Article 13.5 of the EU Nutrition and Health Claims Regulation is often described as the "accelerated" authorisation procedure and is applicable to health claims referring to the role of a nutrient or other substance in the growth, development and functions of the body based on newly developed scientific evidence. Unlike claims approved under article 13, those approved under 13.5 will protect applicants' proprietary data. This is great news!
After intensive lobbying from industry, companies wishing to submit applications under article 13.5 will now be able to do so from this month instead of having to wait until January 2010. Evidence substantiating these claims will afford applicants five years of protection.
Equally attractive is the speed with which the European Food Safety Authority (EFSA) is obliged to assess applications - it has just five months to approve or reject a dossier supporting a claim with a one-month extension if additional data is requested.
Given that we will not discover which claims have successfully made it onto the article 13 list of claims supported by generally accepted science until January 2010, this new procedure offers a very attractive incentive to those looking to get rapid claims approval plus proprietary protection.
The faster submission procedure and the intellectual property protection afforded by this article can only be advantageous to the industry. However, for many applicants, everything could hinge on what type of nutrient profiling system is chosen to underpin the claims system. Watch this space!
Dr Mark Tallon is chief science officer of NutriSciences, which specialises in health-claim substantiation. Contact him at firstname.lastname@example.org