Commission Implementing Regulation (EU) 2021/2049 of 24 November 2021 renewing the approval of the active substance cypermethrin as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

Renewal of the approval of the active substance

Article 1

The approval of the active substance cypermethrin is renewed as set out in Annex I.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force and date of application

Article 3

This Regulation shall enter into force on twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 February 2022.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Cypermethrin CAS No 52315-07-8 CIPAC No 332 (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or (RS)-α-cyano-3-phenoxybenzyl-(1RS)-cis-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate 920 g/kg cis:trans: 40/60 to 60/40 The following impurities are of toxicological concern and must not exceed the following levels in the technical material: hexane: 5g/kg 1 February 2022 31 January 2029 Authorisations shall be limited to professional users. When authorising plant protection products containing cypermethrin for spray applications outdoors, in order to ensure the protection of non-target organisms, in particular aquatic organisms and non-target arthropods, including bees: — risk mitigation measures achieving reduction of drift shall be required that lead to exposure ≤ 5,8 mg a.s./ha in off-crop areas and, in addition, for spring applications to concentrations in water bodies ≤ 0,0038 μg a.s./L, — only uses outside flowering of the crop and when no flowering weeds are present may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cypermethrin, and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to: — the protection of aquatic organisms, non-target arthropods, including bees; — the consumer risk assessment; — the technical specification of the active substance used in plant protection products. Where considered appropriate, Member States shall set monitoring requirements when granting authorisations in accordance with Article 6(i) of the Regulation (EC) No 1107/2009, in order to complement the monitoring under Directives of the European Parliament and of the Council 2000/60/EC  ( 2 ) and 2009/128/EC  ( 3 ) . The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety; 2. the relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR); 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. 4. Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605. The applicant shall submit: — the information referred to in point 1 by 15 December 2022; — the information referred to in point 2 by 15 December 2023; and — the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity shall be submitted by 15 December 2023. ( 1 )   Further details on the identity and the specification of the active substance are provided in the renewal report. ( 2 )   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( OJ L 327, 22.12.2000, p. 1 ). ( 3 )   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides ( OJ L 309, 24.11.2009, p. 71 ).

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 103 on cypermethrin is deleted; (2) in Part E, the following entry is added: ‘14 Cypermethrin CAS No 52315-07-8 CIPAC No 332 (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or (RS)-α-cyano-3-phenoxybenzyl-(1RS)-cis-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate 920 g/kg cis:trans: 40/60 to 60/40 The following impurities are of toxicological concern and must not exceed the following levels in the technical material: hexane: 5g/kg 1 February 2022 31 January 2029 Authorisations shall be limited to professional users. When authorising plant protection products containing cypermethrin for spray applications outdoors, in order to ensure the protection of non-target organisms, in particular aquatic organisms and non-target arthropods, including bees: — risk mitigation measures achieving reduction of drift shall be required that lead to exposure ≤ 5,8 mg a.s./ha in off-crop areas and, in addition, for spring applications to concentrations in water bodies ≤ 0,0038 μg a.s./L, — only uses outside flowering of the crop and when no flowering weeds are present may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cypermethrin, and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to: — the protection of aquatic organisms, non-target arthropods, including bees; — consumer risk assessment; — the technical specification of the active substance used in plant protection products. Where considered appropriate, Member States shall set monitoring requirements when granting authorisations in accordance with Article 6(i) of the Regulation (EC) No 1107/2009, in order to complement the monitoring under Directives of the European Parliament and of the Council 2000/60/EC  ( *1 ) and 2009/128/EC  ( *2 ) . The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety; 2. the relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR); 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. 4. Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 The applicant shall submit: — the information referred to in point 1 by 15 December 2022; — the information referred to in point 2 by 15 December 2023; and — the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards Points 3.6.5 and 3.8.2 of Annex II toRegulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity shall be submitted by 15 December 2023. ( *1 )   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( OJ L 327, 22.12.2000, p. 1 ). ( *2 )   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of EN 5 EN pesticides ( OJ L 309, 24.11.2009, p. 71 ).’