European case law on the need for scientific justification to be able to use on hold health claims
A judgment of the Court of Justice of the European Union (Tenth chamber) was published on 10 September 2020 concerning the scientific substantiation for on hold health claims concerning foodstuffs (in the context of a dispute between the Konsumentombudsmannen (Consumer Ombudsman, Sweden) and Mezina AB). The Court concludes in particular that Article 5(1), Article 6(1) and (2), Article 10(1) and Article 28(5) of Regulation (EC) No 1924/2006 must be interpreted as meaning that, under the transitional arrangements provided for in the latter provision, the burden of proof and standard of proof in respect of the health claims referred to in Article 13(1)(a) of that regulation are governed by Regulation No 1924/2006, which requires the food business operator concerned to be able to justify, by means of generally accepted scientific evidence, the claims which it uses. Those claims must be based on objective evidence which has sufficient scientific agreement.
As a reminder, according to transition period in Article 28.5 of Regulation 1924/2006 on hold health claims (evaluated or not by EFSA) may continue to be used until a European regulatory decision on them only if they comply with general provisions of Regulation 1924/2006 and if they comply with specific national provisions. Particularly, the product must comply with Article 5 of Regulation (EC) No 1924/2006. The use shall only be permitted if nutritional or physiological effect is justified, as established by generally accepted scientific evidence. It is important to remind that therapeutic wordings are forbidden for food or food supplements in all Europe. A case by case analysis is always necessary before using an on hold health claim.