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)
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 18 November 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of lecithins as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).
(2)
The Commission asked the European Food Safety Authority (hereinafter the Authority) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 28 August 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015 and finalised them for the meeting of that Committee of 29 May 2015.
(3)
The documentation provided by the applicant shows that lecithins 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). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.
(4)
It has appeared from the examinations made that lecithins may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve lecithins as a basic substance.
(5)
In accordance with Article 13(2) 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 for the approval which are detailed in Annex I to this Regulation.
(6)
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.
(7)
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
Approval of a basic substance
The substance lecithins as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.
Article 2
Amendments to Implementing Regulation (EU) No 540/2011
Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3
Entry into force
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, 9 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 309, 24.11.2009, p. 1.
(2) Outcome of the consultation with Member States and EFSA on the basic substance application for lecithins for use in plant protection as a fungicide on vineyards, fruit trees, vegetables and ornamentals. EFSA supporting publication 2014:EN-643.34 pp.
(3) http://ec.europa.eu/sanco_pesticides/public/?event=homepage
(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).
(5) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
ANNEX I
Common Name, Identification Numbers |
IUPAC Name |
Purity(1) |
Date of approval |
Specific provisions |
Lecithins CAS No: 8002-43-5 CIPAC No: not allocated Einecs 232-307-2 |
Not allocated |
As described in the Annex to Regulation (EU) No 231/2012. |
1 July 2015 |
Only uses as basic substance being a fungicide are approved. Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof. |
(1)Further details on identity, specification and manner of use of basic substance are provided in the review report.
ANNEX II
In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number |
Common Name, Identification Numbers |
IUPAC Name |
Purity(1) |
Date of approval |
Specific provisions |
6 |
Lecithins CAS No: 8002-43-5 CIPAC No: not allocated Einecs 232-307-2 |
Not allocated |
As described in the Annex to Regulation (EU) No 231/2012. |
1 July 2015 |
Only uses as basic substance being a fungicide are approved. Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof. |
(1)Further details on identity, specification and manner of use of basic substance are provided in the review report.
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