Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2007

The key proposals are:

• To update the definition of 'Directive 2001/15' (regulation 3)
• To change the heading 'FOLIC ACID' to 'FOLATE' in the Section concerning Category 1 (vitamins) (regulation 4)
• To amend the list of substances in the annex to Directive 2001/15/EC to:
  • add calcium-L-methylfolate to the list of substances under the vitamins category which may be added to all PNU foods (without any time limit) (regulation 4)
  • add ferrous bisglycinate to the list of substances under the minerals category which may be added to all PNU foods (without any time limit) (regulation 4)
  • add magnesium L-aspartate to the list of substances under the minerals category which may be added to foods for special medical purposes (without any time limit) (regulation 5)

These regulations implement a new Commission Directive amending Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (PARNUTS foods).

Directive 2001/15/EC includes an annex which contains a �positive list� of substances (sources of vitamins; minerals; amino acids; carnitine & taurine; nucleotides; and choline & inositol) that may be added for specific nutritional purposes in certain foods for particular nutritional uses.

Provisions regarding the addition of substances to infant formulae, follow-on formulae, processed cereal-based foods and baby foods for infants and young children are laid down in separate Directives which apply to those specific categories of parnuts foods.

Article 3 of 2001/15/EC requires that Member States prohibit trade in non-compliant products with effect from 1 April 2004. Directive 2004/6/EC allows the continued use, beyond 1 April 2004, a group of substances which are not currently included in the positive list in 2001/15/EC, whilst the Scientific Committee on Food (SCF), the fore- runner of the European Food Safety Authority, evaluated them for their intended purpose.

The purpose of this directive is to add to the positive list those substances, which have now been evaluated by EFSA and have received a positive opinion.

Member States are required to have implemented these changes into UK law by 31 December 2006. It is anticipated that Regulations in Wales will come into force in Wales on 9 February 2007.

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