Commission Implementing Regulation (EU) 2016/147Show full title

Commission Implementing Regulation (EU) 2016/147

of 4 February 2016

renewing the approval of the active substance iprovalicarb 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 Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC(1), and in particular Article 20(1) thereof,

Whereas:

(1) The approval of the active substance iprovalicarb, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011(2), expires on 30 June 2016.

(2) An application for the renewal of the inclusion of iprovalicarb in Annex I to Council Directive 91/414/EEC(3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010(4) within the time period provided for in that Article.

(3) The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(4) The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 2 September 2013.

(5) The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(6) On 14 April 2015(5) the Authority communicated to the Commission its conclusion on whether iprovalicarb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for iprovalicarb to the Standing Committee on Plants, Animals, Food and Feed on 8 October 2015.

(7) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8) It is therefore appropriate to renew the approval of iprovalicarb.

(9) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. It is, in particular, appropriate to require further confirmatory information.

(10) The risk assessment for the renewal of the approval of iprovalicarb is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing iprovalicarb may be authorised. It is therefore appropriate not to maintain the restriction to uses as a fungicide. In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(11) Commission Implementing Regulation (EU) 2015/1885(6) extended the expiry date of iprovalicarb to allow the renewal process to be completed before the expiry of its approval. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 April 2016.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1 Renewal of the approval of the active substance

The approval of the active substance iprovalicarb, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3 Entry into force and date of application

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 April 2016.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 February 2016.

For the Commission

The President

Jean-Claude Juncker

ANNEX I

a p-methyl-phenethylamine
b Further details on identity and specification of active substance are provided in the review report.
Common Name, Identification Numbers	IUPAC Name	Purityb	Date of approval	Expiration of approval	Specific provisions
Iprovalicarb CAS No 140923-17-7 CIPAC No 620	isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate	≥ 950 g/kg Impurities: Toluene: not more than 3 g/kg	1 April 2016	31 March 2031	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 iprovalicarb, 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 protection of groundwater from the relevant soil metabolite PMPAa when the active substance is applied in regions with low clay containing soil types, the safety of operators and workers, the protection of aquatic organisms in the case of formulated products containing other active substances. 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 the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows

(1)

in Part A, entry 30 on iprovalicarb is deleted;

(2)

in Part B, the following entry is added:

a p-methyl-phenethylamine’
b Further details on identity and specification of active substance are provided in the review report.
Number	Common Name, Identification Numbers	IUPAC Name	Purityb	Date of approval	Expiration of approval	Specific provisions
‘96	Iprovalicarb CAS No 140923-17-7 CIPAC No 620	isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate	≥ 950 g/kg Impurities: Toluene: not more than 3 g/kg	1 April 2016	31 March 2031	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 iprovalicarb, 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 protection of groundwater from the relevant soil metabolite PMPAa when the active substance is applied in regions with low clay containing soil types, the safety of operators and workers, the protection of aquatic organisms in the case of formulated products containing other active substances. 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 the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.

(1)

OJ L 309, 24.11.2009, p. 1.

(2)

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(3)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)

Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

(5)

EFSA Journal 2015; 13(3):4060. Available online: www.efsa.europa.eu.

(6)

Commission Implementing Regulation (EU) 2015/1885 of 20 October 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-D, acibenzolar-s-methyl, amitrole, bentazone, cyhalofop butyl, diquat, esfenvalerate, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), glyphosate, iprovalicarb, isoproturon, lambda-cyhalothrin, metalaxyl-M, metsulfuron methyl, picolinafen, prosulfuron, pymetrozine, pyraflufen-ethyl, thiabendazole, thifensulfuron-methyl and triasulfuron (OJ L 276, 21.10.2015, p. 48).