Commission Implementing Regulation (EU) 2021/1446 of 3 September 2021 correcting Implementing Regulations (EU) No 540/2011 and (EU) No 563/2014 as regards the CAS number of the basic substance chitosan hydrochloride (Text with EEA relevance)

Correction to Implementing Regulation (EU) No 563/2014

Article 1

Annex I to Implementing Regulation (EU) No 563/2014 is corrected in accordance with Annex I to this Regulation.

Correction to Implementing Regulation (EU) No 540/2011

Article 2

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

Entry into force

Article 3

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

ANNEX ISupplementary provisions

ANNEX I Annex I to Implementing Regulation (EU) No 563/2014 is replaced by the following: ‘Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Specific provisions Chitosan hydrochloride CAS No: 70694-72-3 Not applicable European Pharmacopeia Max. content of heavy metals: 40 ppm 1 July 2014 Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 of the European Parliament and of the Council  ( 2 ) and Commission Regulation (EU) No 142/2011  ( 3 ) . Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.’ ( 1 )   Further details on identity, specification and manner of use of basic substance are provided in the review report. ( 2 )    OJ L 300, 14.11.2009, p. 1 . ( 3 )    OJ L 54, 26.2.2011, p. 1 .

ANNEX IISupplementary provisions

ANNEX II In Part C of the Annex to Implementing Regulation (EU) No 540/2011, entry 2 on chitosan hydrochloride is replaced by the following: No Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Specific provisions ‘2 Chitosan hydrochloride CAS No: 70694-72-3 Not applicable European Pharmacopeia Max. content of heavy metals: 40 ppm 1 July 2014 Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011. Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.’ ( 1 )   Further details on identity, specification and manner of use of basic substance are provided in the review report.