Thailand Cosmetics Registration QA

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

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

Evershine RD：

The Food and Drug Administration Thailand (Thai FDA) under the Ministry of Public Health, MOPH is the current cosmetics authority in Thailand.
Thai FDA has six divisions for cosmetics, import and export inspection, pharmaceuticals, food, narcotics and medical equipment.
Among them, the Cosmetic Control Group is solely responsible for controlling, regulating and ensuring that standards in cosmetics comply with current standards and regulations.

A “cosmetic product” shall mean any substance or preparation intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means,) with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition but shall not include ornaments and clothing which are deemed as accessories outside human body.

High-risk cosmetic products: alcohol, sheet-like body cleaning (wet wipes), hidden detergent ingredients, glass ampoules/glass bottles/syringes, marijuana, oral spray/mouthwash, etc., which need to be labeled according to the regulations of each item and attached information.

Cosmetics containing cannabis and cannabis extracts must submit a Substance List Notification and must notify the Food and Drug Administration of which category the “hemp seed oil/extract” in the cosmetic product belongs to (hemp seed oil/hemp seed extract/hemp seed water / Hydrogenated Hemp Seed Oil / Hydrolyzed Hemp Seed Extract / Hydrolyzed Hemp Seed Extract).

【參考連結】

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Permission.aspx

HLF-TH-20

If a foreign company wants to sell cosmetics 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：

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister:

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.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

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

HLF-TH-25

If you need to apply for it, is there a professional service company in Thailand that can assist in applying for a business license for a cosmetic company?

Evershine RD：

PANWA

https://www.companythailand.net/

HLF-TH-30

If a foreign company wants to sell cosmetics 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：

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply for a cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Pursuant to the ASEAN Cosmetic Directive, The company or person responsible for placing the cosmetic product in the market shall report to the regulatory authority of the ASEAN Member State where the adverse event occurred, regardless of the source of the report (consumer, healthcare professional, etc).

1.All serious adverse events should be reported. Non-serious adverse events are not required to be reported.

2.High incidence of Adverse Event (Non-serious/severe reactions)

There are “non-serious” adverse events that occur at a high incidence (as defined by the ratio of events to units sold) of a single “severe” reaction type that may necessitate rapid communication to the regulatory authority. However, appropriate medical and scientific judgment should be applied for each situation of non-serious, single “severe”1  adverse reaction that has a high incidence before reporting to the regulatory authority.

3.Adverse Event Reporting

． Company Particulars: Name and address of Company, Name & designation of the person reporting, Tel No.,Fax No,Email

．Product Particular: Product Name (as in product notification), Ingredient listing & pack size (Please attach a separate list),Product Type/Intended use

．Name of Manufacturer & country of manufacture, Expiry or manufacturing date, Batch No.

．Details of Adverse Event

【參考連結】

https://www.fda.moph.go.th/

https://aseancosmetics.org/asean-cosmetics-directive/post-marketing-surveillance/

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.aspx

HLF-TH-35

If you need to apply for the appointment of a Thai company as a business agent, Is there a professional service company in Thailand that can help?

Evershine RD：

Beauty Buffet

https://www.beautycommunity.co.th/index.php/en/

KARMART Shop

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

HLF-TH-40

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

Evershine RD：

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply for cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Manufacturers, importers and subcontractors for the manufacture and sale of cosmetics must ensure that all cosmetics have labels;

Labels must comply with the following:

1. All information contained on the label must be accurate and must not contain any information which could result in a serious misunderstanding; all information must be ethical and in keeping with Thai cultural norms.
2. The information must be written in the Thai language and must be of a size that is easily legible; information may also be provided in a foreign language. Cosmetics imported for sale in the Kingdom are not required to have a Thai language label on the packaging or wrapping at the time of customs inspection but a Thai-language label must be affixed prior to sale.
3. Labels must bear the following information:

．Name and trade name of the cosmetic.

．Name and location of the manufacturer if the product is manufactured in the Kingdom; name and location of the importer together with the name of the manufacturer and country of origin in the case of imported cosmetics.

．Quantity, directions for use, cautions, warnings, month and year of manufacture and expiry date, batch number or letter, and the names of all ingredients used in the manufacture of the product.

．Any other information intended for the benefit of consumer safety in accordance with the rules and conditions stipulated by the Committee in the Royal Thai Government Gazette.

If a label does not conform to the terms stipulated, the Secretary General, with the approval of the Committee, is authorized to order the Notifying Party to terminate use of the label or to amend said label.

【參考連結】

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Permission.aspx

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/GMP_CMT.aspx

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

HLF-TH-45

Are there any professional service organizations in Thailand that can assist in applying for cosmetic product licenses?

Evershine RD：

P&P https://www.pnpinternationallegal.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 cosmetics packaging and labeling require prior approval?
In addition to the Thailand language, which other languages ​​are allowed? Website?

Evershine RD：

The application for a product license is supposed submitted by a company registered in Thailand.
Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Apply cosmetic license

1. Process: Submit documents/electronic documents → pay relevant fees → review → document review → approval results (three working days)
2. Method:

． Food and Drug Administration’s One-Stop Service Center (OSSC) for

Health Products

． Health Center

． Internet

3. Application form:

． Product name and cosmetic name (Thai and English)

． Cosmetics instructions

． Types (range, purpose)

． Physical properties of cosmetics

． Physical properties of the container

． Cosmetics category (single product or other)

． Manufacturer’s details

． Details of contract manufacturing (contractor, manufacturer)

． Details of import sales (importers, foreign manufacturers)

． Cosmetic ingredient list, details, etc.

4. Precautions

．Any statement related to cosmetic products should be accompanied by a written statement issued by the manufacturer (both domestic and foreign) and signed by the company director.

．If the attachment is in a language other than English, please attach the document translated into Thai, or in English certified by a trusted institution such as a language institute/university.

．If the person in charge of sales in the domestic market is not the company or the same person as the producer, a copy of the authorization letter must be attached.

．If the name, type or characteristics of the product indicate sun protection, the manufacturer or importer must keep for future reference documentation of the results of the above-mentioned sun protection ability test.

．The application for imported cosmetics must be accompanied by the manufacturer’s authorization , the product brand of the manufacturer or product owner, and the relationship between the issuer and the importer (manufacturer/product owner/distributor).

Manufacturers, importers and subcontractors for the manufacture and sale of cosmetics must ensure that all cosmetics have labels;

Labels must comply with the following:

1. All information contained on the label must be accurate and must not contain any information which could result in a serious misunderstanding; all information must be ethical and in keeping with Thai cultural norms.
2. Information must be written in the Thai language and must be of a size that is easily legible; information may also be provided in a foreign language. Cosmetics imported for sale in the Kingdom are not required to have a Thai language label on the packaging or wrapping at the time of customs inspection but a Thai-language label must be affixed prior to sale.
3. Labels must bear the following information:

．Name and trade name of the cosmetic.

．Name and location of the manufacturer if the product is manufactured in the Kingdom; name and location of the importer together with the name of the manufacturer and country of origin in the case of imported cosmetics.

．Quantity, directions for use, cautions, warnings, month and year of manufacture and expiry date, batch number or letter, and the names of all ingredients used in the manufacture of the product.

．Any other information intended for the benefit of consumer safety in accordance with the rules and conditions stipulated by the Committee in the Royal Thai Government Gazette.

If a label does not conform to the terms stipulated, the Secretary-General, with the approval of the Committee, is authorized to order the Notifying Party to terminate use of the label or to amend said label.

【參考連結】

https://aseancosmetics.org/

https://www.fda.moph.go.th/

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

HLF-TH-55

What professional service agencies are there in Thailand that can assist in applying for a license for cosmetic products in the name of a foreign company?

Evershine RD：

Biorius
https://biorius.com/

P&P https://www.pnpinternationallegal.com/

HLF-TH-60

What documents are required when importing approved cosmetics 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：

Under current cosmetic regulations, cosmetic products need to be notified to the FDA before being manufactured or imported in Thailand.
Covers description, labeling and declaration of technical ingredients, good manufacturing practice (GMP) pre-marketing.

Cosmetics GMP certification application materials

1. Applicant, production base number
2. Company name, location of cosmetic production base
3. Laboratory
4. Head office/office address and telephone number
5. Type of cosmetic produced (solid/liquid/gas)
6. Number of employees, working days and hours
7. Other supporting documents

. Production site location map

. Head Office/Office Location Map

. Legal person registration certificate / business registration certificate

. Organization 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

. Raw material receiving and packaging material SOP

. Raw material or non-conforming packaging material handling SOP

. Cleaning SOP

. SOP for Quality Control of Raw Materials / Cosmetics in Production / Cosmetics to Be Packaged / Finished Cosmetics

. Raw material/to-be-packaged cosmetic/finished cosmetic sampling SOP

. Raw material specification, example of one-time packaging and the result of each inspection 2 pieces

. SOP Internal Audit

. SOP for recalling cosmetic products, etc.

【參考連結】

https://www.fda.moph.go.th/

https://www.fda.moph.go.th/sites/Cosmetic/SitePages/Laws.aspx

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

HLF-TH-70
What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

The following documents shall be made available by the company or person responsible for placing the cosmetic products in the market, to the cosmetic regulatory authority:

1. The available methods used by the manufacturer to check the ingredients of cosmetic products corresponding with the Certificate of Analysis.
2. The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products and/or methods for checking compliance with those criteria.

Safety ingredient information: It can be obtained from suppliers, ASEAN Cosmetic Scientific, EU Scientific Committee on Consumer Products, SCCP, US Cosmetic Ingredient Review Board, CIR.

1. Qualitative and quantitative of the product formula (with the international cosmetic ingredient name INCI or the nomenclature approved by the ASEAN Cosmetic Directive ACD, and the ingredient content): Explain the function of each ingredient in the formula.
2. Manufacturing Information: Include the name, country, address and telephone number of the manufacturing plant, assembly plant or packaging plant.

．Briefly describe the product manufacturing process.

．The competent authority may request to provide relevant information such as detailed process information or quality control when necessary.

3. Product inspection specifications and methods:

．Standards for the chemical purity of the microbiological and constituents of a product.

．Analytical methods that can confirm compliance with specifications.

4. Product stability report (product storage time is less than 30 months):

．Stability test results or stability assessments supporting shelf life.

【參考連結】

https://aseancosmetics.org/

HLF-TH-75

Can the Thai cosmetics audit agency accept inspection data from overseas inspection agencies?
If yes, any accredited institutions? Website?

Evershine RD：

The ASEAN Cosmetics Association standard adopts the self-declaration method for cosmetics GMP, and the manufacturer fills in the closing letter and provides the inspection report and analysis method, and the Thai government issues the certificate after verification.

URL：https://aseancosmetics.org/

HLF-TH-77
Which cosmetic inspection agencies in Thailand can provide cosmetic inspection services? Website?

Evershine RD：

Quality Plus

https://www.qualityplus.co.th/en/services/rd/product-lab-test/

Bureau Veritas

https://www.cps.bureauveritas.com/retail/product-line/health-beauty-household

HLF-TH-80

After a foreign subsidiary imports cosmetics and entrusts a distributor in Thailand to sell it, does the distributor need a cosmetics 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：

Any individual wishing to manufacture, import for sale, or subcontract for the manufacture and sale of cosmetics must file a notification and only after the issuing of a notification receipt may the individual undertake the manufacture or import of cosmetics.
Notification and the issuing of a notification receipt shall comply with the rules, procedures and conditions stipulated by the Minister.

Pursuant to the ASEAN Cosmetic Directive, The company or person responsible for placing the cosmetic product in the market shall report to the regulatory authority of the ASEAN Member State where the adverse event occurred, regardless of the source of the report (consumer, healthcare professional, etc).

1.All serious adverse events should be reported. Non-serious adverse events are not required to be reported.

2.High incidence of Adverse Event (Non-serious/severe reactions)

There are “non-serious” adverse events that occur at a high incidence (as defined by the ratio of events to units sold) of a single “severe” reaction type that may necessitate rapid communication to the regulatory authority. However, appropriate medical and scientific judgment should be applied for each situation of non-serious, single “severe”1  adverse reaction that has a high incidence before reporting to the regulatory authority.

3.Adverse Event Reporting

． Company Particulars: Name and address of Company, Name & designation of person reporting, Tel No.,Fax No,Email

．Product Particular: Product Name (as in product notification),Ingredient listing & pack size (Please attach a separate list),Product Type/Intended use

．Name of Manufacturer & country of manufacture, Expiry or manufacturing date, Batch No.

．Details of Adverse Event

【參考連結】

https://aseancosmetics.org/

https://www.fda.moph.go.th/sites/Cosmetic/Pages/Main.asp

HLF-TH-85

Are there any companies in Thailand specializing in legal services related to cosmetic sales and consumer rights?

Evershine RD：

Ibcfirm https://www.ibc-firm.com/

P&P https://www.pnpinternationallegal.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
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linkedin address:Dale Chen

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