The so-called functional health claims or Article 13(1) claims are health claims that describe the role of a nutrient or other substance in growth, development and the functions of the body, psychological and behavioural functions, or weight control.
The first Regulation (EU) No. 432/2012 establishing authorised Article 13(1) health claims, i.e. functional health claims was adopted on 14 June 2012. The application of the Regulation started on 14 December 2012. This means that Article 13(1) health claims rejected by the European Commission may not be used after said date in labelling or marketing foods.
Article 13(5) health claims
Article 13(5) health claims refer to health claims, which are similar in content to Article 13(1) health claims, but which are based on newly developed scientific evidence or which include a request for the protection of proprietary data.
The use of Article 13(5) claims is based on an application procedure. These health claims may not be used until the European Commission has authorised the use of the claim under a Regulation. In other words, claims may not be used already at the stage when the application regarding the claim has been submitted.
By virtue of Article 13.5, the Commission can grant data protection to an authorised health claim, whereby the use of the health claim can be restricted for a certain period of time to the benefit of the applicant.