# Commission Implementing Regulation (EU) No 601/2013Show full title

Commission Implementing Regulation (EU) No 601/2013 of 24 June 2013 concerning the authorisation of cobalt(II) acetate tetrahydrate,            cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated            cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 601/2013                     

# of 24 June 2013

# concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3)                        monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed                        additives                     

# (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised                              pursuant to Council Directive 70/524/EEC(2).

(2)Cobaltous acetate, basic cobaltous carbonate and cobaltous sulphate were authorised without a time limit by Directive 70/524/EEC.                              These products were subsequently entered in the Community Register of feed additives as existing products, in accordance with                              Article 10(1) of Regulation (EC) No 1831/2003.

(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application                              was submitted for the re-evaluation of cobaltous acetate, basic cobaltous carbonate and cobaltous sulphate as feed additives                              for all animal species. Additionally, an application based on Article 10(2) was submitted for the re-evaluation of basic cobaltous                              carbonate in a film granulated form for all animal species. Thirdly, in accordance with Article 7 of that Regulation, an application                              was submitted for the authorisation of cobalt carbonate for ruminants, horses and rabbits. For all five compounds of cobalt                              it was requested that the additives to be classified in the additive category ‘nutritional additives’. The three applications                              were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 12 June 2012(3) (4) and 22 May 2012(5) that, under the proposed conditions of use, cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide                              (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate                              do not have an adverse effect on animal health, consumer health or the environment, and that they are an effective sources                              of cobalt in the respective target species. The Authority also concluded that no safety concerns would arise for users provided                              that appropriate protective measures are taken to avoid inhalation. 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 cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate,                              cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate shows that the conditions                              for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these                              substances should be authorised as specified in the Annex to this Regulation.

(6)Since safety reasons do not require the immediate application of the modifications for the already authorised cobalt compounds,                              it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements                              resulting from the authorisation.

(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 1U.K.Authorisation

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

## [F1Article 1aU.K.Amendment to Commission Regulation (EC) No 1334/2003 (6) 

In the Annex to Regulation (EC) No 1334/2003, the entries ‘cobaltous acetate tetrahydrate’, ‘basic cobaltous carbonate monohydrate’ and ‘cobaltous sulphate heptahydrate’, related to the element E3 Cobalt-Co, are deleted.]                   

Textual Amendments

F1Inserted by Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending Implementing Regulation (EU) No 601/2013                                 concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3)                                 monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed                                 additives (Text with EEA relevance).

## [F2Article 2U.K.Transitional measures

The substances specified in the Annex which were authorised by Directive 70/524/EEC and feed containing them, which are produced                        and labelled before 4 September 2014 in accordance with the rules applicable before 15 July 2013 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for pet                        animals, the time period for production and labelling referred to in the first sentence shall end on 4 March 2016.]                   

Textual Amendments

F2Substituted by Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending Implementing Regulation (EU) No 601/2013                                 concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3)                                 monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed                                 additives (Text with EEA relevance).

## Article 3U.K.Entry into force

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.

## [F2ANNEXU.K.

1

OJ L 268, 18.10.2003, p. 29.                           

2

OJ L 270, 14.12.1970, p. 1.                           

3

EFSA Journal 2012; 10(7):2791.

4

EFSA Journal 2012; 10(7):2782.

5

EFSA Journal 2012; 10(6):2727.

6

[F1OJ L 187, 26.7.2003, p. 11.]                            

Textual Amendments

F1Inserted by Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending Implementing Regulation (EU) No 601/2013                                    concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3)                                    monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed                                    additives (Text with EEA relevance).