EU New Regulations Prohibit Monacolin K Health Claims for Red Yeast Rice, Tannic Acid K Health Claims Application Rejected

According to a notice officially published in the Official Journal of the European Union on 30 July 2024, the European Commission has adopted Implementing Regulation (EU) 2024/2063, which formalizes the regulatory framework relating to health claims on food. The core of this regulation is to explicitly prohibit health claims on foods containing monacolin K in red yeast rice that "contribute to the maintenance of normal blood LDL cholesterol concentrations." This regulation shall come into force on the 20th day after the date of announcement.

According to the current EU Nutrition and Health Claims Regulation (EC) No 1924/2006, all health claims on food products must be officially authorised by the European Commission and included in the list of approved health claims, otherwise they will not be allowed to be used.

In this context, Sylvan Bio Europe BV has submitted an application to the European Food Safety Authority (EFSA) for a health claim regarding tannin K in SYLVAN BIO red yeast rice for the maintenance of normal blood LDL cholesterol levels. EFSA then conducted a thorough scientific assessment.

Assessment results showed that 10 mg of tannin K per day from red yeast rice products (including SYLVAN BIO red yeast rice) may help maintain normal blood LDL cholesterol levels. However, EFSA also notes the possible health risks of tannin K, in particular its potential risk of myopathy/rhabdomyolysis.

In view of the health risks associated with tannin K, the European Commission decided not to approve the health claim and included tannin K in the list of restricted substances in the Regulation on Food Additives (EC) No 1925/2006, allowing its use only under certain conditions.

In response to the applicant's objection, EFSA reiterates its previous assessment that the new evidence provided by the Applicant is not sufficient to alter its original assessment.

As a result, the European Commission ultimately decided not to grant authorization for this health claim for tannin K in SYLVAN BIO red yeast rice.

For more information, please refer to the related link:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202402063