Regulatory Harmonisation of Health Supplements in ASEAN

Since 2004, the ten members of the Association of South East Asian Nations (ASEAN) have been working towards the harmonisation of health supplement regulation. The ambitious overall goal is to transform ASEAN into a competitive single market and production base by 2015. In the sector of health supplements the aim is to benefit the member countries by facilitating a common market and ensuring product quality, safety and efficacy.

This challenging task is the responsibility of the ASEAN Consultative Committee on Standards and Quality Product Working Group for Traditional Medicine and Health Supplements (ACCSQ TMHS PWG), with the assistance of the ACCSQ TMHS Scientific Committee. At the 11th TMHS PWG meeting in July this year, the agreed target date for finalising the ASEAN regulatory model framework for TMHS was set as the end of 2010.

Significant aspects for the drafting of the regulation have already been developed or largely agreed:

2006: The ASEAN working definition of health supplements was established.

2008: The ASEAN Guidelines to minimise the risk of Transmissible Spongiform Encephalopathy (TSE) were adopted, with the purpose of managing sources of ruminant animal, nature of animal material and production processes. These were the first harmonised guidelines to be adopted in this process)

2009: Agreement that maximum level of vitamins and minerals shall be determined based on the World Health Organization (WHO) model for risk assessment of nutrients, rather than recommended daily allowance (RDA).

Other areas under discussion include food labelling, a negative list of ingredients, nutrition and health claims, and Good Manufacturing Practice (GMP) standards.

To develop a common labelling requirement, key guiding criteria agreed during the 10th PWG meeting state that the label should include the essential information that enables the consumer to know the product’s identity and the safety of the product, for example, the product’s name, ingredient listing, manufacturer’s details and batch number.

To ensure consumer safety, a negative ingredient list consisting of substances harmful to human health is in the process of being developed. The listing of prohibited ingredients for use in health supplements will be based on scientific rationale.

A health claims framework similar to the claims framework developed by the global food standards body Codex Alimentarius has been established and work must now proceed on establishing more detailed requirements that will permit a common system to be established.

In terms of GMP standards, in theory, the harmonised GMP standards will be mutually recognised across all of the ASEAN markets. The GMP guidelines are being drafted with input from the industry, and since much resource and time will be needed to put in place GMP, a phased-in approach is likely to be required in future.

Regulatory harmonisation across the ASEAN, therefore, is a major development. The deadline is ambitious but there is a strong push to achieve the implementation date of 2015. Inevitably, it will have a significant impact not only on the ASEAN market but on other Asian markets and globally. While a common regulatory system across ASEAN will mean greater future business opportunities in the health supplement sector, at the same time, companies will in the not too distant future already need to start preparing in order to comply with emerging regulatory requirements.

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