FSA Letter (CPD/027), 14 April 2009
Presentation of progress at the mid-term stage of the impact assessment study related to the revision of Directive 89/398/EEC
The Commission explained that consultants were gathering information to inform its impact assessment (IA); the consultants have met with representatives of the competent authorities of some member states (MS), the food industry and consumer organisations. The Commission is aiming to complete the IA by June and to have completed Commission discussions on a proposal for a revised Directive by the end of the year.
[Note: Directive 89/398 is Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses]
Regulation (EC) 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten
The Commission was asked whether claims such as “this product does not contain a gluten-containing ingredient” or “this food has not been specially designed to meet the particular nutritional requirements of people intolerant to gluten but is a normal food with no gluten-containing ingredients “ or “this product does not contain wheat, rye, barley, oats or their crossbred varieties” could be used with respect to foods for normal consumption containing between 20 and 100 ppm gluten. The Commission and MS agreed that according to 41/2009, normal foods containing <20ppm gluten may only use the claim ‘gluten-free'. The Commission reiterated that the scientific evidence is clear – that gluten-intolerant people need to keep their gluten consumption as low as possible – and that this is the basis for the Regulation.
The Commission was also asked whether foods for normal consumption could only claim to be ‘gluten-free' if the gluten content was <20 ppm and they did not contain a gluten-containing ingredient, as suggested in recital 8 to 41/2009. There was an unsatisfactory discussion on this and it may be discussed again at a future working group meeting.
Draft Commission Regulation on substances that may be added for specific nutritional purposes in foods for particular nutritional uses
The Commission presented a new draft document which consolidates Directive 2001/15 and its amendments into a Regulation and introduces into the Annex certain substances which have recently received positive opinions from EFSA. I have circulated a separate letter asking for comments by 22 April.
Infant formulae (Directive 2006/141/EC) and claims (Regulation (EC) 1924/2006 on nutrition and health claims made on foods)
The Commission was asked whether statements such as ‘easy to digest', ‘gentle for sensitive tummies', ‘gentle on your baby's tummy', for comfortable digestion' were permitted on labels of infant formula (IF). The Commission legal advisor confirmed that these are claims referring to general, non-specific benefits of a nutrient or food for overall good health or health-related well-being (article (10(3) of the nutrition and health claims regulation) and must therefore be accompanied by a specific health claim which, in the case of IF, would have to be listed in Annex 4 to Directive 2006/141. Since there are no such claims listed in Annex 4, these statements are not permitted in relation to IF.
Vitamins and minerals in foods for special medical purposes
There was a brief discussion about high levels of some vitamins and minerals in certain medical foods used as sole source of nourishment and whether these levels were justifiable. The Commission asked MS to provide information about specific products on their markets where levels of vitamins or minerals were above those set out in Directive 1999/21 and whether they were intended as sole source of nourishment or not.
Next Steps: This issue may be discussed at a future working group meeting. If you have any information you would like us to submit to the Commission, please send it to FSA by 14 May.