Access the legislation in detail.
Health Claim Submission Procedure
EFSA published a guidance document to assist all applicants in preparing and presenting their applications for authorisation of Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006.
Articles 13(5), 14, and 19 applications
This guidance applies to health claims related to the consumption of a food category, a food, or its constituents (including a nutrient or other substance, or a fixed combination of constituents). The guidance presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims, which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. Adhesion to the guidance will help the Panel on Nutrition, Novel Foods, and Food Allergens to deliver its scientific opinion in an effective way and avoid delay in the scientific assessment process.
Transparency and sustainability of the EU risk assessments
This guidance has been revised in 2020 to inform applicants of new provisions in the pre‐submission phase and in the application, procedure set out in Regulation (EC) No. 178/2002, as amended by Regulation (EU) No. 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.
Implementation of the transparency regulation
The implementation of the Transparency Regulation in March 2021 introduced new services, processes and provisions that have strongly impacted the lifecycle and renewal procedure for applications. EFSA launched a webinar titled “Webinar on application procedure for health claims” to explain how the new requirements affect applicants in the area of health claims. The webinar provides a step-by-step explanation of the application process, from account creation to risk assessment, adoption, and publication, including a live demonstration of the E‑Submission Food Chain Platform (ESFC). It also sheds light on new requirements related to confidentiality and public consultations.
EFSA’s guidance toolkit
The EFSA applications toolkit provides an overview of all EFSA portals and tools that may be of interest to applicants, including the pre-submission activities gateway, the e‑submission system, and EFSA’s portal for information on its scientific assessment work.
EU list of claims (EU Register)
There is an EU list of health claims called the EU Register. This Register shows:
- all the health claims that are approved for use and conditions that must be met to use them
- claims that have not been approved
- claims waiting for approval which can continue to be used in the meantime
It is important to remember that health claims can only be made for the nutrient/ingredient they refer to and not for the food product itself. See our information on Wording of a Health Claim for more detail on this.
Who Can Use These Claims?
Any food business operator can use these claims provided they meet the conditions set out for their use.
The only exception is claims where protection of proprietary data has been granted. These claims can only be used by the applicant until the date specified. These will not appear under the main register and won’t come up in a search. They can be viewed on the Register in a separate area.
The most up-to-date list of Nutrition claims is on the European Commission's website. These can be used where the conditions for use set out for each claim are met.
General Health Claims (Article 13)
These are health claims describing or referring:
- to the role of a nutrient or other substance in growth, development and the functions of the body; or
- to psychological and behavioural functions; or
- without prejudice to Directive 96/8/EC, slimming or weight control or reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet.
Permitted and non-authorised Article 13 claims
Commission Regulation (EU) No. 432/2012 establishes a list of permitted Article 13 claims.
The Annex to this Regulation lists the permitted claims and details the exact substance or food in question (i.e. the nutrient, substance, food or food category), the claim itself and the conditions of use of the claim as well as any conditions and/or restrictions of use of the food and/or additional statement or warning which must also be indicated on the labelling.
A number of Article 13 claims have yet to be evaluated (including claims on botanicals) and these are effectively ‘on-hold’. Since 14 December 2012, only those claims which are either permitted or ‘on-hold’ are legal for use on foods.
Article 13(5) Health Claims
These are health claims based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data.
An food business wishing to add a health claim, based on newly developed scientific evidence and/or which includes a request for protection of proprietary data, to the Community list of permitted claims, may apply for inclusion of the claim in that list.
Article 14 Health Claims - Definition of claims relating to children’s development and health
The term "children” is not defined in this legislation, but should be understood as reaching the end of the growth period. An indicative age limit of 18 years can be mentioned, but this indication does not intend to define children in the frame of the Regulation.
According to the Guidance on the implementation of Regulation 1924/2006 on nutrition and health claims made on foods the following claims should be considered as Article 14 claims:
- Health claims solely referring to the development and health of children, and where the scientific substantiation is only valid for children. In this case, the scientific substantiation consists of data obtained on studies conducted with children. Example: "calcium is good for children’s growth".
- Health claims used on products intended exclusively to children, like follow on formulae, processed cereal-based foods and baby foods, as defined by Directive 2006/141/EC (no longer in force) and Directive 2006/125/EC, shall be considered as Article 14 claims.
Article 14 Health Claims - Definition of reduction of disease risk claims
The Regulation provides the following definition:
'Reduction of disease risk claim' means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease.'
The prohibition in Article 7(3) of Regulation (EU) No. 1169/2011, which prevents labelling from attributing to any foodstuff the property of preventing, treating or curing a human disease, or referring to such properties, also applies.