Allegations of “general function” under Article 13.1 of the EC Regulation on nutritional and health claims refer to the role of a nutrient An element or compound necessary for normal growth, development, and maintenance of health. Essential nutrients cannot be made by the body and must therefore be consumed from food. or substance in growth, development and bodily functions; psychological and behavioral functions; slimming and weight control, satiety or reduction of available energy from food. These claims do not include those related to child development or reduction of health or disease risks .
EFSA’s scientific assessment helps ensure that claims made on food labeling and advertising regarding nutrition Science of the relationship between food and the body’s subsistence needs. and health are meaningful and accurate, and can thus help consumers make healthy food choices.
EFSA finalized the evaluation of “general function” health claims prioritized by the Commission at the end of June 2011 and 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 final 452 claims for assessment.
The final updated list of 4,637 requests is the result of a consolidation process carried out by the Commission, after examining more than 44,000 requests provided by Member States. The full list was published on the EFSA website as an Access database in May 2010.
The Commission and 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 microorganisms that the Panel initially considered insufficiently characterized, and claims for which the NDA Panel concluded in its initial assessment that there was insufficient evidence to establish a relationship of cause and effect between the consumption of the food. and the claimed effect. Ninety-one claims (74 for micro-organisms, 17 for “insufficient evidence”) were submitted to EFSA by Member States via the Commission, for evaluation before December 2012. The first opinions relating to this evaluation more in-depth were published in June 2012.
Certain allegations of “general function” (1548 botanical Substance used as food or medicine, derived from plants, fungi, algae or lichens.-related applications) were suspended pending final review by the Commission and Member States. They are listed in the “Pending Questions on Botanical Claims” below and on the Commission’s webpage (identified by the claim identification number).
List of claims submitted to EFSA
The list of claims submitted to EFSA for assessment can be found in both the Issues Register and the Access database.
Log of questions
The EFSA Questions Register provides an overview of EFSA’s work on the list of health claims referred to in Article 13.1, including assessment status, question number and deadline for review. evaluation for each claim. All relevant correspondence between EFSA and the European Commission can be found at the bottom of the section relating to the specific mandate (mandate number: M-2008-1061).
Database of health claims submitted to EFSA for evaluation
The consolidated database of health claims under Article 13.1 contains the top 4,637 health claims submitted to EFSA for evaluation. Approximately 10,500 similar health claims/health relationships have been grouped into these top health claim entries. These health claims/reports describe similar effects of a substance on the body and include conditions of use and literature that EFSA will need to take into account in its scientific assessment.
The top 4,637 health claims are also available in the questions log.
The database is regularly updated to reflect scientific opinions published by EFSA on health claims as well as to reflect any changes to the list established by the Commission. Such changes may include, for example, the withdrawal of health claims. More information about the Access database can be found in EFSA Modus Operandi(35.18 KB), which describes how EFSA undertakes its work on Article 13 claims.
To view the database, MS Access 2003 or later is required.
To open the database:
- Right click on the zip file and save.
- Double-click the zip file to unzip it.
- Double-click the “art13claims.mdb” file to open and view the database.
Database of health claims submitted to EFSA for evaluation (updated: July 2011)
How EFSA assesses claims
Review of claims
Before embarking on the scientific evaluation of health claims in 2008, EFSA examined all claims received so far from the European Commission in order to differentiate between claims that could be evaluated by the scientific panel and those for which additional information was necessary. To this end, in October 2008, EFSA scientists agreed to apply six criteria to ensure a thorough and consistent review of health claims. The result of this review is reported for each primary health claim entry in the Access database.
In January 2009, EFSA referred to the Commission for clarification more than 2,000 claims that were vague, poorly described, whose conditions of use were not specified or whose scope or link to health was unclear. . In November 2009, EFSA received comments containing additional information from Member States.
Claims Assessment Procedures
In light of experience gained in the evaluation of health claims, the NDA Group provides guidance to stakeholders on the scientific requirements and general principles for the evaluation of health claims.
In addition, EFSA has consolidated the references of approximately 3,300 health claim entries into consolidated reference lists. Due to their large number, the references have been published in five parts. This compilation of references includes all references submitted for the main health claims that the Commission has asked EFSA to prioritize during the evaluation.
Part 1: identification number 1 – 1000(6.53 MB)
Part 2: identification number 1001 – 2000(5.62 MB)
Part 3: identification number 2001 – 3000(2.16 MB)
Part 4: identification number 3001 – 4705(4.4 MB)
Part 5: Claims Submitted for Further Evaluation(568.56 KB)
