Towards a harmonization of food supplements in the ASEAN area? outheast Asia is a politically, eco- THE 10 REGULATORY STANDARDS nomically and culturally heteroge- Appendix1 : Principles for inclusion or exclusion neous area, composed of ten coun- from the negative list of substances tries: Brunei, Cambodia, Indonesia, Appendix2: Principles for the use of additives in Laos, Malaysia, Myanmar, Philippines, Singapore, supplements Thailand and Vietnam. It is the 3rd region in the Appendix 3 Guidelines for contaminant limits: world in terms of population. Appendix4: Guidelines for minimizing the risk of For several years, a middle class has been develo- transmission of spongiform encephalopathy ping in this region of the world and in a significant Appendix 5: Stability and Best Before Date way, likely to represent new consumers of health Guidelines products and in particular of food supplements. Appendix 6: Safety Principles for Food In 2004, the member states of the Association of Supplements South East Asian Nations (ASEAN) made a com- Appendix 7: Guidelines for claims and their mitment to harmonize the technical requirements substantiation for health supplements throughout the region, in Appendix 8: Guidelines for Good Manufacturing order to guarantee a similar standard of quality Practices and safety in the various countries and to facili- Appendix 9: Guidelines for Labelling tate exports to third countries. Numerous discus- Requirements sions and negotiations have taken place over the Appendix10 General p: rinciples for setting maxi- last 15 years between the different partners, repre- 9 mum levels for vitamins and minerals sentatives of national authorities but also associa- tions specialized in food supplements to reach a In most cases, a leading country has ensured the common definition of food supplements, which billion, in US$ Asian food development of a standard. is an important step forward, as countries initially supplements market It is interesting to detail the different types of proposed different statuses or even no food sup- (except China, Japan, claims retained (see table below). India) plement status at all. Another achievement is the A proportionate approach in terms of scienti- creation of 10 technical standards. Source : NBJ Report fic evidence has been adopted, the study of the different types of claims shows the obvious in- A HARMONIZED DEFINITION fluence of the regulations in force in other regions «Health supplements» means any product used to of the world and, here, the reference to Europe is supplement a diet and to maintain and improve essential. the health of the human body and containing one What must be specified is that here it will be up or more, or a combination of the following: to each national authority to review the scientific A) Vitamins, minerals, amino acids, fatty evidence and approve the claim. acids, enzymes, probiotics and other bioactive Hence the possibility of different claims being substances. approved for the same scientific support from B) Substances derived from natural sources, of one country to another. This could of course lead animal, mineral or botanical origin, in the form of to complications when preparing multilingual extracts, isolates, concentrates or metabolites labelling. C) Ingredients of synthetic origin as described in It should also be noted that, beyond these diffe- A) and B) rent interpretations, the marketing process will Health supplements are presented in unit doses remain national. in the form of capsules, tablets, powders and li- Some countries are very advanced in the im- quids and must not include sterile preparations plementation of standards, others less so. It is such as injectables or eye drops. clear that for a country that does not have a food noitalugeR — noitatnemelgéR- 85 -