FSA Consultation Letter, 11 March 2005

ADDITIVES - Draft Proposals for New EU Regulations on Food Additives and Enzymes

In the FSA letter of 18 September 2003 , the FSA sought views on two draft European Commission working documents for new Framework Regulations on food additives and food enzymes. In a subsequent letter of 12 May 2004 , they circulated a revised version (6th draft) of the working document on food additives.

The FSA are now writing to seek views on the latest drafts of each of these working documents, which were tabled at the Commission's Working Group on Food Additives meeting in Brussels at the end of February. The Commission has indicated that it does not consider that there will be further discussion on either of the proposals. It is committed to formally publishing both of these, together with one on flavourings, during the 4th quarter of 2005. The three proposals will form a package of "food improvement agents".

Given below is a short summary of the food additives and enzymes proposals prepared by the FSA. The text of the proposals has been circulated but is not provided electronically. The Commission is seeking comments from Member States on both documents by 31 March and the FSA would be grateful if these could be sent directly to the Commission.

Draft Proposal For A New European Parliament And Council Regulation On Food Additives Authorised For Use In Foodstuffs Intended For Human Consumption (Doc. WGA1004/03 rev.10)

The Commission's proposal is for a single EU Regulation intended to replace Directive 89/107/EEC (the food additives framework Directive), and eventually replace and repeal Directives 95/2/EC on food additives other than colours and sweeteners, Directive 94/35/EC on sweeteners for use in foodstuffs and Directive 94/36/EC on colours for use in foodstuffs. The key aims of the proposal are as follows

• To simplify food additives legislation by creating a single instrument for principles, procedures and authorisations
• To confer on the Commission and Member States powers to update the EU list of authorised food additives (this is currently carried out under co-decision procedure).
• To consult the European Food Safety Authority (EFSA) on the evaluation of the safety aspects of all currently authorised food additives. This will involve the setting up of an evaluation programme in order to define the need and the order of priorities for the risk assessment.
• To review the technological aspects of all current food additive authorisations, including potential uses of individual additives, technological justification and consumer benefits. This evaluation will be carried out by the Commission and Member States within the forum of the Standing Committee of the Food Chain and Animal Health.
• To establish procedures that will require the re-evaluation of authorised additives every 10 years to ensure that they are regularly re-evaluated according to the latest scientific and technical knowledge, and that additives that are no longer used are removed from the positive list.
• To require the authorisation of additives that consist of, contain, or are produced from a GMO under Regulation 1829/2003 on GM food and feed. Applications for GM derived additives which fall within the scope of Regulation 1829/2003 will require authorisation of the GM element under that Regulation prior to authorisation of the additive itself under the food additives regulation. Where an additive falls outside the scope of 1829/2003 then the GM element will be assessed as part of the overall approval process, and such measures are provided for within this proposal.
• To introduce controls over the use of all additives used in other additives (currently only certain additives are controlled in other additives and in flavourings).

Draft Proposal For A New European Parliament And Council Regulation On Enzymes Used Or Intended For Use In Foods (Doc. WGA1003/03 rev.8)

The Commission's proposal is for an EU Regulation to control uses of enzymes in foods. At present some enzymes used as additives are regulated under Directive 95/2/EC whereas controls on others that are used as processing aids are not harmonised across the EU and are subject to different measures in each Member States. This Proposal will harmonise the regulation of enzymes at Community level. The key aims of the proposal are as follows:

• To establish Community procedures for the risk assessment and authorisation of enzymes. Applications for authorisations will need to be submitted for each particular enzyme preparation and authorisations will include specifications (origin and purity criteria) and conditions of use in food. There will be an initial transitional period of 18 months during which time dossiers will need to be submitted for new and existing enzyme preparations.
• To introduce a positive list of authorised enzymes, including their specifications and conditions of permitted uses in foods.
• To establish procedures that will require the re-evaluation of authorised enzymes every 10 years to ensure that they are regularly re-evaluated according to the latest scientific and technical knowledge, and that enzymes that are no longer used can be removed from the positive list
• To establish Community procedures for labelling of food enzymes used in foods
• To require the authorisation of enzymes that consist of, contain or are produced from a GMO to be evaluated under the Regulation on GM food and feed prior to evaluation under the Regulation. As with the proposal on additives, applications for GM derived enzymes which fall within the scope of the GM food and feed regulation (1829/2003) will require authorisation of the GM element under that Regulation prior to authorisation of the enzyme itself under this regulation. Where an enzyme falls outside the scope of 1829/2003 (as is the case for fermentation products) then the GM element will be assessed as part of the overall approval process, and such measures are contained within this proposal.