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)

• CELEX: Implementing Regulation (EU) 2022/456
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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 II

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 ).