EFSA guidance on the evaluation of Article 13.1, 13.5 and 14 health claims

EFSA guidance on the evaluation of Article 13.1, 13.5 and 14 health claims

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.

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 harmonizes the provisions that relate to nutrition and health claims, and establishes rules governing the Community authorization 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 summarizes 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 characterized 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 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.

http://www.efsa.europa.eu/en/efsajournal/pub/2135.htm?WT.mc_id=EFSAHL01&emt=1

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish