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ASEAN harmonised standards and requirements for health supplements

TAGS: Ingredients
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Currently, each ASEAN Member States have different standards and requirements for permitted health supplement ingredients and levels.

Since 2004, ASEAN, with the support from the ASEAN Consultative Committee for Standards and Quality Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG)[1] has been working on the harmonisation of Health Supplement standards and requirement. The harmonisation has finally comes closer to completion  following the recent ACCSQ TMHS PWG meeting held in November 2020, where it has been agreed for the finalisation of ASEAN Agreement on Health Supplements. The finalised ASEAN Agreement on Health Supplement will be submitted to the Senior Economic Official Meeting (SEOM) for signing by the ministers by end of 2021. Implementation of the Agreement will be thereafter.

The ASEAN Agreement on Health Supplement is a legally binding document. By signing the agreement, Member States will be committed to change their laws/regulations to meet the harmonised technical requirements. The agreement covers Institutional arrangement, i.e. who is to implement the agreement, implementation process and the following technical requirements as annexes to the agreement.

  • Annex I – ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements
  • Annex II – ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements
  • Annex III – ASEAN Guidelines on Limits of Contaminants for Health Supplements
  • Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
  • Annex V – ASEAN Guidelines on Stability and Shelf-Life of Health Supplements
  • Annex VI – ASEAN Guiding Principles on Safety Substantiation for Health Supplements
  • Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements
  • Annex VIII – ASEAN Guidelines on Good Manufacturing Practice for Health Supplements
  • Annex IX – ASEAN Guidelines on Labeling Requirements for Health Supplements
  • Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements

These standards and requirements were developed using other international standards and the agreed definition as reference. The ACCSQ TMHS PWG agreed during the earlier meetings to adopt the following definition for Health Supplements.

A Health Supplement means any product that is used to supplement a diet and to maintain, enhance and improve the healthy function of human body and contains one or more, or a combination of the following:

a. Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances.
b. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates, metabolite
c. Synthetic sources of ingredients mentioned in (a) and (b) may only be used where the safety of these has been proven.

It is presented in dosage forms (to be administered) in small unit doses such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e. injectable, eyedrops)”

Opportunities

Introduction of new products into new markets

Currently, each ASEAN Member States have different standards and requirements for permitted health supplement ingredients and levels. As a result, some of the products, for example vitamin C tablet 1,000 mg/day, are not able to launch in Thailand and the Philippines as health supplements because the level exceed their current maximum levels, which is based on their national Recommended Daily Allowance (RDA). By adopting the ASEAN maximum level of vitamins and minerals, which was develop based on risk assessment approach, the vitamin C tablet would be able to place in these markets as health supplements.

Clearer regulations in emerging markets

Health Supplements products are relatively new to emerging markets like Cambodia, Lao PDR and Myanmar. Currently, such products are evaluated like pharmaceutical products, which may not be the best approach since health supplements and pharmaceutical are different in nature.

With the availability of ASEAN standards and requirements, the health authorities will be better able to regulate health supplement products, thus giving opportunities for companies to bring in more products into these market.

Health claims

Currently, most ASEAN Member States do not have clear guidance on the use of health claims and have the limited resources/knowledge to evaluate new to ASEAN markets. With the availability of the guidelines on claims and claims substantiation, the companies and regulators will have some guidance on collation and evaluation of the scientific data to substantiation of claims, and therefore able to better communicate the benefits of the products to the consumer.

Alignment with international practice

As the standards and requirements are developed with references to International Standards such as those in Codex, WHO, ICH and other pharmacopoeias, products from outside ASEAN which meet these international standards will have the opportunity to market their products in the ASEAN Member Standards. Products manufactured in ASEAN will also be able to compete internationally.

Common standards/cost saving

Currently, each Member States have different test parameters and limits for contaminants. When the Member States implemented the harmonised requirements for heavy metal, microbial contaminants, the cost of testing will likely to be reduced.

Challenges

Despite the benefits harmonisation will bring about, there will be some challenges anticipated. Some guidelines such as Guidelines on safety substantiation are very general, and it is likely that the readers will have different interpretation. There will be possibility that the safety substantiation data will be accepted in some Member States but not the other.

Some of the guidelines such Stability Study and Shelf life study requirements, and GMP requirements, were developed based on the pharmaceutical standards. This will be an issue for as many Health Supplements products are manufactured according to food standards.

Recommendations

As we are expecting the signing of the ASEAN Health Supplements Agreement end of this year. It is advisable for companies that are interested in ASEAN market to start complying to the ASEAN technical standards and requirements.

Though the development of technical requirements is completed, there is still room to negotiate for amendments or fine tuning of the technical requirements after the starting of implementation phase. It is recommended for companies to closely monitor the discussion at the ACCSQ TMHS PWG meetings, providing feedbacks by participating in industry-authority dialogue sessions via local trade association.

Wai Mun Poon, a regulatory affairs consultant at Wong SJ Asia, will be presenting a regulatory update on 'ASEAN harmonisation of health supplements' on 2 February as part of Vitaoods Asia Digital Week. Free registration is now open. 

References

[1] ACCSQ TMHS PWG's delegates include the regulators from the relevant health authorities in each ASEAN Member States and the representative of the ASEAN trade associations

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