EFSA has just published a scientific opinion on the safety of β-hydroxybutyrate (BHB) salts as novel foods.

Safety of b-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283

Abstract from the EFSA Scientific Opinion

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.

Read the full article : https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7449

Analyze of the negative opinion on this novel food application

1st mistake : Work with non-certified manufacturer or laboratory

Your ingredient is produced in a non-certified facility, and you are not able demonstrate the effectiveness of your quality management system as expected by EFSA. In addition, the compositional analyses and toxicological studies were performed in a non-accredited laboratory. EFSA is asking you to provide new certificates of analysis and questions the conclusions of your toxicity studies.

2nd mistake : Discrepancies in the data submitted

The data you initially submitted are not accurate and do not meet EFSA’s evaluation criteria,. You had to submit new data that is inconsistent with the previous data. This is likely to create doubts about the robustness, consistency and credibility of the data submitted

3th mistake: Lack of pertinent safety studies on your product

EFSA requests that the safety of the product must be defended, at a minimum, by genotoxicity tests and a sub-chronic toxicity study carried out with the product for which the request is made.

The safety data for your ingredient is based on a literature review but its identity has not been sufficiently demonstrated.

EFSA’s considers that the assessment was hindered by uncertainties on the composition and specifications of your ingredient.

How FoodChain ID proceed to avoid these mistakes on novel food application ?

1th solution : Selection of qualified partners 

The manufacturing, compositional analysis and toxicological studies of your ingredient must be assessed in the respect of internationally recognized quality standard (ISO, GMP, GLP…).

We can support you in the selection of your qualified partners and evaluate the quality of your analytical data and the relevance of lab certifications.

2nd solution: Upstream review of data and submission of reliable data only

The construction of a complete and coherent dossier that respects the recommendations given by EFSA is key.

We can perform an upstream review of your data and submit reliable and relevant data to support your application.

3th solution: Support in the design and analysis of toxicology studies

The safety of the ingredient can be defended on the basis of a literature review, assuming that the composition of the ingredient is precisely documented.

We can assist you in the selection and presentation of pertinent literature data.

We can also support you in the design and analysis of toxicology study. Indeed, conducting at least genotoxicity assays and a sub-chronic toxicity study on your product is highly recommended.

Learn more and contact us about our Novel Food application service

https://www.foodchainid.com/foodchain-id-consulting-services/dietary-supplements/novel-food-application/

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EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D, Bohn, T, Castenmiller, J, De Henauw, S, Hirsch-Ernst, KI, Maciuk, A, Mangelsdorf, I, McArdle, HJ, Naska, A, Pelaez, C, Pentieva, K, Siani, A, Thies, F, Tsabouri, S, Vinceti, M, Cubadda, F, Frenzel, T, Heinonen, M, Prieto Maradona, M, Marchelli, R, Neuhäuser-Berthold, M, Poulsen, M, Schlatter, JR, van Loveren, H, Albert, O, Goumperis, T and Knutsen, HK, 2022. Scientific Opinion on the safety of β-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2022; 20( 10):7449, 11 pp. https://doi.org/10.2903/j.efsa.2022.7449