20-21 September, 2005, Berlin

Senior government representatives from the food and health sectors of more than twenty EU and neighbouring non-EU countries met with the European Commission, scientific experts and the food supplement industry in Berlin in September to debate the next stages of development of the regulatory environment for Food Supplements.

The delegates explored common approaches for European regulatory models on the setting of maximum levels for vitamins and minerals and the substantiation of health claims and the potential models for the safety
assessment of ingredients other than vitamins and minerals, in particular botanicals.

The debate has global significance because any European approach taken to regulate food supplements is seen as having a significant influence for the development of legislation in the fifty or so countries worldwide that are
currently looking at revising or adopting legislation.

The conference - a sequel to the successful IADSA Prague conference in May 2004 - was organised jointly by BLL (German Federation of Food Law and Food Science), ERNA (European Responsible Nutrition Alliance), EHPM (European Federation of Associations of Health Products Manufacturers) and IADSA (International Alliance of Dietary/Food Supplement Associations).

Directive validated
In his review of the emerging EU regulatory environment for food supplements, Basil Mathioudakis, the acting Deputy Head of Unit, DG SANCO at the European Commission, stressed the importance of the recent European Court case that confirmed the validity of the Food Supplement Directive.

He also referred to the high number of derogations and dossiers submitted, in particular from the U.K, for review by EFSA (European Food Safety Authority) which will lead to the extension of the EU list of authorised vitamins and minerals. He indicated that out of 710 dossiers received by the Commission around 410 had been submitted to EFSA.

Mr Mathioudakis stated that the Food Supplement Directive supports safety as the prime criterion for establishing maximum levels for vitamins and minerals, and that no undue constraint should be put on the marketing of safe products.

Regulatory & safety assessment models explored:

Maximum levels for vitamins and minerals
Professor Albert Flynn, from University College Cork, Ireland, and a prominent member of the EFSA Nutrition Diet and Allergies Panel, presented the ERNA/EHPM risk management model for the setting of maximum levels for vitamins and minerals in food supplements as a possible approach. This model has been successfully put to the test by the Polish National Food and Nutrition Institute who applied it to Polish food intake data and presented the results.

Other ingredients including botanicals
Dr Derek Shrimpton, Scientific Adviser of EHPM, presented a new model, under development by the IADSA scientific working group at the global level, for assessing the safety of substances other than vitamin and minerals.

Professor Robert Anton, who has laid the development of a safety assessment model for botanicals in the Council of Europe Working Group on Supplements, presented this botanical model. This triggered numerous questions from the audience, showing that the debate on how to regulate botanicals in food supplements is still at the early stages and is one of the key issues for the future of food supplements.

Health claims
A lively debate took place on the issues of Nutrition and Health Claims between Mr Basil Mathioudakis, Mrs Dagmar Roth-Behrendt, Vice President of the European Parliament and Mr Patrick Coppens, Secretary General of ERNA, presenting the industry’s views. The debate clearly showed the continuing divergence of the two key EU institutions on the best approach to regulate claims. The Commission called on industry to recognise that compromise will be essential if a solution is to be found.

Professor David Richardson, scientific adviser of EHPM, presented a potential model for the scientific substantiation of Health Claims (Eur J Nutr (2005) 44: 319-324). He highlighted the importance of taking into account all grades of evidence for weighting the claims, including emerging science, and the difficulties in measuring consumer understanding.

Cooperation and dialogue is essential
In his welcome address, Dr Krabichler, chairman of ERNA, stated that there was need for more European and less national thinking in the interests of harmonisation. He added: “We call on the regulators, scientists and industry representatives present to work together to achieve an appropriate, understandable and easy to implement regulatory framework.”

Following the sessions, Peter van Doorn, chairman of EHPM commented: “This conference illustrates the challenges faced by all parties to create an environment in which industry can thrive and innovate as well as continue to ensure consumer protection. We look for continued co-operation between the industry, the Commission, the Parliament and the twenty five Member states to achieve a balanced and transparent regulation.”

In conclusion, Dr Hagen, Chair of the BLL Supplement Group, stated: “This conference has demonstrated the power of dialogue and of jointly looking for solutions to difficult problems across the stakeholders involved with this significant industry.”

For a copy of the conference programme and a more detailed conference report, please visit the web sites of BLL, EHPM, ERNA or IADSA:
BLL www.bll.de
EHPM www.ehpm.org
ERNA www.erna.org
IADSA www.iadsa.org

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