COMMISSION IMPLEMENTING REGULATION (EU) No 269/2012

of 26 March 2012

concerning the authorisation of dicopper chloride trihydroxide as feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition(1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of dicopper chloride trihydroxide. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of dicopper chloride trihydroxide as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 September 2011(2) that, under the proposed conditions of use, dicopper chloride trihydroxide does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an effective source of copper for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) The assessment of dicopper chloride trihydroxide shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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, 26 March 2012.

For the Commission

The President

José Manuel BARROSO

(1)

OJ L 268, 18.10.2003, p. 29

(2)

EFSA Journal

2011; 9(9):2355.

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Content of element (Cu) in mg/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b409

—

Dicopper chloride trihydroxide

Characterisation of the additive:

Chemical formula: Cu2(OH)3Cl

CAS Number: 1332-65-6

crystal form atacamite/paratacamite in a 1:1 to 1:1,5 ratio

Purity: min. 90 %

alpha-crystal: min. 95 % in the crystalline product

Cu content: min. 53 %

Particles < 50 μm: below 1 %

Analytical method (1):

For the identification of dicopper chloride trihydroxide atacamite/paratacamite crystal forms in the additive: X-ray diffraction (XRD).

For the determination of total copper in the additive and premixtures:

—	EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP-AES), or

—	CEN/TS 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion.

For the determination of total copper in feed materials and compound feed:

—	Atomic Absorption Spectrometry (AAS), or

—	EN 15510, or

—	CEN/TS 15621.

All animal species

—

Bovine

—	Bovine before the start of rumination: 15 (total)

—	Other bovine: 35 (total)

Ovine: 15 (total)

Piglets up to 12 weeks: 170 (total)

Crustaceans: 50 (total)

Other animals: 25 (total)

1.	The additive shall be incorporated into feed in the form of a premixture.

2.	For user safety: breathing protection, safety glasses and gloves should be worn during handling.

The following words shall be included in the labelling:

—	For feed for sheep if the level of copper in the feed exceeds 10 mg/kg: ‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’

—	For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg: ‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’

16 April 2022

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx