DoH Letter, 29 September 2011

CLAIMS - Draft list of permitted Article 13.1 Health Claims, September 2011

A copy of the Commission Working document mentioned in this letter is available on this site. See: Commission Working Document - September 2011

The European Commission has prepared a draft list of permitted Article 13.1 health claims in the form of an annex to a regulation. The attached Commission Working document shows the proposed list of claims and conditions of use as they stand at present and we would welcome your comments on them by 17 October. In particular, we would be interested to receive your comments on how to handle the following issues:

1. Claims on substances for which there is no evidence of deficiency in the general EU population e.g. most vitamins and minerals.

2. Claims where no dietary intake is required e.g. “calcium contributes to normal neurotransmission and muscle function” where the claimed effect is not directly related to calcium consumption.

3. Wording of claims

• Claims that may not be understood by consumers due to the use of scientific terms such as “cell differentiation”, “homocysteine metabolism”, “energy yielding metabolism”, “neurotransmitters” .
• Claims that could be considered “medicinal” e.g. “lactulose contributes to a reduction in intestinal transit time”.
• General, non specific claims e.g. “vitamin D has a role in the process of cell division”.
• Mental/psychological/cognitive function claims e.g. “pantothenic acid contributes to normal mental performance”.

4. Comparative claims

• Replacing one ingredient with another e.g. “consumption of food/drinks containing (name of sugar replacer) instead of sugar induces a lower blood glucose rise after meals compared to sugar containing foods/drinks”.

5. Claims for substances considered as medicinal in some Member States e.g. melatonin.

6. Claims giving rise to safety concerns

• Choking: should the conditions of use for claims on glucomannan, pectins, hydroxypropyl methylcellulose, and guar gum include a requirement to give a warning about the risk of choking? Should these claims be authorised?
• Caffeine claims and the risks associated with high consumption by certain groups of consumers.

7. Claims which could be perceived as contradicting Member States’ national dietary recommendations e.g. “fat contributes to the normal absorption of fat-soluble vitamins”.

8. Claims for which no conditions of use (COU) have been proposed by EFSA e.g. “consumption of foods with reduced amounts of lactose may help to decrease gastrointestinal discomfort caused by lactose intake in lactose intolerant individuals”, “arginine contributes to the maintenance of normal ammonia clearance”.

9. Claims with problematic conditions of use e.g. for meal replacement products where the COU require the product to comply with Dir 96/8/EC yet to contain a maximum of 250 Kcal/serving.

10. Wording and COU for “maintenance” claims where the evidence is about “reduction” e.g. “plant sterols/stanols contribute to the maintenance of normal blood cholesterol”.

Please give the reasons for your views and, where applicable, reference the evidence upon which they’re based.