in the Union, in particular due to the number of illegal border crossings and applications for international protection. Greece recorded the highest number of illegal border crossings relative to its Gross Domestic Product (GDP) and population. Furthermore, Greece also received the highest number of applications at Union level in relation to their GDP and population and was also the first Member State in relative terms regarding decisions granting international protection, while it was second with regard to the issuance of orders to leave, but only a small proportion of returns was possible in the period under analysis.
(7) During the reporting period from 1 July 2024 to 30 June 2025, in Cyprus, the migration and asylum situation improved compared to the previous period, but it still faced disproportionate obligations in relation to the overall situation in the Union, in particular due to illegal border crossings, applications for international protection and registrations for temporary protection. Despite illegal border crossings decreased significantly, the number of arrivals put a strain on Cyprus’ asylum and migration system, relative to its GDP and population. Cyprus was in relative terms the second highest receiver of applications for international protection in the period under analysis and also received a significant number of new registrations for temporary protection compared to their GDP and population. Furthermore, while the number of third country nationals ordered to leave remained stable, twice as many third country nationals were returned following an order to leave compared to the previous period.
(8) A high number of persons were disembarked in Italy following SAR operations during the reporting period from 1 July 2024 to 30 June 2025. The share and absolute number of arrivals due to recurring disembarkations following SAR operations were of such a scale that they created disproportionate obligations compared to the overall situation in the Union. Italy accounted for around 40 % of the total number of persons disembarked in the Union.
(9) During the reporting period from 1 July 2024 to 30 June 2025, Spain faced a large number of arrivals due to recurring disembarkations following SAR operations, which were of such a scale that they created disproportionate obligations compared to the overall situation in the Union. Spain also accounted for around 40 % of the total number of persons disembarked in the Union.
(10) During the reporting period from 1 July 2024 to 30 June 2025, based on the findings of the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, when all the relevant quantitative and qualitative data and information are considered and assessed in relation to the overall situation in the Union, Belgium, Bulgaria, Germany, Estonia, Ireland, France, Croatia, Latvia, Lithuania, the Netherlands, Poland, and Finland have been identified as at risk of migratory pressure.
(11) Bulgaria and Croatia, as Member States of first entry into the Union, continued being particularly exposed to the fluctuations of irregular arrivals via the Western Balkans and Eastern Mediterranean routes. Significant increase of irregular arrivals during the year could lead the national migration and asylum systems, already strained, to be affected by disproportionate obligations. During the reporting period from 1 July 2024 to 30 June 2025, although Bulgaria recorded a decrease in the number of applications for international protection compared to the previous period, it still registered a significant number of applications for international protection, one fifth of which were lodged by unaccompanied minors, making Bulgaria the second Member State in relative terms receiving most applications by unaccompanied minors in the Union. Bulgaria also registered a high and steady number of registrations for temporary protection relative to the share of GDP and population. During the reporting period from 1 July 2024 to 30 June 2025, Croatia was impacted by illegal border crossings and refusals of entry, registering 76 % of all arrivals along the Western Balkans route, the second highest number of illegal border crossings at Union level relative to GDP and population, and accounting for the highest number of refusals of entry in the Union in relative terms.
(12) A number of Member States recorded high numbers of unauthorised movements which put particular pressure on their asylum, migration and reception systems. The challenges associated with such unauthorised movements are addressed by acknowledging the possibility of applying responsibility offsets to these cases as part of the solidarity contributions. During the reporting period from 1 July 2024 to 30 June 2025, Germany received a significantly high number of unauthorised movements of applicants for international protection within the Union, resulting in a large number of applications for international protection, which impacted its asylum and reception system; this was further compounded not only by the hosting of the highest number of temporary protection beneficiaries in the EU but also due to a very high number of applications for international protection in the last 10 years. France also received a very high number of unauthorised movements of applicants for international protection within the Union and faced increasing illegal border crossings at exit towards the United Kingdom, which impacted its national asylum and reception system. The Netherlands and Belgium were also impacted by unauthorised movements of applicants for international protection, which put a strain on the reception systems. Ireland has also experienced a sustained high number of applications for international protection and a significant proportion enter the country irregularly principally arriving across the land border of the United Kingdom. This, together with the significant arrivals of persons benefitting from temporary protection, had an impact on the national asylum and reception system.
(13) Hybrid threats linked to the instrumentalisation of migration by Russia and Belarus continue to raise serious migration and security risks at the Eastern border of the Union, especially in Estonia, Latvia, Lithuania, Poland, and Finland. In response to continued state-sponsored attempts to instrumentalise migration, Estonia strengthened border management measures at the border with Russia; Latvia and Lithuania enhanced surveillance measures at their border with Belarus; Poland established a buffer zone along its border and temporarily limits the right to apply for international protection at that border, except for vulnerable groups; Finland closed its crossing points with Russia. However, further attempts by Russia and Belarus to instrumentalise migration could put additional strain on national border protection systems, which may lead to disproportionate obligations.
(14) Based on the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, due to the cumulative effect of the quantitative and qualitative data and information aggregated and assessed during the five-year period 1 July 2020 to 30 June 2025, the assessment concludes that Bulgaria, Czechia, Estonia, Croatia, Austria, and Poland face a significant migratory situation.
(15) In Bulgaria, for the last five years, and notably since 2022, relative to the share of GDP and population, the inflow of registrations for temporary protection, together with a relative high number of international protection applications, put a strain on the system, in particular as Bulgaria issued a significant number of positive decisions and of rejections that created a high burden on the return system.
(16) When assessing the situation in Croatia over the previous five years, and in relation to the overall situation in the Union, the strain on the return system relative to its share of GDP and population had a major impact on the capacities of Croatia in addition to the obligations at its external border, notably as Croatia issued in relative terms a large number of refusals of entry and has experienced more recently a relative high number of illegal border crossings due to increased migrant smuggling activities in the region.
(17) Following Russia’s ongoing war of aggression and escalation of attacks against Ukraine, 4,3 million persons are benefitting from temporary protection in the Union as of 30 June 2025. Since the beginning of the war, Poland and Czechia have recorded among the highest number of temporary protection registrations in the Union relative to their GDP and population. This has put a significant strain on the migration, asylum and border management systems of those Member States over the last years since 2022 and created integration challenges. Estonia has recorded a high number of temporary protection registrations relative to its GDP and population combined with a relative significant number of applications for international protection that resulted in a high number of positive decisions in the last five years.
(18) During the five-year period 1 July 2020 to 30 June 2025, Austria received high numbers of applications for international protection. While this number has decreased, the overall number of applications for international protection, and the resulting number of positive decisions, over the five-year period has had a cumulative effect on the capacity of the migration, reception and asylum system in Austria.
(19) Member States determined by this Decision as under migratory pressure should have access to the Annual Solidarity Pool established by the Council implementing decision referred to in Article 57 of Regulation (EU) 2024/1351 and should inform the Commission and the Council pursuant to Article 58(1) of that Regulation where they intend to make use of the Annual Solidarity Pool, including information on the type and level of solidarity measures needed. Where the Member States under migratory pressure do not make use of the Annual Solidarity Pool or do not notify the need to use it, they may request a full or partial deduction of its pledged contributions to the Annual Solidarity Pool in line with Article 61 of Regulation (EU) 2024/1351.
(20) Member States determined by this Decision as at risk of migratory pressure should have priority access to the Permanent EU Migration Support Toolbox set out in Article 6 of Regulation (EU) 2024/1351.
(21) To facilitate the use of the Permanent EU Migration Support Toolbox by Member States at risk of migratory pressure, the Commission will provide funding support and coordinate with the relevant Union Agencies the possible prioritisation of the provision of operational support.
(22) Member States determined by this Decision as facing a significant migratory situation are entitled to request a full or partial deduction of their solidarity contributions in line with Article 62 of Regulation (EU) 2024/1351.
(23) In order to ensure the balance between solidarity and fair sharing of responsibility and to safeguard the functioning of the Regulation (EU) 2024/1351, Article 60(3) of that Regulation establishes that contributing Member States are not required to implement their pledges or to apply responsibility offsets towards a benefitting Member State where the Commission has identified systemic shortcomings in that benefitting Member State with regard to the responsibility rules set out in Part III of Regulation (EU) 2024/1351 that could result in serious negative consequences for the functioning of that Regulation. Part III of Regulation (EU) 2024/1351 sets out, inter alia, the obligations of the Member State responsible to take charge of and take back applicants and third-country nationals or stateless persons whose application for international protection was registered in another Member State or in relation to whom another Member State was indicated as responsible under Article 16(1) of Regulation (EU) 2024/1358 of the European Parliament and of the Council(4), including to carry out the transfers of those persons with full respect of the applicant’s fundamental rights within the meaning of the Charter of Fundamental Rights of the European Union as outlined in recital 87 and Article 16(3). These rules are in continuity with the rules set out in Regulation (EU) No 604/2013 of the European Parliament and of the Council(5)and they will replace those rules as of their entry into application.
(24) On 4 April 2025 the Communication from the Commission to the Council and the European Parliament on the status of migration management in mainland Greece(6)concluded that transfers to Greece should take place in the same manner as for the other Member States and in accordance with the jurisprudence of the Court of Justice of the European Union regarding the interpretation of Article 3(2) of Regulation (EU) No 604/2013.
(25) In December 2022, Italy suspended the receiving of transfers, with the exception of cases of family reunification of unaccompanied minors. The Court of Justice of the European Union found in its judgement of 19 December 2024 on joined cases C-185/24 and C-189/24(7)that the Member State designated as responsible under the criteria set out in Chapter III of the Regulation (EU) No 604/2013 cannot unilaterally discharge itself from that responsibility.
(26) Member States should ensure compliance with their obligations under EU asylum law. In particular, they should ensure that the current practices already observed in their countries in relation to Regulation (EU) No 604/2013 no longer persist by the entry into application of Regulation (EU) 2024/1351. Continued non-compliance would amount to systemic shortcomings with regard to the rules set out in Part III of Regulation (EU) 2024/1351 that could result in serious negative consequences for the functioning of that Regulation. This should be assessed regularly by the Commission, and if these situations persist, Article 60(3), fourth subparagraph of Regulation (EU) 2024/1351 should apply. To ensure a sustainable transition from the current system of responsibility to the new rules set out in Regulation (EU) 2024/1351, particular attention should be paid to the level of operational cooperation among Member States, including the active engagement to facilitate transfers and progressive cooperation on practical and logistical matters.
(27) In view of taking a comprehensive approach to migration management at EU level, in parallel to the implementation of the Pact on Migration and Asylum, including Regulation (EU) 2024/1351, legislative work should continue as a matter of priority, particularly on the proposals for a common European system for return and for a Union list of safe countries of origin. Together these would help reduce the overall pressure on Member States’ asylum systems and support the functioning of the Pact on Migration and Asylum.
(28) Pursuant to Article 11(1), second subparagraph, consultations were carried out with the Member States identified in this decision as Member States under migratory pressure, at risk of migratory pressure, and facing a significant migratory situation.
(29) In accordance with Article 4 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union (TEU) and to the Treaty on the Functioning of the European Union (TFEU), Ireland has notified, by letter of 14 May 2024, its wish to accept and be bound by Regulation (EU) 2024/1351. Commission Decision (EU) 2024/2088(8)confirmed such participation. Ireland is therefore taking part in the adoption of this Decision.
(30) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application,
Greece
Spain
Italy
Cyprus
Belgium
Bulgaria
Germany
Estonia
Ireland
France
Croatia
Latvia
Lithuania
The Netherlands
Poland
Finland
Bulgaria
Czechia
Estonia
Croatia
Austria
Poland
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2024/1351 of the European Parliament and of the Council of 14 May 2024 on Asylum and Migration Management, amending Regulations (EU) 2021/1147 and (EU) 2021/1060 and repealing Regulation (EU) No 604/2013 (1), and in particular Article 11 thereof,
Whereas:
(1) Under Regulation (EU) 2024/1351, the Commission is to determine every year the Member States under migratory pressure, at risk of migratory pressure or facing a significant migratory situation. By 15 October 2025, and every year after, the Commission is to adopt the European Annual Asylum and Migration Report and adopt a decision determining those Member States.
(2) In order to determine whether a particular Member State is under migratory pressure, risk of migratory pressure, or facing a significant migratory situation, the Commission has carried out an assessment based on the European Annual Asylum and Migration Report (2) and the elements listed in Article 9 and Article 10 of that Regulation. For that purpose, the Commission developed a methodology that considers that pressure is relative to the creation of disproportionate obligations in a Member State taking into account the overall migratory situation in the Union. This methodologywas discussed thoroughly with the Member States. To determine what constitutes disproportionate obligations, the methodology compares each Member State’s situation to the overall situation in the Union (3).
(3) The assessment considers a 12-month period, from 1 July 2024 to 30 June 2025, to identify Member States under migratory pressure and Member States at risk of migratory pressure in accordance with Article 9(1) of Regulation (EU) 2024/1351 and with the definition of ‘migratory pressure’ in Article 2(24) of that Regulation. In accordance with the definition of ‘significant migratory situation’ in Article 2(25) of Regulation (EU) 2024/1351, in order to consider the cumulative effect of current and previous annual arrivals of third-country nationals or stateless persons, the assessment of a significant migratory situation considers the period between 1 July 2020 to 30 June 2025.
(4) During the reporting period from 1 July 2024 to 30 June 2025, illegal border crossings at the Union’s external border decreased by 35 %, showing that the overall migratory situation in the Union continues to improve. Applications for international protection and unauthorised movements also show decreasing trends by 21 % and 25 % respectively, a stable trend already observed since 2024.
(5) During the reporting period from 1 July 2024 to 30 June 2025, based on the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, when all the relevant quantitative and qualitative data and information are aggregated and assessed in relation to the overall situation in the Union, the assessment concludes that Greece and Cyprus are under migratory pressure. The assessment also concludes that Italy and Spain are under migratory pressure because of a large number of arrivals due to disembarkations following search and rescue (‘SAR’) operations.
(6) During the reporting period from 1 July 2024 to 30 June 2025, in Greece, while trends remained overall stable compared to the previous 12-month period, the country faced disproportionate obligations in relation to the overall situation in the Union, in particular due to the number of illegal border crossings and applications for international protection. Greece recorded the highest number of illegal border crossings relative to its Gross Domestic Product (GDP) and population. Furthermore, Greece also received the highest number of applications at Union level in relation to their GDP and population and was also the first Member State in relative terms regarding decisions granting international protection, while it was second with regard to the issuance of orders to leave, but only a small proportion of returns was possible in the period under analysis.
(7) During the reporting period from 1 July 2024 to 30 June 2025, in Cyprus, the migration and asylum situation improved compared to the previous period, but it still faced disproportionate obligations in relation to the overall situation in the Union, in particular due to illegal border crossings, applications for international protection and registrations for temporary protection. Despite illegal border crossings decreased significantly, the number of arrivals put a strain on Cyprus’ asylum and migration system, relative to its GDP and population. Cyprus was in relative terms the second highest receiver of applications for international protection in the period under analysis and also received a significant number of new registrations for temporary protection compared to their GDP and population. Furthermore, while the number of third country nationals ordered to leave remained stable, twice as many third country nationals were returned following an order to leave compared to the previous period.
(8) A high number of persons were disembarked in Italy following SAR operations during the reporting period from 1 July 2024 to 30 June 2025. The share and absolute number of arrivals due to recurring disembarkations following SAR operations were of such a scale that they created disproportionate obligations compared to the overall situation in the Union. Italy accounted for around 40 % of the total number of persons disembarked in the Union.
(9) During the reporting period from 1 July 2024 to 30 June 2025, Spain faced a large number of arrivals due to recurring disembarkations following SAR operations, which were of such a scale that they created disproportionate obligations compared to the overall situation in the Union. Spain also accounted for around 40 % of the total number of persons disembarked in the Union.
(10) During the reporting period from 1 July 2024 to 30 June 2025, based on the findings of the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, when all the relevant quantitative and qualitative data and information are considered and assessed in relation to the overall situation in the Union, Belgium, Bulgaria, Germany, Estonia, Ireland, France, Croatia, Latvia, Lithuania, the Netherlands, Poland, and Finland have been identified as at risk of migratory pressure.
(11) Bulgaria and Croatia, as Member States of first entry into the Union, continued being particularly exposed to the fluctuations of irregular arrivals via the Western Balkans and Eastern Mediterranean routes. Significant increase of irregular arrivals during the year could lead the national migration and asylum systems, already strained, to be affected by disproportionate obligations. During the reporting period from 1 July 2024 to 30 June 2025, although Bulgaria recorded a decrease in the number of applications for international protection compared to the previous period, it still registered a significant number of applications for international protection, one fifth of which were lodged by unaccompanied minors, making Bulgaria the second Member State in relative terms receiving most applications by unaccompanied minors in the Union. Bulgaria also registered a high and steady number of registrations for temporary protection relative to the share of GDP and population. During the reporting period from 1 July 2024 to 30 June 2025, Croatia was impacted by illegal border crossings and refusals of entry, registering 76 % of all arrivals along the Western Balkans route, the second highest number of illegal border crossings at Union level relative to GDP and population, and accounting for the highest number of refusals of entry in the Union in relative terms.
(12) A number of Member States recorded high numbers of unauthorised movements which put particular pressure on their asylum, migration and reception systems. The challenges associated with such unauthorised movements are addressed by acknowledging the possibility of applying responsibility offsets to these cases as part of the solidarity contributions. During the reporting period from 1 July 2024 to 30 June 2025, Germany received a significantly high number of unauthorised movements of applicants for international protection within the Union, resulting in a large number of applications for international protection, which impacted its asylum and reception system; this was further compounded not only by the hosting of the highest number of temporary protection beneficiaries in the EU but also due to a very high number of applications for international protection in the last 10 years. France also received a very high number of unauthorised movements of applicants for international protection within the Union and faced increasing illegal border crossings at exit towards the United Kingdom, which impacted its national asylum and reception system. The Netherlands and Belgium were also impacted by unauthorised movements of applicants for international protection, which put a strain on the reception systems. Ireland has also experienced a sustained high number of applications for international protection and a significant proportion enter the country irregularly principally arriving across the land border of the United Kingdom. This, together with the significant arrivals of persons benefitting from temporary protection, had an impact on the national asylum and reception system.
(13) Hybrid threats linked to the instrumentalisation of migration by Russia and Belarus continue to raise serious migration and security risks at the Eastern border of the Union, especially in Estonia, Latvia, Lithuania, Poland, and Finland. In response to continued state-sponsored attempts to instrumentalise migration, Estonia strengthened border management measures at the border with Russia; Latvia and Lithuania enhanced surveillance measures at their border with Belarus; Poland established a buffer zone along its border and temporarily limits the right to apply for international protection at that border, except for vulnerable groups; Finland closed its crossing points with Russia. However, further attempts by Russia and Belarus to instrumentalise migration could put additional strain on national border protection systems, which may lead to disproportionate obligations.
(14) Based on the European Annual Asylum and Migration Report and the elements listed in Article 9 and Article 10 of Regulation (EU) 2024/1351, due to the cumulative effect of the quantitative and qualitative data and information aggregated and assessed during the five-year period 1 July 2020 to 30 June 2025, the assessment concludes that Bulgaria, Czechia, Estonia, Croatia, Austria, and Poland face a significant migratory situation.
(15) In Bulgaria, for the last five years, and notably since 2022, relative to the share of GDP and population, the inflow of registrations for temporary protection, together with a relative high number of international protection applications, put a strain on the system, in particular as Bulgaria issued a significant number of positive decisions and of rejections that created a high burden on the return system.
(16) When assessing the situation in Croatia over the previous five years, and in relation to the overall situation in the Union, the strain on the return system relative to its share of GDP and population had a major impact on the capacities of Croatia in addition to the obligations at its external border, notably as Croatia issued in relative terms a large number of refusals of entry and has experienced more recently a relative high number of illegal border crossings due to increased migrant smuggling activities in the region.
(17) Following Russia’s ongoing war of aggression and escalation of attacks against Ukraine, 4,3 million persons are benefitting from temporary protection in the Union as of 30 June 2025. Since the beginning of the war, Poland and Czechia have recorded among the highest number of temporary protection registrations in the Union relative to their GDP and population. This has put a significant strain on the migration, asylum and border management systems of those Member States over the last years since 2022 and created integration challenges. Estonia has recorded a high number of temporary protection registrations relative to its GDP and population combined with a relative significant number of applications for international protection that resulted in a high number of positive decisions in the last five years.
(18) During the five-year period 1 July 2020 to 30 June 2025, Austria received high numbers of applications for international protection. While this number has decreased, the overall number of applications for international protection, and the resulting number of positive decisions, over the five-year period has had a cumulative effect on the capacity of the migration, reception and asylum system in Austria.
(19) Member States determined by this Decision as under migratory pressure should have access to the Annual Solidarity Pool established by the Council implementing decision referred to in Article 57 of Regulation (EU) 2024/1351 and should inform the Commission and the Council pursuant to Article 58(1) of that Regulation where they intend to make use of the Annual Solidarity Pool, including information on the type and level of solidarity measures needed. Where the Member States under migratory pressure do not make use of the Annual Solidarity Pool or do not notify the need to use it, they may request a full or partial deduction of its pledged contributions to the Annual Solidarity Pool in line with Article 61 of Regulation (EU) 2024/1351.
(20) Member States determined by this Decision as at risk of migratory pressure should have priority access to the Permanent EU Migration Support Toolbox set out in Article 6 of Regulation (EU) 2024/1351.
(21) To facilitate the use of the Permanent EU Migration Support Toolbox by Member States at risk of migratory pressure, the Commission will provide funding support and coordinate with the relevant Union Agencies the possible prioritisation of the provision of operational support.
(22) Member States determined by this Decision as facing a significant migratory situation are entitled to request a full or partial deduction of their solidarity contributions in line with Article 62 of Regulation (EU) 2024/1351.
(23) In order to ensure the balance between solidarity and fair sharing of responsibility and to safeguard the functioning of the Regulation (EU) 2024/1351, Article 60(3) of that Regulation establishes that contributing Member States are not required to implement their pledges or to apply responsibility offsets towards a benefitting Member State where the Commission has identified systemic shortcomings in that benefitting Member State with regard to the responsibility rules set out in Part III of Regulation (EU) 2024/1351 that could result in serious negative consequences for the functioning of that Regulation. Part III of Regulation (EU) 2024/1351 sets out, inter alia, the obligations of the Member State responsible to take charge of and take back applicants and third-country nationals or stateless persons whose application for international protection was registered in another Member State or in relation to whom another Member State was indicated as responsible under Article 16(1) of Regulation (EU) 2024/1358 of the European Parliament and of the Council (4), including to carry out the transfers of those persons with full respect of the applicant’s fundamental rights within the meaning of the Charter of Fundamental Rights of the European Union as outlined in recital 87 and Article 16(3). These rules are in continuity with the rules set out in Regulation (EU) No 604/2013 of the European Parliament and of the Council (5) and they will replace those rules as of their entry into application.
(24) On 4 April 2025 the Communication from the Commission to the Council and the European Parliament on the status of migration management in mainland Greece (6) concluded that transfers to Greece should take place in the same manner as for the other Member States and in accordance with the jurisprudence of the Court of Justice of the European Union regarding the interpretation of Article 3(2) of Regulation (EU) No 604/2013.
(25) In December 2022, Italy suspended the receiving of transfers, with the exception of cases of family reunification of unaccompanied minors. The Court of Justice of the European Union found in its judgement of 19 December 2024 on joined cases C-185/24 and C-189/24 (7) that the Member State designated as responsible under the criteria set out in Chapter III of the Regulation (EU) No 604/2013 cannot unilaterally discharge itself from that responsibility.
(26) Member States should ensure compliance with their obligations under EU asylum law. In particular, they should ensure that the current practices already observed in their countries in relation to Regulation (EU) No 604/2013 no longer persist by the entry into application of Regulation (EU) 2024/1351. Continued non-compliance would amount to systemic shortcomings with regard to the rules set out in Part III of Regulation (EU) 2024/1351 that could result in serious negative consequences for the functioning of that Regulation. This should be assessed regularly by the Commission, and if these situations persist, Article 60(3), fourth subparagraph of Regulation (EU) 2024/1351 should apply. To ensure a sustainable transition from the current system of responsibility to the new rules set out in Regulation (EU) 2024/1351, particular attention should be paid to the level of operational cooperation among Member States, including the active engagement to facilitate transfers and progressive cooperation on practical and logistical matters.
(27) In view of taking a comprehensive approach to migration management at EU level, in parallel to the implementation of the Pact on Migration and Asylum, including Regulation (EU) 2024/1351, legislative work should continue as a matter of priority, particularly on the proposals for a common European system for return and for a Union list of safe countries of origin. Together these would help reduce the overall pressure on Member States’ asylum systems and support the functioning of the Pact on Migration and Asylum.
(28) Pursuant to Article 11(1), second subparagraph, consultations were carried out with the Member States identified in this decision as Member States under migratory pressure, at risk of migratory pressure, and facing a significant migratory situation.
(29) In accordance with Article 4 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union (TEU) and to the Treaty on the Functioning of the European Union (TFEU), Ireland has notified, by letter of 14 May 2024, its wish to accept and be bound by Regulation (EU) 2024/1351. Commission Decision (EU) 2024/2088 (8) confirmed such participation. Ireland is therefore taking part in the adoption of this Decision.
(30) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application,
HAS ADOPTED THIS DECISION:
The Member States under migratory pressure shall be as set in Annex I.
The Member States at risk of migratory pressure shall be as set in Annex II.
The Member States facing significant migratory situation shall be as set in Annex III.
The Commission shall assess by 12 July 2026 and again by 15 October 2026 whether current practices with regard to applicable rules have not been remedied and thereby constitute systemic shortcomings that could result in serious negative consequences for the functioning of Regulation (EU) 2024/1351, in which case Article 60(3) fourth subparagraph of Regulation (EU) 2024/1351 shall apply.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from the full entry into application of Regulation (EU) 2024/1351.

Greece
Spain
Italy
Cyprus

Belgium
Bulgaria
Germany
Estonia
Ireland
France
Croatia
Latvia
Lithuania
The Netherlands
Poland
Finland

Bulgaria
Czechia
Estonia
Croatia
Austria
Poland

Commission Implementing Decision (EU) 2025/2301 of 14 November 2025 postponing the expiry date of the approval of deltamethrin for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2301 17.11.2025
(1) Deltamethrin was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an active substance for use in biocidal products for product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 27 and 29 March 2022, two applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of deltamethrin for use in biocidal products of product-type 18 (‘the applications’).
(3) On 21 June 2022, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1088(3)postponed the expiry date of the approval of deltamethrin for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the applications.
(7) On 5 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional time needed linked with studies to assess the physicochemical properties of deltamethrin and the criteria for the determination of endocrine-disrupting properties. The evaluating competent authority expects to submit the renewal assessment report to the Agency in mid-2026.
(8) Consequently, for reasons beyond the control of the applicants, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalize the examination of the applications. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of deltamethrin for use in biocidal products of product-type 18, the expiry date should be postponed to 31 March 2028.
(9) After the further postponement of the expiry date of the approval, deltamethrin remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Deltamethrin was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products for product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 27 and 29 March 2022, two applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of deltamethrin for use in biocidal products of product-type 18 (‘the applications’).
(3) On 21 June 2022, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the applications was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1088 (3) postponed the expiry date of the approval of deltamethrin for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the applications.
(7) On 5 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional time needed linked with studies to assess the physicochemical properties of deltamethrin and the criteria for the determination of endocrine-disrupting properties. The evaluating competent authority expects to submit the renewal assessment report to the Agency in mid-2026.
(8) Consequently, for reasons beyond the control of the applicants, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalize the examination of the applications. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of deltamethrin for use in biocidal products of product-type 18, the expiry date should be postponed to 31 March 2028.
(9) After the further postponement of the expiry date of the approval, deltamethrin remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of deltamethrin for use in biocidal products of product-type 18 set out in Annex I to Directive 98/8/EC is postponed to 31 March 2028.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Implementing Decision (EU) 2025/2299 of 14 November 2025 postponing the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2299 18.11.2025
(1) Bacillus thuringiensissubsp.israelensisSerotype H14, Strain AM65-52 was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 30 March 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval ofBacillus thuringiensissubsp.israelensisSerotype H14, Strain AM65-52 for use in biocidal products of product-type 18 (‘the application’).
(3) On 2 February 2023, the evaluating competent authority of Italy informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1085(3)postponed the expiry date of the approval ofBacillus thuringiensissubsp.israelensisSerotype H14, Strain AM65-52 for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the application.
(7) On 13 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional studies needed by the authority to complete the evaluation. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the first quarter of 2026.
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval ofBacillus thuringiensissubsp.israelensisSerotype H14, Strain AM65-52 for use in biocidal products of product-type 18, the expiry date should be postponed to 31 March 2028.
(9) After the further postponement of the expiry date of the approval,Bacillus thuringiensissubsp.israelensisSerotype H14, Strain AM65-52 remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 30 March 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 (‘the application’).
(3) On 2 February 2023, the evaluating competent authority of Italy informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1085 (3) postponed the expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the application.
(7) On 13 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional studies needed by the authority to complete the evaluation. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the first quarter of 2026.
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18, the expiry date should be postponed to 31 March 2028.
(9) After the further postponement of the expiry date of the approval, Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 for use in biocidal products of product-type 18 set out in Annex I to Directive 98/8/EC is postponed to 31 March 2028.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Implementing Decision (EU) 2025/2292 of 7 November 2025 recognising that the report submitted by Poland under Article 31(2) of Directive (EU) 2018/2001 of the European Parliament and of the Council contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize in that Member State

Official Journalof the European Union ENL series
2025/2292 12.11.2025
(1) Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For that purpose, Article 29(10) of that Directive sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. Those typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.
(2) On 24 April 2025, Poland submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council(2). Poland asked for the data to be recognised as accurate in accordance with Article 31(4) of Directive (EU) 2018/2001.
(3) The Commission assessed the report and found that it contained accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize typically produced in NUTS 2 regions in Poland.
(4) The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,
NUTS 2 region according to Regulation (EC) No 1059/2003 Soil N2O Embedded Fuel Use Seed Total
Direct Indirect Fertiliser Neutralisation Pesticide
PL51 DOLNOŚLĄSKI 199,1 73,3 164,6 34,0 4,37 84,0 0,55 560
PL61 KUJAWSKO-POMORSKI 227,9 82,9 185,2 37,5 3,83 78,3 0,56 616
PL81 LUBELSKI 243,9 79,0 170,4 33,6 3,29 75,4 0,50 606
PL43 LUBUSKI 211,4 72,3 173,7 17,2 3,70 82,5 0,63 561
PL71 ŁÓDZKI 244,3 85,5 144,7 28,2 2,85 84,4 0,54 591
PL21 MAŁOPOLSKI 214,8 67,5 157,9 41,6 2,62 77,8 0,48 563
PL92 MAZOWIECKI 203,3 72,4 150,4 30,0 2,02 82,4 0,48 541
PL52 OPOLSKI 234,2 79,4 175,2 34,6 3,91 74,9 0,50 603
PL82 PODKARPACKI 191,7 67,7 182,1 64,6 3,16 83,6 0,52 593
PL84 PODLASKI 236,7 87,7 166,5 20,7 3,42 88,9 0,52 604
PL63 POMORSKI 240,7 75,9 172,8 36,0 3,85 84,7 0,52 614
PL22 ŚLĄSKI 207,9 75,4 145,3 26,7 3,93 95,2 0,52 555
PL72 ŚWIĘTOKRZYSKI 188,8 66,2 136,2 26,6 2,43 78,1 0,45 499
PL62 WARMIŃSKO-MAZURSKI 215,0 75,8 175,2 35,4 4,35 73,9 0,50 580
PL91 WARSZAWSKI-STOŁECZNY 206,9 80,0 150,4 55,3 3,48 82,6 0,46 579
PL41 WIELKOPOLSKI 230,5 87,5 177,4 35,0 4,24 90,0 0,55 625
PL42 ZACHODNIOPOMORSKI 212,9 79,8 194,0 46,1 3,98 82,1 0,53 619
NUTS 2 region according to Regulation (EC) No 1059/2003 Soil N2O Embedded Fuel Use Seed Total
Direct Indirect Fertiliser Neutralisation Pesticide
PL51 DOLNOŚLĄSKI 159,2 39,4 91,6 17,9 1,05 33,1 0,85 343
PL61 KUJAWSKO-POMORSKI 124,5 34,0 71,4 12,2 1,44 38,1 0,84 282
PL81 LUBELSKI 115,5 28,7 57,4 9,8 0,61 60,7 0,73 273
PL43 LUBUSKI 136,4 37,3 64,9 11,7 0,65 43,0 1,04 295
PL71 ŁÓDZKI 126,2 35,0 55,6 9,2 1,37 36,9 0,83 265
PL21 MAŁOPOLSKI 124,1 27,2 44,9 11,4 0,54 33,5 0,74 242
PL92 MAZOWIECKI 150,1 33,6 57,8 9,7 1,89 38,0 1,03 292
PL52 OPOLSKI 115,1 30,1 67,7 12,1 1,16 34,0 0,81 261
PL82 PODKARPACKI 105,4 26,3 63,1 29,8 1,06 35,1 0,88 262
PL84 PODLASKI 146,4 39,9 56,1 22,6 0,72 31,0 0,84 298
PL63 POMORSKI 114,5 28,5 42,5 24,8 1,75 33,7 0,74 247
PL22 ŚLĄSKI 114,6 29,2 59,8 10,1 0,91 38,1 0,82 254
PL72 ŚWIĘTOKRZYSKI 96,5 24,1 49,2 38,3 0,44 41,5 0,61 251
PL62 WARMIŃSKO-MAZURSKI 103,5 27,1 52,5 16,3 0,83 29,7 0,94 231
PL91 WARSZAWSKI-STOŁECZNY 139,5 39,3 72,5 21,5 1,73 40,8 0,98 316
PL41 WIELKOPOLSKI 133,2 38,8 53,5 9,2 1,45 44,6 0,91 282
PL42 ZACHODNIOPOMORSKI 113,0 30,7 52,7 29,5 0,96 46,3 0,95 274
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (1), and in particular Article 31(4) thereof,
Whereas:
(1) Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For that purpose, Article 29(10) of that Directive sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. Those typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.
(2) On 24 April 2025, Poland submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (2). Poland asked for the data to be recognised as accurate in accordance with Article 31(4) of Directive (EU) 2018/2001.
(3) The Commission assessed the report and found that it contained accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize typically produced in NUTS 2 regions in Poland.
(4) The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,
HAS ADOPTED THIS DECISION:
The report submitted for recognition to the Commission by Poland on 24 April 2025 contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed and maize typically produced in NUTS 2 regions in Poland. The summary of the report’s data is set out in the Annex.
If the data contained in the report as submitted for recognition to the Commission on 24 April 2025, changes in a way that might affect the accuracy of the data and thereby the basis for this Decision, Poland shall notify the Commission of such changes immediately. The Commission shall assess the notified changes to determine whether the report still provides the accurate data for which it is recognised.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall cease to apply on 2 December 2030.

Greenhouse gas emissions arising from the cultivation of rapeseed in the Poland NUTS2 regions (grams CO2eq/kilograms rapeseed harvested on dry matter basis)

NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total
Direct
Indirect
Fertiliser
Neutralisation
Pesticide
PL51 DOLNOŚLĄSKI
199,1
73,3
164,6
34,0
4,37
84,0
0,55
560
PL61 KUJAWSKO-POMORSKI
227,9
82,9
185,2
37,5
3,83
78,3
0,56
616
PL81 LUBELSKI
243,9
79,0
170,4
33,6
3,29
75,4
0,50
606
PL43 LUBUSKI
211,4
72,3
173,7
17,2
3,70
82,5
0,63
561
PL71 ŁÓDZKI
244,3
85,5
144,7
28,2
2,85
84,4
0,54
591
PL21 MAŁOPOLSKI
214,8
67,5
157,9
41,6
2,62
77,8
0,48
563
PL92 MAZOWIECKI
203,3
72,4
150,4
30,0
2,02
82,4
0,48
541
PL52 OPOLSKI
234,2
79,4
175,2
34,6
3,91
74,9
0,50
603
PL82 PODKARPACKI
191,7
67,7
182,1
64,6
3,16
83,6
0,52
593
PL84 PODLASKI
236,7
87,7
166,5
20,7
3,42
88,9
0,52
604
PL63 POMORSKI
240,7
75,9
172,8
36,0
3,85
84,7
0,52
614
PL22 ŚLĄSKI
207,9
75,4
145,3
26,7
3,93
95,2
0,52
555
PL72 ŚWIĘTOKRZYSKI
188,8
66,2
136,2
26,6
2,43
78,1
0,45
499
PL62 WARMIŃSKO-MAZURSKI
215,0
75,8
175,2
35,4
4,35
73,9
0,50
580
PL91 WARSZAWSKI-STOŁECZNY
206,9
80,0
150,4
55,3
3,48
82,6
0,46
579
PL41 WIELKOPOLSKI
230,5
87,5
177,4
35,0
4,24
90,0
0,55
625
PL42 ZACHODNIOPOMORSKI
212,9
79,8
194,0
46,1
3,98
82,1
0,53
619

Greenhouse gas emissions arising from the cultivation of maize in the Poland NUTS2 regions (grams CO2eq/kilograms maize harvested on dry matter basis)

NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total
Direct
Indirect
Fertiliser
Neutralisation
Pesticide
PL51 DOLNOŚLĄSKI
159,2
39,4
91,6
17,9
1,05
33,1
0,85
343
PL61 KUJAWSKO-POMORSKI
124,5
34,0
71,4
12,2
1,44
38,1
0,84
282
PL81 LUBELSKI
115,5
28,7
57,4
9,8
0,61
60,7
0,73
273
PL43 LUBUSKI
136,4
37,3
64,9
11,7
0,65
43,0
1,04
295
PL71 ŁÓDZKI
126,2
35,0
55,6
9,2
1,37
36,9
0,83
265
PL21 MAŁOPOLSKI
124,1
27,2
44,9
11,4
0,54
33,5
0,74
242
PL92 MAZOWIECKI
150,1
33,6
57,8
9,7
1,89
38,0
1,03
292
PL52 OPOLSKI
115,1
30,1
67,7
12,1
1,16
34,0
0,81
261
PL82 PODKARPACKI
105,4
26,3
63,1
29,8
1,06
35,1
0,88
262
PL84 PODLASKI
146,4
39,9
56,1
22,6
0,72
31,0
0,84
298
PL63 POMORSKI
114,5
28,5
42,5
24,8
1,75
33,7
0,74
247
PL22 ŚLĄSKI
114,6
29,2
59,8
10,1
0,91
38,1
0,82
254
PL72 ŚWIĘTOKRZYSKI
96,5
24,1
49,2
38,3
0,44
41,5
0,61
251
PL62 WARMIŃSKO-MAZURSKI
103,5
27,1
52,5
16,3
0,83
29,7
0,94
231
PL91 WARSZAWSKI-STOŁECZNY
139,5
39,3
72,5
21,5
1,73
40,8
0,98
316
PL41 WIELKOPOLSKI
133,2
38,8
53,5
9,2
1,45
44,6
0,91
282
PL42 ZACHODNIOPOMORSKI
113,0
30,7
52,7
29,5
0,96
46,3
0,95
274

Commission Implementing Decision (EU) 2025/2284 of 13 November 2025 postponing the expiry date of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2284 17.11.2025
(1) Magnesium phosphide releasing phosphine was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 January 2022 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 28 July 2020, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 (‘the application’).
(3) On 1 October 2020, the evaluating competent authority of Germany informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2021/1285(3)postponed the expiry date of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 to 31 July 2024, in order to allow sufficient time for the examination of the application.
(7) Commission Implementing Decision (EU) 2024/787(4)postponed again the expiry date of the approval to 31 January 2026 due to delays in the examination of the application.
(8) On 8 April 2025, the evaluating competent authority informed the Commission that it expects to submit the renewal assessment report to the Agency in the third quarter of 2025.
(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalize the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18, the expiry date should be postponed to 31 July 2027.
(10) After the further postponement of the expiry date of the approval, magnesium phosphide releasing phosphine remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Magnesium phosphide releasing phosphine was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 January 2022 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 28 July 2020, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 (‘the application’).
(3) On 1 October 2020, the evaluating competent authority of Germany informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2021/1285 (3) postponed the expiry date of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 to 31 July 2024, in order to allow sufficient time for the examination of the application.
(7) Commission Implementing Decision (EU) 2024/787 (4) postponed again the expiry date of the approval to 31 January 2026 due to delays in the examination of the application.
(8) On 8 April 2025, the evaluating competent authority informed the Commission that it expects to submit the renewal assessment report to the Agency in the third quarter of 2025.
(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to finalize the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18, the expiry date should be postponed to 31 July 2027.
(10) After the further postponement of the expiry date of the approval, magnesium phosphide releasing phosphine remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of magnesium phosphide releasing phosphine for use in biocidal products of product-type 18 set out in Annex I to Directive 98/8/EC is postponed to 31 July 2027.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Implementing Decision (EU) 2025/2283 of 13 November 2025 postponing the expiry date of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2283 17.11.2025
(1) Lambda-cyhalothrin was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an active substance for use in biocidal products for product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 24 March 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 (‘the application’).
(3) On 16 September 2022, the evaluating competent authority of Greece informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1087(3)postponed the expiry date of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the application.
(7) On 6 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional time needed by the authority to assess certain endpoints of lambda-cyhalothrin. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the end of 2027.
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of lambda-cyhalothrin for use in biocidal products of product-type 18, the expiry date should be postponed to 30 September 2028.
(9) After the further postponement of the expiry date of the approval, lambda-cyhalothrin remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Lambda-cyhalothrin was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products for product-type 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 30 September 2023 under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 24 March 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 (‘the application’).
(3) On 16 September 2022, the evaluating competent authority of Greece informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2023/1087 (3) postponed the expiry date of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 to 31 March 2026, in order to allow sufficient time for the examination of the application.
(7) On 6 June 2025, the evaluating competent authority informed the Commission that the evaluation is delayed due to additional time needed by the authority to assess certain endpoints of lambda-cyhalothrin. The evaluating competent authority expects to submit the renewal assessment report to the Agency in the end of 2027.
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to enable the examination of the application. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinion and the time needed for the Commission to decide whether to renew the approval of lambda-cyhalothrin for use in biocidal products of product-type 18, the expiry date should be postponed to 30 September 2028.
(9) After the further postponement of the expiry date of the approval, lambda-cyhalothrin remains approved for use in biocidal products of product-type 18 subject to the conditions set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of lambda-cyhalothrin for use in biocidal products of product-type 18 set out in Annex I to Directive 98/8/EC is postponed to 30 September 2028.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Implementing Decision (EU) 2025/2282 of 13 November 2025 postponing the expiry date of the approval of cholecalciferol for use in biocidal products of product-type 14 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2282 17.11.2025
(1) Cholecalciferol was approved as an active substance for use in biocidal products of product-type 14 by Commission Implementing Regulation (EU) 2019/637(2)subject to the conditions set out in the Annex to that Regulation.
(2) The approval of cholecalciferol for use in biocidal products of product-type 14 (‘the approval’) was to expire on 30 June 2024. On 22 December 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval (‘the application’).
(3) On 7 August 2023, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was not necessary. Pursuant to Article 14(2), second subparagraph, of that Regulation, the evaluating competent authority is to perform an evaluation of the application within 180 days of the European Chemicals Agency (‘the Agency’) accepting the application in accordance with Article 13(3) of that Regulation.
(4) On 16 December 2023, the evaluating competent authority submitted a recommendation on the renewal of the approval of cholecalciferol to the Agency.
(5) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for renewal of approval of active substances. The Biocidal Products Committee adopted the opinion of the Agency on 27 February 2024(3), having regard to the conclusions of the evaluating competent authority.
(6) On 1 July 2024, pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012, the Commission requested the Agency(4)to revise its opinion in order to investigate the use of the substance by the general public (non-professionals) and to conclude with certainty whether there are suitable alternatives to substitute cholecalciferol for indoor treatment of house mice, e.g. by the use of mechanical traps.
(7) Commission Implementing Decision (EU) 2024/733(5)postponed the expiry date of the approval of cholecalciferol for use in biocidal products of product-type 14 to 31 December 2025, in order to allow sufficient time to complete the full procedure of the examination of the application.
(8) On 30 April 2025, the Agency informed the Commission that it plans to submit the revised opinion to the Commission in the third quarter of 2025.
(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to complete the examination of the application. Taking into account the time-limits for preparation and submission by the Agency of its revised opinion and the time needed for the Commission to decide whether to renew the approval of cholecalciferol for use in biocidal products of product-type 14, the expiry date should be postponed to 31 December 2026.
(10) After the further postponement of the expiry date of the approval, cholecalciferol remains approved for use in biocidal products of product-type 14 subject to the conditions set out in the Annex to Implementing Regulation (EU) 2019/637,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Cholecalciferol was approved as an active substance for use in biocidal products of product-type 14 by Commission Implementing Regulation (EU) 2019/637 (2) subject to the conditions set out in the Annex to that Regulation.
(2) The approval of cholecalciferol for use in biocidal products of product-type 14 (‘the approval’) was to expire on 30 June 2024. On 22 December 2022, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval (‘the application’).
(3) On 7 August 2023, the evaluating competent authority of Sweden informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was not necessary. Pursuant to Article 14(2), second subparagraph, of that Regulation, the evaluating competent authority is to perform an evaluation of the application within 180 days of the European Chemicals Agency (‘the Agency’) accepting the application in accordance with Article 13(3) of that Regulation.
(4) On 16 December 2023, the evaluating competent authority submitted a recommendation on the renewal of the approval of cholecalciferol to the Agency.
(5) In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for renewal of approval of active substances. The Biocidal Products Committee adopted the opinion of the Agency on 27 February 2024 (3), having regard to the conclusions of the evaluating competent authority.
(6) On 1 July 2024, pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012, the Commission requested the Agency (4) to revise its opinion in order to investigate the use of the substance by the general public (non-professionals) and to conclude with certainty whether there are suitable alternatives to substitute cholecalciferol for indoor treatment of house mice, e.g. by the use of mechanical traps.
(7) Commission Implementing Decision (EU) 2024/733 (5) postponed the expiry date of the approval of cholecalciferol for use in biocidal products of product-type 14 to 31 December 2025, in order to allow sufficient time to complete the full procedure of the examination of the application.
(8) On 30 April 2025, the Agency informed the Commission that it plans to submit the revised opinion to the Commission in the third quarter of 2025.
(9) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to further postpone the expiry date of the approval for a period of time sufficient to complete the examination of the application. Taking into account the time-limits for preparation and submission by the Agency of its revised opinion and the time needed for the Commission to decide whether to renew the approval of cholecalciferol for use in biocidal products of product-type 14, the expiry date should be postponed to 31 December 2026.
(10) After the further postponement of the expiry date of the approval, cholecalciferol remains approved for use in biocidal products of product-type 14 subject to the conditions set out in the Annex to Implementing Regulation (EU) 2019/637,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of cholecalciferol for use in biocidal products of product-type 14 set out in Implementing Regulation (EU) 2019/637 is postponed to 31 December 2026.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Implementing Decision (EU) 2025/2279 of 13 November 2025 postponing the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Official Journalof the European Union ENL series
2025/2279 14.11.2025
(1) Aluminium phosphide releasing phosphine was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an active substance for use in biocidal products of product-types 14 and 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 August 2021 and 31 January 2022, respectively, under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) In addition, aluminium phosphide releasing phosphine was approved as an active substance for use in biocidal products of product-type 20 by Commission Implementing Regulation (EU) No 1034/2013(3)until 30 June 2025 subject to the conditions set out in the Annex to that Regulation.
(3) On 26 February 2020, applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20 (‘the applications’).
(4) On 25 May 2020 (for the applications for product-types 14 and 18), and on 16 June 2020 (for the application for product-type 20), the evaluating competent authority of Germany informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of all applications was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(5) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(6) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(7) Commission Implementing Decision (EU) 2021/1284(4)postponed the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14 and 18 to 31 July 2024, in order to allow sufficient time for the examination of the applications.
(8) Commission Implementing Decision (EU) 2024/732(5)postponed again the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14 and 18 to 31 January 2026 due to delays in the examination of the applications.
(9) Commission Implementing Decision (EU) 2025/461(6)postponed the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-type 20 to 31 January 2026, in order to allow sufficient time for the examination of the concerned application.
(10) On 8 April 2025, the evaluating competent authority informed the Commission that it expects to submit the renewal assessment reports of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20 to the Agency in the third quarter of 2025.
(11) Consequently, for reasons beyond the control of the applicant, the approvals are likely to expire before a decision has been taken on their renewal. It is therefore appropriate to further postpone the expiry date of the approvals for a period of time sufficient to finalize the examination of the applications. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinions and the time needed for the Commission to decide whether to renew the approvals of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20, the expiry date should be postponed to 31 July 2027 for all concerned product-types.
(12) After the further postponement of the expiry date of the approvals, aluminium phosphide releasing phosphine remains approved for use in biocidal products of product-types 14 and 18 subject to the conditions set out in Annex I to Directive 98/8/EC, and for use in biocidal products of product-type 20 subject to the conditions set out in the Annex to Implementing Regulation (EU) No 1034/2013,
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Aluminium phosphide releasing phosphine was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) as an active substance for use in biocidal products of product-types 14 and 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, it was therefore considered approved until 31 August 2021 and 31 January 2022, respectively, under that Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) In addition, aluminium phosphide releasing phosphine was approved as an active substance for use in biocidal products of product-type 20 by Commission Implementing Regulation (EU) No 1034/2013 (3) until 30 June 2025 subject to the conditions set out in the Annex to that Regulation.
(3) On 26 February 2020, applications were submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20 (‘the applications’).
(4) On 25 May 2020 (for the applications for product-types 14 and 18), and on 16 June 2020 (for the application for product-type 20), the evaluating competent authority of Germany informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of all applications was necessary. Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.
(5) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.
(6) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(7) Commission Implementing Decision (EU) 2021/1284 (4) postponed the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14 and 18 to 31 July 2024, in order to allow sufficient time for the examination of the applications.
(8) Commission Implementing Decision (EU) 2024/732 (5) postponed again the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14 and 18 to 31 January 2026 due to delays in the examination of the applications.
(9) Commission Implementing Decision (EU) 2025/461 (6) postponed the expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-type 20 to 31 January 2026, in order to allow sufficient time for the examination of the concerned application.
(10) On 8 April 2025, the evaluating competent authority informed the Commission that it expects to submit the renewal assessment reports of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20 to the Agency in the third quarter of 2025.
(11) Consequently, for reasons beyond the control of the applicant, the approvals are likely to expire before a decision has been taken on their renewal. It is therefore appropriate to further postpone the expiry date of the approvals for a period of time sufficient to finalize the examination of the applications. Taking into account the time-limits for evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinions and the time needed for the Commission to decide whether to renew the approvals of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14, 18 and 20, the expiry date should be postponed to 31 July 2027 for all concerned product-types.
(12) After the further postponement of the expiry date of the approvals, aluminium phosphide releasing phosphine remains approved for use in biocidal products of product-types 14 and 18 subject to the conditions set out in Annex I to Directive 98/8/EC, and for use in biocidal products of product-type 20 subject to the conditions set out in the Annex to Implementing Regulation (EU) No 1034/2013,
HAS ADOPTED THIS DECISION:
The expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-types 14 and 18 set out in Annex I to Directive 98/8/EC is postponed to 31 July 2027.
The expiry date of the approval of aluminium phosphide releasing phosphine for use in biocidal products of product-type 20 set out in the Annex to Implementing Regulation (EU) No 1034/2013 is postponed to 31 July 2027.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.