5. ADDITIVES IN ANIMAL NUTRITION
(23385)
7505/02
COM(02)153
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Draft Council Regulation on additives for use in animal nutrition.
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| Legal base: | Articles 37 and 152 EC; co-decision; qualified majority voting
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| Department: | Food Standards Agency
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| Basis of consideration: | SEM of 21 November 2002 and corrigendum of 28 November 2002
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| Previous Committee Report: | HC 152-xxxii (2001-02), paragraph 5 (12 June 2002)
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| To be discussed in Council: | December 2002
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| Committee's assessment: | Politically important
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| Committee's decision: | Not cleared
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Background
5.1 Feed additives are currently controlled by Council
Directive 70/524/EEC[19],
which provides that only those on an authorised list after having
been assessed for safety, quality and efficacy may be used in
animal feeds and only according to specific conditions of use.
The Commission considers that certain changes are needed to rationalise
and consolidate the existing arrangements, and to clarify the
procedural aspects of authorisations. It therefore proposed in
March 2002 that the Directive should be repealed, and replaced
by a new Regulation, though the latter 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 may be used or marketed.
5.2 The main changes proposed would:
- include additives used in drinking water within the controls;
- prohibit the future authorisation of antibiotics as feed additives,
and phase out the four remaining authorised growth promoters by
2006;
- divide the various categories of additive into groups, according
to their principal function;
- include silage agents within the scope of the controls (as
preservatives).
5.3 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.
5.4 In her Explanatory Memorandum of 22 May 2002, the
then Parliamentary Under-Secretary of State at the Department
of Health (Yvette Cooper) said that the UK accepts the continued
need to control the use of additives in animal nutrition, and
considers that the Commission's proposals would strengthen the
existing controls and rationalise procedures. At the same time,
however, it believes that it is necessary to examine the practical
implications of some of the measures proposed. In particular:
- 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;
- the proposal does not appear to cover other non-feed uses
of additives, such as boluses,[20]
which should continue to be allowed, subject to proper authorisation;
- although the UK agrees on the need to control silage agents,
no details have been provided as to how authorisations might be
carried out;
- instead of categorising additives by their principal function,
the UK favours their being listed in each of the functional groups
where an effect is claimed.
5.5 The Minister also said 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 many
are innocuous, with a history of safe use. She added that the
UK would seek more information on how the arrangements for re-evaluation
will work in practice.
5.6 In our Report of 12 June 2002, we noted the UK's
general support for these proposals, but that there were a number
of aspects where the practical implications need to be explored
further. Also, a more precise assessment of the costs than those
provided in the Government's preliminary Regulatory Impact Assessment
was needed. Consequently, pending receipt of this further information,
we said that we were holding the document under scrutiny. We also
asked the Government to clarify the relative roles of the Commission
and the Member States in authorising products in future, since
it appeared that any decision would be on the basis of a Regulation
prepared by the Commission, whereas we had also been told that
it was the Member State authorities which would have the final
say.
Supplementary Explanatory Memorandum of 21 November 2002
5.7 In her Supplementary Explanatory Memorandum of 21
November 2002, the Parliamentary Under-Secretary of State at the
Department of Health (Ms Hazel Blears) outlined the latest position
in the light of the further discussions in Brussels, and of the
consultations carried out within the UK, which had resulted in
the provision of an updated Regulatory Impact Assessment. In particular,
the latter suggested that, over a ten year period and at a discount
rate of 6%, the costs (arising from the removal of antibiotic
growth promoters, and the submission of dossiers related to silage
agents and generic additives) would amount to just under £600
million, whereas the discounted benefits (arising principally
from a reduction in antibiotic-resistant infections) could range
between £460 million and £921 million, depending on
the assumption made as to the proportion of existing costs which
might be saved as a result of the proposal.
5.8 The Minister said that, as a result, the Government
continued to support the main thrust of the proposal, but would
be pursuing changes to some of the elements in the proposal identified
in our earlier Report. These included the need for all non-feed
uses of additives, such as boluses, to be brought within the scope
of the Regulation; the introduction of a transitional period for
assessing silage agents, which would otherwise face a ban when
the measure comes into effect; and a more selective approach to
the re-evaluation of currently authorised additives, with perhaps
less rigorous procedures applied for additives used for species
which make a comparatively small contribution to the food supply
or in the case of pet food additives. The Assessment said that,
were these amendments to be made, the benefits of the proposal
would be unchanged, but the discounted costs over ten years would
be reduced from £600 million to £560 million.
5.9 The Minister also addressed our query about the relative
roles of the Commission and Member States in authorising additives
in future. She said that the main change proposed was that the
European Food Safety Authority would carry out an assessment of
dossiers for new additives, a function which was currently undertaken
primarily by Member States. However, the procedure for legal adoption
of authorisations would be unchanged, with the Commission having
to submit a draft authorising Regulation to Member State delegates
to the Standing Committee on the Food Chain and Animal Health
for their opinion.
Corrigendum of 28 November 2002
5.10 It had been our intention to consider this information
on 27 November, but, in the meantime, our Clerk received a telephone
call, indicating that the Government was reconsidering the information
it had provided on the possible benefits of the proposal. This
has been confirmed in a corrigendum to the Minister's Supplementary
Explanatory Memorandum, which says:
"There is still debate over the potential benefits resulting
from the banning of the four remaining antibiotic growth promoters.
The particular issue in question is the precise estimate of costs
associated with antibiotic resistance that would be saved. We
will examine this further and seek further views from consultees
before the RIA is finalised."
Conclusion
5.11 We have noted the developments since we last
reported on this proposal, but also that there are still a number
of uncertainties over the potential benefits resulting from the
proposal. Until these have been resolved, we are unable to clear
the document, and we assume that, notwithstanding the Minister's
statement that the Danish Presidency has indicated a wish to obtain
a Common Position by the end of the year, the Government will
reserve its position until it is clear whether, and to what extent,
the benefits of the proposal outweigh the likely costs.
19
OJ No. L.270, 14.12.70, p.1. Back
20
Slow release capsules. Back
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