Food Law News - EU - 2011

DH Letter, 23 June 2011

CLAIMS - Update from the European Commission's Working Group meeting on nutrition and health claims, 20 June 2011

Nutrition Claims –Revision of the List of Permitted Nutrition Claims

“No added sodium / no added salt”

Compromise wording was suggested for the ‘no added salt/sodium’ claim that would make it a ‘no added salt’ claim only and would permit the inclusion of sodium-containing additives in products bearing the claim. This was to address concerns that otherwise it would inhibit product reformulation. However, there was general support for reverting to conditions of use (COU) that would also permit a ‘no added sodium’ claim.

“Now contains X% less”

Concerns about enforcement and compliance with Article 9 of the nutrition and health claims regulation (NHCR) were reiterated; however, there was also support for the claim. Some MS could not support the transition provision that would allow stocks to be marketed until exhausted. Drafting changes were proposed to avoid confusion over the 18-month transition period for the amended claims (‘reduced’, ‘increased’, ‘energy-reduced’ and ‘no added sugars’) and the 12-month period for use of an individual ‘now contains X% less’ claim.

“No added sugars”

There was discussion of the wording ‘with the same prominence’ and whether it should be replaced by ‘with the same visibility and legibility’ but there was no consensus.

A draft regulation covering this package of claims will be presented for a vote at Standing Committee on 11 July.

DISCUSSIONS ON NEW HEALTH CLAIMS OPINIONS RECEIVED FROM EFSA AND RELATED COMMENTS FROM THE APPLICANT/MEMBERS OF THE PUBLIC

Q-2009-00458 (Article 14) EFSA proposed wording: ‘Consumption of saturated fat (SFA)increases blood cholesterol concentrations; consumption of monounsaturated fats (MUFAs) and/or polyunsaturated fat (PUFAs) in place of saturated fat has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of (coronary) heart disease.’ EFSA proposed COU: in order to bear the claim significant amounts of mixed SFAs should be replaced by cis-MUFAs and/or cis-PUFAs in foods or diets on a gram-per-gram basis.

There were various concerns about the claim, namely that: the ‘significant amounts’ must be specified; it went against dietary advice to reduce saturated fat intake; a claim about a diet could be misleading; stating that SFA consumption was harmful cast doubt on the safety/nutritional properties of other foods; that the wording was too long. There was a suggestion that the COU be amended to require compliance with the COU for the ‘high unsaturated fat’ nutrition claim. The Commission will take this discussion into account as it continues to consider the wording of the claim.

Q-2010-01028: (Article 13.5) Lactobacillus rhamnosus GG and maintenance of defence against pathogenic gastrointestinal microorganisms

The Commission is awaiting comments from stakeholders; no MS commented.

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 said that this was not a health claim as defined in the NHCR since it was not related to a function of the body. There were differing views on whether the claim was within the scope of the NHCR. There will be a discussion of such claims (including e.g. those related to beauty) during the meeting about interpretation issues in the autumn.

CONSIDERATION OF HEALTH CLAIMS PREVIOUSLY DISCUSSED

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

Following MS’ recent comments, the Commission proposed authorising the following wording “Oat beta-glucan has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease.” and COU “Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 3g oat beta-glucan. The claim can be used for foods which provide at least 1g oat beta-glucan per quantified portion.”

There was a discussion about how to deal with this and the Article 13 claim which would have similar COU but a different target population (those wishing to maintain normal blood cholesterol). The Commission agreed that both claims were scientifically justifiable, that the Article 14 claim should be authorised, and said that it would like to find a way of authorising both claims with wording and COU that would be useful to consumers.

Article 13.5 ‘Toothkind’ claim

The Commission has asked EFSA for clarification on issues to do with this claim. The EFSA panel will consider its response at its plenary meeting of 28-30 June and there will be more discussion, in this working group, after that.

LIST OF ARTICLE 13 HEALTH CLAIMS

There was useful clarification on some issues to do with wording and conditions of use:

• For the claim “Live yogurt cultures in yogurt improve lactose digestion of the product in individuals with lactose maldigestion” the wording will probably be amended to refer to ‘yogurt or fermented milk products’. EFSA emphasised that the claim would not be valid for food supplements as the evidence was for improved digestion of lactose within the same milk product as the microorganisms.
• The COU for the wheat bran fibre claims should refer to wheat bran fibre specifically.
• The COU for the claim on resistant starch are not restricted to resistant starch from high amylose maize because EFSA considers the evidence to show that the same effect would be achieved by replacing easily digested starch by any slowly-digested starch.
• Substances authorised as additives would not be covered by additives legislation if used for their nutritional / physiological effect rather than for technological purposes.

A draft regulation will be discussed at Standing Committee on 11 July.

FURTHER ASSESSMENT OF CERTAIN ARTICLE 13 CLAIMS

The Commission is updating the DG SANCO website to provide information about the further assessment process. The Commission suggested that, to expedite submission and assessment, identical or very similar claims could be submitted through one MS rather than several however, some MS were concerned that there would be practical difficulties with this. EFSA clarified two points related to the format for submissions:

• Under section 2.2 EFSA requires paper and electronic copies of pertinent references only. Pertinent references are all those related to the claimed effect, both supportive and non-supportive. References that do not relate to the claimed effect should not be submitted.
• Under section 3.1, synopses of pertinent studies are required.

AOB

Article 27 of the NHCR requires the Commission to submit a report on the application of the Regulation to the European Parliament and to the Council by 19 January 2013. The Commission said that it was reflecting upon the timing of the report and how to gather information for it (e.g. from MS, research organisations).

NEXT MEETING

The next Commission working group meeting will be on Monday 18 July.