Health claims (art. 13)
“General function” claims under Article 13.1 of the EC Regulation on nutrition and health claims refer to the role of a nutrient An element or compound needed for normal growth, development and health maintenance. Essential nutrients cannot be made by the body and must, therefore, be consumed from food or substance in growth, development and body functions; psychological and behavioural functions; slimming and weight control, satiety or reduction of available energy from the diet. These claims do not include those related to child development or health or disease risk reduction .
EFSA's scientific evaluation helps to ensure that claims made on food labelling and advertising regarding nutrition The science of how diet relates to the body's need for sustenance and health are meaningful and accurate, and can thereby help consumers in making healthy diet choices.
EFSA finalised the evaluation of the “general function” health claims prioritised by the Commission by the end of June 2011 and has published 341 opinions providing scientific advice on 2,758 “general function” health claims. These were drawn from a list of 4,637 claims submitted to EFSA by the European Commission between July 2008 and March 2010 when EFSA received the latest 452 claims for evaluation.
The updated final list of 4,637 claims was the result of a consolidation process carried out by the Commission, after examining over 44,000 claims supplied by the Member States. The complete list was published on the EFSA website in the form of an Access database in May 2010.
The Commission and the Member States agreed that a limited number of “general function” health claims would be eligible for further assessment by EFSA. These claims include those related to micro-organisms which the Panel initially considered to be not sufficiently characterised, and claims for which the NDA Panel concluded in its initial assessment that there was insufficient evidence to establish a cause and effect relationship between the consumption of the food and the claimed effect. Ninety-one claims (74 for micro-organisms, 17 for “insufficient evidence” claims) were submitted to EFSA from Member States via the Commission, for assessment by December 2012. The first opinions related to this further assessment were published in June 2012.
Some “general function” claims (1548 botanical A substance, used either as a food or a medicine, derived from plants, fungi, algae or lichens-related claims) have been put on hold pending for the Commission and Member States final consideration. They are listed in “Questions on hold Botanical claims” below, and at the Commission webpage (identified by claim ID number)
List of claims submitted to EFSA
The list of claims submitted to EFSA for evaluation can be found both in the Register of Questions and the Access database.
Register of Questions
EFSA’s Register of Questions provides an overview of EFSA’s work on the list of Article 13.1 health claims, including the evaluation status, question number and assessment deadline for each claim. All the relevant correspondence between EFSA and the European Commission can be found at the bottom of the section related to the specific mandate (Mandate number: M-2008-1061).
Database of health claims submitted to EFSA for evaluation
The consolidated database of Article 13.1 health claims contains the 4,637 main health claim entries submitted to EFSA for evaluation. Around 10,500 similar health claims / health relationships have been clustered within these main health claim entries. These health claims/relationships describe similar effects of a substance on the body and include the conditions of use and literature that EFSA will have to take into account in its scientific evaluation.
All 4,637 main health claim entries are also available in the Register of Questions.
The database is regularly updated to indicate the scientific opinions published by EFSA on health claims as well as to reflect any change to the list drawn up by the Commission. Such changes may include for example withdrawals of health claims. Further information on the Access database can be found in EFSA’s Modus Operandi(35.18 KB), which outlines how EFSA undertakes its work for Article 13 claims.
To view the database MS Access 2003 or a later version is required.
To open the database:
- Right click on the zip file and save.
- Double click on the zip file to unzip.
- Double click on the file “art13claims.mdb” to open and view the database.
Database of health claims submitted to EFSA for evaluation (updated: July 2011)
How EFSA evaluates claims
Screening of claims
Before embarking on the scientific evaluation of health claims in 2008, EFSA screened all the claims received from the European Commission up until then in order to differentiate between those claims which could be assessed by the Panel and those for which more information was needed. To this end, in October 2008 EFSA’s scientists agreed to apply six criteria to ensure a thorough and consistent screening of the health claims entries. The outcome of this screening is indicated for each main health claim entry in the Access database.
In January 2009 EFSA sent back to the Commission for further clarification more than 2,000 claims which were vague, not properly described, whose conditions of use had not been spelled out, or whose scope or health relationship were unclear. In November 2009, EFSA received feedback with additional information from the Member States.
Procedures for the evaluation of claims
In light of the experience gained from the evaluation of health claims, the NDA Panel provides guidance to stakeholders on the scientific requirements and general principles for the evaluation of health claims.
In addition, EFSA has combined the references for around 3,300 health claim entries into consolidated reference lists. Due to their large number, references have been published in five parts. This compilation of references includes all references submitted for those main health claim entries which the Commission has asked EFSA to prioritise during evaluation.
Part 1: ID number 1 – 1000(6.53 MB)
Part 2: ID number 1001 – 2000(5.62 MB)
Part 3: ID number 2001 – 3000(2.16 MB)
Part 4: ID number 3001 – 4705(4.4 MB)
Part 5: Claims submitted for further assessment(568.56 KB)