Do you know the scientific requirements for substantiation of a health claim?
The masterclass will explain the EU Regulation 1924/2006 and adjacent Regulations in the EU and GB, both from a historical perspective as well as the current situation. This will be done in a plenary lecture of ca 45 minutes.
Thereafter participants will be distributed over subgroups of ca 3 persons. Each subgroup will get one EFSA Scientific Opinion on health claim and a set of predefined questions. After studying the Scientific Opinion for about 1 hour, participants will report back in plenary.
The cases studies will be distributed over a broad range of scientific evaluations ranging from clearly substantiated, to plainly unsubstantiated and in between cases. This will enable participants to develop a feeling what entails a good scientific dossier in which a health claim is (not) sufficiently substantiated.
Throughout the event, attendees will have the opportunity to ask questions.
Meet your speaker
Professor Dr Hans Verhagen
Professor Dr. Hans Verhagen runs a food safety and nutrition consultancy in The Netherlands. He completed his PhD in food toxicology at the University of Maastricht.
Dr. Hans worked at TNO in Zeist for Unilever for five years, and for the RIVM for 10 years.
In addition, he worked for the European Food Safety Authority for 14 years (nine years as an external scientific expert dealing with a.o. health claims and novel foods).
Dr. Hans is also a visiting professor at the University of Ulster in Northern Ireland and Technical University of Denmark.
Professor Dr. Hans Verhagen’s expertise includes:
- Nine years member of EFSA NDA Panel Member (2006-2015)
- Nine years member of EFSA working group on health claims (2006-2015)
- ca 3000 of health claim evaluations by EFSA as published in their Scientific Opinions during the years 2006-2015
- 4 years steering committee member of the EU project PASSCLAIM (2001-2005)
- Ample publications and presentations on health claims and their scientific substantiation from the 1990’s onwards
Attendees will learn that a nutrition claim means any claim that states, suggests or implies a food has particular beneficial nutritional properties due to:
– The energy (calories) it a) provides, b) provides at a reduced or increased rate or c) does not provide
– The nutrients or other substances it: a) contains, b) contains in reduced or increased proportions or c) does not contain
Currently, in the EU there are 30 nutrition claims permitted. If your product meets the conditions, producers are free to use these nutrition claims.
Attendees will be taught that there are two types of health claims in the EU and GB:
– ‘Health claims other than those referring to the reduction of disease risk’ (Article 13).
These can relate to the growth, development and functions of the body, including psychological and behavioural functions and slimming or weight-control. Article 13.1 claims are based on “generally accepted scientific data”; article 13.5 claims are based on newly developed scientific data.
– ‘Reduction of disease risk claims and claims referring to children’s development and health’ (Article 14).
Health claims on (functional) foods must be scientifically substantiated. Regulation 1924/2006 states that “Health claims should only be authorised for use in the Community after a scientific assessment of the highest possible standard. In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority (EFSA) should carry out such assessments”.
The masterclass will cover how applicants that want to make a health claim on a food or food ingredient must submit a complete dossier containing the scientific data including the evidence in support of the health claim. When evaluating a health claim dossier, the EFSA evaluates the extent to which the food/constituent is defined/characterised, the claimed effect is ‘beneficial to human health’, and if a cause and effect relationship is established. A negative answer in any of these three steps implicates that the claim cannot be scientifically substantiated. To assist with the preparation of a dossier, EFSA has published a series of Guidance Documents on the scientific requirements for health claims.
Lastly, attendees will cover how whereas the Regulation 1924/2006 is in place for ca. 1.5 decade now, there are several issues that remain under discussion and dispute. These relate to: nutrient profiles, health claims on botanicals, health claims on ‘probiotics’ and the consequences of the UK leaving the EU.