Commission Implementing Regulation (EU) No 563/2014 of 23 May 2014 approving the basic substance chitosan hydrochloride 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 Commission Implementing Regulation (EU) No 540/2011 Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 563/2014
• Articles: 5

Article 1 Approval of a basic substance

The substance chitosan hydrochloride as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.

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

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

Article 3 Entry into force and date of application

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 hydrochloride

CAS no: 9012-76-4

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 thereof, 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 Annex to Implementing Regulation (EC) No 540/2011, the following entry is added:

‘2

Chitosan hydrochloride

CAS no: 9012-76-4

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 thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.’