FSA Update Letter, 27 July 2010
The following is the text of an update circulated by the FSA:
Health claim applications, EFSA opinions and draft decisions
EFSA opinions Q-2010-027, 028, 029, 030, 031 (Slimaluma 'helps to reduce waist circumference', 'helps to reduce body fat', 'helps to reduce body weight', 'helps to reduce caloric intake', 'helps to control hunger / appetite'); Q-2009-00767 (a combination of blackcurrant seed oil, fish oil, lycopene, vitamin C and vitamin E 'helps to improve dry skin conditions'); Q-2008-667 (Yestimum 'initiates appropriate innate and adaptive immune responses')
Strictly speaking these Article 13(5) health claims, if rejected, should not be given the six-month transition period referred to in Article 28(6)(b) of Regulation 1924/2006 since they were received after 19/01/2008. However, up to now, other 13(5) claims in the same position have benefited from a transition period except in one case where the claim was not on the market at the time it was rejected. The Commission would like to give all rejected claims a six-month transition period; it will consider further over the summer.
Q-2009-00940 (daily amount of calcium or calcium + vitamin D needed to claim reduction in the risk of osteoporotic fractures in women 50 years and older).
At the next meeting the Commission will propose conditions of use for the Article 14 claim referred to in EFSA-Q-2008-721 on the basis of this EFSA opinion.
Health claim applications still under validation
The Commission urged member states (MS) to deal with the 117 children's health claims and the 13 disease risk reduction claims that have been under validation for two years by withdrawing them or getting companies to provide the information needed to complete validation. None of these are UK claims.
Article 13 health claims
Working document outlining the envisaged process for further assessment of certain Article 13(1) claims already assessed by EFSA.
The Commission reiterated that the only claims that would be eligible for this process were those where EFSA had said that there was insufficient substantiation of a cause and effect relationship and those where there was insufficient characterisation of micro-organisms.
Health claims in the first series of EFSA opinions for which EFSA concluded that there is sufficient evidence for substantiation
Conditions of use
EPA / DHA: Several MS wondered if there might be safety concerns over the daily intakes proposed (3g for maintenance of normal blood pressure; 2-4g for maintenance of normal triglyceride concentrations) but said that, if not, foods bearing the claims should be required to contain more than 15% RDA in order for consumers to stand a realistic chance of consuming enough to get the benefit. They proposed removing these two claims from the annex to the draft Regulation for now. EFSA agreed that above 3g/day there is a risk of bleeding but reiterated that the claimed effects are only achieved with daily consumption of the quantities proposed. The discussion was inconclusive.
ALA, LA: Some MS wondered if it was feasible for consumers to consume the required daily amounts (2g ALA or 10g LA for maintenance of normal blood cholesterol concentrations).
Beta-glucans: several MS and EFSA supported the UK's proposed changes to the conditions of use to bring it into line with the claim authorised with that authorised by the Joint Health Claims Initiative.
Glucomannan: Several MS thought that foods containing glucomannan as an ingredient, particularly the 4g for the claimed effect, might need to carry a warning about the risk of choking; they also queried whether it could be used as an ingredient rather than as an additive.
Wording
Lactase: the Commission proposed amended wording to make this more like a health claim: "lactase improves lactose digestion for people unable to digest lactose easily". Several MS were still unsure about approving the claim.
Health claims in the second series of EFSA opinions for which EFSA concluded that there is sufficient evidence for substantiation
Vitamin D contributes to the normal function of the immune system and healthy inflammatory response. The reference to 'healthy inflammatory response' may need to be amended in light of other health claim applications EFSA is currently considering.
Regular consumption of guar gum contributes to the maintenance of normal blood cholesterol levels. MS may need to consider the same issues as for the conditions of use for beta-glucans.
Melatonin contributes to alleviation of subjective feelings of jet lag. Many MS consider melatonin to be medicinal.
Meal replacement products (as defined in Dir 96/8/EC): substituting two daily meals in the context of energy restricted diets helps to lose weight / substituting one daily meal and one snack helps to maintain body weight after weight loss. One MS noted that the conditions of use for these claims require products to contain a maximum of 250 kcals however Dir 96/8/EC permits a maximum of 400kcals / meal replacement product. EFSA said that the 250 kcal limit was based upon the evidence submitted to substantiate the claims; it doesn't mean that meal replacements containing 250-400kcal don't work as slimming/weight maintenance products it’s just that they can't carry this claim. The Commission does not intend to amend 96/8/EC in light of these claims.
Interpretation of Regulation 1924/2006 on health claims
Article 1(2). One MS asked whether claims made about food ingredients (as opposed to foods delivered to the final consumer) were subject to the Regulation. The Commission pointed out that 'health claim; is defined as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Some MS consider that claims made in any commercial communication (whether or not destined for the final consumer) fall within the scope. This was an unfocussed discussion and there was no obvious conclusion.
Discussions about Article 7(2) and Article 12(c) were postponed to the next meeting.
AOB