Draft Statutory Instrument: The Foodstuffs Suitable for People Intolerant to Gluten (England) Regulations 2009

Who will this consultation be of most interest to?
Manufacturers, caterers and retailers of foods suitable for people intolerant to gluten; enforcement authorities; and consumers intolerant to gluten (coeliacs).

What is the subject of this consultation?
Draft national regulations relating to England, providing execution and enforcement provisions for Commission Regulation (EC) No. 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. This is a consumer protection measure. The EC Regulation puts in place compositional criteria based on internationally accepted safe levels related to the claims 'gluten-free' and 'very low gluten' for foods that have been specifically manufactured to satisfy the particular nutritional requirements of people who are intolerant to gluten, as provided for by Council Directive 2009/39/EC on foods for particular nutritional uses (also known as 'Parnuts'). The Regulation also allows ‘normal foods’ and other Parnuts foods that meet the compositional requirements of the Regulation to be labelled as 'gluten-free'.

What is the purpose of this consultation?
To seek comments on the draft Statutory Instrument 'The Foodstuffs Suitable for People Intolerant to Gluten (England) Regulations 2009' (Annexe C), and accompanying guidance notes (Annexe D) and Impact Assessment (Annexe E). Parallel regulations are also being produced in Scotland, Wales and Northern Ireland and consultations on these will be run concurrently.

On the 21 January 2009, the European Commission published a new Regulation concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (Regulation (EC) No. 41/2009 – see link below). The Regulation puts in place compositional criteria related to the claims ‘gluten-free’ (must not exceed 20mg/kg of gluten) and 'very low gluten' (must not exceed 100mg/kg of gluten) for foods that have been specifically manufactured to satisfy the particular nutritional requirements of people who are intolerant to gluten (this group of people are known as coeliacs) as provided for by Council Directive 2009/39/EC (the 'Parnuts framework Directive' on foods for particular nutritional uses ). The Regulation also allows normal foods and other Parnut foods (that are not specially prepared for people intolerant to gluten) but that meet the compositional requirements of the Regulation to be labelled as 'gluten-free'.

The Regulation ensures 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.

Draft Statutory Instrument: The Foodstuffs Suitable for People Intolerant to Gluten (England) Regulations 2009 (see Annexe C).

The Agency conducted a public consultation on EC Regulation (41/2009), in July 2008. The results of this consultation have been published on our website (see link below). Following the publication of the Regulation, the Agency is now seeking comments on the draft Statutory Instrument (SI).

The key points of the draft SI are to:

• Provide execution and enforcement provisions in England (Regulation (EC) No. 41/2009 is directly applicable, but an SI is required to enforce this legislation in UK law).
• Take advantage of a derogation in the Parnuts framework Directive to extend the scope of the Regulation (EC) No. 41/2009 to non pre-packed food – thus allowing the sale of products specifically formulated for people intolerant to gluten in non pre-packed form (for example, muffins made from rice flour, other gluten free flour or gluten reduced flour sold in catering establishments), provided they meet the criteria related to the claims 'gluten-free' and 'very low gluten'.

FSA guidance on the composition and labelling of foodstuffs suitable for people intolerant to gluten (see Annexe D).

In order to help food businesses and enforcement authorities understand the new rules, the Agency has drafted accompanying guidance notes. These aim to provide:

• informal, non-binding advice on Commission Regulation (EC) No. 41/2009
• best practice advice
• references to guidance on the notification of gluten-free products
• advice on the provision of supplementary information to indicate suitability of foods forpeople intolerant to gluten
• advice on testing methods to determine the level of gluten in food

There are four options considered in the Impact Assessment:

• Option 1: do not adopt the proposal.
• Option 2: adoption of the proposal as drafted providing execution and enforcement provisions for Commission Regulation (EC) 41/2009.
• Option 3: negotiate for amendment of the proposal to take account of issues raised by stakeholders.
• Option 4: adoption of the proposal as drafted providing execution and enforcement provisions for Commission Regulation (EC) 41/2009 and extend the scope to non pre-packed food including catering.

Following the previous consultation, the Agency took forward option 3 as it would have given most consumer benefit while being proportionate to industry as explained in section 4. However, other Member States did not support these changes and the Agency is now forced to take forward option 2. or option 4.

Option 4 is preferred, as it will 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, and avoid breaching EC rules, which would lead to possible infraction proceedings against the UK. This option also has additional benefits (over option 2), in that it will deliver increased dietary choices for coeliacs and allow the continued sale of gluten-free Parnuts sold non pre-packed food – including those sold from catering establishments.

This consultation represents the final phase of consultation on the draft SI, which will provide execution and enforcement provisions in England.

All responses received as part of this consultation will be given careful consideration. These will be summarised and published on the Agency’s website in due course.

Questions asked in this consultation:

• Stakeholders are asked to provide comment on any aspects of the consultation documents. However, in each document we have highlighted a number of specific questions.
• To aid stakeholders a list of all questions on the draft SI, guidance and Impact Assessment are provided at Annexe F.

We welcome comments from all stakeholders. Please send your response by email or post using the contact details above.

• Directive 2009/39/EC of the Parliament and Council on foodstuffs intended for particular nutritional uses
• Commission Regulation (EC) No. 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten

Please see the links provided below.

Responses are required by close Monday 25 January 2010. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).

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 the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk