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Health Claims regulatory framework

A claim is any message or representation, not required by International or national legislation, including representation in the form of pictorial, graphic or symbolic matter in any form, which states, suggests or implies that a food has particular characteristics. A health claim is any claim which states, suggests or implies a relationship between a category of food, a food or one of its constituents and health. Finally, a nutrition claim is, for example, when a source of, or rich in, is indicated for a nutrient or substance.

Regulatory of health claims

Claims on botanical substances for which finalization is pending may continue to be used until they are regulated at the European level according to the national provisions of each country and provided that they comply with the general conditions of Regulation 1924/2006.

For most European countries, they can be used on condition that they can justify them in the event of a control (possible exceptions: example Italy, some not accepted in Belgium).

In France, it is necessary to comply with the conditions of use filed (at a minimum, when the information is available in the EFSA database, the plant, the part of the plant, and the type of extract) and to have a scientific file justifying these claims to be available to the administration in case of control.

The DGCCRF asks, for “pending” plant claims, to respect, at the level of wording, the intended function and the applicable general conditions (e.g.: do not report treatment, prevention, cure of diseases; do not pace weight loss, etc.). Concerning the conditions of use, it is requested to respect a minima, when the information is available in the Access database, the plant, the part of the plant, and the type of extract.

Given that an ID number generally groups together identical claims (same plant, same function), it is a priori possible to mix labels and conditions of use within the same ID number (without having to choose a “label/CoU” pair). However, in the event of a control, it may be necessary to provide proof, particularly on the scientific basis of such a claim. There is also a tolerance on the dose if the scientific justification exists.

Pending claims do not appear in the EU register, but are listed on the Commission’s website (Generic health claims for which the evaluation by EFSA or the decision by the Commission is not finalized). The conditions of use are available in another EFSA document.

REFIT is a European program for “sharp and efficient regulation”, which has two objectives: to make EU legislation more flexible and less costly.
Within this framework, a consultation on plant claims is also being launched. Are we then moving towards a specific evaluation of plant claims taking into account their traditional use?

EUROPEAN COMMISSION. COMMISSION STAFF WORKING DOCUMENT, EVALUATION of the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods (20 May 2020).

This evaluation does not indicate a timeframe or a clear decision on the process for evaluating pending claims on plants. Even if this document opens the possibility to have a specific evaluation of claims on plants, taking into account their traditional use, it seems conceivable that the current situation would continue for several more years.

Simple and binding statements referring to the general and non-specific beneficial effects of a food on the general state of health and health-related well-being may be used without prior authorisation, provided that the following conditions are met :

This statement must be accompanied by an authorized health claim:

  • This authorized health claim must appear “near” or “after” the said general benefit statement.
  • The authorized health claim must relate to the general reference.

The DGCCRF considers that the whole must be on the same side. It is therefore not acceptable to use the asterisk and put the complete claim on the back.

We recommend placing the specific health claim(s) on the same side as the reference to general benefits. These more specific health claims may fall under sections 13 or 14 of the regulations, authorized or pending evaluation, and must be related to the general benefit indicated.

A European Commission guide of December 2007, approved by the member states, specifies the following interpretation: the term “probiotic” is considered a health claim. This term is therefore subject to authorization or must be accompanied by a specific authorized health claim. To date, no health claim including this term has been authorized. A request for recognition of the term “probiotic” as a generic descriptor was made in 2012 but has not yet been processed.

In practice, however, there is a need for consumer information and communication about microorganisms. It is mandatory to label the microorganism present in the food by including this information in the list of ingredients. In the case of food supplements, the name or nature of the nutrients or substances characterising the product must be indicated (Article 6.3 of Directive 2002/46/EC). For example, “food supplements based on [name of the micro-organism]”.

Additional voluntary disclosure: it is possible to use “contains + [name of microorganism]”. The application must be accompanied by a nutrition or physiological benefit of the microorganism and the presence of a significant amount of microorganism to produce the beneficial effect (dossier for substantiation of a nutrition claim contains).

Find all specific permitted and prohibited claims and conditions of use in our database, NOL Data Solution.

Health claim dossier

Do you need a claim? How do you establish a claim file? What is the point of having a specific claim?

The objective of a health claim dossier is to provide scientific evidence (randomized, double-blind, placebo-controlled clinical study(s)) of the efficacy (ingredient + dosage + target population + statistically significant results + validated marker/method + health benefit) of a food or a well characterized ingredient.
A relationship is established between the consumption of the food/ingredient and the claimed effect (for the target group under the proposed conditions of use).

Characterization Specifications, stability, variability, production process, quality, bioavailability…

Only a minority of cases are rejected for insufficient characterization.

The consumption of the product must provide a beneficial effect on health, measured on a target population.

Only a few health relationships (diuretic, increase in breast size) are not accepted by EFSA.

Clinical evidence that the product, at its dosage, for the target population, provides a beneficial, statistically significant effect, as measured by validated methods and markers.

This is the main reason for the rejection of claims.

It is necessary to cross-reference EFSA’s guidelines and opinions on the targeted health effect.

Guidance on scientific requirements for health claims :

  • the functions of the nervous system, including psychological functions
  • physical performance
  • bone, joint, skin and mouth health
  • appetite assessment, weight management and blood glucose levels
  • the immune system, the gastrointestinal tract and defense against pathogenic microorganisms
  • antioxidants, oxidative damage and cardiovascular health
  • Study design : Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving humans.
  • Characteristics of participants
  • Settings
  • Interventions
  • Outcomes
  • Sample size calculation and primary outcome(s)
  • Randomization
  • Blinding

For the claims in Art 13.5 and 14, these are the applications for which it is possible to measure an effect:

  • In healthy subjects (not treated with medication) (with blood pressure, cholesterol, bone mineral density, glycemia, …)
  • With markers and methods (those above)
  • Nutrients (vitamins, minerals, fatty acids, amino acids…)

For example, for a request for a claim related to nutrients and cardiovascular, bone and digestive health, a priori there is a strong chance of being accepted.

Specific case of probiotics

Almost all requests for generic claims (art.13.1) on probiotics were systematically rejected due to insufficient characterization (in 2009). A few claims nevertheless remain outstanding.

However, since then (as of 2010 and even in art. 13.1), probiotics have been sufficiently characterized (the reason for the negative opinion relates to evidence of efficacy):

The food constituent that is the subject of the health claim is Lactobacillus fermentum CECT5716. The Panel considers that Lactobacillus fermentum CECT5716 is sufficiently characterised.

The EFSA guide 2016 [4367] defines how to characterize a microorganism (bacterium or yeast).

In terms of efficacy: Probiotics are “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host” (Hill, 2014).
Like any active ingredient (plants, substances…), efficacy is strain-, dose-, subject-dependent.

Conclusion

Do you need a health claim?

Maybe not if :

  • a generic claim is sufficient
  • Your health product is not a food but depends on another regulatory status (MD, FSMP, drug…).
  • Your brand is sufficiently strong or evocative

To claim easily, you can use generic claims 13.1 or 14 (disease risk, children), or pending claims (+2000) and being able to justify it through a scientific dossier

To differentiate from competitors, use specific claims 13.5 and 14 and file a claim file.

Need support for your dietary supplements?

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This article was originally published on nutraveris.com.

Regulatory & Scientific expertises in Nutrition & Health, www.nutraveris.com

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