FSA Interested Parties Letter (CPD 104), 27 November 2009
A copy of the letter including the Annex A mentioned below, is available on this site. See: FSA PARNUTS letter.
Since my last letter of 22 September [see 22 September 2009], the European Commission has held a further Working Group meeting on 23 November to continue discussions on the revision of Directive 2009/39/EC, the ‘Framework’ Directive on foodstuffs intended for particular nutritional uses (Parnuts).
The meeting focussed on an options paper from the Commission (attached at Annex A), outlining four policy options; Option A – changing the notification procedure to a prior-authorisation procedure; Option B – limiting dietetic foods to a positive list and removal of the notification procedure; Option C – revoking the Framework Directive, but maintaining some or all of the existing specific legislation e.g. Infant Formulae; and Option D – repeal of all Parnuts legislation, leaving MS to introduce national rules.
Member States who spoke declared that they do not have a position or preferred option at this stage and it was clear from the discussion that there is a lot of confusion over the scope and interpretation of the existing rules. However, all Member States welcome the review and are committed to improving legislation in this area, whilst ensuring vulnerable groups are adequately protected. The Commission hinted this is very much a simplification exercise aimed at removing duplication where the legislative affect is achieved by other legislation; therefore all existing legislation (infant formulae and follow-on formulae, weaning, medical foods, slimming foods and gluten-free foods) and other categories of foods (e.g. sports food, lactose-free etc.) will be closely looked at as to whether they are still needed, or whether such foodstuffs could be regulated through other legislation.
Due to the implementation of the Lisbon Treaty, publication of the Commission’s proposal and Impact Assessment has been delayed until summer 2010. As a result the Commission does not intend to arrange any further meetings until they publish their proposal.
We will be conducting a formal consultation once proposals are published, but in the meantime if we are to influence the Commission, we need to present evidence to inform their thinking. To do this we are developing an Impact Assessment and I would welcome your views on each of the proposed options and their possible impact – including estimated costs and benefits. For example, under Option A it would be helpful to know approximately how much additional cost there would be for businesses to compile and submit a dossier to EFSA if prior-authorisation was required. I would be grateful for comments by 15 January 2010. If you wish to discuss the options and possible impacts on your organisation, please do not hesitate to contact me.