Commission Regulation (EU) No 335/2010 of 22 April 2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2010/335@2010-04-22/en
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, 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 the preparation set out in the Annex to this Regulation. 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 zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, to be classified in the additive category nutritional additives.
(4) From the opinion of the European Food Safety Authority (the Authority) adopted on 11 November 2009, read in combination with those of 16 April 2008 and 2 April 2009 it results that zinc chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment. According to the opinion of 16 April 2008, the use of that preparation may be considered as a source of available zinc and fulfils the criteria of a nutritional additive for all animal species. The Authority recommends appropriate measures for user safety. It 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.
(6) By Commission Regulation (EC) No 888/2009 of 25 September 2009 concerning the authorisation of Zinc chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening that preparation was already authorised as a feed additive for chickens for fattening. That Regulation should be repealed.
(7) 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
Regulation (EC) No 888/2009 is repealed.
Article 3
This Regulation shall enter into force on the 20th day following 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, 22 April 2010. For the Commission The President José Manuel Barroso
ANNEX
ANNEX 1.2.
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 (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements 3b6.10 — Zinc chelate of hydroxy analogue of methionine All species — Pets: 250 (total) Fish: 200 (total) Other species: 150 (total) Complete and complementary milk replacers: 200 (total) The additive shall be incorporated into feed in the form of a premixture. For user safety: breathing protection, safety glasses and gloves shall be worn during handling. 13 May 2020
Characterisation of the additive:
Zinc chelate of hydroxy analogue of methionine containing 17,5 %-18 % zinc and 81 % (2-hydroxy-4-methylthio) butanoic acid
Mineral oil: ≤ 1 %
Analytical method: Inductively coupled plasma atomic emission spectrometry (ICP-AES) according to EN 15510:2007
Versions
Cited by
- Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 (Text with EEA relevance) Regulation · Grade B
Commission Regulation (EU) No 335/2010 and Commission Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 authorised several zinc compounds as nutritional feed additives. In order to take into account the conclusions of the Authority in its opinion of 8 April 2014, which were also the scientific basis for the provisions concerning the total zinc content in compound feed for the additives authorised by this Regulation and which are mainly referring to the environmental impact of feed supplementation with zinc, it is appropriate to align the maximum contents of zinc in Regulation (EU)
- Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 (Text with EEA relevance) Regulation · Grade B
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for Zinc acetate dihydrate, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate and Zinc chelate of glycine hydrate and the zinc compounds authorised by Regulation (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
- Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 (Text with EEA relevance) Regulation · Grade B
In the Annex to Regulation (EU) No 335/2010, in the line 3b6.10 the eighth column is replaced by the following: Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total) Piglets, sows, rabbits and all fish species other than salmonids: 150 (total) Other species and categories: 120 (total).
- Commission Implementing Regulation (EU) 2016/1095 of 6 July 2016 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006, (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 (Text with EEA relevance) Regulation · Grade B
Zinc acetate dihydrate, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate and Zinc chelate of glycine hydrate and the zinc compounds authorised by Regulation (EU) No 335/2010 and Implementing Regulations (EU) No 991/2012 and (EU) No 636/2013 and premixtures containing them, which are produced and labelled before 27 January 2017 in accordance with the rules applicable before 27 July 2016 may continue to be placed on the market and used until the existing stocks are exhausted.
- Commission Implementing Regulation (EU) 2021/968 of 16 June 2021 concerning the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 335/2010 (Text with EEA relevance) Regulation · Grade B
Zinc chelate of hydroxy analogue of methionine was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 335/2010.
- Commission Implementing Regulation (EU) 2021/968 of 16 June 2021 concerning the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 335/2010 (Text with EEA relevance) Regulation · Grade B
As a consequence of the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as feed additive, Regulation (EU) No 335/2010 should be repealed.
- Commission Implementing Regulation (EU) 2021/968 of 16 June 2021 concerning the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 335/2010 (Text with EEA relevance) Regulation · Grade B
Regulation (EU) No 335/2010 is repealed.