4 Veterinary medicinal products: maximum
residue levels
| (28570)
8653/07
+ ADDs 1-2
COM(07) 194
| Draft Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90
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| Legal base | Article 37 and 152(4)(b) EC; co-decision; QMV
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| Document originated | 17 April 2007
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| Deposited in Parliament | 24 April 2007
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | EM of 21 May 2007
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information awaited
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Background
4.1 Council Regulation (EEC) No 2377/90[9]
provides that a pharmacologically active substance may be used
in veterinary medicinal products administered to food-producing
animals only if an evaluation shows that it meets the requirements
needed to safeguard human health, and it also establishes a Community
procedure for establishing maximum residue limits (MRLs) for such
substances in foodstuffs of animal origin. In practice, the Regulation
divides these substances into four categories — those for
which an MRL has been agreed; those which pose no threat to human
health, and for which no MRL is considered necessary; those for
which a provisional MRL has been agreed for a specified period,
pending further information; and those which may not be administered
to food animals, and for which no MRL can be set.
4.2 Because of concerns that the procedures set out in the legislation
had led to a reduction in the availability of medicines for use
in food-producing animals within the Community, and hence to adverse
effects for public and animal health and animal welfare, the Commission
launched in 2004 a wide-ranging consultation exercise on possible
changes. The results of that exercise are now reflected in the
proposals in this document.
The current document
4.3 The Commission says that, in addition to the decline in the
number of veterinary medicines, the consultation had identified
that the current legislation is difficult to understand, and had
highlighted a number of other issues which needed to be addressed.
It has therefore proposed that Regulation 2377/90 should be repealed,
and replaced by a new Regulation, incorporating various changes
to the current procedures.
4.4 Two of these relate to the need to tackle the recent reduction
in the availability of medicines for food-producing animals. The
first concerns the maximum residue levels set internationally
under Codex Alimentaruis, which — even in cases where
those levels have been supported by the Community — cannot
at present be adopted in its own legislation without an assessment
being carried out by the European Medicines Agency. The Commission
has proposed that such levels should in future be accepted without
a further risk assessment. (It is also hoped that Codex will reciprocate
by accepting Community maximum residue levels in a similar fashion.)
Secondly, it proposes that, where maximum residue levels have
been set for specific circumstances (for example, the use of an
antibiotic in poultry), consideration should be given to their
extrapolation to other species and/or foodstuffs, where an authorised
product is not available, and subject to the necessary risk assessments
being carried out.
4.5 The third change addresses concerns which have arisen in recent
years over the presence in imports from third countries of substances
which are not permitted for use within the Community. Since no
MRL can be set for these, the Commission subsequently adopted
Decisions[10] which established
minimum required performance levels (MPRLs), based on the analytical
levels which it was felt laboratories in all Member States would
be able to detect, as a means of determining the action to be
taken in such cases and of ensuring a measure of effective and
harmonised control. Thus, where analytical tests show residues
at or above the MRPL, a consignment must be destroyed or re-despatched
outside the Community: however, where the results are below the
MRPL, the products may enter the food chain, subject to their
being monitored by the Member State concerned for any evidence
of a recurrent problem (in which case, the Commission has to be
informed). Though the Commission's intentions are far from clear,
it appears to be proposing that there should be a new procedure
under which it would assess and establish reference points for
action in relation to those substances whose use is not permitted
within the Community.
The Government's view
4.6 In his Explanatory Memorandum of 21 May 2007, the Minister
for Local Environment, Marine and Animal Welfare at the Department
for Environment, Food and Rural Affairs (Mr Ben Bradshaw) says
that effective controls need to be in place to ensure that the
health and welfare of animals are protected, and that any residues
of veterinary medicinal products are at concentrations which present
no risk to the consumer. He adds that Council Regulation 2377/90
provides these controls, and that the UK also maintains a full
monitoring programme of foodstuffs of animal origin in accordance
with the associated Community legislation in order to check that
residues of authorised veterinary medicinal products do not exceed
MRLs, and that banned substances are not being used.
4.7 As regards the changes now proposed, the Minister says that
the current tried and tested procedures are not effected, and
that the UK can support those relating to the Codex and
to the extrapolation of authorisations given for specific combinations,
provided the scientific basis is sound and consumer protection
is not compromised. However, he suggests that those aspects relating
to imports from third countries will prove to be controversial,
and that, whilst there is no doubt that a practical solution is
needed, this needs to be scientifically sound, to protect consumers,
to include measures to ensure consistency between Member States,
and to avoid discriminating between Community producers. He adds
that a Regulatory Impact Assessment will be prepared and submitted
in the middle of July 2007.
Conclusion
4.8 Although many of the changes proposed here appear to be
relatively straight-forward, we are far from clear what changes
the Commission has in mind regarding the presence of banned substances
in imported produce, still less the thinking behind its proposal.
Nor are we are greatly enlightened by what the Minister has said
on this point in his Explanatory Memorandum. We would be grateful,
therefore, if he could shed further light on this when he submits
the promised Regulatory Impact Assessment. In the meantime, we
are holding the document under scrutiny.
9 OJ No. L 224, 18.8.90, p.1. Back
10
2002/651/EC (OJ No. L 221, 17.8.02, p.8.) and 2005/34/EC (OJ No.
L 16, 20.1.05, p.61.). Back
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