Commission Implementing Regulation (EU) 2016/1425 of 25 August 2016 approving the active substance isofetamid 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)

Approval of the active substance

Article 1

The active substance isofetamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Amendment 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

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 .

ANNEX ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Isofetamid CAS No: 875915-78-9 CIPAC No: 972 N -[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide ≥ 950 g/kg 15 September 2016 15 September 2026 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 isofetamid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; (2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; (3) the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. ( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX IISupplementary provisions

ANNEX II In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:   Common Name, Identification Numbers IUPAC Name Purity  ( *1 ) Date of approval Expiration of approval Specific provisions ‘100 Isofetamid CAS No: 875915-78-9 CIPAC No: 972 N -[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide ≥ 950 g/kg 15 September 2016 15 September 2026 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 isofetamid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; (2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; (3) the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’ ( *1 )   Further details on identity and specification of active substance are provided in the review report.