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 23(5) in conjunction with Article 13(2) thereof,
Whereas:
(1) On 30 June 2017, the Commission received an application from Biomolécules et Biotechnologies Végétales (BBV) EA2106 and Institut Technique de l’Agriculture Biologique (ITAB) for the approval of Vitis vinifera cane tannins as a basic substance. 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 Vitis vinifera cane tannins on 2 May 2018(2). The Commission presented the review report(3) and the draft of this Regulation on the non-approval of Vitis vinifera cane tannins to the Standing Committee on Plants, Animals, Food and Feed on 24 June 2019 and finalised them for the meeting of that Committee on 22 October 2019.
(3) The documentation provided by the applicants do not show that Vitis vinifera cane tannins fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(4).
(4) Specific concerns were identified, in the technical report of the Authority, regarding Vitis vinifera cane tannins. No toxicological assessment was available for Vitis vinifera cane tannins used as a plant protection product, especially as regards the protection of children. This applies to the estimation of the non-dietary exposure risk assessment, in particular bystanders and residents. Furthermore, there was insufficient information for performing an environmental risk assessment for the substance.
(5) No relevant evaluation, carried out in accordance with other Union legislation as referred to in Article 23(2) of Regulation (EC) No 1107/2009, was available.
(6) The Commission invited the applicants to submit their comments on the technical report of the Authority and on the Commission’s draft review report. The applicants did not submit comments.
(7) Consequently, as laid down in the Commission’s 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 Vitis vinifera cane tannins as a basic substance.
(8) This Regulation does not prejudice the submission of a further application for the approval of Vitis vinifera cane tannins as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
(9) 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:
Vitis vinifera cane tannins is not approved as a basic substance.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 January 2020.
For the Commission
The President
Ursula von der Leyen
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 Vitis vinifera cane tannins for use in plant protection as protectant and repellent. EFSA supporting publication 2018:EN-1414. 46 pp. doi: 10.2903/sp.efsa.2018.EN-1414.
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).