DH Update Bulletin, 25 November 2013
The draft Commission Regulations discussed under items 1-4 below were sent to Member States (MS) before the meeting and are circulated with this report.
1. Draft Commission Regulation on the authorisation of health claims related to calcium and/or vitamin D (EFSA-Q-2010-01233, Q-2009-00940, Q-2008-721) [see Draft Reg Ca + Vit D] and the refusal of authorisation of health claims related to glucosamine hydrochloride, isolated soy protein and plant sterols combined with Cholesternorm®mix (Q-2009-00412, Q-2011-00784, Q-2009-00237, Q-2011-01114)
The discussion was largely a reprise of those in previous meetings. The conclusions were that: (1) the claim “calcium may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures” could be for use on all kinds of foods including food supplements; (2) the same claim in relation to calcium + vitamin D could be for food supplements only; and (3) the claim “vitamin D may reduce the risk of falling. Falling is a risk factor for bone fractures” could also be restricted to food supplements because this is the only practical way to ensure daily consumption of the amount of vitamin D needed for the claimed benefits. Regarding the first claim, there needs to be further consideration of how much calcium should be in food supplements and in other foods in order to ensure a daily consumption of 1200mg in total when the claim is made.
Regarding use of the word “may” in the third claim, it was suggested that “helps” might be more useful wording for consumers. The conditions of use (COU) for the second and third claims are likely to be amended to say that they “shall only be used on food supplements” to make it clear that they are not to be used on other foods. It’s likely that an amended proposal will be put to a vote at the next opportunity.
2. Draft Commission Regulation amending 983/2009 and 384/2010 as regards the conditions of use of certain health claims related to the effect of plant sterols and plant stanols on lowering blood LDL cholesterol [see Draft Reg Stanols]
During the brief discussion it was clarified that a single label should not bear claims about both ranges of intake for plant sterols / stanols. It’s likely that the proposal will be put to a vote at the next opportunity.
3. Draft Commission Regulation on the authorisation of a health claim related to low fat and low trans spreadable fat rich in unsaturated and omega-3 fatty acids and reduction of LDL cholesterol concentrations (Q-2009-00458) [see Draft Reg Lactalis]
There was a discussion about whether the conditions of use for this claim should be different from those for the authorised Article 13.1 claim for monounsaturated and/or polyunsaturated fatty acids. There were also questions about whether the claim should be limited to spreadable fats and what the comparator product(s) should be. The proposal will be amended.
4. Draft Commission Regulation a uthorising a health claim for supplemental folate intake and reduced risk of neural tube defects (Q-2013-00265) [see Draft Reg Folate]
The proposal is likely to be amended to make it clear that the claim may only be used on food supplements and for the wording and COU to refer to “folic acid” rather than folate. It’s likely that an amended proposal will be put to a vote at the next opportunity.
5. Health claim related to “non-fermentable carbohydrates” and maintenance of tooth mineralisation (Q-2013-00040)
The Commission asked whether this claim is any different from the authorised Article 13.1 claim for sugar replacers; there was little discussion.
6. Health claims related to thiamine (2), vitamin B2, pantothenic acid, ALA (two), vitamin A, magnesium, iron and referring to children’s development and health (Q-2008-183, Q-2008-184, Q-2008-186, Q-2009-00455, Q-2009-00197, Q-2008-666, Q-2008-160, Q-2008-150, Q-2008-199, Q-2012-573)
Discussion of these claims will require collaboration between this working group and that on foods for specific groups (FSG) in order to ensure coherent treatment with regard to wording and conditions of use. There was no detailed discussion today.
7. Conditions of use for health claims related to monacolin K (Q-2012-00736, Q-2012-00968)
At a future meeting there will be discussion of possible side effects associated with monacolin K and whether health claims for that substance need to be associated with warnings and/or restrictions of use.
8. New EFSA opinion on hydroxyanthracene derivatives and improvement of bowel function (Q-2013-00650)
Some delegates said that this product would be considered medicinal and that, should the claim be authorised, it must be accompanied by warnings.
9. New EFSA opinion on glycaemic carbohydrate and contribution to recovery of normal muscle function after strenuous exercise (Q-2013-00234)
The Commission proposed future discussion of this claim together with claims for glucose that had been discussed in the past.
The Commission emphasised the fact that generic descriptors can only be used once they have been authorised as such. Therefore, food business operators who use terms they consider to be generic descriptor should now be working to ensure that applications are made according to the rules in Commission Regulation 907/2013.
The next working group meeting is likely to be in the second half of January, 2014