Consultation on a Regulation on Foods Intended for Infants and Young Children and on Food for Special Medical Purposes (Scotland)

A summary of responses is now available on the Department of Health website

Who will this consultation be of most interest to?
Local Authorities, Food Business Operators, Food Trade Associations and other Government Departments

What is the subject of this consultation?
The European Commission proposes to revise the legislation on foodstuffs intended for particular nutritional uses (PARNUTS) covered by the ‘Framework Directive on dietetic foods’ (Directive 2009/39/EC). The proposal abolishes the concept of dietetic foods and provides for a limited number of well-established and defined categories of food that are considered as essential for certain vulnerable groups of the population i.e. foods intended for infants and young children, and food for patients under medical supervision.

What is the purpose of this consultation?
To seek views on the European Commission’s proposal to revise the legislation on foodstuffs intended for particular nutritional uses (PARNUTS) covered by the ‘Framework Directive on dietetic foods’ (Directive 2009/39/EC). The title of the proposal is 'Regulation of the European Parliament and of the Council on foods intended for infants and young children and on food for special medical purposes'.

This consultation relates to the European Commission’s proposal to revise the legislation on foodstuffs intended for particular nutritional uses (PARNUTS) covered by Directive 2009/39/EC, the 'Framework Directive on dietetic foods'.

The proposal is titled 'Regulation of the European Parliament and of the Council on food intended for infants and young children and on food for special medical purposes'.

The European Commission, as part of its on-going programme of better regulation and simplification, has reviewed the Framework Directive and presented a proposal which aims to simplify and clarify the rules that apply to products hitherto regulated as PARNUTS or 'dietetic' foods. The proposal abolishes the concept of 'dietetic foods' and provides for a limited number of well-established and defined categories of food that are considered as essential for certain vulnerable groups of the population, i.e. foods intended for infants and young children and food for patients under medical supervision. The proposal will also repeal Regulation (EC) 41/2009 on foods for people intolerant to gluten, moving claims into the Nutrition & Health Claims legislation.

In addition, the proposal will provide for a consolidated list of substances such as vitamins, minerals and other substances, and the appropriate levels at which these may be added to the foods covered by the proposal.

The proposed Regulation is expected to be published at the end of 2012 and will come into force two years from publication in the Official Journal of the European Union.

Additional Information

Geographical scope: UK-wide

Getting to this stage: The European Commission initially consulted Member States on the initial options during 2009.

Previous engagement: The Food Standards Agency has previously consulted key stakeholders including industry, consumer organisations and other Government departments on all aspects of PARNUTS legislation and on initial opinions for this proposed Regulation in 2009. This included the re-casting of the Framework Directive 89/398/EEC into Directive 2009/39/EC.

Impact Assessment: A preliminary Impact Assessment (IA) prior to publication of the proposal was conducted for the UK by the Food Standards Agency in early 2010, which provided indicative costs to industry. A detailed IA has been prepared by the European Commission (EC) and a similar BRIA for Scotland is in preparation and will be informed by this consultation.

Compliance with the Government Code of Practice on Consultations: The consultation does not comply with the Code. EU negotiations are underway. Urgent responses to this consultation are required to inform the UK negotiating position at the EU Presidency meeting in October 2011. The consultation period has therefore been shortened to eight weeks.

Additional ways to become involved: It's anticipated there may be scope for a stakeholder meeting in September to complement this consultation.

After the consultation: Responses to this consultation will inform the UK negotiating position.

The Food Standards Agency in Scotland are seeking views from industry, Non-Governmental Organisations and other interested parties on the proposal outlined above to inform EU negotiations, which are due to commence in September 2011. In order to formulate and agree the UK position for these negotiations, we are consulting over an eight week period instead of conducting a full 12 week public consultation.

1. The Commission proposal restricts the scope of PARNUTS foods to three categories of foods: infant formula and follow-on formula, processed cereal-based foods and baby foods for infants and young children, and medical foods. We would be grateful for your views on the proposed list.
2. The proposal plans to repeal Regulation (EC) 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. It is proposed that the statements ‘gluten-free’ and ‘very low gluten’ and their associated requirements would be recast as nutrition claims as defined in Regulation (EC) 1924/2006. The Food Standards Agency in Scotland would welcome views on the impact of the proposed changes to the legislative requirements to these foodstuffs.
3. The proposal aims to repeal Directive 96/8/EC - the slimming foods Directive. What is the impact of this on this food sector?
4. What is the impact of the removal of the concept of dietetic foods from the Framework? How would you like the products marketed as dietetic foods to be handled?
5. What is the impact of the proposed pre-authorisation of PARNUTS being centralised to the European Commission?
6. The Commission expects the proposal will reduce administrative and financial burdens on industry and Member States’ competent authorities. We would be grateful for your views on possible financial implications including costs and benefits, which will inform the Scottish Business & Regulatory Impact Assessment (BRIA).
7. Would the changes proposed impact differently on any of the 'protected characteristics' (age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation) with regard to the Equality Act 2010 and Equality Duty?
8. The Food Standards Agency in Scotland welcome your views on any other questions/issues that you may have with the proposal.

Responses are required by close Monday 3 October 2011. 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).

Please email your responses to: alison.taylor@foodstandards.gsi.gov.uk.

A summary of responses is now available on the Department of Health website.

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.

In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. 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.

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