Your Explanatory Memorandum on the above Proposal was considered by Sub-Committee D at its meeting of 27 June 2007.

  We agree that the Proposal to apply without further examination Codex Alimentarius standards (where the EU has supported them) is a sensible one.

  In principle, greater extrapolation is also a welcome contribution to simplification of the existing rules. Its success, however, is predicated on clarity and we would therefore be grateful for your view on whether Article 5 might be re-drafted in a clearer fashion.

  We have serious concerns about the introduction of "reference points for action" for banned substances. Both you and the Commission emphasise that a problem exists but it would be useful if you could articulate for us the scale of the problem. We consider that, if such reference points are necessary, it is absolutely vital that they are fully justified and that they are set at the right level.

  In the light of the above we shall hold the Proposal under scrutiny and we look forward to your initial Regulatory Impact Assessment in due course.

27 June 2007

  Thank you for your letter of 27 June following your Committee's consideration of the Explanatory Memorandum submitted by Ben Bradshaw.

  I am grateful to the Committee for its support for adopting Codex Alimentarius standards where the EU supports the science. I also note that the Committee supports greater use of extrapolation in principle, but seeks Defra's views on whether Article 5 might be re-drafted in a clearer fashion.

  This was one of the aspects of the proposal discussed at the first Council Working Group of officials last month. Several Member States signalled their support for the adoption of Codex MRLs and greater use of extrapolation, where robust scientific data exists, to increase the availability of authorised veterinary medicinal products (VMPs) without compromising consumer protection. It was noted that guidelines produced by the Committee on Veterinary Medicinal Products (CVMP), which advises the European Commission on the setting of MRLs, were available and in use, but this had not resulted in any extra products being authorised through the extrapolation process. It remains to be seen whether there is scope to relax the system to make more products available without reducing the integrity of the process.

  I agree that Article 5 could be re-drafted in a clearer fashion to establish the scope of the process and ensure that guidelines for the process are adhered to rigorously. This has been suggested to the Portuguese Presidency, and the UK is prepared to offer assistance in this area if it is requested.

  I note the Committee's serious concerns about the introduction of "reference points for action" (RPAs). Unfortunately, the Council Working Group meeting did not move this area any further forward except in giving several Member States the opportunity to express their concern at the current situation. The Government agrees with your Committee that, if such reference points are necessary, they should be fully justified and set at the right level.

  The Government is encouraged by the suggestion in Article 18 that the Commission may forward a request to the European Food Safety Authority (EFSA) for a risk assessment as to whether the RPAs are adequate to protect human health. The Government feels that this would offer the assurances sought by the Select Committee, provided the opinion of EFSA is sought before an RPA formally comes into force. (The Food Standards Agency in particular has suggested interim RPAs may be needed in the meantime to assist enforcement procedures.) However, it appeared from the Commission's comments at the Council Working Group meeting that this provision in the proposal has not yet been discussed with EFSA officials.

  In this, and other areas of the proposal, the Commission has put its thoughts together without, it would appear, too much digging to see what will work. It has, probably correctly, preferred to collect the views of Member States first to see what is acceptable, rather than approach bodies such as EFSA to discuss arrangements, which might be seen by Member States as a fait accompli.

  This approach, together with the relative lack of detail on adopting Codex MRLs and greater use of extrapolation, makes it extremely difficult to compile a meaningful Impact Assessment. Officials have submitted a number of comments to the Council Secretariat and Portuguese Presidency for consideration prior to the next Council Working Group, including those on Article 5 and the role of EFSA in assessing RPAs. The UK objective for that meeting is to clarify key issues to the extent that stakeholders can be consulted with more certainty about how the aim of the proposals will be achieved. As the proposal stands at present, it is in danger of causing elements of confusion and misunderstanding, which must be avoided. This information will then be used to complete the Impact Assessment which will be submitted with a Supplementary Explanatory Memorandum after summer Recess.

26 July 2007

  I wrote to you on 26 July in response to your letter of 27 June following your Committee's consideration of the Explanatory Memorandum submitted by Ben Bradshaw.

  In my letter I explained that the first Council Working Group attended by officials in June did little to clarify key issues in the proposal. The UK objective for the second meeting, therefore, was to achieve clarification to the extent that stakeholders could be consulted with more certainty about how the proposal would affect them, and not run the risk of causing confusion and misunderstanding. The intention, in keeping with common practice, was to use their information to complete the Impact Assessment (IA) and submit it to Parliament with a Supplementary Explanatory Memorandum after summer Recess.

  Unfortunately the second meeting also did little to clarify matters. However, mindful of our commitment, officials carried out an initial consultation over four weeks to seek views from over 630 interested organisations. In spite of a request to supply information where possible to help produce an informed IA none of the 12 responses addressed this issue.

  In that respect I am sorry to say that we are no further forward. There were two further meetings of the Council Working Group in the second half of September, but progress on this dossier was further slowed by the Portuguese Presidency deciding to include discussions on another proposal (10585/07). Whilst the outcome of this was satisfactory for the UK it has impeded progress on this issue.

  There were signs at the last meeting that serious attempts will be made in the first half of October to clarify key issues before the next meetings on 19 and 31 October. I would hope that officials will then be in a position to carry out a full 12 week consultation with a redrafted text and clearer information on the implications for stakeholders.

  Your comments about the clarity of Article 5, with which I agreed in July, have been raised again by officials. They are also seeking more information about the process for setting Reference Points for Action which was of great concern to your Committee.

8 October 2007