Nutrition and health claims made on foods (Scotland)

The Agency seeks views and comments on draft guidance for food business operators on European Regulation 1924/2006 on nutrition and health claims made on foods. It also seeks comments on a draft Scottish Statutory Instrument, which put in place enforcement provisions, and the accompanying Regulatory Impact Assessment.

Regulation1924/2006
Regulation1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods was re-published in its corrected form on 18 January 2007 (OJ No. L12, 18.1.2007, p.3) and will apply from 1 July 2007. This is the first piece of specific legislation to deal with nutrition and health claims and aims to provide a higher level of consumer protection as well as harmonise legislation across the EU to facilitate intra-Community trade. A copy of this regulation can be found at the EU website.

The regulation will control nutrition and health claims by means of positive lists of authorised claims that can be made on food together with the criteria a product must meet to use them. The annex of the regulation contains the list of permitted nutrition claims and the regulation puts in place processes for the compilation of the list of authorised health claims. It also requires the European Commission to establish nutrient profiles as criteria that foods must meet to make claims.

EU regulations are directly applicable in Member States and this regulation will apply from 1 July 2007. The Agency is now putting in place enforcement provisions and invites your views on the following documents:

• draft Agency guidance to compliance with European Regulation 1924/2006 on nutrition and health claims made on foods.
• draft Scottish Statutory Instrument with enforcement provisions
• draft Regulatory Impact Assessment

Agency guidance
The guidance aims to help food business operators who wish to make claims identify what they must do to comply with the regulation; it also explains how new claims will be authorised. It should give you a clear interpretation of the regulation – what it controls, how nutrition claims and health claims are defined, and what businesses must do to make claims on foods in future. We would be grateful for comments on any aspect of the guidance, but have included some structured questions below, which may help to focus your thoughts:

• Is there anything in the regulation that this guidance does not address? Contributions to the text will be considered for the final guidance.
• In preparing this guidance we have had to interpret certain provisions of the regulation. Are the explanations and interpretations clear, unambiguous and easy to understand? Particular points that the Agency would like feedback on are highlighted in the guidance. Suggested alternatives, including relevant examples, will be considered.
• We are particularly concerned that in making an interpretation, and in the absence of case law, we do not go further than the minimum legal requirement to conform to the regulation. Comments to help us here would be useful.
• We would particularly like to receive comments from small and medium-sized enterprises (SMEs) on how useful they find the Small Business Quick Guide in Section 1 of the guidance.
• How useful do you find the summary guide to the regulation in Appendix 1 of the guidance?
• Is there any other information that you would like included, particularly with regard to the question and answer section? Obviously, a comprehensive list of all possible questions cannot be included but if respondents request other specific examples, we will review the content of this section. The current questions are included as a result of stakeholder consultation and enquiries.

In addition to comments on the content, the Agency would also like comments on the structure and format of the guidance. In order to help food business operators find information that is relevant to them, the guidance has been designed as a series of reference tools, rather than as a document that should be read from cover to cover. As well as making the guidance available in hard copy and pdf, the Agency also hopes to use the same information to develop a web-based version. As this is a new format for guidance we would very much appreciate your feedback. In particular:

• Do you like this format? Would changes to the structure be helpful, if so what?
• Is the guidance clear and easy to follow?
• Is it easy to find specific information that is relevant to you?
• Is there any information that you feel would be better placed in a different section of the guidance or under another heading?
• Would you find a web-based version useful?
• Any further comments on the format and structure of the guidance.

Scottish Statutory Instrument
European regulations, such as this one, are directly applicable in UK law and are not required to be translated into UK legislation. We do, however, have to put in place offences linked to the regulation and enforcement provisions and penalties associated with these offences so that the regulation can be enforced in the UK. A draft Scottish Statutory Instrument is included in this consultation and we would welcome your views on it. Text left in square brackets is still under consideration and you may comment on this. In particular, we are still looking at an offence linked to Article 26 of the Regulation concerning monitoring. While we have no immediate plans to require companies to notify use of health claims, we are considering an offence in case in future we should want to activate such a requirement. We would welcome comments here.

You should note that Article 4 of the Regulation empowers the Commission to bring in further controls on claims, via nutrient profiles, and we would implement any such future measure in domestic legislation at that time.

Please also note that certain provisions in the new Regulation will overtake current provisions in the Food Labelling Regulations (FLR) 1996. We have appended a table explaining this to the Agency Guidance.

Regulatory Impact Assessment
Consultations should follow better regulation best practice, including carrying out a Regulatory Impact Assessment. This assessment looks at the impact of new controls, in terms of cost, benefits and risks for businesses, the public sector, charities or the voluntary sector. This RIA was initially drafted in 2003 and we consulted on it together with the Commission's initial proposal. During the negotiations we have reviewed and amended the RIA to take account of changes from the initial proposal reflected in the final Regulation. You now have the opportunity to make any further comments before the final RIA is signed off. A new requirement is to reflect the impact on administrative burdens and this is the first opportunity you will have had to comment on this. In particular we would like your views on the following:

• section 4: labelling costs (sections 3.4, 3.7, 4.2, and 5.2 in guidance)
• Section 4: reformulation costs (section 4.2 and 4.4 in guidance)
• Section 4: scientific dossier costs (section 5.3 and 5.3 in guidance)
• Section 4: administrative burdens (in particular sections 3.4, 3.7, section 4 and section 5 in the guidance)

Stakeholder meeting
We have arranged to hold a stakeholder meeting in London for an open discussion of the key proposals on 3 May 2007 from 11am until 12:30pm. Please register with Catherine Ferro if you wish to attend; and please note that allocation of limited spaces shall be on a first come first served basis, with priority going to trade associations and consumer NGOs.

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. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. 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