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)

• CELEX: Implementing Regulation (EU) 2021/1446
• Articles: 5

Article 1 Correction to Implementing Regulation (EU) No 563/2014

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

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

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

Article 3 Entry into force

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

Schedules & Appendices

ANNEX I

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 II

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.