COMMISSION IMPLEMENTING REGULATION (EU) 2018/1294

of 26 September 2018

concerning the non-approval of Landes pine tar as a basic substance 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

(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 23(5) in conjunction with Article 13(2) thereof,

Whereas:

(1) On 22 December 2015, the Commission received an application from Progarein France SAS for the approval of Landes pine tar 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 Landes pine tar on 30 October 2017 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Landes pine tar to the Standing Committee on Plants, Animals, Food and Feed on 24 May 2018 and finalised them for the meeting of that Committee on 20 July 2018.

(3) The documentation provided by the applicant does not show that Landes pine tar 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 however were identified, in the technical report of the Authority, regarding Landes pine tar. Landes pine tar is a complex mixture, the exact composition of which is unknown. Landes pine tar should be considered as a substance of concern since it can contain substances of concern (e.g. furfurals, phenols). Furthermore the presence of substances of very high concern cannot be excluded (e.g. genotoxic carcinogens such as polycyclic aromatic hydrocarbons). Furthermore, assessment of the risk to operators, workers, bystanders and consumers could not be finalised based on the data available in the application.

(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 applicant to submit its comments on the technical report of the Authority and on the Commission's draft review report. The applicant submitted its comments, which have been carefully examined.

(7) However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

(8) 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 Landes pine tar as a basic substance.

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

(10) 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 The substance Landes pine tar is not approved as a basic substance.

Article 2 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, 26 September 2018. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 309, 24.11.2009, p. 1.

(2) 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 Landes pine tar for use in plant protection as protectant and repellent. EFSA supporting publication 2017:EN-1311. 57 pp.

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

(4) 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).