Why Nutrition and Health Claim Applications Fail  
Common Shortcomings versus Best Practice

Date: 20th June 2016               Place: Marriott Hotel, Budapest

The workshop will focus on the regulatory aspects of nutrition and health claims in relation to the requirements of the European Food Safety Authority (EFSA).

Chaired by: Elinor McCartney, European Union Food Legislation Expert

Participants, using case studies and working through relevant exercises in teams will learn the secrets of success with EFSA in a relaxed and informal environment. No previous experience of EFSA nutrition and health claims applications is required. Introduction to nutrition/health claims and novel foods: The first session will summarise briefly the history of the nutrition & health claims regulation, common deficiencies in application dossiers, and the main problems encountered by applicants. Novel foods and other relevant legal categories will be defined.

  • Participants will have the opportunity to evaluate which types of claims fall within the scope of the nutrition & health claims regulation, and which do not.
  • Participants will work through exercises to help identify when candidate foods are also novel, requiring a pre-market safety assessment.

EFSA guidance documents on nutrition & health claims: In this session participants will work on with EFSA guidance documents for specific types of claims in order to identify the types of claims, wordings and target populations most likely to figure in a good quality application dossier:

    •    Gut & immune function,
    •    Antioxidants, oxidative damage & cardiovascular health,
    •    Appetite ratings, weight management & blood glucose concentrations,
    •    Bone, joints, skin & oral health,
    •    Physical performance,
    •    Nervous system & psychological functions.

EFSA dossier project management: This session will challenge participants to form effective project management teams, identifying key players for best results.

Case studies: Teams will work together on case studies, including functional and bioactive food ingredients, functional foods, dietary supplements, botanicals, essential fatty acids and novel foods. Participants can also propose real case studies for group discussion, if desired.

Study design: This session will invite participants to criticise and improve study designs intended to generate data to support an EFSA health/nutrition claim: in vitro, ex vivo, in vivo.

Who to come: Small and medium enterprise representatives, scientists, researchers, technical supports, regulatory teams involved in the development and presentation of nutrition and health claims dossiers for the European Food Safety Authority.

Why to come: Get an update on the current state of  EFSA’s approach to nutrition and health claims related to food, novel food, dietary supplements, nutraceuticals. You may also learn about the usual pitfalls and the way how to avoid them prior to EFSA  rejection. Case studies will be used for demonstration.

Particpants may submit their own case prior to the event anonimously.

NB! For the convenience of  those  arriving 20th June morning, the Workshop will start at 13:00.

In case you are already registered for IPC2016 and would like to participate at the Workshop, contact us through info@probiotic-conference.net

To register for the Workshop click HERE.

We are looking forward to meeting you in Budapest.




Monday, June 22, 2015


Chair: Yolanda Sanz, Co-Chair: Elinor McCartney

13:00   Elinor McCartney - European Union Food Legislation Expert
            Find Out Why Efsa Will Reject Your Next Nutrition and Health Claims Dossier
14:00   Yolanda Sanz - Vice-Chair, Panel of Members on Dietetic Products, Nutrition
             and Allergies (Nda), EFSA
             EFSA Health Claims Process and Lessons Learnt

15:00   Coffee Break

15:20   Hans Van Der Saag - Bioactor
             Health Claims for SMEs it’s not Easy, but it Can be Done
15:40   Leen Allegaert - Barry Callebaut
            Compiling Your Dossier to Build a Solid Health Claim
16:00   Rosalind Miller -  British Nutrition Foundation (BNF)
            Do You Plan to Apply? We Prepare a“Toolkit“ for You
16:20   Stéphane VidryILSI Europe
            The Approach of Pathway-27 to Support SMSs in the Substantiation of Health Claims

16:40   Rosalind Malcom – University of Surrey
            Work Package on the REDICLAIM project

17:00   Coffee break

17:20   Interactive Breakout Groups - 5-6 groups working on particular tasks

18:40   Industry Panel - Q&A session with companies experienced in the health claims regulation

Barry Callebaut
Vésale Pharma

19:10   Networking Cocktail and Discussion



This Workshop is sponsored by:

Best practice guidelines for EFSA health claims dossiers will be presented by project representatives.


BACCHUS is a four-year FP7-KBBE-funded Collaborative (Research) Project, targeted at a special group, with 28 beneficiaries including 16 Small and Medium Enterprises (SME) from 11 countries, led by the Institute of Food Research (IFR, UK).
This research is funded by the European Commission (Grant Agreement 312090)