Article 13(5) Health Claims

The office of the FSAI has closed due to COVID-19. Any Article 13(5) or Article 14 dossiers received after 26/03/2020 will be processed electronically as a temporary solution. We advise that you contact phn@fsai.ie if you plan to submit an application during this period for further guidance. We apologise for this inconvenience, but this is out of our control.

 These are health claims based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data

An FBO 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.

Submission procedure (Article 18)

Article 13 (5) claims are authorised under the procedures detailed in Article 18.
The Article 18 procedure is applicable from 1st February 2008.

Authorisation process for Article 13 (5) health claims

Guidance regarding the submission of claims under Article 13(5) will be issued by EFSA and this section will be updated accordingly, when the guidance document becomes available.

The application must include the following information:

• the name and address of the applicant;
• the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
• a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in Regulation (EC) No 1924/2006 on nutrition and health claims;
• where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
• a copy of other scientific studies which are relevant to that health claim;
• a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
• a summary of the application;
• the reasons for the request.

Processing of Article 13(5) applications

The application and any information supplied by the FBO will be sent without delay to EFSA for a scientific assessment, as well as to the Commission and the Member States for information.

EFSA will issue its opinion within five months from the date of receipt of the request. This time limit may be extended by up to one month if EFSA requires supplementary information to be submitted by the applicant. If this supplementary information is sought by EFSA it must be submitted by the applicant within 15 days from the date of receipt of EFSA’s request.

In order to prepare its opinion, EFSA will verify:

a. that the health claim is substantiated by scientific evidence and;
b. that the wording of the health claim complies with the criteria laid down in the Regulation.

EFSA will 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.

EFSA will make its opinion public. The applicant or members of the public may make comments to the Commission within 30 days from such publication.

Where EFSA, following scientific assessment, issues an opinion in favour of the inclusion of the claim in the Community list of permitted claims, the Commission will take a decision on the application, taking into account the opinion of EFSA, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration, after having consulted the Member States and within two months of receiving the opinion of EFSA.

Where EFSA issues an opinion that does not support the inclusion of the claim in that list, a decision on the application shall be taken in accordance with Commission implementing procedures.

Community authorisation (Article 17)

Within two months of receiving the opinion of EFSA, the Commission shall submit to the Standing Committee on the Food Chain and Animal Health a draft decision on the lists of permitted health claims including details on the claims, taking into account the opinion of EFSA, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration.

The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.

Authorised claims will added to the list in the Community Register, together with any conditions for use. If the claim is rejected it too will be added to the list in the Community Register, with the reasons for rejection.

Last reviewed: 9/4/2020