Article
Regulatory Compliance

What are health claims?

Understanding claims and their regulatory and marketing issues

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 overview

Categories of claims

More than 2,000 pending plant 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.

Outstanding claims

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.

Impact of REFIT

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.

Types of claims

General Benefit Claims

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 authorization, 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.

Probiotic claims

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 characterizing 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).

Specific health claims

Find all specific permitted and prohibited claims and conditions of use in our database, Supplements R&D Insight.

Health claim procedure

Objective

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).

The 3 main criteria for evaluation of a claim application dossier by EFSA

Characterization of the ingredient

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

Only a minority of cases are rejected for insufficient characterization.

Beneficial health effect

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.SA.

The scientific justification

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.

Which markers, measured by which methods?

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

How to assess the quality of clinical data?

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

Identification of winning applications

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.

Register of health claims

Find the list of permitted, pending and prohibited claims directly on the EU website.

FAQ

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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