FSA Interested Parties Letter (CPD/027, 104, 118), 18 September 2008
EC Directive on Gluten-free foods
The Commission explained the changes that had been made to the draft Regulation (see link below). The main changes are as follows:
Definition of ‘pure oats': Following discussions within the Commission, this definition has been deleted from the Regulation and ‘oats' are now included in the list of gluten containing cereals. However, a new description has been added in Article 3(3) to cover the types of oats that may be included in foods labelled ‘gluten free' or ‘very low gluten'.
In addition, the Commission confirmed that products labelled as ‘gluten free' or ‘very low gluten' in accordance with this regulation can also be labelled as ‘suitable for coeliacs'.
The following provisions are relevant to foods for particular nutritional uses specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten
Revision of Article 3(2): The text of this paragraph has been revised to require such foods with a gluten content below 100mg//kg, and containing ingredients specially processed to reduce the gluten content, to be labelled as ‘very low gluten'. However, they may be labelled as ‘gluten free' if the level of gluten in the food as sold to the consumer is below 20mg/kg. This should ensure better consistency in labelling of products and therefore reduce consumer confusion.
Article 4, paragraph 2: This new provision covers such foods which include substitute ingredients together with specially processed ingredients.
For a copy of the draft text, see: Draft COMMISSION REGULATION concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten
The revised draft of the Regulation will be subject to a vote at the meeting of the Standing Committee on 13th October. The Agency would welcome comments from all stakeholders by 30th September as part of the ongoing formal consultation on this legislation.
Commission Regulation (EC) 1609/2006 authorising placing on the market of infant formula based on hydrolysates of whey protein derived from cows' milk protein for a two-year period.
The Commission explained that this Regulation had been adopted in October 2006 under the provisions of Article 4(1)(a) of Council Directive 89/398/EEC to allow infant formula based on hydrolysates of whey protein derived from cows' milk protein to be placed on the market in the EU. Specifications for the protein source, processing and quality are set out in the Annex. In particular a cross reference is made to Annex V of Commission Directive 91/321/EEC. However, whilst Annex VI of Commission Directive 2006/141/EC on infant formula and follow on formula incorporates the authorisation provisions set out in Commission Regulation 1609/2006 on a permanent basis, the cross reference to Annex V of Directive 91/321/EC has not been transposed into the revised Directive.
Therefore, to rectify this situation, the Commission has drafted a technical amendment of Directive 2006/141/EC. This is achieved by:
A copy of the the proposal is available on this site. See: Preliminary Draft COMMISSION REGULATION amending Directive 2006/141/EC
The draft amending Regulation will be subject to a vote at the meeting of the Standing Committee on 13th October. The Agency would welcome comments from all stakeholders by 3rd October 2008.
Commission Proposal for amendments to Directive 89/398/EEC.
The Commission updated Member States stating that work on an impact assessment on the scope and functioning of Council Directive 89/398/EEC on foodstuffs for particular nutritional uses would begin shortly. This impact assessment will inform amendments that may be made to this Directive and as part of the impact assessment stakeholders will be asked to provide information.