FSA Letter, 6 August 2009
As mentioned in our recent update letter, at the Commission Working Group meeting on 17 July the Commission announced that EFSA was unable to assess certain claims. A list of these claims has been sent to Member States for comment, and the UK claims affected are shown on the attached spreadsheet [SeeExcel spreadsheet at: Claims Spreasheet]. As the likely consequence of this exercise is the withdrawal of these claims from the Article 13 process, or a negative opinion being given by EFSA, we are writing to offer submitters the opportunity to provide further clarification. Submitters should note that the issues detailed below may not be confined to claims on the attached spreadsheet and it is possible that further decisions on other claims could be taken on these principles.
EFSA is unable to assess claims that:
1) Relate to a comparative health effect where the comparator is undefined
EFSA has stated that it cannot assess claims about a health effect that, rather than referring to a direct relationship between consumption of a particular food and health, results only when the food is eaten instead of another product which has not been clearly defined e.g. “keeps you feeling fuller for longer”, “kinder to your teeth”. These are indicated on the attached spreadsheet by a number 1 in column E (“comparative”). If submitters are able to clearly define the comparator for these claims, and this is supported by the scientific evidence, the Agency will pass these comments to the European Commission to consider. However, please note that consideration will also be given to whether these claims are useful to consumers. For example, if a product claims to keep you feeling fuller for longer, but this is in comparison to drinking water, then the claim is likely to be misleading. Also, these claims must not give rise to doubt about the safety or nutritional adequacy of other foods in accordance with Article 3(b) of the Regulation. Any other comments or justification for why these claims should be assessed under Article 13 are welcomed.
2) Relate to a food or food component that is a specific (brand named) product
The Article 13 list will be a generic list of health claims that can be used on any product meeting the conditions of use. If the food component is a specific product and the evidence submitted in support of the claim refers to that specific product then the applicant should re-submit it for assessment under Article 13(5) and withdraw it from the Article 13 list. We recognise this could impact on the transition period available for claims about psychological and behavioural functions (Article 13(1)(b)) and slimming and weight control (Article 13(1)(c)) and will ask the Commission what the consequences of this are likely to be. If the evidence relates to a generic component or ingredient within the specific product then this must be made clear to EFSA to enable the claim to be assessed under Article 13. The Agency is inviting submitters to clarify the food component for claims on the attached list where the number 1 appears in column F (“product specific”). If you are unable to provide clarification it is likely that these claims will be withdrawn from the Article 13 process.
The Commission have asked Member States to comment on these claims by mid-September so your comments are requested by 9 September. Please clearly state the ID number(s) of the claim(s) to which your comments relate.
Please ignore the clarification code in column G of the attached spreadsheet, as this does not take into account the information submitters provided recently to clarify these claims for EFSA. The Agency has passed your comments to the Commission so there is no need to repeat these.