FSA Letter, 20 July 2007
This letter is to update interested parties on recent discussion on implementation of Regulation (EC) 1924/2006 on nutrition and health claims made on foods. Please find enclosed two documents that were on the agenda of the Commission Working Group on nutrition and health claims on 2 July. The meeting had time only to consider the “Interpretative guidance”; the paper about amendments to the Annex was not discussed. The agenda also looked at the Article 13 process, an update on nutrient profiles and the transition period for claims referring to children's health and development. This is reported below.
The Commission outlined how they foresaw dealing with the Article 13 health claims process, and asked Member States for an update on collection of these claims. Where some Member States are doing more than screening claims for eligibility, this fuller assessment is likely to represent only a part of their final list. The Community list is likely to cover between 700 and 1000 claims.
The Commission reported back on progress by EFSA on establishing a model nutrient profile for testing, and publication of their opinion on the scientific basis for nutrient profiles, required by January next year. A first model should be ready in September, and would need to be tested against a database of foods to see how a broad range of European products would perform.
Claims referring to children's development and health
The Commission presented its proposal (Doc No 11351/07) for a transition period for these claims. There was a consensus that a specific transition period should be applied to these claims. However, the Commission felt that the European Parliament (EP) would not easily accept this proposal and further concessions would be needed to secure agreement.
First, there was no specific date as a cut-off for the proposed transition period (this is due to use of existing text). Most Member States felt that January 2010 would be appropriate, consistent with that for Article 13 claims. Second, the Commission took the view that there should be a better indication of the group to whom these claims applied and suggested an upper age limit for children. The Commission conceded that it would be better to consider the growth period in light of the evidence substantiating the claim, but that this was possible within an upper figure of 18 - and if necessary this could be proposed. There was discussion about the lower age limit: at birth or at 3 years old were suggested because of PARNUTS legislation, but no conclusions emerged.
The Commission had drafted a paper to give guidance on the interpretation of some aspects of the Regulation. This was developed in response to questions raised in previous working groups on “borderline” issues. It seeks to differentiate between authorisation routes for different claims. The guidance proposes that claims based on general population data (rather than specifically on trials on children) and which do not mention children's health and development are subject to Article 13; claims that refer to children's health and development or are based exclusively on children's data are subject to Article 14. A number of Member States thought that claims from the Article 13 list should not be used on foods for exclusive consumption by children; these foods should only bear claims authorised under Article 14. This would include PARNUTS foods specifically for children. Others thought this approach should also extend to any foods where ranges or brands target children in advertising and packaging. This issue would be discussed again in September.
On the borderline between Article 13 and disease risk reduction claims, the guidance highlights examples and seeks to distinguish between maintenance and reduction. Thus, ‘maintains blood cholesterol' would be seen as Article 13, but ‘reduces blood cholesterol' would be Article 14. Some Member States pointed out that this interpretation did not reflect the reality of the market, where such claims are being made. The Commission agreed that there were differences between current interpretations in Member States; on cholesterol and stanols / sterols, this was a special case because these claims fell under Commission Regulation 608/2004. However, the Commission thought that for other substances the majority of Member States did not have cholesterol reduction claims and this should form the basis of the guidance. As Member States had different approaches on this point, it will be discussed again in September. The UK will maintain its position that whatever the eventual classification of these claims, those that are on the UK market should remain pending authorisation and if successful continue on the Community list.
On the borderline between Article 13 and the “contains” claim in the Nutrition Claims Annex, there was common agreement to the interpretation that where the claim is about a function (e.g. any substance with an antioxidant function), even though it may look like a content claim – “contains antioxidants” – this would require Article 13 authorisation.
The guidance also looks at comparative claims and the operation of Article 9. It includes “as much as” as a comparative claim, discusses interpretation of comparison between and within food categories, and the reference product with which a comparison is to be made. This seeks to deal with comparisons of different product types, such as soy “milk” products with cows' milk, and what the range of appropriate products for comparison might be. While most Member States appreciated the spirit of the guidance, they noted that comparisons such as “as much as” were not within the scope of Article 9, and thus the Regulation as a whole. The Commission disagreed with this view.
The paper also sought to prompt discussion about how reformulation of foods could be communicated to consumers. The UK described its experience of reformulation, underlining that this was a step process (for technical or organaleptic reasons) and could not be represented in amounts that would meet the comparative claims criteria in the Regulation. The UK message was that ways to communicate the changes in formulation were important for both consumer and manufacturer. The Commission, agreed that reformulation was an important strategy and part of the EU platform on diet and health commitments and so it was important to consider how to communicate this within the bounds of legislation.
There was no time to discuss the second paper on additions to the Nutrition Claim Annex.