26 June, 2020

Judgment of the Court of Justice of the European Union on health claims

Regulation of health claims

Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (hereinafter Regulation 1924/2006), aims to harmonize the laws, regulations or administrative provisions of the Member States relating to nutrition and health claims. The purpose of this rule is to ensure the efficient functioning of the internal market while providing a high level of consumer protection.

Article 2.2.1 of Regulation 1924/2006 states that a claim means any message or representation that is not mandatory under Community or national legislation, including any form of pictorial, graphic or symbolic representation, which states, suggests or implies that a food has specific characteristics. There are two types of claims: nutritional and health claims.

Concept of healthy claims

A nutrition claim, according to Article 2.2.4 of Regulation 1924/2006, is any claim that states, suggests or implies that a food has specific beneficial nutritional properties by reason of energy, nutrients or other substances. Only authorized nutrition claims are allowed and only if they comply with the conditions set forth. The judgment that will be analyzed below refers to these statements as specific health claims.

Health claims, regulated by Article 2.2.5, are any claim that states, suggests or implies that there is a relationship between a food category, a food or one of its compounds, and health. Only those that are authorized or under evaluation are allowed. The judgment that will be analyzed below refers to these statements as specific health claims.

On the other hand, a general claim is that reference to general and non-specific benefits of the nutrient or food for general good health or health-related well-being. In this regard, account should be taken of the provisions of Implementing Decision 2013/63/EC, in relation to “Reference to general and non-specific benefits (Article 10(3))”:

“(…) For this reason, when we refer to general, not specific, health benefits, it is necessary to accompany these references with a specific health claim from the lists of health claims allowed in the Union register. For the purposes of the Regulation, the specific health claim accompanying the reference to general, non-specific health benefits must appear “next to” or “following” that reference.”

Therefore, general health claims can and should be accompanied by specific health claims from the lists of permitted health claims.

Judgment of the Court of Justice of the European Union on health claims

The Court of Justice of the European Union (CJEU) has ruled on two questions referred for a preliminary ruling by a German court.

The first question posed was about whether: “Article 10(3) of Regulation No 1924/2006 must be interpreted as meaning that the a requirement that any reference to the general and non-specific benefits of a nutrient or food must be accompanied by a specific health claim included in the lists referred to in Articles 13 or 14 of that regulation is satisfied where the packaging of a food supplement contains, on its front face, a reference to the general and non-specific health benefits of a nutrient or food, while the specific health claim intended to accompany that reference appears only on the reverse side of the packaging and there is no explicit cross-reference, such as an asterisk, between the two.”

Article 10(3) of Regulation 1924/2006 provides:

“Reference to general and non-specific benefits of the nutrient or food for general good health or health-related well-being may be made only if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.”

As stated in this precept, any reference to the general and non-specific benefits of a nutrient or food must be accompanied by a specific health claim included in the lists referred to in Article 13 or 14 of Regulation 1924/2006.

So where and how should these references appear on a package? The CJEU says that this obligation is not fulfilled when the packaging of a food supplement contains, on its front side, a reference to the general and non-specific health benefits of a nutrient or food, while the specific health benefit claim intended to accompany it only appears on the back side of that packaging and there is no explicit cross-reference, such as an asterisk, between the two.

That is to say, en all references to the general and non-specific benefits of a nutrient or food, accompanied by a specific health claim, should appear on the front of the package. However, a reference to the general and non-specific health benefits of a nutrient or food may be allowed to appear on the front side, and a statement of specific health benefits on the back side, if an explicit reference is made between the two sides, with an asterisk, for example.

The CJEU ruling of January 30, 2020, notes in this regard:

“Therefore, the visual dimension of the “accompanying” requirement under Article 10(3) of Regulation No 1924/2006 must be understood as referring to the immediate perception, by the average, reasonably well-informed and reasonably observant consumer, of a direct visual link between the reference to the general and non-specific good health benefits and the specific health claim, which requires, in principle, a spatial proximity or immediate closeness between the reference and the claim.

However, in the specific case where specific health claims are so numerous or extensive that they cannot appear in their entirety on the same side of the packaging as the reference they are intended to support, the requirement of a direct visual link could, exceptionally, be considered satisfied by an explicit cross-reference, such as an asterisk, where the latter ensures, in a clear and perfectly understandable manner for the consumer, the correspondence of content, spatially, between the health claims and the reference.”

The second question on which the CJEU was to rule was: “(…) whether references to the general and non-specific benefits of a nutrient or food for general good health or health-related well-being, pursuant to Article 10(3) of Regulation No 1924/2006, must be substantiated by scientific evidence within the meaning of Articles 5(1)(a) and 6(1) of that Regulation.”

Article 5, letter a, of Regulation 1924/2006, states:

“The use of nutrition and health claims shall only be authorized if the following conditions are met:

1. the presence, absence or reduced content in a food or category of foods 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, established by generally accepted scientific data”.

Por su parte, el artículo 6 apartado 1 de la citada norma europea, dice:

“Nutrition and health claims should be based on and substantiated by generally accepted scientific data.”

Thus, according to these precepts, health claims must have scientific value. But the CJEU was questioned as to how this requirement is met.

The CJEU has stated that it is sufficient for health references to be accompanied by specific health claims, included in the lists referred to in Article 13 or 14 of Regulation 1924/2006.

In other words, if these health claims appear in the lists provided for in Articles 13 or 14, the legal requirements are met.

It should be noted that the European Union has complied with the provisions of Article 20.1 of Regulation 1924/2006 (“The Commission shall establish and maintain a Community Register of nutrition and health claims made on foods, hereinafter referred to as “the Register”), and has established such registers. If the nutrition declaration is included in these lists or registers, its scientific value is presumed and it complies with the provisions of Regulation 1924/2006.