Food Supplements (England) (Amendment) Regulations 2007

Key proposals for the amendment regulations
In Schedule 1 (which list vitamins and minerals that may be used in the manufacture of food supplements), to amend the heading �FOLIC ACID� to �FOLATE�.

In Schedule 2 (which sets out the form of vitamin and mineral substances that may be used in the manufacture of food supplements) to make the following changes-

• Section A (Vitamins) to amend the heading �FOLIC ACID� to �FOLATE� and under that revised heading insert Calcium-L-methylfolate as a substance that can be used in food supplements
• Section B (Minerals) insert Ferrous bisglycinate as a substance that can be used in food supplements

Detail of Consultation
These draft Regulations will amend The Food Supplements (England) Regulations 2003, SI 2003 1387. They are intended to implement, in England, Directive 2006/37/EC of 30 March 2006, which amended Directive 2002/46/EC relating to food supplements by adding two new substances to the positive lists in the Annexes. Parallel implementing legislation will be made in Scotland, Wales and Northern Ireland.

Directive 2002/46/EC lays down certain requirements relating to food supplements. Positive lists of permitted vitamins and minerals are included in the Annexes to the Directive. It also specifies the forms and units of measurement that may be used in food supplements and the labelling, presentation and advertising allowable and provides scope for future amendments to establish maximum and minimum levels of nutrients used in food supplements.

The purpose of the amendment Directive 2006/37/EC, which is being implemented by the draft regulations, is to add to the positive list those substances that have now been evaluated by EFSA and have received a positive opinion. In addition, it makes an amendment to one of the headings in the Annexes. Member States are required to implement these changes into their legislation by 30 April 2007. It is anticipated that these Regulations will come into force in the UK on 6 April 2007.

Derogation from the requirement for vitamin and mineral substances to be listed in the Annexes to the Directive has been allowed in the UK, where safety dossiers were submitted for assessment by EFSA not later than 12 July 2005. Derogation may apply until the end of 2009, if EFSA have not given an unfavourable opinion in respect of the use of that substance in food supplements. The substances to be added to the positive list of permitted sources of vitamins and minerals are on the UK derogation list and are, therefore, already permitted on the UK market.

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 Judith Taylor, the FSA Consultation Co-ordinator, on 020 7276 8633.
Email: judith.taylor@foodstandards.gsi.gov.uk