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‘Health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.
In the EU, health claims made on foods are regulated by REGULATION (EC) No 1924/2006.
There are two categories of health claims:
Article 13 health claims refer to the role of a nutrient in growth, development of the body or in psychological or behavioral functions,
Article 14 health claims, called ‘reduction of disease risk claims’, refer to health claims that state, suggests or imply that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.
Regulatory check:
- Is the intended Health Claim allowed in the EU?
- Is the intended Health Claim already authorized?
A priori, it has to be determined whether the intended claimed effect is allowed in the EU. This may require consultation with competent authorities of individual EU Member States or directly with EFSA.
Secondly, it has to be determined whether the health claim has already been authorized. This can be checked in the EU register of health claims, containing information on both authorized and non-authorized health claims.
NutriClaim values its personal relationships with EFSA NDA-panel members, and officials, including the team leader of the Working Group on Novel Foods, at the European Commission.
Procedure
In the EU, the authorization of health claims made on food is regulated by the Novel Foods Regulation (EU) 1924/2006. This regulation is intended to ensure that the claims made are truthful.
A request for marketing authorization takes the form of a Health Claim application.
The primary goal of a Health Claim application is to scientifically substantiate the cause-and-effect relationship between the food or food ingredient and the claimed effect.
The submission of a Health Claim application proceeds through the National Competent Authority of a Member State in the European Union.
The scientific evaluation of the application is carried out by the European Food Safety Authority. (EFSA)
Marketing authorization of the health claim is made public through a regulation issued by the European Commission.
Scientific substantiation
Three principles for the scientific substantiation have been laid down:
- Health claims shall be based on and substantiated by generally accepted scientific evidence.
- The use of the health claim shall be justified.
- All relevant elements and data establishing compliance with the Regulation shall be provided.
Health claims may be substantiated based on publicly available data and/or newly generated data.
Although publicly available, often peer-reviewed data is generally accepted as scientific evidence, it still may not qualify as valid evidence for health claim substantiation, primarily due to a different scope of the study design.
Study design
Acceptable scientific evidence for Health Claim substantion has to meet the requirements as set out by EFSA in its Guidance documents on the scientific requirements for health claims.
The guidance implies that the study design requires a Health Claim-targeted approach and mindset, which is definitively different from the academic approach to elucidating potential mechanisms of action and generating hypotheses.
For successful health claim substantiation based on newly developed scientific evidence, and to secure return-on-investment, an EFSA-oriented mindset is imperative.
Statistical Analysis Plan
Health Claim-targeted human intervention studies do not aim at generating ‘recommendations for future research’. On the contrary, and because of the considerable investments involved, health claim-targeted studies should have a hole-in-one approach.
It is therefore imperative to start any study targeted at health claim substantiation with a sound statistical analysis plan (SAP). This SAP drives the choice for the characteristics of the study subjects and size of the study population to be included, as well as the duration of the trial and potentially anticipated post hoc analyses. All these factors greatly impact the costs of a trial and should therefore be thoroughly considered beforehand.
In order to accommodate for this requirement, NutriClaim has engaged in a longstanding collaboration with expert statistician Dr. Wim Calame of StatistiCal BV, Wassenaar, the Netherlands, who is also acts as hearing statistical expert for the European Food Safety Authority (https://www.statistical.nl/). His investigative mind and skills have proven invaluable in the many projects NutriClaim and StatistiCal have undertaken together.
A non-exhaustive list of relevant questions for EFSA claim legislation to be considered upfront:
- Is the aim of the study unequivocal?
- Is the outcome validated for its purpose?
- Is the read-out reliable/standardized?
- Is an appropriate power analysis conducted upfront?
- Is the threshold level per measurement not conflicting with the sensitivity and specificity of the study?
- Is the variation in read-out not conflicting with the power of the study?
- Are conditions potentially affecting the outcome, such as temperature, standardized?
- Are all relevant confounding factors known?
Currently, NutriClaim and Statistical are currently involved in a challenging health claim project, introducing a new risk factor, on top of those already established by EFSA, and showing its predictive value in relation to an EFSA-accepted health benefit.
Study design
Acceptable scientific evidence for Health Claim substantion has to meet the requirements as set out by EFSA in its Guidance documents on the scientific requirements for health claims.
The guidance implies that the study design requires a Health Claim-targeted approach and mindset, which is definitively different from the academic approach to elucidating potential mechanisms of action and generating hypotheses.
For successful health claim substantiation based on newly developed scientific evidence, and to secure return-on-investment, an EFSA-oriented mindset is imperative.
Services NutriClaim
NutriClaim provides full project management services pertaining to Health Claim authorizations, including determining the claimed effect, wording of the claim and type of claim, study design, contracting Clinical Trial Service providers to preparation of the application and the follow-up of the submission.
NutriClaim BV, from its founding in 2007 onwards, has gained a wealth of experience in this area at the intersection of science, legislation and level-headed approach towards health claim-focussed study design.
