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IADSA Assesses Safety Levels For Bioactives

Many bioactive substances have been shown to be associated with a variety of health benefits. Omega-3 fatty acids, glucosamine and lutein are now household names, and interest in bioactives across governments and the global food industry is growing.

In November the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discussed the addition of bioactive substances that are essential constituents to foods. Following on from the extensive studies conducted on the safety of vitamins and minerals, the International Alliance of Dietary/Food Supplement Association (IADSA) has published “The Risk Assessment and Safety of Bioactive Substances in Food Supplements”.

Prepared by IADSA’s Scientific Group with the help of international experts, the report addresses the addition of non-nutrient bioactive substances to foods. It details the methodology behind the risk assessment model used to develop upper safe levels for a number of bioactive substances including glucosamine, omega-3, coenzyme Q10 and lutein.

David Pineda Ereño, IADSA’s Regulatory Affairs Manager, said: "This authoritative scientific report provides a global perspective on risk assessment to determine upper safe levels for bioactive substances. It is a timely evaluation of many of the most commercially important substances that can be used as a reference point for governments worldwide.”

The report’s risk assessment model evaluates safe supplementation levels based on the type of hazard that results from excessive intake, the dose-response relationship of the identified hazard, and a consideration of uncertainty. A number of the risk assessment papers (creatine, coenzyme Q10, the carotenoids lutein and lycopene, carnitine and chondroitin sulfate) are closely related to publications also written by members of the Scientific Group, which were peer-reviewed in the journal, ‘Regulatory Toxicology and Pharmacology’ last year. One further paper on omega-3 fatty acids has been submitted for peer-review by the same journal.

The report has been circulated to more than 100 key policy decision-makers throughout the world, is available on IADSA’s website, and as a result of its popularity is currently being translated into Spanish and Japanese.

The Scientific Group is in the process of drafting a follow-up publication “The Risk Assessment and Safety of Amino Acids in Food Supplements”, which will be available at IADSA’s annual meeting in Yokohama, Japan, April 2007.

For more information contact David Pineda Ereño, IADSA Manager, Regulatory Affairs, 50 Rue de l’Association, 1000 Brussels, Belgium. Tel: +32 (0)2 209 1155, fax: +32 (0)2 223 3064 or email


IADSA is the leading voice of the worldwide supplement manufacturing industry and an accredited
international non-governmental organisation (INGO) with a seat at the table of the main
international regulatory bodies.

IADSA has more than doubled in size since its creation in 1998, and now represents 55 national trade associations and over 9,500 member companies.

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