DH Letter, 19 July 2011

CLAIMS - Update from the European Commission’s Working Group meeting on nutrition and health claims, 18 July 2011

Nutrition claims

The proposal to amend the nutrition claims annex to the nutrition and health claims regulation (NHCR) is likely to be presented for a vote at Standing Committee on 12 October.

Discussions on Article 13(5) and 14 health claims opinions

Q-2009-00458 (Article 14) regarding replacement of saturated fats with unsaturated fats

There was a discussion about how to frame clear conditions of use (COU) and it was suggested that foods bearing the claim could be required to comply with the COU for the ‘high in unsaturated fats’ nutrition claim. However, it’s not clear how to word the requirement that a significant amount of saturated fatty acids must also have been replaced by unsaturated fatty acids.

Q-2010-01092 (Article 13.5) zinc and prevention of bad breath by neutralising volatile sulphur compounds in the mouth and oral cavity

EFSA’s opinion stated that the claimed effect did not relate to a function of the body therefore the application did not comply with the requirements of the NHCR. There was some discussion of whether this claim and others (e.g. beauty claims) were within the scope of the Regulation however no conclusions were reached and this issue will come up again at the working group on interpretation issues in the autumn.

Article 13.5 ‘Toothkind’ claim

In response to questions from member states (MS), EFSA clarified various aspects of its follow-up opinion. A further proposal for wording and conditions of use is likely to be made in the autumn.

List of article 13 health claims.

There was discussion of the following outstanding general issues:

• claims whose wording may not be understood by consumers and which therefore could be misleading;
• wording and COU for ‘maintenance’ claims where the evidence is about ‘reduction’ i.e. similar Article 13.1 and Article 14 claims such as those for plant sterols/stanols and blood cholesterol, beta-glucans and blood cholesterol;
• calcium claims where the claimed benefit is not directly related to calcium consumption;
• claims for nutrients where EFSA has commented that there’s no evidence of deficiency in the EU;
• claims for substances considered medicinal in some MS;
• the target population for claims about reduced post-prandial blood glucose rise;
• wording of ‘replacement’ claims e.g. sugar replacers for sugars, unsaturated for saturated fats;
• claims where there may be safety concerns;
• COU for claims about meal replacement slimming products;
• claims for which EFSA has not been able to propose COU;
• reasons for rejecting certain claims e.g. those that may be outside the scope of the NHCR.

No conclusions were reached and these points will be discussed again.

Further assessment of certain Article 13 claims

The Commission has put information about the further assessment process on its website. The list of eligible claims has been extended to include a total of seven from the fourth and fifth batches of EFSA’s opinions; one from batch six will be added when these opinions are published on 28 July. The deadlines for the further assessment process will remain unchanged unless it becomes obvious that they need to be amended to accommodate these few additional claims.

Two points about the process were clarified and one issue of concern highlighted:

• Where a ‘lead’ MS has no food business operators (FBOs) in its own country wishing to co-ordinate an application, it should retain lead responsibility for that claim and accept an application from a coordinating FBO in another MS if there is one.
• For ‘insufficient evidence’ claims, it may be problematic if FBOs are not willing to combine applications for claims which EFSA had grouped for the original assessment. It’s important to examine the EFSA opinions to see where the evidence was deemed insufficient as these areas are likely to be the same for grouped claims. It’s also important to note that these health relationships cannot now be changed and EFSA may still decide to assess them together.
• Some co-ordinating FBOs have said that they do not wish their contact details to be published on the Commission’s website. There was grave concern that this would hinder the inclusion of all relevant information in applications and that it would make it difficult for submitting MS to certify that all FBOs who wished to be involved were content with the final applications. Therefore, FBOs are urged to reconsider their positions.

Next meeting

The date for the Commission working group meeting in September is not yet confirmed.