Regulatory Framework Workshop - Health Claim Approval of Probiotic Food in the European Union
Organizing Secretariat IPC2010
Pamida International Ltd.
Komenskeho 2656
024 01 Kysucke Nove Mesto
Slovakia
Under the current European regulation of health claims permitted to use for the promotion of food, probiotics are subjects to considerable impediments when facing the requirements of the European Food Safety Authority (EFSA).
Until the end of 2009 no probiotic health claims under the new EU regulation has yet received a positive opinion from the scientific assessors of EFSA. All probiotic claims referring to reduction of disease risk and to children’s development and health (Article 14) and health claims other than those referring to the reduction of disease risk and to children's development and health (Article 13) has been rejected by EFSA.
It is the purpose of the workshop to explore the reasons for claim rejections by analysing the current situation, the reasons for failures of health claim substantiation and to present possible pathways to overcome obvious and overseen barriers.
The subjects of the workshop are within in the following areas:
- The regulatory framework of health claims in the European Union
- Why probiotics in food are special as to health claims
- Reasons for probiotic health claim rejections
- How to adapt product development to health claim success
- Clinical study design and claim substantiation
- Dossier structure and requirements
- Possible strategies to success
Who to join: scientists from industry and academia who are involved with health claim substantiation of already marketed or prospective probiotic food, specialist in design and implementation of clinical trials, marketers of probiotics, corporate regulatory advisors and health authority officials.
