Select Committee on European Scrutiny Thirty-Second Report




COM(02) 153

Draft Council Regulation on additives for use in animal nutrition.

Legal base:Articles 37 and 152 EC; co-decision; qualified majority voting
Document originated:22 March 2002
Deposited in Parliament:17 April 2002
Department:Food Standards Agency
Basis of consideration:EM of 22 May 2002
Previous Committee Report:None
To be discussed in Council:No date set
Committee's assessment:Politically important
Committee's decision:Not cleared; further information awaited


  5.1  Feed additives are currently controlled by Council Directive 70/524/EEC[14], which provides that only those on an authorised list may be used in animal feeds and only according to specific conditions of use. In order to be on the list, additives must first be assessed for safety, quality and efficacy, on the basis of a dossier submitted by an applicant to a Member State, which must then distribute copies to the other Member States: if no objections are received within a set period, the Commission then refers the application to the Standing Committee for Feedingstuffs for a decision (which may include advice from the Scientific Committee for Animal Nutrition).

The current proposal

  5.2  As foreshadowed in its White Paper on Food Safety,[15] the Commission considers that certain changes are needed to rationalise and consolidate the existing arrangements, and to clarify the procedural aspects of authorisations. It is therefore proposing that Directive 70/524 should be repealed, and replaced by a new Regulation, though this would retain a number of the essential features of the Directive, including the provisions on labelling, and the fundamental principle that only additives on an authorised list based on safety, quality and efficacy may be used or marketed.

  5.3  The main changes proposed would:

  • widen the scope of the controls to include additives used in drinking water;

  • prohibit the authorisation in future of antibiotics as feed additives, and phase out the four remaining authorised antibiotic growth promoters by 2006;

  • divide the various categories of additive into groups, such as preservatives, colourants, and vitamins, according to their principal function (though additives for which more than one claim is made would have to be assessed for each);

  • include silage agents within the scope of the controls for the first time (as preservatives);

  • require dossiers for new additives to be assessed by the European Food Safety Agency, with authorisations being awarded on the basis of a Regulation drafted by the Commission for ten years, and renewable.

  5.4  In addition, the Commission proposes to evaluate according to updated criteria over 350 substances which were permitted for use before the latest guidelines were drawn up. This exercise would cover many generic substances, and the eventual authorisations would be specific to authorisation holders. The Commission also says that it has considered whether coccidiostats (which are added to feed to kill or inhibit the growth of certain parasites, mainly in poultry) should be classified as veterinary medicines. In the proposal, it has decided to retain their status as feed additives, but it will re-evaluate the position four years after the Regulation comes into force.

The Government's view

  5.5  In her Explanatory Memorandum of 22 May 2002, the then Parliamentary Under-Secretary of State at the Department of Health (Yvette Cooper) says that the UK accepts the continued need to control the use of additives in animal nutrition, given their implications both for consumers and animal health. The Government also considers that the Commission's proposals would strengthen the existing controls and rationalise procedures.

  5.6  At the same time, however, it believes that it is necessary to examine the practical implications of some of the measures proposed. In particular, the Minister says:

  • that, although the UK supports controls over the use of additives in drinking water, the proposal does not specify how the assessments required for authorisations should be carried out, and that these may have to be based on criteria different from those already established for feedingstuffs;

  • that the proposal does not appear to cover other non-feed uses of additives, such as boluses[16], which are an important feature in animal nutrition and should continue to be allowed, subject to proper authorisation;

  • that the UK shares the concerns which have led the Commission to propose the phasing out of antibiotic growth promoters, and, although it is satisfied that the four currently remaining in use are not related to any therapeutic antibiotics used in human or veterinary medicine, it can support their phasing out on a precautionary basis, which should give time to develop alternative products and husbandry methods;

  • that the UK agrees on the need to control silage agents, but will make the point that no details have been provided as to how authorisations (which might be required within two or three years) might be carried out;

  • that, as regards the proposal to categorise additives by their principal function, the UK favours an alternative approach whereby they would be listed in each of the functional groups where an effect was claimed;

  • that, although Member States will have the final say in the authorisation of a substance, this will take into account the European Food Safety Authority's independent assessment, and it is important therefore that the Authority should be properly resourced, and not required to carry out unnecessarily burdensome work.

  5.7  The Minister also says that the UK can support the re-evaluation of substances which may have been authorised a number of years ago according to less strict criteria, but that it should be noted that many are innocuous, with a safe history of use in animal feeds (and some in human food), even though a number of recent incidents have indicated their susceptibility to contamination in the manufacturing process. She says that the UK will seek more information on how the arrangements for re-evaluation will work in practice.

  5.8  Finally, the Minister has attached to her Explanatory Memorandum a preliminary Regulatory Impact Assessment which she says will be finalised after interested parties have been consulted. However, the Assessment does little more at this stage than identify the main areas where costs might arise, and makes no real attempt to quantify these.


  5.9  Whilst the UK has indicated its general support for these proposals, the Government's Explanatory Memorandum makes it clear that there are a number of aspects where the practical implications need to be explored further. Also, a more precise assessment of the costs is needed before we can sensibly take a view on the significance or otherwise of the proposals. Consequently, pending receipt of this further information, we are holding the document under scrutiny.

  5.10  When the Government does provide further information, we would be glad if it could deal with the relative roles of the Commission and the Member States in authorising products in future. According to the Explanatory Memorandum provided recently, any decision following the appraisal of the European Food Safety Authority will be on the basis of a Regulation prepared by the Commission, whereas we were also told that it is the Member State authorities which will have the final say. It may be that this is intended simply to reflect the fact that any such Regulation would have to be approved by a Standing Committee comprising representatives of the Member States, and that the latter's functions would thus be exercised collectively at Community level. Either way, however, it would be helpful to have clarification of this point.

14   OJ No. L.270, 14.12.70, p.1. Back

15   (20875) 5761/00; see HC 23-x (1999-2000), paragraph 2 (1 March 2000). Back

16   Slow release capsules. Back

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