Article
Regulatory Compliance

Novel food : How to avoid EFSA Negative Opinion?

Case study : example with the EFSA opinion about the "Safety of b-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283"

In October 2022, EFSA issued a negative opinion on b-hydroxybutyrate salts as a novel food.

Here is the summary of that opinion, which you can also find on their website:

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion onb-hydroxybutyrate (BHB) salts as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of sodium, magnesium and calcium BHB salts, and is proposed to be used by adults as a food ingredient in a number of food categories and as food supplement. The data provided by the applicant about the identity, the production process and the compositional data of the NF over the course of the risk assessment period were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the test item used in the subchronic toxicity study and human studies provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established.

Avoidable mistakes were made in the submission of this novel food dossier. In order to obtain a marketing authorization for this type of ingredient, it is necessary to follow the procedures established by the Commission to the letter and to be surrounded by experts who are used to carrying out this process.

This is how we would have done it :

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