3 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 for 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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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | Minister's letter of 18 January 2009
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| Previous Committee Report | HC 41-xxv (2006-07), chapter 4 (13 June 2007) and HC 19-ii (2008-09), chapter 2 (17 December 2008).
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| Discussed in Council | 17-18 December 2008
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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
3.1 Council Regulation (EEC) No 2377/90[16]
provides that a pharmacologically active substance may be used
in veterinary medicinal products administered to food-producing
animals only if it safeguards human health, and it also establishes
a Community procedure for establishing maximum residue limits
(MRLs) for such substances in foodstuffs of animal origin. However,
because of concerns that the procedures in the legislation had
led to a reduction in the availability of such medicines within
the Community, the Commission put forward this proposal in April
2007, repealing Regulation 2377/90, and replacing it by a new
Regulation, incorporating various changes to the current procedures.
3.2 Two of these related to problems over the availability
of veterinary medicines, whilst the third addressed concerns which
had arisen over the presence in imports from third countries of
substances which are not permitted for use within the Community
(and for which no MRL can be set). The Commission had therefore
subsequently adopted Decisions[17]
which established so-called minimum required performance levels
(MRPLs), based on the analytical levels which it was felt laboratories
in all Member States would be able to detect: and, although its
current intentions were far from clear, it appeared to be proposing
that so-called reference points for action (RPAs) should be established
in relation to those substances whose use is not permitted within
the Community, and which would perform the same function as MRPLs
do at present.
3.3 As we noted in our Report of 13 June 2007, the
Government was able to support the other changes proposed, but
felt that those relating to imports from third countries would
be controversial. It also said that an Impact Assessment would
be prepared and submitted in the middle of July 2007. We observed
that we were far from clear as to what the Commission had in mind
regarding imports, and we therefore asked for further light to
be shed on this in the promised Assessment.
3.4 We subsequently received a letter of 26 July
2007 from the then Minister (Lord Rooker) saying that various
uncertainties had hindered the preparation of the Assessment,
but that he hoped sufficient progress would be made to enable
one to be submitted shortly. In the event, we next received from
the current Minister of State (Farming and the Environment) at
the Department for Environment, Food and Rural Affairs (Jane Kennedy)
a Supplementary Explanatory Memorandum of 8 December 2008.
3.5 On the question of imports, this pointed out
that those of meat and meat products into the UK did not show
any significant problems, the major issues in recent years having
been the presence of banned substances in farmed fish, farmed
crustaceans, and honey; that this situation would be exacerbated
if the Commission were (as proposed) to set analytical limits
(RPAs) for prohibited substances based on the lowest residue concentration
which can be quantified with an analytical method validated according
to Community requirements; and that the UK and several other Member
States were therefore keen that these methods should be capable
of being routinely achieved in Member State laboratories handling
large numbers of samples. It also addressed two additions to the
proposal which had been made following its consideration by the
European Parliament, one relating to the availability of veterinary
medicines under the so-called "cascade system", and
the other to biocides.
3.6 This Supplementary Explanatory Memorandum was
accompanied by a letter from the Minister, in which she said that,
there having been little progress in Brussels, the French Presidency
had moved the proposal forward at pace. As a result, a text acceptable
to all Member States had been agreed with the European Parliament
and Commission, and was to be presented to the Council for adoption
on 17-18 December 2008, and then to the Parliament's plenary session,
probably early in the New Year. She added that the Government
would carry out a consultation shortly on the latest text, and
that it hoped to elicit enough information to enable a full and
informed Impact Assessment to be produced.
3.7 In our Report of 17 December 2008, we commented
that, as it was over a year since we had last heard from the Government,
it was unacceptable that the Minister should now have written
little more than a week before the Council at which the proposal
was to be adopted, particularly as it contained two new elements.
We added that, although the Government's hope that it could produce
a full and informed Impact Assessment was welcome so far as it
went, we considered this should have been done before agreement
was reached in the Council. Finally, we said that we would welcome
clarification on two points arising on the new arrangements for
imports — it was not evident whether the proposed RPAs differed
in substance from the existing MRPLs, or whether they simply represented
a change in terminology, and nor was it clear how they would be
established.
Minister's letter of 19 January 2009
3.8 We have now received from the Minister a letter
of 19 January 2009, which seeks to address these points in turn.
The short notice given before the Council
"I fully understand your concerns at having
such a short timescale between receiving my letter, which was
sent later than hoped, and the Council meeting. The UK is recorded
as abstaining from the vote, in view of the fact that both Scrutiny
Committees hold the proposal under scrutiny. All other Member
States are recorded as voting in favour. I also recognise your
concern that it was over a year between Jeff Rooker's last letter
and mine. As indicated in the SEM, this proposal has progressed
in a very unsatisfactory and uncertain manner, and there was no
substantive progress to report for much of the year. However,
I acknowledge that a letter updating your Committee and your Lords
counterparts, even if only to report that key aspects of the proposal
remained confused, could have been sent prior to the summer Recess."
The need for an Impact Assessment before
agreement was reached in the Council.
"Carrying out a further consultation at an earlier
stage is something which officials at the Veterinary Medicines
Directorate kept under review. However, the earlier consultation
had not yielded any information which could feed into an Impact
Assessment, and as the situation on the issues included in that
consultation were unchanged, with the Commission not making the
situation on Reference Points for Action in particular any clearer,
there was little point in repeating the process.
The two late additions to the proposal
"On the other two issues, I explained that the
pressure from the European Parliament on increasing the availability
of veterinary medicinal products came towards the end of the first
reading. Their amendments seek some fairly fundamental changes
to the system — particularly in the revision of withdrawal
periods for medicines used under the cascade system. The UK expressed
surprise that the Commission had accepted these amendments without
any consultation, and sought a statement for the Council minutes
that the EU would not act with undue haste on this matter. This
was achieved. The outcome is that the Commission has promised
to present in 2010 an assessment of the problems in the application
of the Veterinary Medicinal Products Directive, with a view to
making legal proposals where appropriate.
"On the second issue — establishing procedures
for setting Maximum Residue Limits for pharmacologically active
substances in biocides — this was included in the original
proposal as a single line in a recital, with no indication of
the Commission's thinking emerging for several months. This is
why it was excluded from the original consultation. In fact the
position remained unresolved for a long time owing to the reluctance
of the Commission to give more detailed information. As explained
in the SEM, there was disagreement between the Commission, which
wanted supplementary work in establishing MRLs carried out by
Member States without fees, and the position of several MS, which
wanted to ensure that this unknown quantity of work would be resourced.
A solution which the UK believes will work was agreed late in
the process, but there was little point in carrying out a consultation
before then inviting stakeholders to comment on a situation where
there was no clarity on the way forward.
"I agree that the ideal situation is for a full
and informed Impact Assessment to be produced before the vote
in Council, and Defra works hard to achieve this where it can.
However, in this instance, with the French Presidency seeking
a speedy resolution to the problem areas and other Member States
dropping their concerns, there was inadequate time to carry out
an appropriate consultation before the vote."
Whether reference points for action differ in
substance from minimum required performance levels, and how they
will be established
"The UK's understanding is that the existing
Minimum Required Performance Limits (MRPLs) will become Reference
Points for Action (RPAs) — it is simply a change in terminology.
However, in spite of several enquiries, it is not clear to us
when or how the Commission Decisions establishing the MRPLs will
be revoked, to enable them to become RPAs.
"MRPLs were established on the analytical limits
which the relevant Community Reference Laboratories felt Member
States laboratories could achieve. The UK would prefer a scientific
basis to these limits, not least to give an indication of the
lowest concentration the analytical methods need to achieve to
safeguard public health. It is costly to revalidate analytical
methods to new standards — costs which Member States are
required to recover from their industries as part of the wide-ranging
residues surveillance programme."
Conclusion
3.9 We note the Minister's acknowledgement that
she should have written sooner to alert us to the situation prior
to the meeting of the Council in December 2008, and that she also
accepts that a full and informed Impact Assessment should be produced
before a vote in the Council. We are however concerned at the
extent to which the lack of clarity over the Commission's intentions,
and its inadequate consultation, on a number of aspects of the
proposal prevented such an Assessment being provided in this instance.
Likewise, we are concerned that the Presidency should have forced
a vote on a proposal which had been so inadequately prepared,
and moreover that every other Member State should have voted in
favour of this.
3.10 Such an approach is hardly designed to instil
confidence in the way in which the Council works (or, for that
matter, in the statement which the Government secured in the Council
minutes on the cascade system). Moreover, whilst we recognise
that, with qualified majority voting applying to this proposal,
there is ultimately little which the UK could have done to prevent
such an outcome, we are struck by the gap between the Community's
alleged commitment to better law-making and the way in which this
was applied in practice on this proposal. We therefore regret
that, when the issue was put to the vote, the UK chose simply
to abstain, rather than to vote against.
3.11 We are therefore drawing these latest developments
to the attention of the House, but, as we assume that the consultation
now being carried out by the Government is still intended to produce
an Impact Assessment, we are continuing to hold the document under
scrutiny, pending receipt of this.
16 OJ No. L 224, 18.8.90, p.1. Back
17
2002/657/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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