Prováděcí nařízení Komise (EU) 2017/2068 ze dne 13. listopadu 2017, kterým se v souladu s nařízením Evropského parlamentu a Rady (ES) č. 1107/2009 o uvádění přípravků na ochranu rostlin na trh neschvaluje sorbát draselný jako základní látka (Text s významem pro EHP)

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/EECOJ L 309, 24.11.2009, p. 1 . , and in particular Article 23(5) in conjunction with Article 13(2) thereof,

The substance potassium sorbate is not approved as basic substance.

OJ L 309, 24.11.2009, p. 1 .

(1) In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 9 October 2015 an application from Decco Iberica Post Cosecha S.A.U for the approval of potassium sorbate as a basic substance. On 14 July 2016 the Commission received an updated application. That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

(2) The Commission asked the European Food Safety Authority (the Authority) for scientific assistance. The Authority provided the Commission with a Technical Report on potassium sorbate on 12 May 2017 EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for potassium sorbate for use in plant protection as fungicide on citrus, stone and pome fruits. EFSA supporting publication 2017:EN-1232. 53 pp. doi:10.2903/sp.efsa.2017.EN-1232. . The Commission presented the review reporthttp://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN and the draft of this Regulation on the non-approval of potassium sorbate to the Standing Committee on Plants, Animals, Food and Feed on 20 July 2017 and finalised them for the meeting of that Committee on 6 October 2017 .

(3) The documentation provided by the applicant shows that potassium sorbate fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 ). .

(4) Specific concerns however were identified, in the Technical Report of the Authority, regarding exposure to potassium sorbate specifically through residues of pesticide use. The Authority concluded that the information on residues was very limited and, as a result, it could not conduct a reliable consumer risk assessment. An exceedance of the temporary Acceptable Daily Intake of potassium sorbate due to the additional consumer exposure to residues from pesticide use of potassium sorbate cannot be excluded.

(5) The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted no comments.

(6) Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve potassium sorbate as basic substance.

(7) This Regulation does not prejudice the submission of a further application for the approval of potassium sorbate as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

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

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for potassium sorbate for use in plant protection as fungicide on citrus, stone and pome fruits. EFSA supporting publication 2017:EN-1232. 53 pp. doi:10.2903/sp.efsa.2017.EN-1232.

Article 1 Article 1

Article 2 Article 2

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 ).

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