Probiotic regulations in the Asia Pacific

According to a presentation given by Kevin Gillies at the International Probiotics Association (IPA) World Congress earlier this month, there is little regulatory harmonization between countries within the Asia Pacific. While regulatory claim structures are similar in that they recognize basic health claim principles such as structure/function, risk reduction and disease reduction, a singular approach to the way in which probiotic health claims does not exist. For instance, Indonesia and Singapore have health claim regimes in place whereas many Asian countries do not. ASEAN (the Association for South East Asian Nations) is working on developing a "shared view",​ with Codex and European Union principles being employed as regulatory guides. Supplements are an initial focus for the group of 10 countries whose members include Indonesia, Singapore, Thailand and Malaysia Japan​​​In Japan, probiotic claims for foods and supplements are not strictly regulated and hence claims such as "good for your health"​ are permitted. ​However in the more tightly regulated Foods for Specific Health Uses (FOSHU) market, pre-market approval is required for products that seek to make health claims and bear the FOSHU logo. Epidemiological cohort studies and clinical trials are required to substantiate any claims. While there are reduction of disease risk claims approved for calcium (osteoporosis) and folic acid (neural tube defects), none as yet exist for probiotics. But a list of centralized FOSHU claims has potential for use in probiotics if Japanese regulators approve clinical trials. Existing claims include:

• Improves gastrointestinal conditions

• Modulates cholesterol

• Modulates blood pressure

China​​​China is another market where few health claims can be made for probiotics, although the Culture (human, not probiotic) and Health ministries are in discussion about how best to regulate the market. Guidelines are being developed for both foods and supplements that will see claims attached to individual probiotic strains as a positive list of claims is built. For those that don't make the positive list, novel foods approval is required and some probiotic strains have reached market via this avenue. In lieu of that, an "approval certificate of health (functional) foods"​ can be issued to those foods that demonstrate functional potential and ingredients such as Lactobacillus​ and Bifidobacterium​ are listed as functional ingredients. Australia​ and New Zealand ​ ​Health claims regulations have been under review in Australia for some time, with conclusions expected next month from the regulator there, Food Standards Australia and New Zealand (FSANZ). The system is divided between high and general-level claims. General-level claims consist of claims relating to the ability of foods to affect performance, well-being and non-serious disease. There is a pre-approved central list of claims. "Calcium is good for strong bones and teeth, when consumed as part of a healthy diet containing a variety of foods"​ or "Gives you energy, when consumed as part of a healthy diet with a variety of foods"​ are examples.​​A probiotic claim in this field may state something like: "Yoghurt high in strain X and Y may reduce your risk of stomach upset, when consumed as part of a healthy diet with a variety of foods." ​​Higher level claims require pre-market approval and refer to the ability of a food to reduce the risk of disease, control disease or improve health. Scientific substantiation is required for each along with dosage information. There is a split in regulations governing dietary supplements because supplements in Australia are regulated under the Therapeutic Goods Act, which very strictly controls health claims under a centralized registry. New Zealand's regulations, while operating under a different structure, are similar in effect. Bifidobacterium​species and Lactobacillus​ species are listed as approved active ingredients for complementary medicines. India​​​The Food Safety and Standards Act of 2005 (FSSA) defines "foods for special dietary uses or functional foods, nutraceuticals or health supplements." ​​While this piece of legislation is still being implemented, it is a relatively liberal regulation that permits claims as long as they are not misleading. Supplements are more strictly controlled, with most considered as drugs and pre-market approval is required for probiotic health claims. For yesterday's article on rules governing the European probiotics market click​ here​​.​ For Friday's article on Canada click​ here​​. For Thursday's article on the US click​ here​​.​