Documents considered by the Committee on 28 January 2009 - European Scrutiny Committee Contents


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

Legal baseArticle 37 and 152(4)(b) EC; co-decision; QMV
DepartmentEnvironment, Food and Rural Affairs
Basis of considerationMinister's letter of 18 January 2009
Previous Committee ReportHC 41-xxv (2006-07), chapter 4 (13 June 2007) and HC 19-ii (2008-09), chapter 2 (17 December 2008).
Discussed in Council17-18 December 2008
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information awaited

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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