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Article 14 Health Claims

These are claims referring to reduction of disease risk and to children’s development and health.

Under the Regulation, reduction of disease risk claims and claims referring to children's development and health may be made where they have been authorised in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of the Regulation. Once authorised, they will be included in a Community list of permitted claims together with all the necessary conditions for their use. 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.

Definition of claims relating to children’s development and health

The term "children”, which is not defined in the Regulation, 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 and Directive 2006/125/EC, shall be considered as Article 14 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.

Article 14 submission procedure

The FSAI is now accepting Article 14 applications.

EFSA published a guidance document to assist all FBOs in preparing and presenting their applications for authorisation of Article 14 claims. The guidance presents a common format to assist the applicant in the preparation of a well-structured application. This will also help EFSA to deliver its scientific advice in an effective and consistent way. FBOs are advised to use this document in the preparation and presentation of Article 14 applications.

Two paper copies and two electronic copies (e.g. CD) of the dossier are required to comply with the requirements of Article 15(2)(a)(iii), to circulate the dossier to EFSA. The paper copies will be considered the formal application. Electronic copies should use common electronic formats, such as MS Office type documents or Adobe Acrobat Reader. The files should be searchable using the search facilities of standard software packages. Submissions should be addressed to: 

Health Claims, Public Health Nutrition, Food Safety Authority of Ireland, The Exchange, George’s Dock, IFSC, D01 P2V6, Dublin 1.

On January 11 2008 the European Council agreed to an amendment to EU Regulation 1924/2006 to introduce a transition period for health claims referring to children’s development and health.Under the amendment, food business operators with claims related to children’s development and health which have been on the market before 19 January 2007 were required to submit an application pursuant to the Regulation to the FSAI by 19 January 2008.

FBOs wishing to put claims relating to children's development and health on the market (after January 2007) can only do so provided an application is made pursuant to the regulation and the health claim is authorised.

Authorisation procedure (Article 15)

On receipt of the application the FSAI will:

  • inform EFSA without delay; and
  • make the application and any supplementary information supplied by the FBO available to the EFSA.

Processing of Article 14 claims

On receipt of the information from a Member State, EFSA will

  • inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
  • make the summary of the application supplied by the FBO available to the public.

EFSA will provide an opinion on an application within five months from the date of receipt of a valid application. Whenever EFSA seeks supplementary information regarding the application, the time limit shall be extended by up to two months following the date of receipt of the requested information from the applicant.

In preparing its opinion, EFSA shall verify:

  • that the health claim is substantiated by scientific evidence
  • that the wording of the health claim complies with the criteria laid down in the Regulation.

In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:

  • the name and address of the applicant
  • the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics
  • a proposal for the wording of the health claim, including, as the case may be, the specific conditions of use
  • where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.

EFSA shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based. This opinion will be made public and the applicant or members of the public may make comments to the Commission within 30 days from such publication.

 

 

Last reviewed: 18/9/2019

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