FSA Letter, 9 June 2009
SUMMARY OF MEETING
The Commission reported on its plans to amend the nutrition claims Annex. It will make a proposal in the next few weeks for the addition of specific claims with conditions of use for: “source of” and “high in” omega 3 fatty acids; “high in” mono-, poly- and un-saturated fat; and to amend criteria for making ‘reduced' claims. Other claims would be considered, but no guarantee of action within transition periods. European trade organisations are lobbying on this.
Several Member States are hesitant about the proposed changes to 353/2008 on implementation of the claims application process which would require Member States to forward only valid applications and clarify when and how applications may be withdrawn.
EFSA explained the apparent discrepancy in opinions on DHA and confirmed that the difference was about development of the structure of the brain and effect on the function of the brain.
Amendment of the nutrition claims Annex
The Commission confirmed that it would make a draft proposal for discussion, but this would be confined to the five claims for fatty acids for which there was an EFSA opinion and about which there had already been some discussion. It would consider amending criteria for the reduced claim (from 30% to 25%) and the added sugar criteria to take account of table top sweeteners if Member States were in agreement. Member States were generally open to amendments, but there was no indication as to what other claims the Commission would be prepared to consider. The UK spoke about the importance of being able to communicate reformulation to consumers and that such an amendment should be considered. An industry proposal (from the Confederation of the Food and Drink Industries of the EU) for a claim based on a 10% reduction in a nutrient and comparing it to the product recipe, rather than another reference product, was on the table, but the Commission will need to be persuaded to include this in future discussions.
Stakeholders are requested to contact the Agency before the end of August with their views on industry proposals for a claim “contains x % less of energy, nutrients or other substances” - where the decrease is nutritionally significant or represents at least 10% as compared to the average composition in a category; and of any other claims which it is thought needs to be added to the Annex as a priority within the transition period.
Amendment to Commission Regulation (EC) 353/2008
The purpose of this amendment is to clarify the role of the Member State in forwarding only valid applications under Articles 13 and 14 of the Claims Regulation. The Commission introduced a revised text after consultation with EFSA. Several Member States expressed doubts about the ability to weed out all ineligible claim applications before an EFSA assessment. The Commission admitted they did not understand what difficulties could exist to this process and asked for written explanations. On the withdrawal of claims the text was simplified to reflect that an application for a claim could be withdrawn after submission up to the time that EFSA adopts its opinion, but after this it would have to go to Standing Committee for a decision. While Member States were generally content with this, several questioned how submitters could be kept up to date on the process and so have an opportunity to withdraw a claim; e.g. when would a claim be adopted. The Commission clarified that if EFSA goes back to the submitter for more information, failure to satisfy their request could have two consequences – the submitter would be invited to give a satisfactory clarification or withdraw the claim; failure to give a satisfactory clarification and not withdraw the claim would lead EFSA to give a negative opinion. The Commission would look at the text to see if this could be clarified, but it would have to be cautious about the language used in a legal text.
Article 13(5) and 14 health claims
Very brief comments were made on two draft Regulations due to go for a vote at the next Standing Committee (22 June). The UK asked for clarification on the EFSA opinion on Algatrium. EFSA explained that the biomarker was not validated. There were no comments on the three Article 14 claims for Melgaco mineral water, Kinder chocolate and Ocean Spray Cranberry juice. The Commission said it would finalise its proposals to reject these claims for a vote on 22 June. In response to a question, the Commission said it would consider the possibility of a written voting procedure for these applications, noting that similar procedures are followed elsewhere (e.g. the cosmetics sector).
New EFSA opinions
The Commission noted that it had loaded a number of new EFSA opinions and several comments from submitters and others onto its website to which Member States have access. The claim for milk protein and satiety excluded from the vote at last month's Standing Committee may go for a vote in June, although Member States were still undecided about how satiety claims should be treated. The Commission outlined three options: to require that there be a consequential reduction in energy intake and weight loss as a benefit from a satiety claim; to accept weight maintenance as the beneficial endpoint; or to note that satiety is proven but tell the consumer that this in itself has no discernable benefit. It noted that there are about 50 similar claims in the A13 list and so a precedent would be set here.
After discussion several Member States were of the opinion that satiety claims in their own right should be allowed, some with weight maintenance as the outcome, and others with the suggested warning to consumers. Some Member States insisted that without a consequential reduction in energy intake and weight loss, consumers would be misled by such claims. One was of the view that the Regulation required satiety to be linked to weight loss. UK noted that weight maintenance was one outcome of satiety claims, the question was whether this was beneficial, and whether such a claim with appropriate conditions of use would help rather than mislead consumers. The Commission said it would consider these comments for a proposal.
Discussion then turned to the apparent discrepancy between EFSA opinions on DHA claims (including ALA conversion to DHA). EFSA explained that there was no discrepancy, but that the issue was around the absence of intake values for DHA and the debate as to whether it is, or is not, an essential fatty acid (which is the case for ALA), and crucially the distinction between the claims which were for DHA and brain function and/or brain development. Evidence supported claims for the latter, but not the former. UK asked about the intake value of 0.3% total fatty acids where the Follow on Formula Directive had a value of 0.2%. EFSA said that it could not comment at this stage, but was in the middle of an exercise to establish reference values for fatty acids. Commission said that intake values could be revised in light of the result of this exercise.
The Commission gave an update on the A13 process and reminded Member States of deadlines on the clarification exercise. EFSA said several more general issues had come to light (not an exhaustive list):
Member States were not ready to comment, but the Commission said these issues would need to be solved in order to move forward. Member States were concerned about transition periods and not finishing the work in time. The UK raised the issue of clarification by means of very specific disease related and medicinal language, stating the belief that this should not rule claims out of scope because the clarification was specific to this exercise, to help EFSA make an assessment. After the assessment a decision could be taken on if and how claims can be expressed to the consumer and remain in scope. The Commission said it had heard similar concerns from industry and said it agreed that any clarification was intended to help EFSA make an assessment. A decision on the specific wording, with advice from EFSA, would follow a positive opinion; if no wording in scope is possible to reflect the science then the claim may get a negative decision.