Food For Particular Nutritional Uses (Miscellaneous Amendments) (England) Regulations 2007

Please note that very similar legislation is also being prepared in Wales However, there will not be a separate consultation. Therefore, if you are in Wales, please forward your comments on these documents to Derek Hampson at the above address.

The key proposals are:

• to allow partially hydrolysed infant formula based on hydrolysates of whey protein from cows� milk, provided that the protein content is between 1.86g/100kcal and 3g/100kcal and the protein is sourced and processed as provided in the Annex of Commission Regulation 1609/2006, to be placed on the UK market (Regulation 2)
• to update the definition of the directive referred to in the Medical Food (England) Regulations 2000 to reflect the accession of Bulgaria and Romania to the European Union (Regulation 3)
• to update the definition of 'the Directive' in the Processed Cereal-based foods and Baby Foods for Infants and Young Children (England) Regulations 2003 so that it refers to Directive 2006/125/EC instead of Directive 96/5/EC as amended (Regulation 4)

Background
Regulation 2: This proposed regulation will provide for the execution and enforcement of, in England, Commission Regulation 1609/2006 of 27 October 2006, to allow partially hydrolysed infant formula based on hydrolysates of whey protein from cows� milk to be placed on the UK market, provided that the protein content is between 1.86g/100kcal and 3g/100kcal and the protein is sourced and processed as provided in the Annex of Commission Regulation 1609/2006. This regulation will amend the Infant Formula and Follow-on Formula Regulations 1995 SI 77 accordingly. A RIA is attached at Annex E.

Regulation 3: This regulation amends the Medical Food (England) Regulations 2000 to update the definition of the Directive to reflect the accession of Bulgaria and Romania to the European Union in 2007.

Regulation 4: This regulation updates the definition of 'the Directive' in the Processed Cereal-based foods and Baby Foods for Infants and Young Children (England) Regulations 2003 so that it refers to Directive 2006/125/EC instead of Directive 96/5/EC as amended. The new European Directive brings together Directive 96/5/EC and its amending directives (1998/36/EC, 1999/39/EC and 2003/13/EC).

Regulatory Impact Assessment
The purpose of a Regulatory Impact Assessment (RIA) is to assess and record the likely costs and benefits of the forthcoming provisions for businesses, consumers and enforcement bodies. Given that the proposed changes in Regulations 3 and 4 do not change any of the requirements of national legislation we do not anticipate that the implementation of these regulations will impose any costs or savings on businesses. Therefore, a RIA has not been prepared to accompany these amending regulations at this stage. However, if you consider that Regulations 3 and 4 will impose additional costs on business or the public sector, please provide evidence and estimated costs in your response to this consultation and we will consider preparing a RIA.

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