In a very recent conference in Taipei entitled “Expanding Overseas Market of Functional Foods & Dietary Supplement Products aimed at Southeast Asia” on 9 December 2010, Dr Daniel Tsi of EAS Strategic Advice, gave an update on the regulatory landscape in Southeast Asia (ASEAN) markets to a full-house audience from the Taiwanese functional food and dietary supplement industry. During the 2-hour session, Daniel Tsi presented the practical aspects of regulatory requirements to market these products as well as an overview of the market trend and situation.
It was emphasised to the audience that international regulatory development at the CODEX Alimentarius level has an important influence on national regulations in ASEAN markets. As of now, there is no legal definition and category for functional foods in most ASEAN markets. Functional foods are considered as food and must comply with individual national food regulations. On the other hand, dietary supplements can be governed under food regulations, health supplement regulations, traditional medicine or pharmaceutical regulations. Such complex regulatory classification arises due to the different national criteria. The main criteria that affects the classification of dietary supplements under one of the above 4 regulatory categories are:
- product presentation format in fixed dosage form, whether tablets, capsules or pills
- whether the ingredient and dosage are permitted for dietary supplement use
- the benefit being claimed
With ASEAN harmonisation in progress over the next few years, Dr Tsi stated that the regulatory classification framework for dietary supplement will be clearer. In addition, almost all the ASEAN countries require some form of pre-marketing approval for functional foods and dietary supplements. The ASEAN countries in which functional food require pre-marketing approval are Indonesia, The Philippines, Thailand and Vietnam. The registration of dietary supplements is necessary in Indonesia, Malaysia, The Philippines, Thailand and Vietnam.
He then brought the audience through the area of health claims, a topic of great interest among the company representatives. For functional food, the types of claims permissible in different countries are;
- Nutrient Function claim in accordance with a pre-defined list: Indonesia, Malaysia, Singapore, Thailand
- Other Function claim: Malaysia, Indonesia, Singapore
- Disease risk reduction: require approval from the authorities in Indonesia, Philippines and Singapore
Similar to the product classification, the regulatory situation pertaining to health claims of dietary supplement is also diverse in ASEAN markets. Currently, Malaysia is one of the strictest market, allowing very general claim. Functional claims can be made based on a predefined list of claims in Malaysia and Thailand. In Philippines, approval is required before Functional claim can be used. In Singapore, the onus is on the manufacturers to ensure claims are not misleading and substantiated by scientific evidence. Disease risk reduction claims are limited and require case-by-case approval in ASEAN markets.
The ASEAN regulatory session concluded with an explanation and an update on the ASEAN harmonisation of Traditional Medicine and Health Supplement. For future business growth and in line with global standards, Dr Tsi recommended that it is timely for companies to plan and implement quality in manufacturing, which includes shelf-life stability studies.
In view of the evolving regulatory environments that exist today, EAS has released a series of useful guides, the “HOW TO Apply the Nutrition and Health Claims Regulation”, “HOW TO Apply the novel food regulation” and “How to apply mutual recognition principle”. To read more and order, please go to: www.eas.eu/Publications.aspx.