DoH Interested Parties Letter, 15 September 2011
Nutrition claims
The Commission’s most recent revised draft proposal is circulated with this letter [for copy, see: Nutrition Claims Working Document]. The Commission plans to present a draft Regulation for a vote at Standing Committee on 13 October and we expect to see the text two weeks before the meeting, as usual.
Discussions on Article 13(5) and 14 health claims opinions
EFSA’s opinion is positive. The Commission is considering whether proprietary data protection can be granted in this case where the studies in question were needed to establish conditions of use (COU) but not the health relationship.
EFSA’s opinion is negative and the applicant has submitted comments. The Commission noted that while EFSA said that there was ‘insufficient’ evidence to establish a cause and effect relationship there is no process for further assessment of Article 14 claims.
EFSA’s opinion is negative and there have been no comments from stakeholders.
EFSA’s opinion is negative and there have been no comments from stakeholders.
EFSA’s opinion is positive and there have been no comments from stakeholders.
List of article 13 health claims.
It was suggested that it might be better to turn this health claim into a nutrition claim (e.g. ‘low lactose’ or ‘lactose-free’) with defined thresholds. However, EFSA has said that it’s not possible to set such thresholds due to variation in individual tolerances. Delegates were asked to consider whether a ‘reduced lactose’ claim (i.e. a comparative nutrition claim entailing 30% reduction compared with other products) would be useful to consumers.
It was suggested that the COU should require use under medical supervision.
The COU currently proposed say ‘In order to bear the claims, a food should contain a maximum of 250 kcal/serving and comply with specifications laid down in Directive 96/8/EC’. In light of the Commission’s proposal to revise the parnuts legislation, which would repeal Directive 96/8, delegates discussed whether it was better to retain the reference to the Directive or to include detailed compositional requirements encompassing those from 96/8.
It was suggested that it would be inappropriate to authorise claims without COU since this would be contrary to various requirements of the nutrition and health claims regulation, would make it impossible for food business operators to know how to use them and would make enforcement impossible.
It was suggested that there might be certain population sub-groups that could benefit (e.g. sportsmen might need higher sodium intake than others) so it might be possible to specify particular target populations other than the general population.
There was some support for adding more detail to the choking warnings for glucomannan, guar gum, pectins and HPMC. Some delegates expressed concerns over the safety of caffeine when consumed by sportspeople; others consider that the fructose claim should include a warning for diabetics. Certain DHA claims are on hold pending EFSA’s safety assessment of DHA due next year.
It was confirmed that botanical claims that have received negative EFSA opinions and which would have qualified for being put aside during the current reflection process will not be rejected when the list of authorised Article 13.1 claims is published. They will be handled in the same way as the botanical claims that have been set aside.
Further assessment process
It was confirmed that Member States should send paper and electronic (CD) copies of applications to the Commission for onward transmission to EFSA.
Guidance on the verification of validity of applications for authorisation of health claims
Since the last draft (November 2010) a few additions, but no substantive changes, have been made. This document will go to standing committee on 13 October for agreement.
Next meeting
The date for the Commission working group meeting in October is to be confirmed.