FSA Interested Party Letter, 10 June 2008
Two Commission documents were circulated with this letter are are available on this website. See
The Commission Working group on Nutrition and Health claims met on 5 June. The agenda comprised of nutrient profiles and Article 13 health claims process.
The Commission presented its working document with the results of a first pass at a nutrient profile model. The Commission said it would make the full database available to Member States once it had undergone another verification exercise. A full discussion of the working document will take place at the next meeting on 4 July when definition of food categories, and approach on the generic profile and exemptions would be discussed in detail.
The meeting then considered the final stage of the Commission process to consolidate the Community list of Article 13 health claims for assessment by EFSA. A paper outlined the criteria for eligibility applied and that Member States would receive a copy of the list in sections for a final consultation. We would get two weeks to comment after receipt of the relevant section. The last deadline is 14 July.
Under AOB the Commission clarified that it would not be able to discuss amendment of the annex of nutrition claims until the beginning of 2009.
The Commission introduced its paper (see link above) testing a prototype ‘generic' nutrient profile model featuring 3 nutrients – saturated fat, sugar, sodium – with thresholds set at levels of WHO dietary recommendations. The results of testing on the EFSA database of test foods were shown by food group (these are an EFSA categorisation) on a per 100g and 100Kcal base. The paper also discussed how to achieve the EFSA recommendation for possible exemptions for certain food categories, suggesting either a blanket exemption (for food supplements, some PARNUTS foods, small portion consumption products with a qualifying factor of less than 25Kcal energy content and some fruit and vegetable products) or by way of an amended threshold. A tool in excel has been developed to manipulate the source data and the formulas to calculate compliance with whatever threshold level is set. Under questioning the Commission acknowledged that there was a concern about the strength of the source data. Some Member States signalled they would be sending supplementary data and the Commission was attempting to get data from industry.
The Commission asked Member States to consider the food categories definitions for operation of amended profiles to allow exemptions. For example, if fruit and vegetables were to be given a blanket exemption, should this apply to processed fruit and vegetables, where would juices and juice/water combinations fall and if some fruit and vegetable products were excluded from the blanket exemption, should an amended profile also be considered? The Commission stated that nothing was ruled in or out at this stage, including choice of nutrient, base, use of food categories and how amended profiles might operate. Member States proposed adding categories, e.g. bottled waters, honey, and frozen fish. The Commission said that discussion of additions to the list already set out in the EFSA opinion was not an option, but after further testing of the profiles this might be reviewed.
Article 13 health claims
The Commission presented a paper (see link above) summarising its approach to co-ordinating claims into a final draft Community list to be submitted to EFSA. This paper confirmed the exclusion factors at this stage, based on the requirements clearly set out in the Regulation. When questioned about the clarification around conditions of use the Commission said that conditions of use were required for EFSA to be able to make a proper scientific assessment and that claims without explicit conditions of use would not be submitted. It acknowledged that this may not have been clear during the period industry was submitting claims and so an opportunity would be given to supply missing conditions of use. For practical purposes, the Commission had decided on a rolling consultation up to 14 July, allowing Member States only two weeks to elicit comments on each of the 9 groups of claims in the final list. The Commission resisted attempts to extend the deadlines for this, saying that EFSA will need the consolidated list by the end of July at the latest to manage its work. For any residual exceptional problems, the Commission could consider a supplementary list at the beginning of September.
Some Member States queried the inclusion of what appeared to be Article 14 “children's claims”, and thought these should have been excluded. The Commission, supported by various Member States noted that the interpretation in the Commission guidance was used and while some Member States were now questioning this, it should not affect submission to EFSA.
EFSA had tabled a paper on progress on Article 14 claims, with a number of questions on about 2% of all submissions. The Commission said these questions were more in the nature of risk management and not really for EFSA; Member States were asked if they should filter claims before submission. A problem of legality arose: the Regulation requires Member States to validate Article 13(5) claims, but Article 14 claims are to be passed direct to EFSA. If a new procedure is required, how this could be put into effect needed looking into. The Commission said it would consider further and consult Member States again.
The Commission confirmed that it would not be able to begin consideration of amendments to the Annex of nutrition claims until January 2009 at the earliest, but that transition periods allowed this delay.
On Article 11 and whether international (and European) associations and health related charities could be treated in the same way as national associations, Member States and the Commission agreed that this should not present a problem.
Date of next meeting: 4 July.
For previous news item on this topic, see: 13 May 2008 CLAIMS - Commission Working Group on Nutrition and Health claims, 21 April 2008