Food Law News - EU - 1999
26 January 1999: ADDITIVES - Poposal Amending Directives on Purity Criteria
JFSSG Letter, 26 January 1999
Commission Proposal Amending Directives 95/31/EC, 95/45/EC and 96/77/EC on Purity Criteria Concerning Food Additives from Genetically Modified Organisms
Further to the JFSSG letter of 22 December 1998, this letter describes the outcome of the Commission Working Group discussion on the above subject in Brussels on 19 & 20 January 1999.
The Commission Working Group had a useful discussion in which the Commission accepted that its proposed approach needed to be revised in a fundamental way in order to make it clearer, realistic and workable (in terms of legal implementation and enforceability).
The Commission pointed out that they were looking for a horizontal and uniform approach to deal with food additives from sources which had not been evaluated by the SCF. The Commission recognised that its proposal was very much a first draft, which required amendment in order to overcome all the attendant practical difficulties. Nevertheless, most Member States thanked the Commission for progressing work in this important area and were pleased with the shift of focus away from the recitals into the main articles of the legislation.
The Commission confirmed that the SCF was already completely overloaded with work on the additives front, and it was currently reviewing its working procedures. One idea currently being considered was the setting up of a task force or working group specifically to consider food additive specifications.
Some Member States wanted the scope of the Commission's proposal restricted to GM additives, but most (including the UK) favoured a more general approach. The UK provided a paper listing the UKís main concerns (and shown below). Several Member States supported the UK views, in whole or in part.
It was agreed that the Commission should invite representatives of the SCF secretariat to the next discussion on this subject (possibly in April) so that they could indicate what evaluation work the SCF was realistically able to do in the short and medium-term. It was generally agreed that the SCF needed to simplify its procedures; the key point was clear and pertinent questions needed to be put to the SCF to avoid unnecessary consideration and lengthy delays.
The Commission's stated aim was to have clear rules not only for national governments, but also for manufacturers and enforcement authorities. To this end, they intend to draft some Commission guidelines to accompany the proposal, which would set out the respective roles of the Commission, the SCF, national authorities and others. Member States have been asked to send in any drafting suggestions for incorporation into the Commission's proposal.
Comments or suggestions are invited and requested by 31 March.
UK Comments on the Commissionís Proposals
- Agree completely with the principle that GM additives should be brought into line with other GM ingredients by requiring pre-market approval.
- Welcome Commission's action in drafting a proposal so that detailed discussion can take place.
- Also, very much agree that additives must be properly evaluated. However, the approach we finally adopt must be realistic, workable and legally enforceable. It should also avoid unnecessary duplication of evaluation work.
- However, current proposal does not seem to us to meet the requirements. Furthermore, it is unenforceable and does not take account of additives from novel (GM) sources that may already be on the market.
- Legislation should not be specific about evaluation route. This would remove any degree of flexibility in the procedures and is not done elsewhere in additives legislation.
- Some additives are, or are derived from, novel foods/ingredients which are themselves subject to pre- market evaluation under Regulation 258/97. Insofar as these additives require evaluation, this should be in parallel with the evaluation of the source material and not a separate evaluation by the SCF.
- Need to avoid creating an inconsistency in policy and in evaluation procedures between GM additives and GM derived ingredients and foods.
- We also need to avoid overloading the SCF with work with which it will be unable to cope. The re-evaluation procedure envisaged could entail a massive exercise and seems disproportionate to the matter being addressed.
- With regard to the general requirement that any significant changes in relation to the source of method of production would trigger a re-evaluation of the additive by the SCF, it is doubtful whether this would be practicable. In many cases the original evaluations by the SCF were carried out several years ago on bases which are neither well documented nor readily available. It is likely to be difficult to determine whether present production practices are in line with those providing the bases for the original evaluations and, in all possibility, impossible to determine whether current production practices represent "significant" changes. We would find it very difficult to implement into UK law.
- A simplified procedure should be available for additives produced from modified source materials, or by modified production processes, when the additives thus produced are "substantially equivalent" to those already approved by the SCF and comply fully with the specifications laid down for them in EU law.
- However, agree that it would be desirable to implement a solution relatively quickly by a suitable amendment to the 3 Commission Directives on purity criteria.
- Proposal as drafted would not achieve the required objective for GM products, since it does not prohibit the use of products which have not yet been evaluated. It would not even prohibit those which "failed" the safety evaluation envisaged.
- Any legislation will have to take account of products which may already be on the market, allowing for some sort of transition period while these are evaluated and approved.
Relationship with Novel Foods Legislation
- The proposal assumes that a starting material derived from a genetically modified organism will in all cases be a significantly different source. An automatic requirement for an evaluation by the SCF ignores the concept of "substantial equivalence" enshrined in Regulation 258/97, to which no reference is made in this proposal. Articles 3(4) and (5) of the Novel Foods Regulation do not presume a review of their safety by the SCF.
- Advocate consideration at national (Member State) level as part of novel foods assessment, where there is a food/ingredient parallel.
- References to "additives from GM sources" etc. should follow the same wording as used in the novel foods regulation - although this may not be completely precise, it will allow a consistent interpretation across the different legislation.
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