# Commission Implementing Decision of 12 August 2013 allowing Member States to extend provisional authorisations granted for            the active substances benalaxyl-M and valifenalate (notified under document C(2013) 5184) (Text with EEA relevance) (2013/431/EU)         

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U.K.

# Commission Implementing Decision

# of 12 August 2013

# allowing Member States to extend provisional authorisations granted for the active substances benalaxyl-M and valifenalate

# (notified under document C(2013) 5184)

# (Text with EEA relevance)

# (2013/431/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular the fourth subparagraph of Article 8(1) thereof,                        

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(2), and in particular Article 80(1)(a) thereof,                        

Whereas:

(1)In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Directive 91/414/EEC shall continue to apply to active                              substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011.

(2)In accordance with Article 6(2) of Directive 91/414/EEC, in February 2002 Portugal received an application from ISAGRO IT                              for the inclusion of the active substance benalaxyl-M in Annex I to Directive 91/414/EEC. Commission Decision 2003/35/EC(3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements                              of Annexes II and III to that Directive.

(3)In accordance with Article 6(2) of Directive 91/414/EEC, in September 2005 Hungary received an application from ISAGRO SpA                              for the inclusion of the active substance valifenalate in Annex I to Directive 91/414/EEC. Commission Decision 2006/586/EC(4) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements                              of Annexes II and III to that Directive.

(4)Confirmation of the completeness of the dossiers was necessary in order to allow them to be examined in detail and to allow                              Member States the possibility of granting provisional authorisations, for periods of up to three years, for plant protection                              products containing the active substances concerned, while complying with the conditions laid down in Article 8(1) of Directive                              91/414/EEC and, in particular, the conditions relating to the detailed assessment of the active substances and the plant protection                              products in the light of the requirements laid down by that Directive.

(5)For these active substances, the effects on human health and the environment have been assessed, in accordance with the provisions                              of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The rapporteur Member States submitted                              the respective draft assessment reports to the Commission on 21 November 2003 (benalaxyl-M) and on 19 February 2008 (valifenalate).

(6)Following submission of the draft assessment reports by the rapporteur Member States, it has been found to be necessary to                              request further information from the applicants and to have the rapporteur Member States examine that information and submit                              their assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the                              evaluation within the timeframe provided for in Directive 91/414/EEC, read in conjunction with Commission Implementing Decision                              2011/671/EU(5).

(7)As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility                              of prolonging provisional authorisations granted for plant protection products containing the active substances concerned                              for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination                              of the dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on                              a possible approval in accordance with Article 13(2) of Regulation (EC) No 1107/2009 for benalaxyl-M and valifenalate will                              have been completed within 24 months.

(8)The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain                              and Animal Health,

HAS ADOPTED THIS DECISION:

# Article 1U.K.

Member States may extend provisional authorisations for plant protection products containing benalaxyl-M or valifenalate for                     a period ending on 31 August 2015 at the latest.                  

# Article 2U.K.

This Decision shall expire on 31 August 2015.

# Article 3U.K.

This Decision is addressed to the Member States.

Done at Brussels, 12 August 2013.

*For the Commission*                            

Tonio Borg                            

*Member of the Commission*                            

1

OJ L 230, 19.8.1991, p. 1.                           

2

OJ L 309, 24.11.2009, p. 1.                           

3

OJ L 11, 16.1.2003, p. 52.                           

4

OJ L 236, 31.8.2006, p. 31.                           

5

OJ L 267, 12.10.2011, p. 19.