Department of Health Letter, 12 July 2013
Health claim applications, European Food Safety Authority (EFSA) opinions and draft decisions
Calcium and /or Vitamin D (EFSA-Q-2010-01233, Q-2009-00940, Q-2008-721)
This item continued previous discussion about appropriate conditions of use (COU) for three disease risk reduction health claims on calcium, vitamin D, and calcium + vitamin D. COU should ensure that the target populations were clearly identified and that individuals in those populations knew how to consume enough calcium/vitamin D daily to achieve the claimed benefit.
Plant sterols/stanols (EFSA-Q-2011-01241, Q-2011-00851, Q-2012-732, Q-2012-733)
This discussion was about how to amend the COU for existing cholesterol-lowering claims for plant sterols and plant stanols in the light of recent EFSA opinions. It was agreed that sterols and stanols should be treated as having the same effect as each other and that consumption should not exceed 3g/day. There was also discussion about the range of sterol/stanol intakes and cholesterol reductions that could be referred to in relation to certain foods.
Health claims on mandatory nutrients in specific categories of foods (EFSA- Q-2008-183, Q-2009-00455, Q-2009-00197, Q-2008-666)
The context for this discussion was positive EFSA opinions for health claims on alpha linolenic acid (ALA) and thiamine in specific types of foods including follow-on formulae (FOF), weaning foods and medical foods. For each of these foods the legislation sets minimum levels for thiamine and ALA but Article 2 of the food labelling Directive also applies to the use of claims and means that a health claim should not be presented in a way suggesting that a product possesses special characteristics when all similar products have the same characteristic. The Commission invited Member States’ (MS’) views on whether it was permitted to make health claims for ALA, thiamine and other mandatory ingredients in the foods mentioned above. Differing policy views on such claims were noted. Some people consider that permitting claims on mandatory ingredients in e.g. FOF could be misleading if consumers do not know that all FOF have very similar compositions;furthermore, such claims could discourage breastfeeding. Others feel that not allowing FOFs to claim on e.g. calcium would discriminate unfairly between these products and others such as cow’s milk if milk was permitted to do so.
Health claims on glucose and energy-yielding metabolism (EFSA-Q-2012-00266, Q-2012- 00267, Q-2012-00268, Q-2012-00269, Q-2012-00270)
EFSA had published positive opinions on five related health claim applications but had reduced them all to one (“glucose contributes to normal energy-yielding metabolism”); for three claims the applicant had proposed that the target population be “healthy active, as well as endurance-trained, men and women” and for the other two the proposed target population was “the general population”. EFSA had said that they had seen no evidence to show that the claimed effect was more beneficial to sports people that to the general population.
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 (EFSA-Q-2009- 00458)
This claim is very similar to the authorised Article 13(1) claim “Replacing saturated fats with unsaturated fats in the diet contributes to the maintenance of normal blood cholesterol levels [MUFA and PUFA are unsaturated fats] which requires foods bearing the claim to comply with the COU for the ‘high in unsaturated fats’ nutrition claim. There was a brief discussion on how to set COU that would distinguish the cholesterol-reducing claim (Article 14(1)(a)) from the Article 13(1) claim.
Some of the claims above may be discussed again after the summer break.
L-tyrosine contributes to normal synthesis of dopamine (ESFA-Q-2011-00319)
Delegates were invited to consider whether this health claim, submitted under Article 13(5) of the nutrition and health claims Regulation, could be authorised. It was noted that the similar Article 13(1) claim had not been authorised and that information about specific conditions of use had been submitted for the 13(5) claim. However, MS did not consider that the information supported setting conditions of use.
Draft Commission Regulation amending Commission Regulation (EU) No 432/2012 and authorising an Article 13 health claim (EFSA-Q-2011-00972)
The Commission presented a draft Regulation that would authorise a health claim for sugar beet fibre “contributes to an increase in faecal bulk” submitted under Article 13(5) of the claims Regulation.
New EFSA opinions (Q-2012-00839, Q-2012-01007, Q-2013-00015, Q-2013-00087)
EFSA has recently issued negative opinions on four health claim applications: VeriSol®P and change in skin elasticity leading to an improvement in skin function; Bimuno® GOS and reduction of gastrointestinal discomfort; Lactobacillus rhamnosus GG (LGG) and maintenance of normal defaecation during antibiotic treatment; and Transitech® and improvement in bowel function. There were no comments from MS.
AOB – matters of interpretation of the nutrition and health claims Regulation (1924/2006)
Delegates briefly discussed whether an image of a heart on a food label (considered an Article 10(3) non-specific claim) could be accompanied by an authorized Article 14(1)(a) claim e.g. “X reduces blood cholesterol, high cholesterol is a risk factor for the development of coronary heart disease” or by an authorized Article 13.1 claim e.g. “Y contributes to maintenance of normal blood cholesterol levels”? Some that spoke considered that the overall context of the image and what it conveyed to consumers should be considered case-by-case. Others thought that a heart image conveyed a strong message and therefore should be accompanied by an Article 14 claim.
There were brief comments on whether the phrase “beneficial ratio of omega-3 and omega-6 fatty acids” on a food label was an Article 10(3) health claim? One MS said that, depending on context, it could be seen as an unauthorized nutrition claim, a statement of fact or a health claim. Others considered it to be an Article 10(3) health claim.
The next claims working group meeting is likely to be in mid-October.