General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims


EFSA Journal
EFSA Journal 2011;9(4):2135 [24 pp.].
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Guidance of the Scientific Committee/Scientific Panel
On request form
Question Number
25 March 2011
26 April 2011
European Food Safety Authority (EFSA), Parma, Italy
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The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to provide general guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims of Regulation (EC) No 1924/2006 which harmonises the provisions that relate to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. This general guidance is a combined and updated version of two previous briefing documents (frequently asked question document related to the assessment of Article 14 and 13.5 health claim applications, and a briefing document for Member States and the European Commission on the evaluation of Article 13.1 health claims). This guidance document summarises the general principles applied by the NDA Panel in the evaluation of health claims, and covers issues such as the totality of available scientific evidence, pertinent studies for substantiation of health claims, wording of claims, the extent to which a food needs to be characterised for the claimed effect, claimed effects which are beneficial physiological effects, definition of a risk factor for the development of a human disease, compliance/eligibility issues for health claims, and procedural aspects. The guidance document (previously called briefing document) was subject to public consultation (17 May 2010 to 1 June 2010), and was also discussed at a stakeholder meeting on 1 June 2010. The general guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims, and it may be further updated as appropriate as additional issues are addressed.

Health claims, scientific requirements, Article 13 claims, health claims applications, general principles
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EFSA - European Food Safety Authority
Food technology and food safety
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