IADSA briefs - May 2009

Top officials to meet in Moscow at international food supplement conference
Regulatory officials and scientific experts from across the globe will meet at an international symposium in Moscow from 16-18 to discuss the evolving regulatory frameworks of the food supplement market.

The symposium, titled 'Optimal Nutrition: role of biologically active components of food,' is the first grouping of industry and government officials in which the myths and reality of food supplements will be debated as well as how to reach the perfect balance between information, education and marketing in the global arena.

Topics for discussion will include global trends and regulatory frameworks and challenges for food supplements and health foods in China, the EU, Russia and the United States; methods and approaches to quality control; harmonisation of approaches in food supplement regulation and risk assessment worldwide; the role of clinical studies in risk assessment; and the substantiation of claims for food supplements.

The symposium is being organised jointly by the Federal Office of Surveillance of Consumer Right Protection and Wellbeing, Russian Ministry of Health; the Russian Academy of Medical Sciences; the Russian Institute of Nutrition; CDSP; the Russia National Association of Dieticians and Nutritionists; the Moscow Medical Academy and IADSA.

EU mutual recognition regulation becomes applicable
A new European Union regulation setting down rules for operators and national authorities on how to apply the principle of mutual recognition became applicable on 13 May 2009, European trade organisation EHPM has said.

EHPM Director of Regulatory Affairs Lorene Courrege said that the Regulation could be a vital tool for the food supplement sector in helping to break down national trade barriers in the EU.

The Regulation is based on the concept of mutual recognition of national rules, which stems from the principle of the free movement of goods guaranteed by the EU treaties. It applies to areas of EU legislation not yet harmonised and sets up a compulsory dialogue between Member States and companies facing restriction to market access for their products because of national technical rules.

Courrege said: "This regulation is doubly important in light of the European Commission's recently released opinion that no further harmonisation of bioactive and botanical ingredients used in food and nutritional products is necessary at this stage. It means companies may find barriers to trade among different Member States, although ingredients lawfully marketed in one EU member state should, in principle, be accepted in all other EU markets. The new Regulation should be a useful tool to overcome these hurdles."

Controversial nutrient profiles scheme moves up to Barroso level
Lack of consensus among EU Member States and internal opposition over the European Commission's proposal for a nutrient profiling scheme has led the issue straight to the cabinet of Commission President José Manuel Barroso. Miguel Da Silva, adviser at international food and nutrition policy consultancy EAS, said in a recent podcast interview that pressure on the Commission from the EU Member States, the European Parliament, the food sector and other stakeholders, as well as strong internal opposition within the Commission itself to a draft proposal by the Commission's Directorate-General for Health and Consumers (DG Sanco) which is in charge of developing the profiles, has caused the cabinet of President Barroso to get involved in the discussions to try to find an acceptable solution.

Nutrient profiles has been the subject of intense debate among the EU Member States in recent months, but DG Sanco received an additional blow in March this year when it circulated its proposal internally within other Commission services and it came back with a host of negative opinions.

These included among other things criticism that the draft proposal was based on a restrictive approach that would reduce innovation incentives for certain food categories, and that it could jeopardise the sustainability and development of a range of food categories in Europe. Concerns were also raised about the proportionality of the proposal and its respect for the principle of equal treatment.

"Of course, none of these criticisms are new," said Mr Da Silva, "however, these comments now come from within the Commission itself, which makes things quite challenging for everyone involved. Members of the Barroso Cabinet are now coordinating the discussions on the setting of nutrient profiles. This illustrates how political these discussions have become — at the highest level possible!"

The deadline originally set in the EU's Nutrition and Health Claims Regulation for adopting a profiling system — January 2009 — has not yet been met.

Belgian Ministerial Order could signal start of higher ingredient level across EU
A recent Belgian Ministerial Order setting a 200mg maximum daily level for coenzyme Q10 (ubiquinone) in food supplements could signal the start of a trend towards higher levels for the ingredient in supplements and foods across the European Union (EU), international food policy consultancy EAS has said.

EAS Regulatory Adviser Pieter Lagae said that the agreed level for coenzyme Q10, which is higher than that accepted in a number of EU Member States, is a significant step as Belgium is well respected for its rigid notification system and its levels could be taken as a benchmark in other Member States setting their national rules for the use of bioactive and botanical substances.

The Belgian Order's list currently only covers coenzyme Q10, choline and carnitine, all of which have undergone a rigorous safety assessment with levels set on the advice of Belgium's Superior Health Council.

"Across the EU, where maximum levels have been established, they are often between 30mg and 100mg," said Mr Lagae. "Belgium's decision to set it at 200mg is a significant move. The level is based heavily on scientific evidence submitted, and it could play an important role in setting a maximum level for coenzyme Q10 in Europe. In Denmark too, for example, a daily maximum level of 180mg is being considered for coenzyme Q10."

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