DH Update Bulletin, 27 September 2013
This was the European Commission’s first technical working group meeting on Foods for Specific Groups with Member States (MS).The attached document was circulated to MS by the Commission shortly before the meeting. The document focusses on a number of issues related to two delegated acts that the Commission will have to adopt on:
Overall, for most of the issues discussed in the paper there was general support, in principle, to the alignment with new general labelling rules under the Food Information to Consumer Regulation (FIC) (Regulation (EU) No 1169/2011) and MS supported the Commission’s general approach to rules on processed cereal-based foods and baby foods.
However, a number of questions were raised for further consideration (see below) and we would welcome your views. These discussions are at an early stage and consultations across MS are ongoing.
A. Definition of FSMP – introduction of FSMP categories
The Commission has indicated that the 3 types of medical foods currently defined under Art. 1(3) of 1999/21/EC should be retained. There continues to be widespread problems with categorisation of FSMP products and overlap with other foodstuffs such as food supplements. This issue could be considered in the development of Commission Guidance.
Q1. Would this approach help provide clarity for businesses and enforcement officials when decisions are made on the classification of medical foods?
Q2. Would you consider it beneficial to provide a list of examples of recognised appropriate dietary conditions and/or product types considered FSMPs?
B. Labelling requirements for FSMPs
The European Commission has indicated that it would like to see the labelling of medical foods brought more into alignment with the general labelling rules as set out in the Food Information to Consumers Regulations (FIC), whilst maintaining a number of specific mandatory provisions where appropriate.
Q3. Would you consider this approach beneficial for medical foods?
Q4. Do you consider that derogations from the general labelling rules of the FIC, should be permitted where a justified case can be put forward. For example, should the FIC mandatory minimum font size for labelling apply to mandatory information on medical foods?
i. Nutrition labelling requirements
Q5. There was support to retain mandatory declaration of sodium, as it is important for healthcare professionals. Would it be beneficial to permit the declaration of salt in addition to sodium, what would be your preferred format for the declaration?
Q6. Do you have any reason to consider that it would not be appropriate to provide information on percentage of Reference Intakes (RI) for vitamins and minerals as required by the FIC? For example, because these values are for the healthy population?
Q7. Would it be beneficial to align the order of ingredients in medical foods with the FIC?
Q8. The application of country of origin labelling to ingredients of normal foods e.g. milk products under the FIC is being considered, would you consider this appropriate or beneficial for medical foods?
C. FSMP’s for infants
There are a number of infant and follow-on formula products which are sold as medical foods. There are concerns that there are a number of formula milks on the EU market that are inappropriately marketed as FSMPs, which do not respect the full provisions of the infant formula rules. Discussions under Regulation (EU) No 609/2013 on Food for Specific Groups (FSG) sought to address this by introducing a procedure to harmonise the categorisation of products (article 3) and to review which of the labelling and advertising provisions in Directive 2006/141/EC should also apply to FSMPs for infants.
i. Annex – levels of vitamins and minerals
Q9. Do you consider that the recommended maximum levels for vitamins and minerals of FSMP’s for infants should be updated with those that apply to regular infant formula and follow-on formula?
ii. Additional requirements (other than composition)
Q10. Do you consider that it is appropriate to apply all the same advertising and promotion restrictions to infant formula medical foods which apply to normal infant formula? Please give reasoning if you consider that it is not appropriate to apply a restriction.
iii. Other aspects (e.g. general principles and requirements, sales denomination, notification procedure)
Q11. Do you consider that there is any reason to change the general principles, sales denominations and notification procedure for FSMPs?
Processed cereal based-foods and baby foods for infants and young children
A. Nutrition labelling requirements
ii. Mandatory declaration on minerals and vitamins
There was support for the mandatory declaration of vitamins and minerals to be retained. There was some discussion regarding which Reference Intakes (RI) values should be used for processed cereal based-foods and baby foods to assist purchasers’ comparison across a range of food products, including non-specialist foods.
Q12. Should the reference intakes for vitamins and minerals of Annex XIII of the FIC Regulation (foreseen for adults) apply to processed cereal –based foods and baby foods intended for infants and young children rather than the reference values for nutrition labelling in Annex V of Directive 2006/125/EC (appropriate to the specific age group)?
B. Other Labelling requirements:
i) Statements on the appropriate age from which the product may be used
Q13. Do you agree that a mandatory statement on the appropriate age from which a product may be used as stated in Article 8(1)(a) of Directive 2006/125/EC is necessary to ensure the appropriate use of the products and therefore this specific requirement should be maintained as such in the delegated act?
Q14. Do you consider that it is beneficial to include on the label a statement recommending weaning from 6 months of age, unless advised by a health professional to begin weaning at an earlier age (i.e. between 4 – 6 months)? Please provide reasoning and examples of alternative options.
ii) Mandatory information on the presence/absence of gluten
Q15. Should the mandatory requirements of Article 8(1)(b) of Directive 2006/125/EC be maintained in the future delegated act?
Q16. Do you consider that the provisions in Article 9(1)(c) of the FIC would be sufficient to inform consumers of processed cereal-based foods and baby foods on the presence or absence of gluten in such products?
iii) Mandatory instructions on preparation
There was support for the mandatory requirements of Article 8(1)(e) of Directive 2006/125/EC relating to the instructions for appropriate preparation of processed cereal-based foods and baby foods, and inclusion of a statement as to the importance of following those instructions should be maintained.
Q17. Please provide views if you consider that an alternative approach is preferable, such as using FIC provisions?
The next working group meeting has not been confirmed and will possibly cover infant formula and follow-on formula issues. Ahead of this meeting we would welcome views on any issues you would like to raise with us. Where possible please provide examples and evidence to support your views.