December 1, 2020

Botanical health claims: Clarification from the Court of Justice of the European Union

On September 10, 2020, the Court of Justice of the European Union (“CJEU”) ruled on health claims referencing the effects of plant or herbal substances, commonly known as botanical substances (“Botanicals”), in case C-363/19. The CJEU held that the standard of proof and the burden of proof required for the health claims cited in Article 13.1.a of EU Regulation No. 1924/2006/CE (“Regulation”) are governed by the Regulation itself and not by national provisions. Indeed, a food business operator that uses a health claim in connection with Botanicals should be able to prove the genuineness of the effects of the substance by means of objective and scientific evidence supported by sufficient scientific agreement. However, it is left to national law to set out how evidence is to be provided and the methods for obtaining it.

Furthermore, the CJEU clarified that in case of conflict between the provisions of the Regulation and those of EU Directive No. 2005/29/CE concerning unfair business-to-consumer commercial practices in the internal market (“Directive 2005/29”), the Regulation shall prevail.

This judgment of the CJEU seems to confirm the approach followed by the Italian administrative court of last instance (“Council of State”) in a recent decision on a similar case.

1. European legal framework for health claims regarding Botanicals

The Regulation governs health claims regarding food supplements and, in particular, Article 13.3 requires the European Commission (“EC”) to create a list of permitted claims, as these have been only partially established by means of EC Regulation No. 432/2012, which set forth a list of permitted health claims about foods, other than those referring to the reduction of disease risk and to children’s development and health (“Regulation 432/2012”). Claims may be included on this list subject to prior consultation of the EC with the European Food Safety Authority (“EFSA”).

Nevertheless, Regulation 432/2012 does not yet include a number of claims regarding the effects of Botanicals submitted to the EC for evaluation for which the EFSA has yet to complete a scientific evaluation. These claims are subject to the transitional arrangements set forth in Article 28.5 of the Regulation, meaning that operators can use them, under their own responsibility, provided that they comply with the Regulation and with existing applicable national provisions.

2. The case at issue and the stance of the CJEU

In this case, the Swedish Consumer Ombudsman (“SCO”) brought an action before the Swedish Patents and Market Court (“Court”) asking that a company that produced and marketed natural remedies and food supplements (“Company”) be prohibited from making specific health claims in marketing its products. The health claims referenced specific substances (Botanicals) – including, among others, ginger, rosehip, and blueberry – and were the subject of an application for inclusion in the list under Article 13.3 mentioned above. The health claims also referred to general properties, such as encouraging “stomach balance” and helping to “maintain normal vision.” The SCO submitted to the Court that those claims did not meet the requirements of the Regulation or the applicable national law.

Against this backdrop, the Court decided to stay the proceeding and to refer to the CJEU five questions for preliminary ruling.

In particular, the referring Court asked whether certain articles of the Regulation are to be interpreted as meaning that, under the transitional arrangements set forth in Article 28.5 of the Regulation, the burden of proof and the standard of proof required with regard to the health claims cited in Article 13.1.a of the same are governed by the Regulation rather than by national law.

In addition, the referring Court asked which provisions shall be applied in the event of a conflict between provisions of the Regulation and those of Directive 2005/29 on unfair business-to-consumer commercial practices.

3. The judgment of the CJEU

The CJEU held that the Regulation governs both the standard and the burden of proof required in Article 13.1.a.

As regards the standard of proof, the CJEU clarified that a health claim should be based on objective and scientific evidence supported by sufficient scientific agreement as to the benefits of the substance. Thus, the evidence should not be limited to beliefs, hearsay, or the observations or experiences of persons outside the scientific community.

Concerning the burden of proof, the CJEU held that operators should be able to justify the health claim made. Indeed, both Article 28.5 and Article 6.2 refer to operators as the parties responsible for the claims and the parties that should justify the use of the claims. Nevertheless, the Regulation does not require them to produce a particular kind of evidence (e.g., evidence prepared by appropriate institutions), provided that the evidence is of sufficient scientific value.

Consequently, since the Regulation does not govern how evidence is to be provided or the methods for obtaining it, these aspects are regulated by national laws, subject to application of the principles of equivalence and effectiveness.

Finally, in case of conflict between provisions of the Regulation and those of Directive 2005/29, the CJEU stated that the Regulation shall prevail and shall apply to unfair commercial practices in relation to health claims. Indeed, Directive 2005/29 applies only in the absence of (a) specific European or national provisions on health and safety aspects of products; and (b) specific European provisions regulating aspects of unfair commercial practices. In this case, the Regulation contains specific rules on health claims, constituting a special rule as compared to the general rules on protection of consumers against unfair commercial practices.

4. CJEU judgment impact in light of Italian case-law

In the context of the CJEU judgment, it is worth mentioning a recent decision of the Council of State (judgment No. 2371 of April 10, 2020) providing significant clarification regarding health claims that can be used with respect to Botanicals.

In that judgment, the CJEU confirmed the Council of State’s stance on the lawfulness of health claims. Indeed, the Council of State clarified that the fact that Botanicals are not included in the list under Regulation 432/2012 does not per se indicate that related claims are unlawful, since the relevant authorities are still carrying out the necessary evaluation of such claims; as a result, the claims are subject to the transitional arrangements under Article 28.5 of the Regulation.

Furthermore, the Council of State maintained that the competent authority – which, in that case, sanctioned the operator for unlawful health claims concerning Botanicals – must consider the scientific evidence produced by the operator and assess whether it is sufficient to substantiate the properties of the Botanicals described in the health claims. That approach appears to be in line with the principle set out by the CJEU: that the lawfulness of the claim should be assessed in light of the evidence provided by the operator concerned.

Nevertheless, the CJEU added a very significant statement concerning the prevalence of the Regulation over Directive 2005/29 in case of conflict. This raises a very interesting issue regarding the criteria to be used by the authority vested with the power to enforce the breach of provisions concerning health claims for food supplements.

Indeed, in Italy the Italian competition authority (“AGCM”), in its role as the authority in charge of overseeing business-to-consumer commercial practices, is the entity that generally sanctions operators for breach of the Regulation that results in an unfair commercial practice (while the Ministry of Health is the authority in charge of enforcement of the Regulation). Therefore, in the light of this CJEU’s judgment, question is whether the AGCM, for the purpose to assess if a certain claim for food supplements triggers an unfair business-to-consumer commercial practice, has only to check if such claim has been authorized under the Regulation or it can autonomously evaluate the proof provided by the operator on a case-by-case basis.

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