..... ..... ..... ..... ..... .....
DoH Update Document, 19 February 2014
The European Commission held a technical working group meeting on Foods for Specific Groups (FSG) with Member States (MS) on 7 February 2014. The discussion built on previous meetings to tease out some of the issues that need further consideration regarding which rules on labelling, presentation, advertising, and promotional and commercial practices should apply to Foods for Special Medical Purposes (FSMP) and to Infant formulae presented as FSMPs.
Two documents summarising the issues for discussion were circulated to Member States by the Commission shortly before the meeting. These covered:
The discussions raised a number of questions in respect of the new delegated acts of the FSG legislation Regulation (EU) No 609/2013: (see Commission Staff working documents for details.) [See documents on tis site: (1) COMMISSION STAFF WORKING DOCUMENT on certain requirements for FSMPs, and (2) COMMISSION STAFF WORKING DOCUMENT on FSMPs for infants]
1. The elements of the FIC Regulation (EU) No 1169/2011 that should apply to FSMPs and where there should be derogations?
2. Which additional mandatory requirements should apply?
3. Is it appropriate for the presence of significant amounts or an indication of a percentage of the reference intakes to be declared on FSMP labels?
4. Should nutrition and health claims be permitted for FSMPs? What would be the advantage? Which specification (eg conditions of use) should apply?
5. Some of the products that have been notified as FSMPs for infants in Member States may not be appropriately marketed within the correct category: should the permitted ingredients and claims on Infant formula be reviewed to permit some of these products under the Infant formula and Follow-on Formula Regulations 2006/141/EC? (eg antireflux and lactose-free formula products.) What is the distinction between these products and those for more serious medical conditions, such as Gastro-oesophageal reflux disease or severe allergies?
6. What level/ route of communication and provision of information/ samples should be applicable to FSMPs for infants?
There have been a number of requests to the Commission from Member States regarding the interpretation of the FSMP definition, particularly with regard to the category Article 1.3(c); therefore a meeting is planned for discussion of these issues:
7. The Commission has requested information from Member States on the type of products where there is difficulty in determining the correct classification within the FSMP definition; your views on the interpretation of the definition and generally accepted indications are requested by 26 February 2014.
The date for the next FSG delegated acts meeting is yet not confirmed.
The date for the next ‘Parnuts’ meeting on FSMP definition interpretation is proposed for 14th March but is not yet confirmed.