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
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)
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| 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
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.’ |
|---|---|---|---|---|---|
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