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,
Whereas:
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.
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.
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.
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.
It is therefore appropriate to renew the approval of iprovalicarb.
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.
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.
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 1Renewal 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 2Amendments 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 3Entry 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
Common Name, Identification Numbers | IUPAC Name | Purity8 | 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:
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:
Number
Common Name, Identification Numbers
IUPAC Name
Purity10Date 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 PMPA9 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.