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)

Approval of a basic substance

Article 1

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.

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Entry into force

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

ANNEX ISupplementary provisions

ANNEX I Common name, identification numbers IUPAC Name Purity  ( 1 ) 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  ( 2 ) . 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. ( 1 )   Further details on identity, specification and manner of use of the basic substance are provided in the review report. ( 2 )   Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).

ANNEX IISupplementary provisions

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 ‘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  ( 2 ) 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.’ ( 1 )   Further details on identity, specification and manner of use of basic substance are provided in the review report. ( 2 )   Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).