“ASEAN aims to sign harmonised Traditional Medicine & Health Supplement regulatory guidelines”


Singapore based Evon Chan is Regulatory Affairs Adviser at EAS Strategies – Asia Pacific. She specialises in regulatory affairs for food and health supplement products in a regional capacity and has been providing advice to companies on various food regulations issues. Prior to joining EAS, she has extensive experience in new product development, nutrition analysis, food quality control/quality assurance and halal certification. Evon has a Bachelor’s degree in Food Science and Nutrition. Evon will be speaking on ‘Functional Food and Health Supplement Regulations and Market Trends in Indonesia’ and ‘in Malaysia’ at Vitafoods Asia, an event dedicated to the nutraceutical, functional food and beverages, and dietary supplement industries in Asia scheduled to be held in Hong Kong from September 2 – 3, 2015. She shared her thoughts on the market trends for Functional Food and Health Supplement in Malaysia and Indonesia with NuFFooDS Spectrum in an email interview.

What are the current market trends for Functional Food and Health Supplement in Malaysia and Indonesia respectively?

As people become increasingly health conscious, the functional foods and health supplements markets in Indonesia and Malaysia are rapidly growing.

Has the government (for Malaysia and Indonesia) been supportive to the companies? What kind of help have they offered?

The Government has been very supportive of the industry. Workshops are always provided to facilitate a better understanding of International standards or practices. This can also help the manufacturers with locally manufactured products to enter international market and compete internationally.

The Government would also invite the industry to participate in the public consultation on the draft regulations to ensure they are aware of new regulatory requirements and would be able to comply with them.

What are some challenges that the companies in Functional Food and Health Supplements face in Malaysia and Indonesia?

There are currently no harmonised technical requirements for functional food and health supplement products. Different ASEAN countries may have different regulatory requirements. It is a challenge to develop a product that is in compliance with legislation and regulations across nations.

What are the future opportunities in Malaysia and Indonesia for the companies in Functional Food and Health Supplement?

ASEAN aims to finalise and complete the signing of harmonised Traditional Medicine and Health Supplement regulatory framework and guidelines in 2017. By implementing the harmonised requirements, there will be many opportunities for industry. Health supplement products are relatively new to emerging markets like Cambodia, Lao PDR, and Myanmar. Such products are evaluated like pharmaceutical products, which may not be the best approach since health supplements and pharmaceuticals 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 markets.

Also, currently most ASEAN countries do not have clear guidance on the use of health claims and have the limited resources 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.

At present, different ASEAN countries have different test parameters and limits for contaminants. When the harmonised requirements are implemented (e.g. heavy metal, microbial contaminants), the cost of testing will likely be reduced.

What is the current regulatory scenario in Malaysia and Indonesia related to Functional Food and Health Supplements?

The Food Safety and Quality Division (FSQ) of the Ministry of Health is responsible for assuring that foods sold in Malaysia are safe, wholesome and properly labelled.

Both the Food Act 1983 (Act 281) and Food Regulations 1985 are federal laws governing food products consumed in the country (either produced domestically or imported). These laws protect the public against health hazards and fraud in the preparation, sale, and use of food.

In Malaysia, food products are currently not subject to pre-marketing approval and licensing from the FSQ. Manufacturers, importers, and distributors are responsible in ensuring their products comply with the relevant regulations.

Health supplement products must be registered with NPCB prior to manufacturing and sale. Manufacturers must ensure compliance in accordance with the Malaysian Drug Registration Guidance Document based on the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetic Regulation 1984. Health supplement is defined in Drug Registration Guidance Document as any product that is used to supplement a diet and to maintain, enhance, and improve the health function of the human body. It is presented in small unit dosage forms (to be administrated) such as capsules, tablets, powder, liquid, and shall not include any sterile preparations (i.e. injectable, eye drops). It may contain one or more, or the following combination:

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

In Indonesia, food products come under the purview of the National Agency for Drug and Food Control (NADFC). In general, food products are governed by:

• The Food Act of the Republic of Indonesia Number 7 (1996) which was promulgated on 4 November 1996;
• Government Regulation of the Republic of Indonesia No. 69 Year of 1999 on Food Labelling and Advertisement;
• Decree of Head of Drug and Food Administration Republic Of Indonesia Number 1 Year of 2013 pertaining E-Registration Processed Food;
• Decree of Head of Drug and Food Administration Republic Of Indonesia Number HK. Year of 2011 pertaining Registration of Processed Food;
• Decree of Head of Drug and Food Administration Republic Of Indonesia Number HK. Year of 2011 pertaining Management of Processed Food Registration, and;
• Decree of Head of Drug and Food Administration Republic Of Indonesia Number HK. Year of 2011 pertaining Supervision Claims on Labelling and Advertising of Processed Food.

According to Decree HK., food products have to go through registration procedure to assess the safety, quality, and nutrition criteria of the products. The registration can be done online.

The Republic of Indonesia’s National Agency of Drug and Food Control (NADFC) has detailed the following regulations relating to food supplements:

• Decree of Head of Drug and Food administration Number HK. pertaining to the Principles of Food Supplement Inspection;
• Regulation of Head of Drug and Food Administration Number HK. pertaining to the Procedures of Food Supplement Registration.

Food Supplements are defined as products for supplementation of the normal diet and contain concentrated sources of one or more vitamins, minerals, amino acids, or other substances (plant/animal origin, herbal, enzymes, metabolites, extracts) with a nutritional or physiological effect. Health supplements in oral forms (capsules, tablets, soft gels, liquids, pastilles, powders, granules and so forth) are permitted in Indonesia.

Food Supplements in Indonesia must comply the following criteria:
• Use of materials that meet the quality standards and requirements;
• The efficacy of the composition must be supported by clinical data;
• Must be produced in accordance with the principles of GMP.

In Indonesia, food supplements must be registered with the NADFC prior to marketing. New registrations are broadly divided into three main categories:
• Category (1) – Food supplements which consist of one or more forms of vitamins, minerals, amino acids, carbohydrates, protein, fatty acids or other substances, such as isolates
• Category (2) – Food supplements which consist of one or more of the above plus other ingredients from natural sources, and
• Category (3) – Food supplements from categories 1 or 2 with new function claims, new dosage forms or dosage levels.

Registration for a food supplement product is divided into two stages, a pre-evaluation stage and an evaluation stage. During the pre-evaluation stage, the authority will review the submitted documents for completeness (but not the contents at this stage). Once the pre-evaluation stage is deemed appropriate, the product will move to the evaluation stage. The registration process takes 6 to 12 months, but that does not include time taken for supplementary information from the applicant.

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