FSA Consultation, 28 February 2007

CLAIMS - Nutrition and health claims made on foods (England and Wales)

Consultation on implementation of European Regulation 1924/2006 on nutrition and health claims made on foods and Food Standards Agency guidance on compliance. Responses are requested by: 24 May 2007

Consultation details

The Agency seeks views and comments on draft guidance for food business operators on European Regulation 1924/2006 on nutrition and health claims made on foods.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 Statutory Instrument, which puts in place enforcement provisions, and the accompanying Regulatory Impact Assessment. A stakeholder meeting has been planned for 3 May.

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 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 its self. 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.

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 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 have comments 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.

Stakeholder Meeting

We have arranged to hold a stakeholder meeting for an open discussion of the key proposals on 3 May 2007 from 2pm until 5pm. Please register with Sarah Paterson 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.