DoH Interested Parties Letter, 24 February 2011
1) Nutrition claims – discussion on revision of the list of permitted nutrition claims
There was general support for the Commission’s latest draft proposal (see the text at the end of this note) although one or two member states (MS) reiterated concerns about the reformulation claim. Regarding the ‘no added salt’ claim there was no support for the proposition that it should require products to be labelled as containing naturally-occurring sodium, where applicable, and no support for a suggestion that it should be permitted on products including additives containing salt/sodium.
The Commission aims to put a draft regulation to standing committee on 2 May.
2) Discussions on opinions received recently from EFSA
Q-2009-0455: thiamin and maintenance of normal neurological development and function (Article 14)
The European Food Safety Authority (EFSA) opinion states that, while the target population in this application was infants and children up to three years, the role of thiamin in normal neurological function is not specific to any population group. Therefore, the Commission proposes authorising the claim in relation to all children. The wording of this and the similar Article 13 claim will be aligned.
One MS asked whether a food whose composition was controlled by Directive 2006/125/EC on ‘weaning foods’ could bear a health claim such as this for thiamin when all such foods had a similar thiamin content. The Commission reminded delegates that Article 2 of Directive 2000/13/EC on food labelling could be interpreted to mean that a claim should not be used in such a case.
Some MS suggested that a claim could be used as long as it was also made clear that the composition of similar products was comparable; others thought this would still be misleading. There was then a follow-up question: could a food marketed for consumption by young children, but which was not a weaning food according to Directive 2006/125/EC, bear a thiamin claim and, if so, was this fair? The Commission is seeking legal advice on this point.
Q-2010-00784:”Toothkind” drinks and reduction of tooth demineralisation (Article 13(5))
This is the first comparative health claim with a positive EFSA opinion. Some MS were unsure whether the NHCR permitted comparative health claims. They also considered that this claim denigrated the comparator products, thereby contravening Article 3(b) NHCR, and that it could be perceived as promoting frequent consumption of ‘toothkind’ drinks. The Commission noted MS’ concerns but maintained that the claim could be useful for frequent consumers of fruit juices / soft drinks and that it should be possible to word it so that it would inform such consumers without misleading others; it hoped to propose new wording at the next meeting.
Q-2009-00776: oat beta-glucan and lowering blood cholesterol and reduced risk of heart disease (Article 14)
The Commission asked for MS’ views on whether the reduction in blood cholesterol should be quantified in the conditions of use (COU) for the claim as had been done for plant sterols / stanols? EFSA stated that the evidence did not permit this; MS agreed, noting that it was not proposed for other ‘reduction’ health claims and that for sterols / stanols it was not an obligatory part of the claim and was only valid for certain food matrices. EFSA agreed with the Commission that the cholesterol-lowering effect of oat beta-glucan (OBG) depends partly upon molecular weight (MW) but reiterated that the evidence presented did not permit a threshold MW to be identified.
A number of MS advocated setting a minimum content of OBG for foods bearing the claim on grounds that this would benefit consumers and enforcers. The Commission asked MS to provide information on the levels of OBG in foods currently on the market in order to help setting such a threshold.
3) List of article 13 health claims.
There was discussion of the following issues.
Concerns about choking (e.g. claims for glucomannan, guar gum, pectins)
The Commission noted that these claims are likely to be used only on food supplements. One MS pointed out that the food additives legislation addresses safety issues with some of these substances by means of warnings and restrictions on use and asked if EFSA could do safety assessments for the relatively large quantities that would be in products bearing the claims. The Commission did not appear to draw any conclusions from this discussion
Claims referring to normal psychological function
There seemed to be agreement that referring to ‘normal brain function’ instead of ‘normal psychological function’ would be more informative to consumers and less emotive.
Claims referring to tiredness and fatigue
The Commission asked how ‘second-step function’ health claims e.g. ‘iron can contribute to a reduction of tiredness and fatigue’ should be communicated to the consumer. There seemed to be agreement that it would be more useful if the claim explained how the health benefit was achieved e.g. through red blood cell formation.
Lactase
In light of previous discussion the Commission had amended the proposed wording to ‘Lactase enzyme improves lactose digestion in individuals with lactose maldigestion’. MS seemed to be content with this although the wording might yet be improved by referring to ‘individuals who have difficulty digesting lactose’.
‘Meal replacement’ products
The products that are the subject of the EFSA opinion do not comply with the compositional requirements for meal replacements in Directive 96/8/EC on ‘slimming foods’ since their protein content is too low. Consequently, there was some discussion about the name of these products and whether they should be allowed to bear weight control claims. The Commission agreed that it would be better if they were not called ‘meal replacement’ products and said that, since Article 13(1)(c) NHCR allows for claims referring to slimming or weight control, it was possible for the products to bear such health claims authorised under the regulation.
Melatonin
EFSA has given a positive opinion on the claim ‘melatonin contributes to alleviation of subjective feelings of jet lag’. All MS who spoke considered products containing melatonin to be medicinal and several expressed concern that authorising this health claim could encourage the marketing of melatonin containing foods. However, the Commission emphasised that, as long as melatonin is on the EU market in foods, it must consider authorising this claim.
The Commission again invited constructive written comments on Article 13 health claims ahead of the next WG meeting.
4) Commission’s suggestion for an ad hoc working group on issues of interpretation of the NHCR
MS supported this idea and the Commission agreed to circulate a list of potential agenda points for MS to comment on; the meeting will probably be held after the summer.
5) Next Working Group meeting.
The next Commission working group meeting on nutrition and health claims will be on Monday 21 March.