Addition of vitamins and minerals and certain other substances to foods (Scotland)

The Agency seeks comments on draft guidance for food businesses operators on European Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.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 Scottish 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 Scottish 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.

Regulatory Impact Assessment
Criterion 6 of the Cabinet Office Code of Practice states that a consultation must 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 (section 4.7 in the guidance)
• Section 4: reformulation costs (section 4.2 to 4.6 in the guidance)
• Section 4: scientific dossier costs – any substances missing from the Annex. (section 4.3 in the guidance)
• Section 4: administrative burdens (section 4 in the guidance)

Stakeholder meeting
We have arranged to hold a stakeholder meeting 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