Regulatory of health claims

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 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.

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 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).

Specific health claims

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