Thailand Health Food Regulations QA

Email: bkk4ww@evershinecpa.com
Manager Paul, Speak Thai, English
WeChat: Paul0864580532

HLF-TH-10
What are the categories of health food in Thailand?
What is its official name? What is the intensity of management of different categories?
What is the governmental authority of health food? Website?

Evershine RD：

The Food and Drug Administration of Thailand under the Ministry of Public Health.
Its main responsibilities are to control food from pre-market to post-market, including establishing food standards, managing food production and import, regulating food hygiene and labeling requirements, and issuing certifications (such as free sales certificates, hygiene certificates, GMP certification, HACCP certification, etc.) , food spot inspection and audit, and advertising management, etc., to ensure consumer safety. In the food law classification, dietary supplements are standardized foods.

Food supplement means products taken for consume other than conventional foods which contain nutrients or other substances as ingredients, are in forms of tablets, capsules, powders, flakes, liquids or others ; which are not conventional foods for consumers who expect for benefit of health promotion. Nutrients or other substances mean :

1. Vitamins, amino acids, fatty acids, minerals and produces obtained from plants or animals.
2. Concentrates, metabolites composition or extracts of substances of 1.
3. Artificial substances imitated like substances of 1 or 2.
4. Mixtures of one or more of substances of 1 ,2 or 3.
5. Substances or others as to Food and Drug Administration prescribed according to an approval of the Food Committee.

【參考連結】

http://food.fda.moph.go.th/law/TH/pages/product.html

http://food.fda.moph.go.th/law/act.php

HLF-TH-20
If a foreign company wants to sell health food in Thailand, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

Yes, it is required to obtain an approval.

1. The producer, importer or production and sales contract must meet the following conditions:

．Natural person: it must have Thai nationality and the minimum age is twenty years old.

．Juridical Person: it must be registered in Thailand.

2. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

【參考連結】

https://www.dbd.go.th/dbdweb_en/index.php#

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-25

假如需要辦理，請問泰國有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

PANWA

https://www.companythailand.net/

INTERLOOP

https://inlps.com/

HLF-TH-30

If a foreign company wants to sell health food in Thailand, can it assign a Thailand company to act as a business agent?
What are the requests for acting as a business agent?
What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

1. The producer, importer or production and sales contract must meet the following conditions:

．Natural person: it must have Thai nationality and the minimum age is twenty years old.

．Juridical Person: it must be registered in Thailand.

2. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

The license holder or company shall be responsible for product-related issues and cooperate with relevant periodic and ad hoc inspections by the Food and Drug Administration.

【參考連結】

https://www.dbd.go.th/dbdweb_en/index.php#

http://food.fda.moph.go.th/ESub/pages/register.php

HLF-TH-35

假如需要辦理指派泰國公司擔任營業代理人，請問泰國有專業服務公司可以協助？

Evershine RD：

KARMART

https://www.karmarts.co.th/th/home

Do Day Dream Public Co., Ltd.

https://www.dodaydream.com/th

HLF-TH-40

Do foreign companies need to apply for an approval before importing health food sold to Thailand? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold. Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

． Applicant’s name, age, nationality, ID number, residential address, telephone

． Family register copy or photo.

． Certified copy or photograph of registration, objective, authorization documents.

． Documents proving that the applicant has appointed an authorized person to operate the legal entity.

． Copy or photograph of trade registration or business registration.

．Legal person nationality certificate issued by the Ministry of Commerce.

2. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

．List of equipments used for keeping or preserving of food quality as necessary (if applicable).

．Map of locations of import premises, holding premises and neighboring constructions.

． Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
2. Food serial number.
3. Name and address of producers or importers, as the case may be, as follows:

．For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

．For imported food, name and address of importer and country of producer.

4. Food supplement quantities shall be expressed as the case may be, as follows:

．Food supplement in form of tablets or capsules expressed as the number per pack.

．Food supplement in form of liquid expressed as net volume.

．Food supplement in form of solid or others expressed as net weight.

5. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
6. Declaration of “ utilizing preservatives” (if any)
7. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
8. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
9. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10. Instruction for use.

11. Instruction for food storage. (if any)
12. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
13. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【參考連結】

https://privus.fda.moph.go.th/index.aspx

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-45

請問在泰國有哪些專業服務機構，可以協助辦理保健食品產品許可證？

Evershine RD：

P&P

https://www.pnpinternationallegal.com/

Pacific Legal Group

http://www.pacificlegalgroup.com/

HLF-TH-50

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to the Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

Application of license should meet the following requirements:

1. The producer, importer or production and sales contract must meet the following conditions:

．Natural person: it must have Thai nationality and the minimum age is twenty years old.

．Juridical Person: it must be registered in Thailand.

2. Business registration is subject to electronic registration with the Ministry of Commerce of Thailand.

Dietary supplements are standardized foods and need to pass the manufacturing/import license, GMP certification and FDA review before they can be sold.  Licensed importers can import a variety of food products, provided they are approved by the Thai FDA. The designated warehouse or warehouse must be inspected and approved by the Thai FDA before a license can be issued. Import licenses are also renewed every three years:

1. Those who intend to apply for a license of importation of food to sell, An Application Form attached with the regulation shall be submitted together with documents specified in Application.

Application form content

． Applicant’s name, age, nationality, ID number, residential address, telephone

． Family register copy or photo.

． Certified copy or photograph of registration, objective, authorization documents.

． Documents proving that the applicant has appointed an authorized person to operate the legal entity.

． Copy or photograph of trade registration or business registration.

．Legal person nationality certificate issued by the Ministry of Commerce.

2. The Applicants, according to clause 1, shall attach two copies of the following documents to apply for the license:

．List of equipments used for keeping or preserving of food quality as necessary (if applicable).

．Map of locations of import premises, holding premises and neighboring constructions.

． Layout of inside holding premises which having ratio corresponded to their dimensions and indicates the following items:( Neighboring area of holding premises, Separation of spaces of the holding premises, ventilation including installation of equipments use for keeping or preserving of food quality as necessary.)

Labeling of food supplement products for sale to consumers shall be expressed in Thai language text but foreign language text may also be presented; and shall have texts to express as follows:

1. Names of food, “food supplements” shall be displayed as a part of the name, or accompanied with.
2. Food serial number.
3. Name and address of producers or importers, as the case may be, as follows:

．For food produced within country, name and address of producers or re-packers for sale shall be displayed, or name and address of head office of producers or re-packers may be displayed instead.

．For imported food, name and address of importer and country of producer.

4. Food supplement quantities shall be expressed as the case may be, as follows:

．Food supplement in form of tablets or capsules expressed as the number per pack.

．Food supplement in form of liquid expressed as net volume.

．Food supplement in form of solid or others expressed as net weight.

5. Name and quantity of main ingredients of food supplement and constituents which claims for usefulness, on the label of food supplement .
6. Declaration of “ utilizing preservatives” (if any)
7. Declaration of “natural colour added” or “artificial colour added” if utilizing, as case may be
8. Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”, “natural flavour”, or “imitate natural flavour” if any, as case may be.
9. Clear statement of “Receiving any nutrients should intake by consuming five categories of principal foods and in appropriate proportion.

10.Instruction for use.

11. Instruction for food storage. (if any)
12. Date, month, and year of expiration for consumption or date, moth, and year in which food is in good qualities or standards for food supplement with minimum durability of not more than 90 days; or month, and year of expiration for consumption or , moth, and year in which food is in good qualities or standards for food supplement with minimum durability of more than 90 days; and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before” , as the case may be; and date, month, and year shall be respectively expressed. The declarations, according to (12) under the packaging, on the label shall present statement which indicate the position of that declaration.
13. Warning of food supplement consuming shall be followed the Notification of the Ministry of Public Health, Re : Health claim and Warning of food consuming.

【參考連結】

https://www.dbd.go.th/dbdweb_en/index.php#

https://privus.fda.moph.go.th/index.aspx

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-55

請問在泰國有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？

Evershine RD：

Biorius
https://biorius.com/

SGS

https://www.sgs.co.th/en/agriculture-food/food

Pacific Legal Group

http://www.pacificlegalgroup.com/

HLF-TH-60

What documents are required when importing approved health food into Thailand?What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

Dietary supplements in Thailand must comply with food GMP regulations, and GMP certificates must also be attached when importing products for sale in Thailand.
GMP accepted by the Thai FDA can be in any of the following forms:

1. GMP under Thai law.
2. GMP by Codex.
3. HACCP.
4. ISO 9000.
5. Other equivalent or higher sanitary standards (eg ISO 22000, BRC, IFS, etc.).

Application materials for GMP certification for dietary supplements:

1. Applicant, production base number
2. Company name, location of dietary supplement base
3. Laboratory (with/without)
4. Operator name, head office/office address, telephone
5. Types of food for which permit/licensing has been applied
6. Other documents:

． List of food production sites/plans and machines

． Food pantry (if the storage location is not co-located with the production site)

． food storage location

． Monitoring system equipment

． Legal person registration certificate / business registration certificate

． Organizational chart

． Work flow chart

． Factory floor plan

． Photos of the machine production site, surroundings, various rooms and production-related areas

． Elevation of the building

． Staff training SOP

． Health Check SOP

． Staff Dress SOP

． Machine or equipment horsepower and number of employees

【參考連結】

https://www.fda.moph.go.th/sites/food/SitePages/gmp.aspx

HLF-TH-70

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

The following supporting documents are required to apply for a food license to the Food and Drug Administration

1. Physical and chemical quality standards, and microbiological specifications of raw materials (as the case may be)

. The scientific name and characteristics of each plant material.

. The number of servings of each raw material, the uniqueness of the raw material, the inspection method for quality control, the consistency of the inspection method.

. The type of drug and the type of extraction solution, its concentration, and the ratio of raw materials to extractable active substances per 1 gram.

. Analysis method of the main component/substance/marker of the substance in the raw material.

2. The detailed formula information of raw materials and detailed documents of all ingredients and quantities provided by the manufacturer, especially the essential and non-essential ingredients in the formula (expressed in percentage and weight).
3. The actual detailed manufacturing process of the dietary supplement provided by the manufacturer.
4. The physical and chemical product information (product specifications) of the micro-organisms provided by the manufacturer
5. Analysis results of dietary supplements: It must be the analysis results of institutions or organizations designated by domestic and foreign governments or laboratories or institutions recognized by the government agencies of the country.

【參考連結】

http://food.fda.moph.go.th/law/TH/pages/product.html

HLF-TH-75

泰國保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

可以，膳食補充劑分析結果必須是國內外政府指定的機構或組織或由該國政府機構認可實驗室、機構的分析結果。

HLF-TH-77

請問在泰國有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？

Evershine RD：

SGS

https://www.sgs.co.th/en/agriculture-food/food

TÜV SÜD

https://www.tuvsud.com/zh-tw

Cotecna

https://www.cotecna.com/

HLF-TH-80

After a foreign subsidiary imports health food and entrusts a distributor in Thailand to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

FDA conducts regular, ad hoc (suspect/request) spot checks of marketed foods.
The purpose of post-market control is to ensure that the food distributed to consumers is hygienic and of a quality that conforms to national food standards.
Therefore, the measure mainly concerns law enforcement activities. Regular inspections of all food factories and establishments across the country are carried out, and food samples are analyzed and tested to ensure compliance with legal requirements.
In the event of violations, measures such as seizures, recalls and prosecutions will be taken. In general, inspections are divided into two

1. Periodic Inspections: Planned inspections to ensure the successful implementation of FDA’s annual food program.

. Routine Inspections: Regular inspections, especially of licensed premises.

. Follow-up Inspections: To confirm that the licensee or company has taken certain corrective actions as indicated after the last inspection.

. Checkpoint Inspections: Performed by food inspectors stationed at checkpoints (customs) to ensure that food entering the country is safe and complies with relevant regulations.

2. The suspect or request inspection: A special type of inspection for the purpose of investigating and collecting the necessary evidence for legal action. This includes examining the reasons for complaints or refusals by the importing country, thereby addressing issues with food manufacturers and food products.

The Food and Drug Administration’s Division of Public Health Medicine is responsible for food analysis.

URL：http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

【參考連結】

http://thaihpvc.fda.moph.go.th/thaihvc/index.jsf

https://www.fda.moph.go.th/sites/fda_en/SitePages/Food.aspx?IDitem=LawsAndRegulations

HLF-TH-85

請問在泰國有哪些專精於保健食品銷售與消費權益相關法律服務的業者？

Evershine RD：

Ibcfirm

https://www.ibc-firm.com/

P&P

https://www.pnpinternationallegal.com/

Pacific Legal Group

http://www.pacificlegalgroup.com/

Contact Us

Bangkok Evershine BPO Service Limited Corp.
Email: bkk4ww@evershinecpa.com
Manager Paul , Speak in Thailandese English
WeChat: Paul0864580532

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4bkk@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
linkedin address:Dale Chen

Additional Information

Evershine has 100% affiliates in the following cities:
Headquarter, Taipei, Xiamen, Beijing, Shanghai, Shanghai,
Shenzhen, New York, San Francisco, Houston, Phoenix Tokyo,
Seoul, Hanoi, Ho Chi Minh, Bangkok, Singapore, Kuala Lumpur,
Manila, Dubai, New Delhi, Mumbai, Dhaka, Jakarta, Frankfurt,
Paris, London, Amsterdam, Milan, Barcelona, Bucharest,
Melbourne, Sydney, Toronto, Mexico

Other cities with existent clients:
Miami, Atlanta, Oklahoma, Michigan, Seattle, Delaware;
Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
Kaohsiung, Hong Kong, Shenzhen, Donguan, Guangzhou, Qingyuan, Yongkang, Hangzhou, Suzhou, Kunshan, Nanjing, Chongqing, Xuchang, Qingdao, Tianjin.

Evershine Potential Serviceable City (2 months preparatory period):
Evershine CPAs Firm is an IAPA member firm headquartered in London, with 300 member offices worldwide and approximately 10,000 employees.
Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

Please send email to HQ4bkk@evershinecpa.com

More Cities and More Services please click Sitemap