Draft Commission Regulation foods suitable for people intolerant to gluten (England)

The key proposals are set out in the following documents: a draft Commission Regulation concerning the composition and labelling of gluten-free foods and a draft Impact Assessment.

Background

The proposed Commission Regulation will put in place compositional criteria related to the claims ‘gluten-free’ and ‘very low gluten’ for foods that have been manufactured specifically to satisfy the particular nutritional requirements of people who are intolerant to gluten, as provided for in Commission Directive 89/398/EEC (as amended) on foods for particular nutritional uses.

In addition, the proposed Regulation will also introduce a provision to allow foods that are naturally free of gluten (i.e. those for normal consumption) to be labelled as ‘gluten free’ as long as the foods meet certain compositional requirements in relation to the levels of gluten.

This Regulation should ensure that all foods that are labelled to indicate their suitability for people intolerant to gluten will use harmonised labelling terms, thereby reducing consumer confusion about these products. In addition, this new regime will facilitate better consumer understanding about how much gluten there is in the foods that they buy and, thereby, help to improve the health of these consumers. This Regulation will also align the EC legislation with the recently agreed Codex international standard for foods targeted at people intolerant to gluten, thereby facilitating international trade.

Once in force, the Regulation will apply in all EU Member States. Provision as to execution and enforcement will be made in national Regulations for England, Scotland, Wales and Northern Ireland.

Draft Impact Assessment

The draft impact assessment (IA) provided in Annex F of this consultation, considers the impact of the regulation (in terms of cost, benefits and risks) on consumers, businesses, the public sector, charities and the voluntary sector.

The IA provided in Annex F of this consultation aims to quantify the impact of:

• Maintaining the status quo (i.e. opposing the proposal);
• Adopting the proposal as drafted (Annex A)
• negotiating for amendment of the proposal (Annex A) to take account of issues raised by stakeholders

The Agency would welcome comments and evidence from stakeholders in those areas highlighted throughout the IA. In summary, the Agency would welcome comments from stakeholders regarding:

• their preferred option regarding the proposed options
• the policy and administrative compliance costs that are over and above what a business would do commercially
• the appropriate transition periods for sell-through of products with current packaging
• the potential cost of reformulation of existing products on the market currently claiming to be ‘gluten free’ or ‘verylow gluten’
• the potential cost of loss of products and numbers of products that may be discontinued
• potential costs of any new testing regime that will be put in place as a result of the new Regulation
• if there are any further changes that should be made to the EU proposal
• the impact on enforcement authorities of the new Regulation
• the economic, social and environmental costs and benefits associated with maintaining the status quo and adopting the Regulation so that a sustainability assessment can be completed
• any other aspect of the Regulation, the proposed options or the draft IA not addressed above.

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. Responses will be open to public access upon request. The FSA will also publish a summary of responses, which may include personal data, such as your full name and contact address details. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Data protection form (Word)

Data protection form (pdf)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact Judith Taylor, the FSA Consultation Co-ordinator, on 020 7276 8633.
Email: judith.taylor@foodstandards.gsi.gov.uk