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Health Claims

What is Health Claims?

A health claim is any statement about a relationship between food and health.

The Commission authorises different health claims provided they are based on scientific evidence and can be easily understood by consumers. The European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence supporting health claims.

The Commission draws up lists of health claims including the different types of authorised and rejected health claims in the EU.

Regulation on nutrition and health claims pdf

Type of Health Claims

The so-called ' Function' or Article 13 health claims:

The so-called 'risk reduction claims' or Article 14(1)(a) claims on reducing a risk factor in the development of a disease e.g.

Health claims referring to children's development ( Article 14(1)(b) claims e.g.

Authorising procedures

Establishing the EU list of permitted 'function' claims ('Art. 13 list')

EU-countries provided national lists of approximately 44,000 health claims to the Commission. These were consolidated into a list of some 4600 claims and sent to EFSA for evaluation. The opinions of EFSA are published in series.

The Commission announced the adoption of the Article 13 list in 2 steps:

  1. health claims other than those for botanical substances;
  2. health claims for botanical substances.

Press release

A Further Assessment for certain health claims is also foreseen.

Procedure for adoption of the list of permitted 'Art. 13' health claims:

  1. The Commission prepares a draft decision establishing the list, and submits it to the Standing Committee on the Food Chain and Animal Health composed of representatives of EU-countries' competent authorities.
  2. After a favourable opinion of the Committee by qualified majority, the European Parliament and the Council have the right of scrutiny on the Commission's draft decision.
  3. If there is no objection, the Commission adopts the draft decision.

Authorisation procedurefor Individual applications - Art. 14 (1)(a) and 14 (1)(b)

Risk reduction claims and those referring to children's development follow a different authorisation procedure based on individual applications involving:

A similar procedure applies to 'function' claims which are based on newly developed scientific evidence and/or proprietary data (so-called 'Article 13(5) claims').

Visual of the authorisation procedure pdf

Comments on EFSA's opinions and stakeholder concerns

Stakeholders and the public may send comments to the Commission on EFSA opinions for Article 14 and Article 13(5) health claims. Comments relating to scientific issues are passed to EFSA for a response. This is made public here.

The Regulation does not foresee comments from stakeholders or the public on EFSA's opinions for Article 13 claims.

EU-countries are active in the process of establishing the EU-list. Third parties may address their concerns to their country's competent authority.

The Commission received numerous letters about the effects of the Regulation on the sector of food supplements sector after the first and third series of EFSA opinions on Article 13 claims.

1st collective answer pdf

2nd collective answer pdf

A campaign circulated on the Internet urging EU citizens to sign a petition against the implementation of the Regulation. The European Commission took this opportunity to provide more complete and accurate information on the implementation of the Regulation. EN FR pdf