6. Registration Processes

General Foods
Thailand

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

N/A

6.2 Product Registration

The Food Act [1] classifies foods into three main categories as follows:

1. Specially Controlled Foods – Registration is required for foods in this category. Legal provisions are related to food standard quality, specifications, packaging, and labeling requirements, as well as other aspects of good manufacturing practices. The Food Committee may make recommendations to the Minister of Public Health specifying specially controlled foods.
2. Standardized Foods – Standard foods do not require registration but their quality and labeling have to meet the standard requirements as specified in the Notification of the Ministry of Public Health.
3. Other Foods – Foods, raw or cooked, preserved or non-preserved, processed or non-processed, if not listed under categories 1 or 2 (see the list in the annex) will be considered as General Foods. Although registration is not required, general food products are controlled and monitored with regard to hygiene, safety, labeling, and advertisement. Foods in this category may be subdivided into (a) foods that must bear standard labels and (b) other general foods.

(a) Product registration requirements

Registrations are required for foods classified under Specially Controlled Foods. 

Specially Controlled Foods include, for example, modified infant milk formula, infant food, complementary food for infants and young children, weight-control food, food additives, cyclamates, and steviol glycosides [2].

(b) Authority responsible for product registration

The Thai Food and Drug Administration, Ministry of Public Health, is the authority responsible for product registration.

(c) Overview of food product registration: 

Importers of food products deemed to be specifically-controlled foods are required to register the products before importation for sale [3]. Applications for product registration should be submitted to the Food Bureau, TFDA. The application can be submitted to the following addresses:

• One-Stop Service & Consultation Center (OSSC), Food and Drug Administration Building, Ministry of Public Health 
• Provincial Public Health Offices where food production premises or headquarters of importers are located 
• Apply via the internet (E-submission) http://food.fda.moph.go.th/esub/d

(d) List of mandatory required documents for product registration [4]:

1. The complete 100% formula (w/w, w/v, v/v) under the letterhead of the manufacturer
2. Product description (presentation form, direction for use, indication - if any, packing size, shelf-life)
3. A flow process for manufacturing the food under the letterhead of the manufacturer
4. Finished product specification
5. Test report (CoA) (refer to Section 6.3 below)
6. Ingredient specification (refer to Section 6.3 below)
7. Product label in Thai language and/or English (original and in color)
8. Packaging material specification
9. Good Manufacturing Practice (GMP) Certificate issued by the government of the country of origin (or HACCP or equivalent ISO quality system certificate, which has been legalized by the Thai embassy in the country of manufacturing)
10. Free Sale Certificate issued by the manufacturer or importer and legalized by the Thai embassy in the country of manufacturing

(e) Estimated cost and duration for product registration:

Application for registration of foods [3, 5]: 

• For Specially Controlled Foods with special purposes, such as infant food or food for small children with abnormal digestive systems: 4,000 THB each
• For other foods: 3,000 THB each

Application for amendment of food registration particulars: 1,000 THB each

The approximate amount of time required for product registration, starting from submitting the application can be from 5 days to 3 months depending on food categories. However, delays are usually caused by inaccurate or incomplete information, which is usually the basis for failing to register a product.

6.3 Other Notes or Requirements

Requirements for test report (CoA) [2]

Testing results must be analyzed by one of the following agencies:

1. Government agencies in Thailand and/or in the exporting country 
2. Agency or organization assigned or certified by the government agency of the exporting country. The test report issued by these laboratories must be enclosed with the evidence of being assigned or certified by the government agency of the exporting country.
3. Organizations and agencies both qualified and internationally certified by accreditation according to international standards. Test reports issued by these laboratories must be accompanied by evidence of certification by a laboratory accreditation agency that meets at least the international standard (ISO/IEC 17025). The food being registered with the Thai FDA must be within the certification scope of that laboratory.

The test report must be an original document not older than 1 year, from the date of issuance of the analysis report to the date of filing requested and from the same agency. In case the test reports are issued by multiple agencies, they must be referring to the results of the same product and same production lot.

In the event that an analysis or additional analysis is required by the Thai FDA, the analysis must be sent to the same agency only, except when the agency cannot analyze the list. In case of the latter, the applicant shall submit a declaration stating the reason that the original agency could not test for the specific analysis and thus another agency has been selected. 

In the event that the analysis report indicates a food name, brand name, name, and/or place of production that does not match what was stated in the registration dossier, the applicant has to certify that “the sample submitted for analysis has the same formula as the food registration submission...” The applicant has to inform the name of the food and/or the location of the actual production place and explain the reason why the test report indicates the food name, brand name, name, and place of production that do not match with the food registration submission.

6.4 Manufacturing Site Registration

Manufacturing site registration is NOT required for imported food (see Section 7 of this guidebook).

6.4.1 Standard/Rules for Manufacturing Site

Food producers or importers for sale shall follow the Notification of the Ministry of Public Health, Re: Production Processes, Production Equipment, and Food Storage [7], which generally sets forth the requirements for the location of the production plant, the conditions of the facilities, the production process, and the mandatory sanitation applicable to Thai domestic production plants. 

Importers are required to hold certifying documents showing that their standards of manufacturing practices are equivalent to or not lower than the requirements prescribed in the Annex of Notification No. 420 [7].

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A

6.5 References

1. FOOD ACT B . E. 2522

http://food.fda.moph.go.th/law/data/act/E_FoodAct2522.pdf

2. Thailand FDA - Law and Regulations 

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

3. Thai FDA - The public manual for entrepreneurs  

https://www.fda.moph.go.th/sites/food/manual/trader/EngVersion.pdf

4. Manual and Checklist by Thai FDA

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

5. Announcement of the Ministry of Public Health, Subject: Expenses to be collected from applicants in the food product licensing process B.E. 2560 (Thai)

https://www.ratchakitcha.soc.go.th/DATA/PDF/2560/E/199/23.PDF

6. Criteria and Guidelines for Permission of Dietary supplements, Royal Jelly and Royal Jelly Products 

https://www.fda.moph.go.th/sites/food/manual/Manual_5.1.pdf 

7. MOPH Notification No. 420  Re: Food Production Processes, Processing Equipment/ Utensils, and Storage Practices 

https://food.fda.moph.go.th/law/data/announ_moph/V.English/P420_E.pdf