There is currently no official harmonized definition or harmonization of the technical requirements and guidelines for functional food products in Asia. Academics and food companies generally understand functional foods to contain or to be fortified with nutrients or other bioactive compounds that help to maintain and promote health.
Functional foods in Asia tend to be regulated under the conventional food category. However, Northeast Asian countries such as China, Japan, South Korea and Taiwan have developed specific national regulations for functional or health food products with
health claims.
Nutrition and health claims Common claims permitted for use on conventional food labels in Asia are:
• Nutrient content claims – which state the level of certain nutrients on the product label.
• Nutrient comparative claims – which describe the nutrient content or energy value relative to other similar foods.
Some countries permit nutrient function claims to be used on products to a limited extent. These claims refer to the physiological role of the nutrient in the growth, development and functions of the body. China, Malaysia, Taiwan and Thailand have also developed national lists of nutrient function claims that are permitted for use.
Disease risk reduction claims established by the international standards setting body Codex Alimentarius (one of the key references used by the Asian food authorities for their national food legislations)are generally not permitted in Asia. However, these claims are used in Northeast Asian countries that have established regulations for functional foods.
However, the health claim regulatory environment is evolving and significant changes in the next five years are expected.
Health claims in Southeast Asia
Indonesia has developed principles and guidelines to regulate functional food claims. Products containing permitted nutrients and bioactive ingredients might bear claims on nutrient content, nutrient function or health, in line with stipulated conditions. A claim could be written as ‘polyphenol in green tea extract could assist to reduce the risk of heart disease, a disease affected by multiple factors’.
The Philippines adopted the full Codex Guidelines on the use of nutrition and health claims in 2007. Malaysia, Singapore and Thailand have lists of permitted nutrient function claims for conventional food that is also applicable to functional food products. In the last few years, Thailand and Singapore have taken steps to develop their national framework with a view to possibly permit other health claims (such as disease risk reduction claims) for food products in line with the Codex guidelines.
Health claims in Northeast Asia
Specifc national regulations on functional foods have been well developed in China, Japan, South Korea and Taiwan. These regulations www.eas-asia.com stipulate that scientific data must be submitted by companies for evaluation before a product could be approved for market launch. Data include research and development, quality (chemical manufacturing), preclinical (safety assessment), clinical (health benefit assessment)and epidemiological reports. A typical functional food application could take two years or more to be approved in Northeast Asia. The cost of development studies for each application is likely to cost from
$10,000 to $150,000.
Navigating the regulatory maze
The evolving Asian regulatory landscape is affected by factors such as globalization, international regulatory developments and harmonization initiatives currently underway among the Association of Southeast Asian Nations (ASEAN). Regulations would continue to play a crucial role in the development and use of responsible health claims for the benefit of public health.
Regulatory developments could offer companies a window of opportunity for introducing new and innovative functional food products. However, as there is no common definition for functional food or pan-Asian harmonization initiative, manufacturers would need to balance their costs and strategies for launching products in different national regulatory markets.
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