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How can Health Food (Dietary Supplement) Enter into the Market of China, Japan, Korea, USA, Australia, New Zealand, ASEAN and EU?

from CIRS by

Health,Food,Registration,Dietary,Supplement,Compliance

In recent years, with the rapid improvement of social medical level and the living standard, Chinese consumers are paying close attention to health. Besides, the outbreak of coronavirus pandemic since the beginning of 2020 has made everyone become more aware of the importance of health and the pursuit of health has become more urgent. Therefore, health food with specific health functions and/or could regulate body functions have gradually become the focus of consumers.

The regulations for health food are different in different countries/regions. To help companies have a better understanding of the general requirements for health food of different countries, CIRS has summarized the requirements of several countries/regions from various aspects such as deification, related regulations and compliance process and made a comparison as follows:

Category Name and Definition

For the health food products, their category names, and definitions are different in different countries/regions.

Table 1 Category name and definition of food supplement

Country/region

Category name

Definition

China

Health food

Health food refers to foods that claim to have specific health functions or supply vitamins and minerals. Health food is specific to certain group, and modifying organic functions in humans, but is not for the purpose of treating diseases, and does not cause any acute, sub-acute or chronic harm to the human body.

USA

Dietary supplements

The term dietary supplement -(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

Consumed as in tablet, capsule, powder, soft capsule or liquid; not as traditional foods, or as the only component of a diet.

EU

Food supplements

Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses). A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.

Australia

Complementary medicine

Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

Item Ingredient or kind of ingredient: 1. an amino acid; 2. charcoal; 3. a choline salt; 4. an essential oil; 5. plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and

Chlorophyll; 6. a homoeopathic preparation; 7. a microorganism, whole or extracted, except a vaccine; 8. a mineral including a mineral salt and a naturally occurring mineral; 9. a mucopolysaccharide; 10. non-human animal material (or a synthetically produced substitute for material of that kind), including dried material, bone and cartilage, fats and oils and other extracts or concentrates; 11. a lipid, including an essential fatty acid or phospholipid; 12.a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis; 13. a sugar, polysaccharide or carbohydrate; 14. a vitamin or provitamin etc.

New Zealand

Dietary supplements

The definition of dietary supplements is:

1. It is an amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin; 2. It is sold by itself or in a mixture; 3.It is sold in a controlled dosage form as a liquid, powder, or tablet (which might be described on the label as a cachet, capsule, lozenge, or pastille instead of as a tablet).

4. It is intended to be ingested orally; 5. It is intended to supplement the amount of the amino acid, edible substance, herb, mineral, synthetic nutrient, or vitamin normally derived from food.

Canada

Natural health product

The definition of natural health product includes the purpose and ingredients:

1. purpose of natural health product include: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; restoring or correcting organic functions in humans; or modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

2. The raw materials of natural health products are allowed to use a total of 8 categories: 1) plants or plant materials, algae, bacteria, fungi or non-human animal materials; 2) extracts or isolates of the substances described in category 1), the main molecular structure and extraction Or the same before separation; 3) vitamins (biotin, folic acid, niacin, etc.); 4) amino acids; 5) essential fatty acids; 6) Composites of the substances described in categories 2) to 5); 7) Minerals; 8) Probiotics.

ASEAN

Health supplements

Health supplements refer to any product that maintains, enhances and improves human health functions and is used to supply the diet, and contains one or more or a combination of the following: 1) vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances 2) Substances of natural origin, including animal, mineral, and vegetable substances in the form of extracts, isolates, concentrates, metabolites; 3) Synthetic sources of the ingredients mentioned in the first two items. Health supplements are presented in small dosage units such as capsules, tablets, powders, liquid dosage forms (to be taken) and do not include any sterile preparations (i.e. injections, eye drops)

Japan

Health functional food

(保健機能食品)

Health functional food covers 3 categories, including food for specific health use, functional labelled food and nutritional functional food:

1) Foods for specific health use refer to foods that contain health-care functional ingredients that affect the physiological functions of the body, help maintain normal blood pressure, cholesterol, and regulate the stomach and intestines, and are marked with specific health-care purposes.

2) Functional labelled food refers to the food produced based on scientific basis, not targeting patients, and by ingesting the "active ingredients" in such food, it helps to maintain or promote physical health.

3) Nutritional functional foods refer to health functional foods for the purpose of supplementing specific nutrients.

Korea

Healthy functional food

(건강기능식품)

Health functional food refers to food produced (including processed) using functional raw materials or raw materials useful to the human body, where "functional" refers to regulating nutrition for human body structure or function, or providing beneficial health care functions, such as physiological functions.

Taiwan

Health food

(健康食品)

Health food refers to products that have health benefits and are labeled or advertised to have such benefits.

Related Regulations and Laws

For health food related products, each country has its own regulation framework. CIRS has summarized some relative regulations with health food in the table below.

Table 2 Food supplement relative regulations

Country/region

Related regulations and laws

China

Health Food Registration and Filing Regulation

Guidelines for application of health food registration

Health Food Filing Work Guide

GB 16740-2014 Food national standard health food

USA

Federal Food, Drug and Cosmetic Act (FD&C Act)

Dietary Supplement Health and Education Act (DSHEA)

Nutrition Labeling and Education Act (NLEA)

Current Good Manufacture Practice in Manufacturing, Packaging, labeling, or Holding Operations for Dietary Supplements (CGMP)

EU

2002/46/EC

EC No 1924/2006

Australia

Therapeutic Goods Act 1989

Therapeutic Goods Regulation 1990

Australian regulatory guidelines for complementary medicines

New Zealand

Dietary Supplements Regulations

Canada

Natural Health Product Regulation

Pathway for licensing natural health products making modern health claims

Pathway for licensing natural health products used as traditional medicines

ASEAN

ASEAN Health Supplements Agreement

Japan

Health Promotion Act

Food Sanitation Law

Revision of Operation and Guidance Points for Examination of Specified Health Foods

Nutrition Labeling Standards

Korea

Healthy Functional Food Law

Implementation Regulations of the Healthy Functional Food Law

Enforcement Decree of Health Functional Food Law

Healthy Functional Foods Codex

Taiwan

Healthy Food Control Law

Enforcement Rules of the Healthy Food Management Law

Health Food Application Licensing Measures

Principles of Health Food Inspection and Registration Review

Table 3 Regulatory requirments in different countries/ regions

Country/region

Authority

Compliance process

China

State Administration for Market Regulation and the market supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government

1) Registration: Use the ingredients outside the raw material dictionary and excipient dictionary

2) Filing: Use the ingredients listed in the raw material and excipient dictionary

USA

Food and Drug Administration (FDA)

1 Responsible by the manufacturers and distributors: most products

2 Notification/registration: including the dietary supplement contains a new ingredient etc.

EU

The European Commission and the competent authorities of the Member countries.

The compliance process is different in different EU member states, mostly notification/registration

Australia

Therapeutic Goods Administration

(TGA)

1) Registration: such as using the ingredients outside of the therapeutic Goods Listing Notice

2) Listed: Listed medicines are considered to pose a low risk to consumers than registered medicines, use the ingredients in the therapeutic Goods Listing Notice

3) Assessed listed: Use the ingredients in the therapeutic Goods Listing Notice but the added level exceeds the limit.

New Zealand

Medsafe

1) No pre-approval process for most dietary supplements: dietary supplement must comply with the regulations and the sponsor shall be responsible for ensuring the product complies with the law.

2) Submit the declaration: dietary supplements containing folic acid

Canada

Nature and Non-prescription Health

Products Directorate (NNHPD)

Tiered registration (depending on product safety and feature claims)

ASEAN

ASEAN Consultative Committee on Standards and Quality (ACCSQ) and the authorities of member states

Each member countries approves their own products (mostly registration)

Japan

Consumer Affairs Agency

1)Registration: Food for Specified Health Use

2) Filing: functional labelled food

3)Self-certification: nutritional functional food

Korea

Ministry of Food and Drug Safety (MFDS)

1) Registration: specific health functional food

2) Record: general health functional food

Taiwan

Health authority

"Dual-track" inspection and registration:

1) Check and register according to the principle of case-by-case review (Track 1)

2) Comparing with the existing specifications and standards for inspection and registration (the second track system, currently only red yeast rice and fish oil)

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