Generic health claims, clarification from Court of Justice

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The EU Court of Justice, in a ruling on 30.1.20, clarified how to follow when a food label refers to generic health claims. (5)

Nutrition and Health Claims, the rules

Regulation (EC) No. 1924/06 – Nutrition and Health Claims, NHC – introduced in the EU the possibility of making nutrition and health claims about food products, in marketing information about them. Through uniform rules that also apply to trademarks and B2B(business-to-business) information, as well as labels and advertisements (including those on the Web and social media).

The NHC regulations define:

nutrition claims, ‘any claim that states, suggests or implies that a food has particular beneficial nutritional properties‘ related to the presence or absence of macro- or micronutrients, or other substances. (1) The only
nutrition claims
allowed are those mentioned in the Annex to reg. EC 1924/06. Therefore, to be understood as an exhaustive list,

health claim: ‘any claim that states, suggests or implies the existence of a relationship between a food category, a food or one of its components and health.’ (2)
The only health claims allowed are those expressly authorized by the European Commission, following scientific evaluation by Efsa.

In contrast, the difference between functional claim and disease risk reduction claim, provided for in Regulation (EC) 1924/06 in Articles 13 and 14, has been nullified in Regulation (EC) 353/08, which in fact prescribes an identical level of scientific demonstration of the health benefits being claimed for authorization.

General health claims

Claims that refer to general health benefits-and they often appear on the front of the label-express an immediate appeal. Consumers are attracted to a particular product because it is ‘good for health‘ or otherwise ‘favorable‘ for, say, a physiological function. These types of claims may be allowed provided they are congruent with a health claim that the product can boast of and actually boasts, in close proximity.

‘Reference to general, non-specific benefits of the nutrient or food for overall good health or well-being resulting from the state of health is permitted only if accompanied by a specific health claim included in the lists in Articles 13 or 14′ (EC Reg. 1924/06, Article 10.3).

The generic indication must therefore be corroborated by the specific one in both substance, that is, content, and form, and thus appearance. Indeed, the NHC regulation pursues the goal of ensuring a high level of consumer health protection (although the European Commission has not to date introduced so-called nutrient profiles, which are necessary to prevent the use of NHC on junk food).

Generic directions, the ECJ ruling

The European Court of Justice (ECJ) has been asked to decide on a question referred for a preliminary ruling by the German Federal Court of Justice regarding the application of Article 10.3 of Reg. EC 1924/2006. To clarify the indispensable relationship between generic and specific health claims made on the label. The Court recalls the special guidelines of the European Commission, where it is specified that the specific health claim should be placed ‘next to‘ or ‘after‘ the generic claim. (3)

In any case, the Court reiterates, the same general benefits must be scientifically grounded. Albeit in the absence of specific reference in Article 10.3 to the requirements in Articles 5 and 6 of the NHC Regulation above. (4) However, the scientific basis of generic claims can be considered to be fulfilled where precisely reference is made to a specific health claim included in the list in Annex to Reg. EU 432/12 as amended. (5)

Would an asterisk suffice?

In the particular case where the specific health claims cannot fully appear on the same side of the package as the reference they are intended to support, due to their large number or length, it should be considered that the requirement for a direct visual link could exceptionally be satisfied by an explicit reference, such as an asterisk, if the latter ensures, in a clear and perfectly comprehensible manner for the consumer, the correspondence in content, spatially, between the health claims and the reference‘. (6)

Thus, the asterisk on the label front may refer to indications that may exceptionally come on another side of the package. The case from which the controversy arose, for example, is that of a dietary supplement where the numerous authorized claims in relation to B vitamins were made explicit on the back of the box by means of a special reminder. However, it is up to the national court, the Court reiterates, to assess the circumstances of the case.

Dario Dongo and Alessandra Mei

Notes

(1) Regulation (EC) 1924/06, NHC, Art. 2.2.4

(2) NHC, art 2.2.5

(3)
Implementing Decision 2013/63/EU
Commission of January 24, 2013, adopting guidelines on the implementation of specific conditions for health claims as referred to in Article 10 of Regulation (EC) No. 1924/2006 of the European Parliament and of the Council (OJ 2013, L 22, p. 25), entitled “Reference to general and non-specific health benefits-Article 10(3).”

(4) ‘The use of indications nutrition and health is permitted only if the following conditions are met: a) the presence, absence or reduced content in a food or food category of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, based on generally accepted scientific data’ (EC Reg. 1924/06, Article 5.1.a).
Nutrition and healthclaims are based on generally accepted scientific data’ (EC Reg. 1924/06, Article 6.1).

(5) Case C 524/18, Dr. Willmar Schwabe GmbH & Co. KG v. Queisser Pharma GmbH & Co. KG.
ECJ Judgment 30.1.20
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(6) Conversely, the requirement ‘is not satisfied where the packaging of a dietary supplement has, on the front, a reference to general and non-specific health benefits of the nutrient or food, while the specific health claim intended to accompany it appears only on the back of that packaging and there is no express cross-reference, such as an asterisk, between the two‘ (judgment cited in footnote 5, para. 50).

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

Graduated in Law from the University of Bologna, she attended the Master in Food Law at the same University. You participate in the WIISE srl benefit team by dedicating yourself to European and international research and innovation projects.