DH Letter, 26 May 2011

CLAIMS - Update from the European Commission’s Working Group meeting on nutrition and health claims, 23 May 2011

Nutrition claims – discussion on revision of the list of permitted nutrition claims

The Commission introduced a new proposal which: takes into account earlier drafting comments; introduces new conditions of use for the ‘reduced’ claim when referring to saturated fat or sugars; and foresees an 18 month transition period should the claims be authorised. The Commission expressed unequivocal support, at the highest levels, for the reformulation claim and urged member states (MS) to accept it in the interests of public health. A draft regulation is likely to go to Standing Committee in July.

The text of the proposal is annexed to this letter [see Commission’s proposal] and we would welcome your comments on it by Friday 10 June. In particular, we would be interested to receive your comments on the following points:

• Is the proposed transition period acceptable?
• With regard to claiming ‘reduced saturated fat’ or ‘reduced sugars’, what impact would result from the new conditions of use?

Discussions on health claims opinions received from EFSA and related comments from the applicant/members of the public

Q-2008-0397 and Q-2008-0398: Protequine and reduced risk of ‘flu and common cold; Protequine and reduced risk of common cold with sore throat (Article 14)

Both EFSA opinions are negative; the Commission has not yet received any comments.

Q-2009-00197: alpha-linolenic acid (ALA) contributes to brain and nerve tissue development (Article 14 children’s development and health)

The EFSA opinion is positive and does not limit the target population to infants and young children; the target population can therefore be extended to include all children up to 18 years of age. The Commission has been reflecting upon previous discussions and MS’ written comments to try to set conditions of use for the ALA claim in EFSA Q-2008-666 and potentially amend the conditions of use (COU) for the ALA claim already authorised (Q-2008-079, Commission Regulation 983/2009). A draft Regulation covering these three claims may be submitted to Standing Committee after the summer.

Q-2009-00776: oat beta-glucan and lowering blood cholesterol and reduced risk of heart disease (Article 14)

EFSA reiterated its advice that the cholesterol-lowering effect of oat beta-glucan (OBG) depends partly upon molecular weight (MW) but that the evidence presented did not permit a threshold MW to be identified. The Commission therefore proposed authorising the claim without setting such a threshold noting that should new scientific data become available the COU could be amended in future.

The Commission asked for MS’ views on whether the COU should require information to be given to the consumer that a food bearing the claim is intended for individuals wishing to lower their cholesterol (to parallel the labelling requirement for plant sterols and stanols). This initiated a discussion on the pending Article 13 claim for OBG and maintenance of normal cholesterol levels. In each case, substantiation relies upon cholesterol reduction and EFSA confirmed that it’s not possible to distinguish between them scientifically (e.g. in the magnitude of the effect). MS were asked to consider whether to authorise the Article 13 and the Article 14 claim or just one of them. The group noted that if it decides to authorise the Article 14 claim and not the Article 13 one for OBG it will need to decide whether to authorise an Article 13 claim for the other beta-glucans included in the proposed Article 13 claim.

The Commission will send proposed conditions of use for the Article 14 claim to MS for comments. A draft Regulation is likely to go to Standing Committee in July.

List of article 13 health claims.

Some MS gave comments on claims with positive opinions in EFSA’s fourth batch of opinions; these included:

• concerns that, as in previous batches, many claims would not be understood by consumers;
• concerns that claims for caffeine might encourage over-consumption;
• a view that claims about water, meat, fish and poultry were not claims but simply dietary advice;
• concerns over the safety of betaine;
• a view that the claims for activated charcoal and arginine might be medicinal;
• concerns that the claim for walnuts could encourage consumption of a food with a high fat content;
• views that many of the COU needed to be more precise.

MS will submit comments in writing.

The Commission is preparing a draft positive Article 13 list, in the form of an annex to a draft regulation, which it plans to present to MS after the summer.

Further assessment of certain Article 13 claims - update

The Commission has considered MS’ comments from the 14 April ad hoc meeting and has decided to keep the scope of the process as originally proposed. It will write to MS shortly to officially launch the process and give details including deadlines and justification for the scope. In response to questions, the Commission said that adoption of the list of authorised Article 13 health claims could go ahead while the further assessment process and reflection on how to deal with botanicals were underway; the legal instrument adopting the list would make provision for the claims concerned.

Botanicals

The Commission acknowledged that the decision to exclude health claims for botanicals from assessment during a period of reflection was taken after opinions on some botanical claims had been published in the first three batches; where appropriate these will be reflected upon further.

Arrangements for a meeting on issues of interpretation of the NHCR

The Commission is proposing a two-day working group (WG) meeting in October to accommodate this discussion. The agenda will include the following issues: healthcare professionals (definition / communication of health benefits to HCPs and by HCPs); business-to-business communication; use of the statement ‘clinically-proven’; claims that make reference to recommendations of associations other than those in Article 11; whether dietary guidelines are in scope; use of the term ‘unsalted’; scope of ‘contains other substance’ (e.g. lycopene); applying transition measures now deadlines are passed.

If you would like to suggest other items, please send them to me by 1 July along with examples to facilitate discussion.

Commission guidance documents

Commission guidance on MS’ responsibility for validity checks is in intra-Commission consultation and will be put to Standing Committee soon.

Commission guidance on using authorised health claims in compliance with the NHCR will need to take into account all the discussions on authorising Article 13 claims; it has therefore been put aside for now and the current draft is likely to be thoroughly revised.

Derogations for generic descriptors e.g. ‘digestive’ biscuits

The Commission will not begin work on implementing measures until after two current European court cases have concluded.

The next claims working group meeting will be on Monday 20 June.