Commission Implementing Regulation (EU) 2018/755 of 23 May 2018 renewing the approval of the active substance propyzamide, 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 as a candidate for substitution

Article 1

The approval of the active substance propyzamide, as a candidate for substitution, 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 the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 July 2018.

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Propyzamide CAS No 23950-58-5 CIPAC No 315 3,5-dichloro- N -(1,1-dimethylprop-2-ynyl) benzamide 920 g/kg 1 July 2018 30 June 2025 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propyzamide and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the protection of operators, — the protection of groundwater in vulnerable areas, — the protection of birds, mammals, non-target plants, soil and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the completion of assessment of toxicological profile of metabolites identified in significant concentration in primary and rotational crops; 2. the soil degradation of major metabolite RH- 24580; 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. The applicant shall submit the information mentioned under point (1) by 31 October 2018 and the information mentioned under point (2) by 30 April 2019. The applicant shall submit the confirmatory information mentioned in point (3) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 55 on propyzamide is deleted; (2) in Part E, the following entry is added: No Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions ‘9 Propyzamide CAS No 23950-58-5 CIPAC No 315 3,5-dichloro- N -(1,1-dimethylprop-2-ynyl) benzamide 920 g/kg 1 July 2018 30 June 2025 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propyzamide and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the protection of operators, — the protection of groundwater in vulnerable areas, — the protection of birds, mammals, non-target plants, soil and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the completion of assessment of toxicological profile of metabolites identified in significant concentration in primary and rotational crops; 2. the soil degradation of major metabolite RH- 24580; 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. The applicant shall submit the information mentioned under point (1) by 31 October 2018 and the information mentioned under point (2) by 30 April 2019. The applicant shall submit the confirmatory information mentioned in point (3) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission.’ ( 1 )   Further details on identity and specification of active substance are provided in the review report.