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EU Document No. 7505/2 Relating to Additives in Animal Nutrition

European Standing Committee C

Wednesday 2 July 2003

[Mr. Bill Olner in the Chair]

EU Document No. 7505/02 Relating to Additives in Animal Nutrition

2 pm

The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): It is a great pleasure to be in Committee under your chairmanship, Mr. Olner.

The proposal in European Commission document 7505/02 relating to additives in animal nutrition is much needed and long overdue. It provides a welcome opportunity to rationalise and consolidate the existing rules on additives in animal feedstuffs and to clarify the procedures on dossier evaluation and on the granting of authorisation with respect to feed additives. The rules are intended to safeguard the health of food consumers and animals. The Food Standards Agency has taken the lead in negotiations and, as will be seen, the United Kingdom has made significant gains that reflect points made during extensive consultation.

I should first like to outline the current legislation. Feed additives such as vitamins, trace elements, and preservatives are currently controlled by Council directive 70/524/EEC. One of the main principles of the directive is that only additives on an authorised list can be used in animal feed; that is done according to certain conditions of use. The basic feed additives legislation has undergone five major amendments over the past 33 years, and there have been more than 100 modifications to its annexes. There has not been any consolidation of the text since 1984, and I am sure that hon. Members will agree that review and rationalisation are overdue.

A new additive is included on the authorised list only after being assessed for safety, quality and efficacy. That requires companies or other applicants to provide a dossier of information for assessment via a member state rapporteur, who subsequently presents the dossier to other member states to be considered for European Commission authorisation. The already complex legislation is further complicated by the existence of different types of authorisation. They include provisional, 10-year or non-time-limited authorisations and, in some cases, authorisations that are linked to an applicant company.

I want to deal now with the main elements of the Commission's proposal and the Government's view of it. Some of the provisions reflect the existing controls in directive 70/524/EEC. For example, the fundamental principle of a permitted list of feed additives based on safety, quality and efficacy is retained.

The most significant new provision, and the issue that has attracted most stakeholder and public interest, is the proposed phasing out and ultimate banning of the four remaining antibiotic growth

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promoters—sodium monensin, sodium-salinomycin, flavophospholipol and avilamycin—from 1 January 2006.

Chris Grayling (Epsom and Ewell): Could the Minister say that again?

Miss Johnson: No, I could not.

Mr. Jim Murphy (Eastwood): Can she spell it?

Miss Johnson: I can do that.

The phasing out of growth promoters and the attendant difficulty in estimating potential costs and benefits appears to have been the foremost issue in the European Scrutiny Committee's request for this afternoon's debate.

The authorisation for a number of antibiotic growth promoters has already been withdrawn. The Commission's proposal to phase out the authorisation of the remaining four follows the advice of its Scientific Steering Committee to cease the use as growth-promoting agents of antimicrobials belonging to classes that are, or may be, used in human or veterinary medicines. That is because of concern about the risk of transfer of antimicrobial resistance from micro-organisms of livestock origin to human pathogens.

Antimicrobial resistance is a serious problem in human medicine, and has resulted in increasing concern about the use of antimicrobial products in human medicine, veterinary medicine, animal production, agriculture and horticulture. The Government have made it clear that they take the problem seriously and have developed a comprehensive strategy for maintaining the effectiveness of antimicrobial products.

A key element of the strategy is the carefully managed phasing out and ultimate banning of the use of antibiotic growth promoters in animal production. That is one of the main planks of the Commission's proposal and one that the Government support.

The importance of a carefully managed phasing-out period, which allows for the development of alternative products or husbandry methods, was clearly shown when those products were discontinued in Denmark. The Government therefore support the proposed date of January 2006 for prohibition of those products on a precautionary basis. A shorter period might have resulted in a more pronounced and equally unwelcome therapeutic use of antibiotics—a view that is shared by the independent Advisory Committee on Animal Feedingstuffs, which advises Agriculture Ministers and the Food Standards Agency.

Analysis of the benefits of the regulation suggests large potential gains from reducing some of the costs to human health that are associated with antibiotic resistance. Those benefits are generated from reducing the costs of illness and the increased death rates that have been associated with the acquisition of antibiotic-resistant infections. However, the exact contribution of the drugs to be banned to the overall pool of antibiotic resistance and their impact on human health is complex and highly uncertain. For that reason, a range of assumptions had to be used, as was also the

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case for the costs that will fall on the industry. Depending on the exact assumptions that are used, the regulation could produce a net economic gain or loss. Owing to the potential but uncertain benefits to human health, we propose to proceed with implementation on a precautionary basis.

Before taking questions, I shall put the Commission's proposal into context by briefly referring to some of its other elements, to the Government's views, to the state of negotiations in Brussels and to the likely outcome as we see it. The Government support the Commission's proposal that the European Food Safety Authority should carry out safety assessments for new feed additives. That appears to be a more independent procedure when compared with the present one, as it involves applications made by member states that first assess and then present and answer questions on the dossier of information. However, during negotiations in Brussels, the UK has made the point that the European Food Safety Authority will need to be properly resourced to carry out that job—especially as it is proposed that it should re-evaluate some 350 currently authorised substances against the revised criteria.

Experts from member states can assist the European Food Safety Authority. The major task of re-evaluating existing authorisations will not commence immediately, as applicants for most products have been given seven years to submit dossiers, which will provide sufficient time for the authority to build up resources and expertise. There will be a less complex regime for the re-evaluation of some categories of additives where attendant risks to animal or human health are likely to be negligible, as there will be for generic substances already authorised for use in human food and additives for minor species, such as horses.

Industry organisations are carrying out a survey to identify any additives that may not be supported by companies. If those are deemed to be important for, say, animal welfare purposes, industry organisations may decide to support their re-evaluation. The Commission has clarified that authorisation for generic additives, such as binders, trace elements and preservatives, will not be specific to authorisation holders. Brand-specific authorisation will be confined to the zootechnical additive category, which includes more complex additives such as enzymes, micro-organisms and growth promoters.

A provision in the Commission's original proposal required additives to be categorised by their principal function. However, the UK favoured an alternative approach, whereby such additives would be listed in each of the functional groups where the effect was claimed. For example, an organic acid might act as a preservative, but, at higher rates of incorporation, it might have growth-promoting effects. The alternative approach will provide more clarity for the users of such substances, and the text of the Commission's proposals has been amended so that the additives will be listed in each functional group where they have an effect.

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The regulation also proposes a review of the system for authorising coccidiostats and histomonostats as feed additives. Coccidiostats and histomonostats are added to feed to kill or inhibit the growth of certain intestinal parasites, mainly in poultry. It is proposed that existing arrangements should continue until 31 December 2008. However, before 1 January 2008, the Commission would need to submit a report on the use of those substances, together with a legislative proposal on arrangements for their future authorisation where appropriate. We recognise the need for such a review and believe that, in the longer term, such products should be classed as veterinary medicines. That would enable improved controls on their use and help to address the risks of their contribution to the build-up of antimicrobial resistance.

Besides being incorporated in feeds, additives can be given to animals in other ways, such as in pastes and slow-release capsules. The proposal extends the coverage only to include use in drinking water. The implication could be that other non-feed uses would be banned. I am advised that the other non-feed uses of additives are widespread in the UK and, indeed, in other member states. Interested organisations claim that the removal of such additives from the market would create economic animal health and animal welfare problems. The Government line is that it is necessary to control all ways of administering additives to animals. All non-feed uses should be considered on the same basis as feed additives, provided that safety in use and importance to animal nutrition, health and welfare can be demonstrated. The European Food Safety Authority will consider methods of authorisation when it draws up new guidelines.

During negotiations, the Commission said that an amendment to the text on mixes of additives may be used for the authorisation of other types of non-feed use. However, for the longer term, some member states thought that further specific legislation should control those uses, and a Council statement will call on the Commission to consider such legislation.

Similarly, the Government think that agents used to assist ensilage of grass and crop forage—which are not currently subject to control—should be required to undergo safety assessments. Residues of those agents may be present in silage when it is used for feeding. However, the Commission's original proposal would have meant that all those assessments would have to have been carried out before the regulations came into force—possibly in two or three years' time.

During negotiations, the UK pointed out that, given the number of agents that might be involved, that timetable was too short. The Commission amended its proposal to provide for a transitional period of seven years to allow applicants to prepare relevant dossiers on silage agents.

Stakeholders generally support the proposed ban on antibiotic growth promoters, following a properly managed phasing-out period. Two representations were received about the lack of scientific evidence to support the ban; others favoured the precautionary

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approach. Several consultees had animal welfare concerns about the exclusion of non-feed uses of feed additives from the proposal, on the ground that those products are an important source of nutrients for animals in upland and remote areas. Some consultees thought that silage agents should be subject to separate legislation, with less stringent authorisation procedures and requirements. Others thought that the authorisation regime for additives used in pet food should not be as rigorous as that for additives used in livestock feed.

Finally, it is important to update the Committee on the state of negotiations in Brussels. Agriculture Ministers adopted a common position on the Commission's proposal on 17 March. That position has been the subject of a Second Reading discussion in the European Parliament, where further amendments are being considered by member states in the Council. The European Commission's consideration of amendments tabled by the European Parliament during that stage is now complete, and the Commission will consider revising its proposal to reflect those amendments.

I hope that that sets out the scope of the proposals, the views of the Commission and stakeholders, the Government's approach and the state of negotiations. The Government are firmly committed to ensuring consumer safety and the Commission's proposals should help to fulfil that commitment. We give the proposal general support as a measure that will provide additional protection to consumers of livestock products and that will rationalise authorisation procedures. I hope that the Committee will unite to support the motion.


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