News - November 26, 2022

Suspension in assessment of botanical health claims violates EU rule of law

Art. 28 para. 5 HCR is no longer applicable due to an unlawful act of suspension by the European Commission

The former president judge at the German Constitutional Court Professor Dr. Udo Di Fabio stated in a legal opinion that the suspension in the assessment of botanical health claims at the European Food Safety Authority (EFSA) by order of the European Commission is unlawful. The current standstill introduced by the European Commission in 2010 violates the principles of EU law. The transitional provision of Art. 28 para. 5 of Regulation (EC) No. 1924/2006 (Health Claims Regulation – HCR) therefore is no longer applicable. An application of the transitional provision would be contrary to its wording and would ignore the intention of the legislator. Those botanical health claims which yet have not been assessed by EFSA are not allowed to be used until they are finally assessed. Authorities and national courts are no longer supposed to tolerate health claims which are used solely on transitional provisions.

Consumer protection hampered

The current standstill cannot be justified on the grounds of consumer protection as it has the opposite effect: It leaves consumers absolutely in the dark about whether the concrete health claim is scientifically substantiated or not. “If it is not possible to scientifically substantiate a particular claim, that claim clearly must not be used towards consumers”, the legal opinion underlines with regards to the legal purpose of the HCR.

 Suspension by the Commission is contra legem

The clear intention of the legislator, who wanted all health claims to be evaluated in a timely manner, is ignored by the European Commission; its suspension order was contra legem. The suspension of the regulation due for implementation in 2010 resulted in an indefinite deadlock in evaluation of botanical health claims. The Commission by law is not empowered to simply extend the transitional provisions of a regulation on its own by a mere press release; this requires a formal law with the participation of all EU institutions involved in legislation. The Commission cannot refer to political reflection processes to justify the suspension but must rather fulfill its duties and obligations foreseen in the Health Claims Regulation (HCR). “The standstill can no longer be justified by technical difficulties of law enforcement but it is based on an unlawful decision of the European Commission”, states Professor Di Fabio’s legal opinion explicitly.

Transitional provision induces unfair competitive advantage for food operators

According to Professor Di Fabio it is for the Commission to now – finally – authorize EFSA to assess the remaining botanical health claims. The standstill conflicts with the purpose of the HCR which aims at educating consumers about the potential effects of food supplements. It also violates the right of equal treatment of manufacturers of chemical substances used in food supplements and of herbal medicinal products. As long as food operators are practically exempted from having the proof of efficacy endorsed by EFSA due to the indefinite application of transitional provision, they gain a tangible advantage over those companies which put the substance on the market as a medicinal product. For various reasons, foodstuff and medicinal products are neither factually nor legally comparable, and a simple transfer of the concept of traditional use from one system to the other is not appropriate.

Transitional provision inapplicable

Professor Di Fabio concludes: “The transitional provision of Art. 28 para. 5 HCR is based on the condition that the Commission actually evaluates and publishes the lists of health claims applied for under the HCR according to Art. 13 para. 3 Regulation (EC) No. 1924/2006”. Since this condition has not timely been met and the lists of health claims have not been put into effect in an unlawful manner, Art. 28 para. 5 HCR no longer applies. The Health Claims Regulation is directly applicable law in Germany and must be adhered to by the health-authorities and courts applying health-law in the same way as national law. According to Professor Di Fabio, any application of the transitional provision nowadays violates the principle of the rule of law, to which every authority and every court is bound, due to the time lapsed; the norm should therefore no longer be applied.

Dr. Di Fabio Legal Opinion (English Version)   |  Dr. Di Fabio Legal Opinion (German Version)


For further information on the matter, please contact EUCOPE’s Government Affairs Manager Stefano Romanelli