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Commission Implementing Regulation (EU) 2022/456 of 21 March 2022 approving the basic substance chitosan 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 Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

In forceVersion 2022-03-21from 2022-04-11
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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 19 December 2018, the Commission received an application from KitoZyme for the extension of use of chitosan hydrochloride, approved by Commission Implementing Regulation (EU) No 563/2014 as a basic substance. As that application was not complete, on 28 November 2019, KitoZyme submitted a revised application 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 8 July 2020 with the summary of the outcome of the consultation with Member States on the basic substance application for an extension of use of chitosan hydrochloride and presenting EFSA’s scientific views on the individual comments received. Based on that technical report and the documentation provided by the applicant, it is appropriate to define the scope of the application as covering the active substance chitosan. The Commission presented its review report on the substance chitosan to the Standing Committee on Plants, Animals, Food and Feed on 19 May 2021.

(3) The information provided by the applicant shows that chitosan 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 nevertheless it can be useful in plant protection, in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance pursuant to Art 23 of Regulation (EC) No 1107/2009.

(4) After examination of the application and all related documents, it has been established that chitosan 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 chitosan as a basic substance.

(5) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6(a)(b)(d)(j) 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 chitosan as specified in Annex I is approved, and subject to the conditions as laid down in that Annex, as a basic substance.

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, 21 March 2022. For the Commission The President Ursula von der Leyen

ANNEX

ANNEX I

Common name, identification numbers IUPAC Name Purity Date of approval Specific provisions Chitosan CAS No: 9012-76-4 EC No: 618-480-0 Chemical name (not IUPAC): poly[4-O-(2-acetamido-2-deoxy-β-D-glucopyranosyl)-2-amino-2-deoxy-β-D-glucopyranose] ≥ 85 % chitosan heavy metals: max. 20 mg/kg Food grade, meeting the specifications for chitosan extract from fungi as set out in Commission Implementing Regulation (EU) 2017/2470. 11 April 2022 Chitosan shall be used in accordance with the specific conditions included in the conclusions of the review report on chitosan (SANTE/10594/2021) and in particular Appendices I and II thereto.

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 24 Chitosan CAS No: 9012-76-4 EC No: 618-480-0 Chemical name (not IUPAC): poly[4-O-(2-acetamido-2-deoxy-β-D-glucopyranosyl)-2-amino-2-deoxy-β-D-glucopyranose] ≥ 85 % chitosan heavy metals: max. 20 mg/kg Food grade, meeting the specifications for chitosan extract from fungi as set out in Commission Implementing Regulation (EU) 2017/2470 11 April 2022 Chitosan shall be used in accordance with the specific conditions included in the conclusions of the review report on chitosan (SANTE/10594/2021) and in particular Appendices I and II thereto.

Versions

  1. 2022-03-21

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