FSA Consultation, 1 March 2007

FORTIFICATION - Addition of vitamins and minerals and certain other substances to foods (England and Wales)

Consultation on the implementation of European Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, and draft Food Standards Agency guidance on compliance. Responses are requested by: 24 May 2007

Consultation details

The Agency seeks comments on draft guidance for food businesses operators on European Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. It also seeks comments on a draft Statutory Instrument, which will put in place enforcement provisions, and the accompanying Regulatory Impact Assessment. A stakeholder meeting has been planned for 3 May.

Regulation 1925/2006

Regulation 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods was published on 30 December 2006 and will apply from 1 July 2007. This is the first piece of specific legislation to deal with the voluntary addition of vitamins and minerals to food and aims to provide a higher level of consumer protection as well as harmonise legislation across the EU to facilitate intra-Community trade. It also sets provisions to allow control of the addition of other substances to food. A copy of this regulation can be found on the EU website.

The regulation will control the voluntary addition of vitamins and minerals to food by means of positive lists of authorised substances that may be added to food, and allows for purity criteria and for minimum and maximum levels of such additions to be set. The regulation makes provision for the compilation of a list of other substances that may be restricted or prohibited from being added to food. It also requires additional labelling controls.

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 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
• Draft Statutory Instrument with enforcement provisions
• Draft Regulatory Impact Assessment

Agency guidance

The guidance aims to help food business operators who wish to fortify, or otherwise add vitamins and minerals and other substances to food, identify what they must do to comply with the regulation. It should give you a clear interpretation of the Regulation – what it controls, what an 'other substance' is, and what businesses must do if wishing to add vitamins and minerals and other substances to food 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 version.

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? 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 would also be useful on the following points:

• The Agency's initial view is that the addition of vitamins and minerals to food to restore levels lost during manufacture and processing is covered by the Regulation. Comments to help the Agency further refine this view would be useful, in particular on the requirement to have minimum levels present.
• We would particularly like to receive comments from SMEs on how useful they find the Small Business Quick Guide in Section 1 of the guidance.
• Section 4.8 offers guidance on purity criteria and refers to existing Community legislation and generally accepted international recommendations. Comments on what purity criteria should apply to vitamin formulations and mineral substances not covered by these existing purity criteria, including standards to which industry currently work, would be useful.
• 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 previous stakeholder consultation and enquiries.

In particular during this consultation we would like to bring to your attention to section 7.3 which looks at safeguards and explains the UK 's approach to introducing such measures.

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 cover to cover. We would like to avoid making the guidance available in hard copy for reasons of sustainability, but provide electronic (pdf) versions, and develop an web-based version. As this is a new format for guidelines 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.

The following documents are available on this site:

• Addition of Vitamins, Minerals and Other SubstancesRegulations 2007 (England and Wales): Consultation documents Draft SI, Draft RIA and list of consultee
• European Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods Draft FSA guidance to compliance