Draft Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009

Who will this consultation be of most interest to?
Manufacturers of foods for particular nutritional use, enforcement authorities and lawyers.

What is the subject of this consultation?
Draft Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009, which will provide for the execution and enforcement provisions for Commission Regulation (EC) No. xx/2009¹ on substances that may be added for specific nutritional purposes in foods for particular nutritional uses in England and will repeal the following Statutory Instruments:

• The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002 (SI 1817)
• The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (SI 649)
• The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006 (SI 3116)
• Regulation 5 of the Food for Particular Nutritional Uses (Miscellaneous Amendments) (England) Regulations 2007 (SI 2591)

What is the purpose of this consultation?
To seek comments on the draft Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009. Parallel regulations are also being produced in Scotland, Wales and Northern Ireland and consultations on these will be run concurrently.

¹ This consultation was launched before publication of the Regulation in the Official Journal of the European Communities and is based on the agreed text communicated to the European Council. The Regulation number must be inserted into the SI before it comes into force.

1. Do nothing, i.e. fail to implement appropriate execution and enforcement provisions in England for the Commission Regulation.
2. To introduce the appropriate provisions into law in England to allow for the execution and enforcement of national legislation enforcement of Commission Regulation (EC) No. xx/2009.

Option 2 is preferred, firstly because it increases the range of sources of vitamins and minerals and of other substances (notably amino acids) that may be addeds to foods for particular nutritional use; and secondly because EC regulations are binding in their entirety and are directly applicable in all member states. A failure to provide for the execution and enforcement of Commission Regulation (EC) No. xx/2009 could lead to possible infraction proceedings against the UK. In addition, this represents a simplification of current legislation because the provisions will be consolidated into one Statutory Instrument making it easier to read.

In order to achieve a coming-into-force date of 1st January 2010 we are consulting over a four week period instead of conducting a full 12-week public consultation. The Agency has previously consulted all interested parties throughout the duration of EU negotiations on the Commission Regulation and we have received comments broadly supporting the new regulation. On this basis, we consider that a shortened consultation at this stage is appropriate and allows us to update domestic legislation according to the timetable set by the Commission, which is of benefit to all stakeholders.

In addition, we do not expect the coming-into-force date to pose a problem to manufacturers of 'parnuts' foods because the date coincides with the expiration of the derogation.

All responses received as part of this consultation will be given careful consideration. These will be summarised and published on the Agency’s website in due course.

Questions asked in this consultation:

1. Do you have any comments on the drafting of this Statutory Instrument? If so, please let us have them.
2. Do you have any comments on the draft sustainability assessment at Annexe D?

We welcome comments from all stakeholders. Please send your response by email or post using the contact details above.

• Council Directive 2009/39/EC on foodstuffs intended for particular nutritional uses (see link below)
• Commission Regulation (EC) No. xx/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses

Responses are required by close 2 November 2009. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).

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