6. Registration Processes

Food Supplements
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

Food supplements are prescribed to be the food subject to the qualities or standards and, hence, it is required to be registered with the label to be approved before use [1].

• First applying (Active ingredients don’t exist on FDA list) (SorBor or Form 3)        
• First applying (Active ingredients exist on FDA list) (SorBor or Form 5)                       
• Correction of food details (Active ingredients don’t exist on FDA list) (SorBor or Form 4)
• Correction of food details (Active ingredients exist on FDA list) (SorBor or Form 6)

6.3 Other Notes or Requirements

In addition to testing requirements for General Foods (see Section 6.3 of the "General Foods" guidebook for Thailand), some additional testing requirements are needed for Food Supplements: 

Requirements for ingredient specification [2]

Ingredient specification is required for the important ingredients that are used as active ingredients in food supplements. These main ingredients can be divided into 4 groups, namely chemical components or synthetic substances, components that are derived from plants or animals, extracted ingredients, and ingredients other than the above. 

1. Chemical components: 

• Vitamins and minerals such as vitamin B1, calcium, etc.
• Amino acids such as L-Glutathione, L-Carnitine, etc.
• Other compounds such as coenzyme Q10, alpha lipoic acid, etc.

Information that must be provided in the regulatory documents on the standard quality requirements is as follows:

1.1 Substance name

1.2 Quality requirements or reference standards of ingredient*

1.3 Shelf life of ingredient or date, month, year of production, and the expiration of ingredient

1.4 Contents of substances and the importance of chemicals 

2. Components derived from plants or animals

• Plants such as turmeric, soybeans, black ginger, etc.
• Animals such as oyster meat powder, mussel meat powder, etc.

Information that must be provided in the regulatory documents on the standard quality requirements is as follows:

2.1 Name of ingredient

2.2 Quality requirements or reference standards of ingredient *

2.3 Shelf life of raw ingredient or date, month, year of production, and the expiration of ingredient

2.4 Characteristics of ingredients and methods for controlling their consistency of ingredient **

2.5 Scientific name and part used

3. Extract ingredients

• Grape seed extract, pomegranate extract, oyster extract, etc. 

Information that must be notified in the regulatory documents on the standard quality requirements is as follows:

3.1 Name of the extract

3.2 Quality requirements or reference standards of ingredient *

3.3 Shelf life of ingredient or date, month, year of production, and the expiration of ingredient

3.4 Scientific name and partly used ingredient

3.5 The ratio between the amount of ingredient used per 1 part of the extract (extraction ratio)

3.6 Types and concentrations of reagents extraction solution

3.7 Type and amount of substance: the essence or group of substances obtained from the extraction.

4. Other components or ingredients must have quality or standards according to specific notifications of the Ministry of Public Health (if any), for example:

4.1 In case of containing Royal Jelly, the standard quality of royal jelly must comply with the Notification of the Ministry of Public Health (No. 294) B.E. 2548 regarding Royal Jelly and Royal Jelly Products.

4.2 In case there are oil and fat components such as soybean oil, olive oil, Incan fuchsia oil, palm oil, etc., the standard quality of oils and fats shall comply with the Notification of the Ministry of Public Health, Re: Oils and Fats.

4.3 In case of containing fish oil, the standard quality of fish oil must comply with the Notification of the Ministry of Public Health, Re: Fish Oil.

4.4 In case of containing milk powder, the standard quality of powdered milk must comply with the Notification of the Ministry of Public Health, Re: Cow's Milk, etc.

* Quality requirements or reference standards of such ingredient that have been established, for example, USP, BP, FCC, etc. If such ingredient does not have reference standards, it is required to clarify the purpose of use of the ingredient or confirm that the ingredient can be used in food, such as food grade, etc.

** Ingredient characteristics and methods to control the consistency of Ingredients. In the case of plant material, clarify the details of the selection of ingredient used in order to obtain good quality and consistent ingredient, such as the age of the plants used, harvest time, removal of contaminants (rocks, soil, sand, other plants that have been contaminated with unwanted plant parts), pesticide residues, heavy metals, moisture, mold, etc.

6.4 Manufacturing Site Registration

There are no manufacturing site registration requirements specific to “Foods supplements”. It should comply with the requirements set in Section 6.4 of the “General Foods” guidebook for Thailand. 

6.4.1 Standard/Rules for Manufacturing Site

There are no manufacturing site registration requirements specific to “Foods supplements”. It should comply with the requirements set in Section 6.4.1 of the “General Foods” guidebook for Thailand.

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

N/A

6.5 References

1. MOPH Notification No. 293 B.E.2548 (2005) Re. Food Supplement

https://food.fda.moph.go.th/law/data/announ_moph/V.English/No.293-48%20Food%20Supplement.pdf

2. 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