What are "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.
Types of Health Claims
- The so-called 'Function Health Claims'(or Article 13 claims)
- Relating to the growth, development and functions of the body
- Referring to psychological and behavioural functions
- On slimming or weight-control
- The so-called 'Risk Reduction Claims' (or Article 14(1)(a) claims) on reducing a risk factor in the development of a disease. For example: "Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease"
- Health 'Claims referring to children's development' (Article 14(1)(b) claims). For example: "Vitamin D is needed for the normal growth and development of bone in children"
Establishing the EU list of permitted 'Function' claims ('Article 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 the European Food Safety Authority for evaluation. EFSA's opinions were published in series.
The Commission announced the adoption of the 'Article 13 list' in 2 steps:
Health claims other than those for botanical substances
Health claims for botanical substances.
Procedure for adoption of the list of permitted 'Article 13' health claims:
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
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
If there is no objection, the Commission adopts the draft decision.
Commission Regulation (EU) No 432/2012 established the list of permitted health claims which were subject to the above described procedure. This Commission Regulation started to apply since 14 December 2012.
The list of permitted health claims established by Commission Regulation (EU) No 432/2012 is regularly updated with newly authorised health claims subject to individual application submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006.
Authorisation procedure for individual applications [Article 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:
The competent national authorities
European Food Safety Authority (EFSA)
The European Commission.
- Applicants must submit an application, via the E-submission Food Chain Platform, to an EU-country's competent authority that checks admissibility before the application is transmitted to EFSA. The Commission's implementing rules, established by Commission Regulation (EC) No 353/2008, inform applicants what their application should include. More guidance on the definition and classification of the scientific data for the assessment of a health claim is available on the EFSA website
- EFSA informs the national competent authorities and the Commission of the receipt of the application and gives a publicly available opinion
The Commission prepares a draft decision and submits it to the Standing Committee on Plants, Animals, Food and Feed after EFSA publishes its opinion
- After a favourable opinion of the Standing Committee on the Food Chain and Animal Health, the European Parliament and the Council have the right of scrutiny on the Commission's draft decision
- If there is no objection, the Commission adopts the draft decision.
Comments on EFSA's opinions and stakeholder concerns
Stakeholders and the public may send comments to the Commission on EFSA's opinions for Article 14 and Article 13(5) health claims. Comments relating to scientific issues are transmitted to EFSA for a response. This is made public here.
The Regulation did not foresee comments from stakeholders or the public on EFSA's opinions for Article 13 claims.
The 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.
- Implementation of the Transparency Regulation (training and support material provided by DG SANTE for the use of the e-submission platform)
- Nutrition applications: regulations and guidance
- Press release: Commission reviews the progressive adoption of the list of permitted health claims
- Flowchart of Authorisation Procedure