
Article 1 
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 
The Part C of Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 23 May 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Specific provisions
Chitosan hydrochlorideCAS no: 9012-76-4 Not applicable European PharmacopeiaMax 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 and Commission 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.



ANNEX II

In Part C of Annex to Implementing Regulation (EC) No 540/2011, the following entry is added:
'
2 Chitosan hydrochlorideCAS no: 9012-76-4 Not applicable European PharmacopeiaMax 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.'
