EFSA has updated its advice for applicants seeking approval of health claims made on food products. As well as revising the general scientific guidance – which applies to health claims across the board – the Authority has updated its specific guidance for claims related to the immune system and the gastro-intestinal tract.
Valeriu Curtui, head of EFSA’s Nutrition Unit, said: “Because of the scientific and technical complexity of applications on health claims, it has always been a priority for EFSA to develop clear criteria for the substantiation of health claims and guidance for those submitting such claims.
“The updated guidance documents will give applicants a better understanding of the step-by-step approach followed by our nutrition experts and help them to decide what type of claim they wish to submit given the data available to them.”
Concrete examples from previous applications will guide applicants on the requirements for substantiation in particular areas and on the most common drawbacks to avoid, Dr Curtui added. “Better applications will result in a more efficient evaluation process, which will benefit applicants, consumers and EFSA.”
The two documents now include:
- A detailed explanation of each step of the evaluation process – characterisation of the food/constituent, characterisation of the claimed effect, identification of pertinent human studies – illustrated with concrete examples from previous evaluations.
- An explicit differentiation between the principles applied to the evaluation of health claims based on the essentiality of nutrients and those applied to other claims. These differences relate to the definition of the claimed effect, the substantiation of the claim and the conditions of use.
- Examples of applications that have been evaluated with a positive outcome to indicate the number, type and quality of studies that may be needed for substantiation of a claim.
- Examples of applications evaluated with an unfavourable outcome to illustrate the kind of shortcomings that can prevent the substantiation of certain claims.
- Guidance on the main steps and scientific aspects which applicants should consider when preparing an application.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies decided to revise the guidance documents in light of the experience it has gained in evaluating nearly 3,000 “general function” claims and more than 250 other applications over the past few years. It was also responding to requests from stakeholders for greater clarity on general issues common to all claims and, in particular, claims related to gut and immune function.
The documents were finalised following public consultations that yielded valuable feedback from stakeholders and other interested parties.
The rules governing authorisation of health claims made on foods in the EU are covered by Regulation (EC) 1924/2006. According to the Regulation, health claims can be authorised for use in the EU only after a scientific assessment has been carried out by EFSA. For a detailed explanation of EFSA’s work on health claims, please see our topic page.