• Identifying what is not harmonised across the EU: vitamins, minerals, herbs and other bioactive
08.45-09.15 Registration
09.15-09.30 Welcome and introduction
09.30-09.50 Clarifying the EU regulatory framework for food supplements
EAS Food Law Adviser Elodie Lebastard will give an overview of the key step towards marketing food supplements:Ms Lebastard will clarify the food supplement definition, the difficulties in classifying some nutritional products andhighlight mandatory and optional harmonised rules.
09.50-10.40 Identifying what is not harmonised across the EU: vitamins, minerals, herbs and other bioactive substances
Katarina Wagner, EAS Regulatory Affairs Manager will clarify the extent to which food supplement ingredients are not harmonised at the EU level and explain the national rules surrounding these ingredients. Ms Wagner will then outline:
10.40-11.00 Question and Answer Session
11.00-11.20 COFFEE BREAK
11.20-11.50 Mutual recognition as a tool for pan-EU product launches
Elodie Lebastard will explain how the principle of mutual recognition can strategically help companies break down national trade barriers and offer a practical solution to successfully marketing products across the EU. She will give:
• Strategic advice on using mutual recognition to enter different national markets
• An explanation of the newly applicable Regulation
11.50-12.10 Question and Answer Session
12.10-12.40 Current challenges and future changes to the EU Novel Food Regulation
The EU Novel Food Regulation is a major challenge for the food industry, and in January 2008 the Commission put forward a proposal to amend the current Regulation. EAS Regulatory Adviser Pieter Lagae will explain and analyse:
• The essential elements of the current EU Novel Food Regulation
• What is novel and what is not?
• Borderline cases
• Procedures that currently apply
• Changes and implications of the Commission’s proposal
12.40-13.00 Question and Answer Session
13.00-14.00 LUNCH
14.00-14.45 EU Claims Regulation: the practical impact for product marketing
A key step of the process is to ensure that your product claim can be used on the EU market. EAS Regulatory Affairs Manager Stefanie Geiser will explain the practical implications of the Claims Regulation for companies looking to launch products in the EU. She will cover:
• Status of work towards the ‘Community list’ of Article 13 health claims, including the outcome of
EFSA’s evaluations and future timing/expected trends
• EFSA Article 14/13.5 claims dossier opinions and latest clarifications on the dossier application
procedure (e.g. scientific substantiation criteria, proof for proprietary data protection, Member States
dossier acceptance and withdrawals)
• Transition periods for the various type of claims
14.45-15.15 Question and Answer Session
15.15-15.45 Ensuring compliance with the labelling legislation
Product labelling is a common stumbling point for companies. Pieter Lagae will explain the EU requirements for a food supplement label, and give practical examples for preparing compliant labels.
15.45-16.00 Question and Answer Session
16.00-16.15 Conclusions
16.15 END OF WORKSHOP