Building a Regulatory Strategy
for Marketing Food Supplements in Europe:
The key steps to a successful product launch

EAS Expertise
Since its creation in 1992, EAS has operated and specialised in the area of food, nutrition and health. As a team of skilled, experienced food law and policy advisors, EAS experts work with companies and government bodies to find practical solutions to often complicated problems. We excel in finding practical solutions to often complex problems. EAS consultants speak at national, European and international conferences and workshops, working with bodies across the world to deliver up-to-date information, expert advice and solutions in the changing marketplace.

Highlights of the workshop:
• Strategies for notification of food supplements
• Clarification of how mutual recognition really works in the EU
• Vitamin and mineral levels today and future harmonisation
• Opportunities and challenges for herbal and other bioactive substances
• Understanding distribution and market practice
• Labelling compliance
• Update on rules for nutrition and health claims

This one day workshop will guide companies through the practicalities of launching food supplement products in Europe. Companies will get a clear picture of the different legislations and practices in Europe’s markets, from notification requirements to product distribution, and find out how to avoid common pitfalls to a successful product launch.

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The Programme

9.00-9.30 Registration
9.30-9.45 Welcome address and introduction
9.45-10.10 Notification strategies: an entrance ticket into Europe?
EAS Regulatory Adviser Pieter Lagae will explain the first step in the process – notification procedures across
different Member States. He will show the benefits of a solid notification strategy towards launching a product
in and across the EU, highlighting:
• Basic requirements for notifying your food supplement product in the EU
• Most demanding versus least demanding Member States
• Advantages and disadvantages of notifying your product in specific countries
10.10-10.30 Mutual recognition in practice: reality or fiction
Does the principle of mutual recognition exist in practice across Member States when marketing food supplements?
EAS Regulatory Affairs Manager - Nutritional Products, Katarina Wagner, will explain how mutual recognition works in the European Union and where it may offer a practical solution to marketing your supplements across national borders, clarifying:

• How Member States apply the mutual recognition principle
• Where the main opportunities and pitfalls lie
• Current and future trends to be aware of when planning a business strategy
10.30-11.00 Question and Answer Session
11.00-11.15 Coffee Break
11.15-11.40 Vitamins and minerals: towards one product formula across Europe
An outline of the permitted vitamin and mineral substances and their levels across Europe, with Pieter Lagae
explaining how national derogations work and the future impact of steps towards EU harmonisation on businesses.
11.40-12.00 Herbs and other bioactive substances: diversity in national approaches
Which herbs and bioactive substances can be used in food supplements in Europe? Katarina Wagner will give an
explanation of the national rules surrounding these ingredients, outlining key areas of opportunity and concern.
12.00-12.30 Distribution and market practice: adapting to the climate
Successfully launching a food supplement in Europe involves knowing where the widest distribution possibilities lie.
Katarina Wagner and EAS Nutritional Product Regulatory Affairs Manager Stefanie Geiser, will give an overview of
which countries have the best market practice for specific product profiles, and detail where organised controls exist.
12.30-13.00 Question and Answer Session
13.00-13.45 Lunch
13.45-14.15 Labelling compliance: do's and don'ts
A common stumbling point for companies is product labelling. Pieter Lagae will explain the EU requirements for a
food supplement label, and give practical examples of the do’s and don’ts in food supplement labelling.
14.15-15.00 EU Claims Regulation: the practical impact for product marketing
Stefanie Geiser will clarify what the recently introduced EU Claims Regulation means in practical terms for companies
looking to launch products in the EU. She will cover:
• Status of work towards the draft ‘Community list’ on Article 13 health claims, including latest Commission/
Member States’ discussions and timings for EFSA evaluation
• Member States’ policies on ‘national Article 13 lists’
• Impact of transition periods and timing for required product compliance
15.00-15.30 Question and Answer Session
15.30 End of Workshop

THE BIOGRAPHIES

Katarina Wagner
is Regulatory Affairs Manager - Nutritional Products at EAS’ Brussels office. As a specialist in providing regulatory and strategic advice for the marketing of nutritional products in Central and Eastern Europe, she is a biologist (University of Bratislava - Slovakia, and University of Bayreuth - Germany) and has gained an MBA in International Marketing at University of Reutlingen - Germany. Katarina manages the EAS international network of independent regulatory and
technical experts.

Pieter Lagae
is a Regulatory Adviser at EAS, also based at the Brussels office. He advises clients on how to launch their nutritional products into different markets, specialising in product formula and label compliance, as well as notification dossiers. Pieter has a masters in Biomedical Sciences (KU Leuven - Belgium) and Intellectual Rights (KU Brussels - Belgium). Before joining EAS he has worked in the field of Regulatory Affairs for pharmaceuticals.

Stefanie Geiser
is Regulatory Affairs Manager at the EAS branch based in Italy. While following the European Food Safety Authority (EFSA) developments in Parma closely, at EAS-Italy she assists companies in overcoming regulatory barriers for the EU approval of their health claims and innovative food ingredients. Stefanie has specialised in
biochemistry and plant physiology (University of Aachen - Germany, and University of Bologna - Italy). Following her studies she worked in the field of organic food products at the European Commission, DG VI, Agriculture. Since joining EAS in
1995 she has been an adviser on regulatory issues to European and international industry associations.

The EAS team has co-authored a number of publications including the recent guide to ‘Marketing food supplements, fortified and functional foods in Europe - Legislation and Practice 2008’ and a recent European Commission study on the use of herbs and other bioactive substances.