(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)

Choline chloride was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species as part of the group ‘Vitamins, pro-vitamins and chemically well-defined substances having similar effect’. That product was subsequently entered in the European Union Register of Feed Additives as an existing product, 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 thereof, an application was submitted for the re-evaluation of choline chloride, as a feed additive for all animal species, requesting that additive to be classified in the additive category ‘nutritional additives’. That application was 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 opinion of 6 September 2011 (3) that, under the proposed conditions of use in feed, choline chloride does not have an adverse effect on animal and consumer health, and it is not expected to pose additional risk for the environment. The Authority also concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. 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 choline chloride 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 substance should be authorised as specified in the Annex to this Regulation.

(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additive, premixtures and compound feed containing it, as authorised by Directive 70/524/EEC.

(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,

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

(2)

The substance 3-acetyl-2,5-dimethylthiophene was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species as part of the group ‘Flavouring and appetising substances — All natural products and corresponding synthetic products’. That substance was subsequently entered in the European Union Register of Feed Additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003, with CAS number 2530-10-1 and Flavis number 15.024.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of this substance as a feed additive for all animal species, requesting that additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The substance 3-acetyl-2,5-dimethylthiophene was also included in the list of flavouring substances in Part A of Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (3), as a flavouring substance under evaluation for which additional scientific data had to be submitted. Such data was submitted.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2013 (4) about the use of this substance as a flavouring substance in food that this substance is mutagenic in vitro and in vivo and that its use as a flavouring substance in food raises a safety concern.

(6)

This assessment indicates that 3-acetyl-2,5-dimethylthiophene is very likely to be mutagenic also for animals consuming feed containing this substance as a sensory additive. Consequently, it has not been established that this substance does not have an adverse effect on animal health, when used as a feed additive under the proposed conditions of use.

(7)

The conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are therefore not satisfied. Accordingly, the authorisation of 3-acetyl-2,5-dimethylthiophene as a feed additive should be denied.

(8)

Since further use of 3-acetyl-2,5-dimethylthiophene as a feed additive may cause a risk to animal health, it should be withdrawn from the market as soon as possible.

(9)

Taking into account practical reasons, a transitional period should be laid down to address the situation of existing stocks of feed containing the flavouring substance 3-acetyl-2,5-dimethylthiophene already in the market before the entry into force of this Regulation.

(10)

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

(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)

A preparation of Enterococcus faecium NCIMB 11181 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on calves for rearing and for fattening and weaned piglets by Commission Regulation (EC) No 1333/2004 (3). That preparation was subsequently entered in the European Union Register of feed additives as an existing product, in accordance with Article 10(1)(b) 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 that preparation as a feed additive for calves for rearing and for fattening and weaned piglets, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was 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 opinion of 1 February 2012 (4) that, under the proposed conditions of use, the preparation of Enterococcus faecium NCIMB 11181 does not have an adverse effect on animal health, human health or on the environment, and that it is efficacious in improving zootechnical performance of calves for rearing and for fattening and weaned piglets. 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 the preparation of Enterococcus faecium NCIMB 11181 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)

As a new authorisation is granted in accordance with Regulation (EC) No 1831/2003, Regulation (EC) No 1333/2004 should be repealed.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for the disposal of existing stocks of the additive, pre-mixtures and compound feed containing it, as authorised by Regulation (EC) No 1333/2004.

(8)

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

(1)

The active substance pyrethrins was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (5).

(2)

In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for pyrethrins (6) on 12 December 2012. The Authority communicated its view on pyrethrins to the notifier. The Commission invited it to submit comments on the draft review report for pyrethrins. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 July 2013 in the format of the Commission review report for pyrethrins.

(3)

It is confirmed that the active substance pyrethrins is to be deemed to have been approved under Regulation (EC) No 1107/2009.

(4)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to amend the conditions of approval of pyrethrins. In particular, it is appropriate to require further confirmatory information.

(5)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(6)

A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products containing pyrethrins to meet the requirements resulting from amendment to the conditions of the approval.

(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,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

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capacity allocation and congestion management rules including governance for day-ahead and intraday markets including capacity calculation (Commission adoption phase),

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network connection rules:

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system operation rules (7):

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balancing rules including network-related reserve power (Commission adoption phase),

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rules for longer term (forward) capacity allocation (Commission adoption phase),

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rules regarding harmonised transmission tariff structures (scoping by ACER to prepare framework guideline (8)).

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interoperability and data exchange rules (Commission adoption phase),

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rules regarding harmonised transmission tariff structures (ENTSOG drafting network code),

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rules regarding an EU-wide market-based approach on the allocation of ‘new build’ gas transmission capacity (drafting of amendment of network code on capacity allocation mechanisms by ACER and ENTSOG as well as including respective tariff rules in the network code on transmission tariff structures),

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rules for trading related to technical and operational provisions of network access services and system balancing (scoping by ACER to identify whether binding EU rules for the further harmonisation of the design of capacity products and contracts as regards firmness, restrictions to allocation or secondary markets are needed, taking into account the implementation of the guideline on congestion management procedures and the network codes on capacity allocation mechanisms and on balancing).