Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria

  • EFSA opinions and guidance on the same applications/ingredients.
  • Clinical studies on the applications/ingredients
  • Characterization data on the applications/ingredients

Experts Recommendations

  • Strengths and weaknesses of the substantiation
  • Suggestion of alternative claims to apply, in line with your expectations, general EFSA requirements and available scientific data.
  • Complementary elements to provide including additional clinical studies.

File constitution & submission

  • Preparation of the health claim file.
  • National then EFSA authority submission

Authorities follow up & exchange (Member states, EFSA & European Commission

What is a health claim?

A health claim is “any claim which states, suggests or implies a relationship between a food category, a food or any of its constituents and health”.

How many generic health claims are allowed?

229

How to use outstanding generic health claims?

For most European countries, they can be used as long as they can be justified in case of control.

Must the wording of a claim be strictly adhered to?

It is recommended that operators should use as close as possible to the authorised wording. The wording cannot be “stronger” than the authorised claim.

How to make a claim on probiotics, as this term is considered as a health claim and is not authorized?

It is possible to use “contains + [name of the microorganism]”, provided that the beneficial nutritional or physiological nature of the microorganism and the presence of a significant amount of the microorganism to produce the beneficial effect can be substantiated (dossier for substantiation of a nutrition claim contains).

What clinical data are necessary to apply/justify a health claim 13.5 or 14 to EFSA?

Confirmatory clinical studies are required, all conducted on the same ingredient, at the same dosage, in a target population of subjects representative of the healthy general population, giving statistically significant results, on validated markers measured by validated methods, all demonstrating a benefit to human health.

Which health effects are most likely to win a positive opinion from EFSA?

Applications for which it is possible to measure an effect such as lipemia, blood glucose, bone mineral density, intestinal transit…

Does a health claim necessarily have to target a single ingredient?

No, as shown by the positive opinion of the Limicol® complex formulation.

How long does it take to evaluate a claim file?

It is on a case-by-case basis and generally 9-12 months.

Is it possible to communicate without a proprietary health claim?

Of course thanks to generic claims, or by changing regulatory status (FSMP, drug…).

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Example of Health claims success
New Health Claim for Nutriose ® 06 from Roquette Freres - 12/11/2014
Nutraveris has get a positive opinion for Nutriose® 06, a resistant dextrin made from wheat or maize starch, developed and commercialized by the French company Roquette Freres, one of the five world leaders in the starch manufacturing industry. The application, related to the reduction of post-prandial glycaemic response, provided six proprietary and unpublished clinical trials in accordance with EFSA requirements.
Positive opinion for Sylvan Bio’s Health Claim on red yeast rice - 12/02/2013
Nutraveris succeeded in getting a positive opinion from EFSA for the French company Sylvan Bio, on a claim promoting the cholesterol-managing effects of their red yeast rice, under article 13.5 of the EU Health Claim regulation. EFSA’s opinion recognizes that monacolin K in Sylvan Bio red yeast rice is sufficiently characterized. The maintenance of normal blood LDL-cholesterol concentrations has been also acknowledged by EFSA as a beneficial physiological effect. However, the main factor that made this achievement possible is the proven efficacy of Sylvan Bio’s red yeast rice to lower LDL-cholesterol levels in blood, as clearly highlighted by two proprietary clinical trials. These studies, conducted in a population accepted by EFSA (i.e. non-treated hypercholesterolemic subjects), have shown a significant reduction in LDL-cholesterol levels after at least 12 weeks of consumption of Sylvan Bio’s Red yeast rice.




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