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Commission Implementing Regulation (EU) 2021/81 of 27 January 2021 approving the basic substance Allium cepa L. bulb extract 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

In forceVersion 2021-01-27from 2021-02-17
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Contents
  1. Preamble
    1. Article 1 Approval of a basic substance
    2. Article 2 Amendments to Implementing Regulation (EU) No 540/2011
    3. Article 3 Entry into force
  3. ANNEX
  4. ANNEX I
  5. ANNEX II

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

Whereas:

(1) On 4 September 2018, the Commission received an application from l’Institut de l’agriculture et de l’alimentation Biologique (ITAB), for the approval of Allium cepa L. bulb extract as a basic substance. That application was accompanied by the information required by 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 Allium cepa L. bulb extract on 12 December 2019. The Commission presented the review report and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020.

(3) The information provided by the applicant shows that the Allium cepa L. bulb extract 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. Moreover, it is not predominantly used for plant protection purposes but the extract can be useful in plant protection in a product consisting of the substance. Consequently, it is to be considered as a basic substance.

(4) After examination of the application and all related documents, it may be expected that the Allium cepa L. bulb extract satisfies, 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 the Allium cepa L. bulb extract 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.

(6) In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 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 Allium cepa L. bulb extract as specified in Annex I is approved as a basic substance subject to the conditions as laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

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, 27 January 2021. For the Commission The President Ursula von der Leyen

ANNEX

ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Specific provisions Allium cepa L. bulb extract CAS No: not allocated CIPAC No: not allocated Not applicable The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae 17.2.2021 Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof.

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 Date of approval Specific provisions 23 Allium cepa L. bulb extract CAS No: not allocated CIPAC No: not allocated Not applicable The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae 17.2.2021 Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof.

Versions

  1. 2021-01-27

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