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Welcome to GPC Thailand - Regulation

The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is under the regulation of Thailand FDA. The ASEAN Cosmetic Directive originated under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation of Thailand FDA. 

  • The Minister of Public Health is in charge of formulating and issuing cosmetic regulations, measures and standards and the execution of the regulations. 

  • The Food and Drug Administration regulates the notification and post-market surveillance of cosmetic products. 

Regulations 

Implementation Date 

Status 

Cosmetic Act B.E. 2558 (2015) 

2015-9-9 

In force 

Regulations of Notification Receipt 

2018-08-23 

In force 

Criteria, Procedures and Conditions for Production or Import of Cosmetic Products 

2018-05-04 

In force 

Requirements for Application of Accreditation and Certification of Manufacture and Import Sites 

2018-05-17 

In force 

Criteria, Procedures and Conditions for Manufacturers for Sale, Importers for Sale or Manufacture Contractor to Keep Cosmetic Information for Examination 

2018-04-12 

In force 

Requirements for Cosmetic Labelling 

2019-06-15 

In force 

  • Any company or a single individual who wants to import or manufacture cosmetics product for sale in the kingdom, must inform about the complete details of cosmetic product to be imported or manufactured to the authority of concern.  

  • The submission and issuance of Import permit or information receipt should strictly follow the regulation and condition as specified by ministerial regulation of Ministry of Public Health.  

  • The import permit or manufacturing permit or information receipt is issued by Cosmetic division of Thai FDA. Once issued the permit, it is valid for the time period of 3 years from the date of issue.  

  • Renewal of such permit should be applied before the expiry of the information receipt.  

  • Thai FDA implies following regulatory measure to ensure quality and safety of cosmetic product manufactured or imported in Thailand 

  • Notify the information of cosmetic products to the authority prior to producing or importing. Once the information is completed and correct, the applicant will receive the notification receipt which is valid for 3 years. 

  • Manufacture or import the cosmetic product according to the notification. 

  • Prepare label. Information must be written in Thai language and must be the size that is easily legible. The content written over the label must be accurate and must not be misleading to anyone. References (from where content included) must be documented for inspection. 

  • The cosmetic product must be advertise based on its fact without misleading the content/ reference. References should be documented for inspection. 

Permission for manufacturing or importing samples of products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review. The Requirements for Registration of Specially Controlled Cosmetics:

  • Application form and attachment 

  • Master formula certified by the authorized person 

  • Certificate of free sale (for the importation of products) duly notarized by the Thai Embassy 

  • Corporation registration issued by the Ministry of Commerce of Thailand 

  • Labelling information 

  • Analysis method approved by the Medical Sciences Department of the Thai Ministry of Public Health 

  • Storage direction 

  • Photocopy of sample permit 

  • Batch process 

  • Sample products 

  • Photocopy of draft label 

  • Documents indicating evidence for supporting claims 

All cosmetic products must have Thai legal labelling within 30 days after importation date before putting in market. Labels must bear the following information: 

  • Product name and trade name: (Font size must be bigger than other content) 

  • Type: (i.e. shampoo, conditioner, whitening skin care, etc) 

  • Full ingredient list (FIL) 

  • Direction for use 

  • Manufacturer name + country or Importer name + address 

  • Net content in metric (ml or gram): (Font size 2mm. (<50)3mm (50-200)4 mm. (200-1000) 5mm (1000 up) 

  • Batch no 

  • Manufacturing date 

  • Expiry date (for products with shelf-life less than 30 months) 

  • Warning (in accordance with MOPH notification) 

  • Notification receipt number 

Any products having pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as pharmaceutical products are outside the scope of cosmetic regulation. List of names of cosmetic products prohibited for manufacturing, importing and sale defines certain cosmetics which are prohibited for manufacture, import and sale. Some prohibited and restricted substances are preservatives, colorants and sunscreens. 

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The Ministry of Industry in Thailand published its new regulation B.E. 2558 on the notification of the production and import of hazardous substances in Government gazette. The regulation came into force immediately on 19th Feb 2015.

Manufacturers and importers of hazardous substances exceeding 1 ton per year are required to notify their hazardous substances (substance or mixture that is classified with any of the hazard properties listed in the new annex 5.6 of Thailand Hazardous Substances List) to the Department of Industrial Works (DIW) via DIW's online system. The notification shall be submitted within 60 days from the date of manufacture or importation (only once). This notification is also called Thailand Chemical Inventory Notification.

Information Required for Thailand Chemical Inventory Notification

The following info is required:

  • Legal entity info;
  • Type of activity : production or import;
  • Type of hazardous substances: substance or mixture;
  • Trade name and HS code;
  • Transport info : UN number, class;
  • Composition;
  • Packaging details;
  • Manufacturer name and country of origin;
  • GHS classification;
  • Content in SDSs: physio-chemical properties, toxicological info, eco-toxicological info and disposal considerations.
  • A copy of GHS SDS prepared in Thai or English needs to be provided when submitting the notification.

The current Hazardous Substance Act B.E. 2535 was issued in 1992 which was the important chemical control law in Thailand with a purpose of protecting human health and our environment. The Act promulgates lists of hazardous substances for particular conditions of various products and classifies them into 4 types according to the needs for control. The manufacture, import, export, having in possession (sale, use, storage, transport or dispose) should comply with the Hazardous Substance Act

B.E. 2535 (HSCA)

By definition, a hazardous substance means any of the following substances:

  • Explosives
  • Flammable substances
  • Oxidizing agents and peroxides
  • Toxic substances
  • Infectious substances
  • Radioactive substances
  • Mutant causing substances (mutagens)
  • Corrosive substances
  • Irritating substances
  • Other substances either chemicals or otherwise which may cause injury to humans, animals, plants, properties, or the

Due to the diverse characteristics and uses of hazardous substances, the Hazardous Substances Act is enforced by Three ministries, namely the Ministry of Industry (MOI), the Ministry of Agriculture and Cooperatives, and the Ministry of Public Health are directly involved in the control of hazardous substances. Other ministries such as the Minister of National Resources and Environment, the Minister of Energy, and the Minister of Interior, the Minister of Science and Technology are also involved.

  • Producer, importer, exporter of hazardous substance type 1, type 2 or type 3 in total amount from 1,000 metric ton/year.
  • Processor of hazardous substance whose storage area of hazardous substance is from 300 m2;
  • Producer, importer, exporter or processor of hazardous substance that is flammable substance or oxidizing agent and
  • Exemption: a hazardous substance producer, importer, exporter or processor who keeps hazardous substance in tank, silo, portable/bulk container cryogenic liquefied gas or refrigerated liquefied gas should be

There are over 1,585 entries in current Hazardous Substances List in Thailand covering various chemicals that are controlled by various authorities (including pesticides and biocides). This list is issued and maintained by the Ministry of Industry (MOT). There are 4 types of hazardous substances. Each type of hazardous substance is subject to different regulatory controls such as registration or license.

Type1:

Hazardous substances that require monitoring due to their low degree of hazard; Compliance with the rules, procedure and conditions as prescribed by responsible Ministry;

Type2:

Hazardous substances that that are subject to both monitoring and controlling; Registration required;

Type3:

Hazardous substances that are subject to stricter control because of their higher degree of hazard;

Registration & license required;

Type4:

Hazardous substances that are considered to pose a vital risk to humans; Prohibition of production, import, export, or possession;

Thailand Hazardous Substances List:

Chemicals (over 1,585 entries defined in Annexes 5.1-5.6.) list is further divided into 6 annexes based on responsible authorities.

Annex 1

Department of Agriculture; (698 items)

Mainly pesticide active ingredients, products containing active ingredients and banned pesticides;

Example: glyphosate, crop protection formulations containing active ingredients.

Annex 2

Department of Fisheries; (21 items)

Chemicals used in biocides for the purpose of controlling, preventing, and destroying microorganisms, parasites, plants or other animals in fisheries and aquatic animal farming;

Example: Sodium hypochlorite;

Annex 3

Department of Live Stock Development; (36 items) Veterinary drugs; and

Chemicals used in disinfection and cleaning products for animal feed manufacturing, animal farm, slaughter house and animal processing product manufacturing; Example: coumatetralyl, chlorine or chlorine releasing substances, cathionic surfactants;

Annex 4

Food and Drug Administration; (258 items)

Mainly for chemicals used in household or public health activity (killing or preventing insects, rodents, etc.);

Example: Cyclohexyl acetoacetate;

Annex 5

Department of Industrial Works (DIW); (570 items)

Industrial hazardous chemicals with clear identifies (for example, chorine, acrylic acid, acetic acid, ozone-depleting substances);

Chemical wastes;

Special substances such as dry cell batteries;

An application for registration of following hazardous substance should be submitted to the Department of Industrial Works (DIW) of MOT, or to other authorities designated by MOI by the producers or imports of below hazardous substance type:

  • type 2 or type 3

The following info is required:

  • Application form;
  • Safety data sheet;
  • Specification of the hazardous substance;
  • Document or photograph evidencing characteristic of containers or tanks;
  • Document or photograph evidencing methods used to secure the containers (if any);
  • A document proving specification (i.e., an analytical lab approved by DIW) or

Notification required for the Type 1, 2, & 3 scope sectors to the supply chain of Manufacturer, importer, exporter, having in possession

License:

Without license granted by the competent authority no person shall produce, import or export, or have in possession of type 3 hazardous substances. This license is valid for 3 years. As mentioned in (The Ministerial Regulation B.E. 2537 (1994)

There are 5 separate application forms for producer, importer, exporter and having in possession, storage need to be filled out and submitted, respectively.

Basic information on the substance to be submitted includes:

  • Importer - name, address and commercial license
  • Chemical identification - trade name, formula name, quantity to import/export, country of origin, producer company and means of
  • Material safety data sheet (in the case of industrial chemicals) or the results of efficacy trial, residue trial, quality analysis, toxicological data assessment (in the case of pesticides)
  • Warehouse - address, location, protective and preventive measures on warehouse structure and occupational health and safety

Procedure for license application

On-site inspection would be conducted by competent officials once the application for permit/license has been received with complement materials submitted which will cover the site of the production facility, storage facility, machinery and the accuracy of documents.

For importer, exporter or having in possession, inspection would be conducted on the site of storage facility and the accuracy documents.

Accompanying Duties

For On-site safety facilities, with permit/license obtained, the obligation does not end. The recipient of a permit for production would need the following facilities:

  • import, export or possession of hazardous substance should be equipped with safety facilities including emergency shower and eyewash, personal protection equipment (PPE), first-aid kit together with first-aid advice,
  • Transportation

If the recipient of a permit is also a carrier of hazardous substances, MSDS, a symbol or a mark indicating the properties of the transported hazardous substance must be displayed on both sides of the vehicle.

An importer or an exporter of the hazardous substance shall declare the following information of the particular substance to the DIW prior to their custom clearance for each shipment: (see form WoAo./AoKo.6 in the regulation of DIW B.E. 2547)

  • Chemical identification: name, chemical formula and proportion, trade name, common name or abbreviation (if any)
  • Quantity (of the chemical imported or the container), characteristic of containers
  • Location of storage facility
  • Transportation means
  • Customs port, anticipated arrival date to or departure date from the port
  • Invoice
  • Bill of loading
  • Specific document for the restricted control chemicals

Hazard Substance Manufacturer

Hazard Substance Importer

Type1: Comply with specified criteria and procedures

Type2: Registration—Notification— Import/Export Declaration per shipment

Type3: Registration—License (Inspect locations and warehouse)—Import& Export Declaration per shipment

Type1: comply with specified criteria and procedures

Type2: Registration—Notification— Import/Export Declaration per shipment

Type3: Registration—License (Inspect locations and warehouse)—Import& Export Declaration per shipment

Confidential business information (CBI) 100% Composition Disclosure :

  • DIW would require 100% composition disclosure for
  • Companies may choose to keep some composition information to themselves due to CBI
  • Under such circumstances, the company must take its own risk since the DIW could only evaluate the chemicals are hazardous or not based on the information
  • To avoid disclosing this information, the consultant recommends using a third-party representative to deal directly with the DIW on substance
  • Companies may provide 100 % composition to the authority directly via email at: cbi@ diw.mail.go.th within 3 months and the consultation result must align with the SDS. Authority will make an evaluation and if product has any hazardous components, company (supplier) needs to agree to disclose hazardous ingredients and percentage. The CBI procedure may take around 8-12 months (minimum).

Operational Person:

  • A specialized person needs to be assigned in order to ensure that hazardous substances are operated appropriately,, certain criteria and methodology needs to be adopted for the designation procedure, according to (The Notification of MOI Re: Designation of a specialized person responsible for safety of hazardous substance storage under Authorization of Department of Industrial Works at the Hazardous Substance Business Facility E. 2551 (2008)

Submission the Import/Export Declaration:

There are two choices to submit the import/export declaration:

  1. Single window of It takes 15 minutes to complete all processes by one stop service.
  2. Submit the application online http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp

A producer, importer, exporter, or processor should declare the following to the competent authority

  • Chemical Identification: name, chemical formula and proportion, trade name, common name or abbreviation (if any)
  • Registration number (if any)
  • Produced, imported, exported, or possessed quantity, sold quantity, its customer and his/her purpose of purchasing

o Activities need to be reported to the competent authority within the corresponding deadline.

Period during which Activities are Conducted

Declaration Deadline

Jan to Jun

Jul of the same year

Thailand Existing Chemicals Inventory (TECI) is the national inventory that contains chemical substances imported and produced in Thailand. The development of TECI is part of a project listed under the 4th National Strategic Plan on Chemical Management (2012-2021). The TECI maintained by FDA is designed as main national database for checking if a chemical substance is new or not. However, the inventory (volume 1) published in 2016 only includes 7,212 chemical substances chemical substances imported and produced in Thai market during 1st January – 31st December 2012.

Many companies have submitted hazardous substance notification in 2016 - present. Those substances will be evaluated and might be listed up to the inventory. After the closure of nomination, substances not listed on the existing chemical inventory will be considered to be new substances. However, even if the substances are on the TECI, the obligation of registering hazardous products still exists. This will not change and following are specification of TECI:

  • Each substance has been assigned with a TECI
  • For DIW's Preliminary Existing Chemicals Inventory; the preliminary existing chemicals inventory developed by DIW contains a list of chemical substances that have been declared as hazardous substances and other chemical substances that have been notified to DIW between 2012 and
  • Non-hazardous substances are not
  • According to the 4th national strategic plan on chemical management, DIW might change from the “hazard based” to “risk based” in the future and once it changes, substances in the TECI will be screened.
  • Substances that has production/import volume ≥ 10T/Y will be evaluated the hazard Classification according to the GHS
  • Substances fall under “high risk” group will be included in Priority List and the Full Risk Assessment report will be
  • The full risk assessment report of CMR substance is required. And meeting the following criteria will be prioritized for Full Risk Assessment report submission;
  • Carcinogenic, mutagenic, reprotoxic (CMR) substances;
  • PBT (persistent, bioaccumulative and toxic) and/or vPvB (very persistent and very bioaccumulative);
  • Endocrine disrupting substance;
  • Substances of equivalent concern;
  • Substances included in internal conventions;
  • Substances of Very High Concern (SVHC);

New chemical substances that are not hazardous or do not meet SVHC criteria qualify for a Simplified risk assessment information (SDS). Otherwise, a full risk assessment report will be required. Currently, DIW is under the exploring step and might based on approaches from other regions, such as the EU, US and Japan, and focus on human health and ecological risk assessment.

GHS Implementation in Thailand:

Thailand has implemented GHS through the Hazardous Substance Act and Hazard Classification and Communication System of Hazardous Substances B.E. 2555 (2012). GHS SDSs and labels are required for hazardous substances from 13th March 2013 and for mixtures from 13th March 2017.

  • The ministerial notification E.2555 (2012) on GHS is promulgated by the DIW under the Hazardous Substance Act
  • in compliance with 3rd revision of UN GHS
  • currently only applicable for chemicals under the scope of DIW and FDA

DIW is the first authority to enforce GHS, followed by FDA. In consistence with UN GHS 3rd revision, Thailand GHS adopted 28 hazards

Out of Scope

· Hazardous substance that is not under responsibility of Department of Industrial Works (DIW), i.e., pesticides, etc.;

· Chemical waste, etc.;

Classification

· Adopted all building blocks of GHS R

HSCA Amendment

In 2013, an amendment in the project is initiated by DIW to improve the current version by identifying the existing hurdles and consulting all stakeholders. Several highlights of the amendment could include:

  • Add "Transit" in scope and definition (there are only "import" and "export" in the existing regulation);
  • HS type 4 used for R&D could be
  • New responsibility given to Information Center for Hazardous Substance of MOT;
  • New power given to local authority to revoke registrations;

List of Hazardous Substances Amendment:

Ministry of Industry (MOI) on Feb 19th, 2015, published a notification pertaining to the List of Hazardous Substances (No. 2) B.E. 2558 (2015). According to the notification, manufacturers and importers of chemical substances that meet certain criteria will have to notify chemical substances to the Department of Industrial Works (DIW).

Upon gathering enterprise notification information, DIW aims to prepare Thailand's inventory of existing chemicals and determine the appropriate approaches for chemicals management in Thailand.

  • Notification should be submitted within 60 days from the date of manufacture or importation of any listed hazardous materials that exceed a designated quantity threshold. The notification could be submitted on-line or through other means as prescribed by
  • Once notified, the substances will be added into a new Annex (Annex 5.6) of the current list of hazardous substances. Moreover, the notified substances will be exempted from some compliance duties stipulated by HSCA E. 2535 (1992).

The notification procedures and requirements are outlined in the illustration on the right.


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