What Claims Can be Used

What are the claims that can be used?

EU list of health claims (EU Register)
Who can use these claims?
Nutrition claims
General Health Claims (Article 13)
Permitted and non-authorised Art 13 claims
Article 13(5) Health Claims
Article 14 Health Claims
Definition of claims relating to children’s development and health
Definition of reduction of disease risk claims
Application for authorisation of new claims
Article 14 Claims Submission Procedure
Authorisation procedure (Article 15)
Processing of Article 14 claims
Article 13(5) Submission Procedure
Authorisation process for Article 13 (5) health claims
Processing of Article 13(5) applications
Community authorisation (Article 17)

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

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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.

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Nutrition claims

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.

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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.

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Permitted and non-authorised Art 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.

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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.

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Article 14 Health Claims

Claims referring to reduction of disease risk and to children’s development and health.

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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.

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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.

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Application for authorisation of new claims

Article 14 Claims Submission Procedure

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 PDF files. 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.

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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.

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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.

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Article 13(5) Submission Procedure

Article 13 (5) claims are authorised under the procedures detailed in Article 18.

The Article 18 procedure is applicable from 1st February 2008.

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Authorisation process for Article 13 (5) health claim

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.

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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.

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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.

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