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Registration

-   Applicant (approval of premises)

A local entity is necessary to complete registration of imported food supplements.The applicant must have the import premises approved by the FDA.

-   Type of registration (approval of product)

A distinction is made between food supplements containing authorized ingredients [N1] and food supplements containing other active ingredients that are not included in the list.

The first - food supplements containing authorized ingredients - are subject to normal food registration. Food supplements containing new – unapproved- substances are subject to ´label approval´. Label approval demands that evidence and documents are forwarded to substantiate the use of the compounds and demonstrate the safety of the product.

However in the case of the product bears non-approved health claims or contains novel food components, the corresponding procedures need to be completed first.

-   Novel food components

Ingredients in a food supplement may also be subject to novel food[3] safety assessment. Novel foods are regulated under Notification of the Ministry of Public Health (No.376) B.E 2559 (2016) Re: Novel food[4]. The novel food assessment should precede the label approval.

-   Procedure

An application for ´label approval´ requires that the applicant presents himself personally with the application form after making an appointment with the Bureau of Food of the FDA. If he is not the responsible operator or authorized director of the legal entity, a letter of authorization is required.

As explained below, health claims also require registration.

-   Documentation

An application for ´label approval´ (non-autorized substances), requires that form (SorBor. 3 Form) is completed. At least the following is required:

i.        Purpose of the product or use instructions

ii.        Characteristics of the food

iii.       Ingredients

iv.       The container used

-   Outcome

There is no deadline given for the final decision, however when the authorization evaluation is finished the applicant will be informed within 7 days working days from the day the consideration is finished. Duration Counting will start when all documents are completely received until finishing the consideration step and record permission data in IT system excluding duration of correction and clarification of the business operator. 

Composition

A.    NUTRIENTS

Vitamins should contain at least 15% of the established the values established in the nutrient list for Thai Recommended Daily Intakes for age of 6 years and up (Thai RDI) forFood supplements whose purpose as to give vitamins or minerals. The same list equally contains the maximum levels.

The Thai recommended daily intakes are specified in a document dating 12 July 2016.

B.    PLANTS

The list of available plant substances in food supplements can be consulted on the FDA website consolidating all the applicable acts[5]. The latter website is however in Thai only. The latest version of the positive plant list[6] contains Latin names and English common names.

C.    OTHERSUBSTANCES

No list found.

D.    ADDITIVESANDEXCIPIENTS

Application of Notification(No. 281) B.E. 2547 (2004) regarding the use of food additives applicable to food.[7]

Clause 6 allows the use of the additives as listed in the most current Codex General Standard for Food Additives and The Announcement of the Food and Drug Administration according to an approval of the Food Committee. The use of other additives is subject to approval by the FDA. 

Thailand

Classification

The basic act for food supplements concerns Notification 293 B.E.2548 (2005)[1]. It includes the following definition:

Food supplement means products taken for consume other than conventional foodswhich 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 ofhealth promotion.

(Other) substances in the sense of the definition comprise

(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).

Regulations are only partly available in English, but the Thai FDA has published an English Public Manual on ´Application for permission of a product and correction of permitted items: for food supplement, royal jelly and royal jelly products[2]

Labelling

Clause 9 of Notification 293 B.E.2548 (2005) indicates that mandatory labelling information is regulated under No. 367 regarding the labelling of prepackaged foods[8]. HoweverClause 10 of the same notification (Notification 293 B.E.2548 (2005)) also refers to specific labelling particulars for food supplements. The elements of both acts have therefore been consolidated here.

The following particulars should be included:

i.        Name of the food – “Food Supplement”

ii.        Food serial number

iii.       Name and address of manufacturer or packers or importers head officeFood. Imported from foreign countries shall display name and address of importers by having text of “importer” or “imported by” appeared together and also display name and country of manufacturers.

iv.       Content of food using the metric system, for food supplements presented in tablets or capsules, the number per pack may be indicated instead

v.        Name and quantity of main ingredients of food supplement and constituents with claims

vi.       for usefulness, on the label of food supplement .

vii.      Food allergy information [“Information for food allergycontain/may contain”]

viii.      Functional class of additives

ix.       Shelf life information

x.        Warning statements, if any

xi.       Storage instructions, if any

xii.      Cooking instructions, if any

xiii.      Instruction for use and essential text for food intended use for infant or new-born baby or for particular individuals;

xiv.      Additional texts as specified in an Annex;

xv.      Particular texts as specified by particular Notification.

xvi.      Declaration of “ utilizing preservatives” (if any)

xvii.     Declaration of “natural colour added” or “artificial colour added” if utilizing

xviii.    Declaration of “natural fragrance”, “imitation natural fragrance”, “synthetic fragrance”,“natural flavour”, or “imitate natural flavour” if any

xix.      Clear statement of “Receiving any nutrients should intake by consuming five categories ofprinciple foods and in appropriate proportion.

The information needs to be provided in Thai, the presence of other languages is allowed.

-   Nutrition Labelling

Notification of the Ministry of Public Health (No. 182) B.E. 2541 (1998) Re: Nutrition Labelling[9].

The notification requires that the following categories of foods include nutrition labelling:

1.1 Foods which have nutrition claim.

1.2 Foods which utilizing food value in sale promotion.

1.3 Foods which define consumer groups in sale promotion.

1.4 Other foods to be notified by Food and Drug Administration, which are approved

Nutrition labelling must at least be provided in Thai language, but other languages are explicitly allowed. The appendixes provide the requirements regarding presentation, determination of portion/serving indication, the recommended daily intakes and criteria for the use of nutrition claims. These Appendixes are however not included in the translated version of the Notification.

Claims

Note that under Section 40 of the Food Act BE 2522 anyone is prohibited to make false or deceptive indications/advertisementregarding the quality, usefulnessof a food.

The Thai FDA has English Manual on Requesting for assessment of health claim[10] available. The use of claims requires ´advertisement permission´. The application requires an appointment with the Food Bureau of the FDA.

Therefore, any person intends to make health claim of food or food ingredients shall prior apply for health claim assessment to the FDA and shall follow criteria and condition of application for health claim assessment and criteria for advertisement permission. More details on the procedure and documentation requirements can be found in the Public Manual on “Requesting for assessment of health claim“[11].

Health claim means presentation of picture, photograph, invented design, mark, trade mark, or any texts on label relates to food, food ingredients or nutrients directly or indirectly relevant to health. Three types of claims are distinguished:

1.   Nutrient function claims: mean presentations of properties or benefits that describe the physiological role of the nutrient in growth, development and normal functions of the body.

2.   Other function claims mean presentations of properties or benefits that describe specific beneficial effects of the consumption of foods or their constituents, in the context of the total diet on normal functions or biological activities of the body; such claims relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health.

3.   Reduction of disease risk claims mean presentations of properties or benefits relating the consumption of a food or food constituents, in the context of the total diet, to the risk reduction of developing a disease or health-related condition.

As a general rule ”The claimed benefit should arise from the consumption of a reasonable quantity of the food or food constituents in the context of a healthy diet and shall not depend on benefit from consumption together with other food although it is normal practice or having intention to consume together such as breakfast cereal is consumed with milk”.

Moreover, the labelling of health claims should comply with the conditions provided in the advertisement permission and include at least the following particulars:

(a) The amount of claimed nutrients or their constituents;

(b) Target group (if any);

(c) Instruction for use the food to obtain the claimed benefit ;

(d) Recommendation to vulnerable groups or groups who need to avoid such food (if any);

(e) Maximum safe intake of the food or constituents (where necessary);

(f) A statement as “should routinely intake varieties of 5 food categories in an appropriate amount” and “no effect on relieve, cure or prevent diseases”.

The inclusion of health claims also requires that the claims are based on relevant and available evidence on the cause effect relationship. Depending on the type of claim, the documentation requirement are different as is set out in the Manual on Requesting for assessment of health claim[12].

-   Nutrient function claims

Nutrient function claims relate to the nutrient listed in the FDA list of Recommended Daily Intakes. Nutrient function claims are only allowed if the food corresponds with the indicated nutritional limits per serving or per 100 gram.

The list of permitted nutrient function claims is included under the Announcement of the Food and Drug Administration Re: Declaration of Nutrient Function Claim[13]. Moreover the Announcement requires the statement “should eat a variety of 5 food groups in an appropriate proportion on a regular basis” is included on the label.

[1] Notification of Ministry of Public Health (No. 293) B.E.2548 (2005), http://extwprlegs1.fao.org/docs/pdf/tha159970.pdf

[2]<http://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Manual/%E0%B8%9C%E0%B8%A5%E0%B8%B4%E0%B8%95%E0%B8%A0%E0%B8%B1%E0%B8%93%E0%B8%91%E0%B9%8C/01%20PM%20food%20supplement%20royal%20jelly%20and%20its%20product.pdf>

[3]A novel food is any substance used as food or food ingredients which has been significantly used for human consumption

for less than 15 years based on scientific or reliable evidence, or any substance used as food or food ingredients to which has

been applied a production process not currently used, where that process gives rise to significant changes in the composition

or structure of such food that affects their nutritional value, metabolism, or levels of undesirable substances.

[4]<http://food.fda.moph.go.th/law/data/announ_moph/V.English/No.376_Re_Novel_food.pdf>

[5]<http://food.fda.moph.go.th/law/index.php>

[6]<http://food.fda.moph.go.th/law/data/announ_fda/600810_name.pdf>

[7] Notification of the Ministry of Public Health (No. 281) B.E. 2547 (2004) Re: Food Additives, http://food.fda.moph.go.th/law/data/announ_moph/V.English/No.%20281%20Food%20Additives.pdf

[8] Notification of the Ministry of Public Health (No. 367) B.E. 2557 (2014) Re: Labeling of Prepackaged Foods, http://food.fda.moph.go.th/law/data/announ_moph/V.English/No.%20367%20Labeling%20of%20Prepackaged%20Foods%20-edit%2010-2-15.pdf

[9]<http://extwprlegs1.fao.org/docs/pdf/tha160326.pdf>

[10]<http://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Manual/%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B9%80%E0%B8%A1%E0%B8%B4%E0%B8%99%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B8%9B%E0%B8%A5%E0%B8%AD%E0%B8%94%E0%B8%A0%E0%B8%B1%E0%B8%A2/02%20PM%20Requesting%20for%20assessment%20of%20health%20claim.pdf>

[11]< http://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Manual/%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B9%80%E0%B8%A1%E0%B8%B4%E0%B8%99%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B8%9B%E0%B8%A5%E0%B8%AD%E0%B8%94%E0%B8%A0%E0%B8%B1%E0%B8%A2/02%20PM%20Requesting%20for%20assessment%20of%20health%20claim.pdf>

[12]<http://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Manual/%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B9%80%E0%B8%A1%E0%B8%B4%E0%B8%99%E0%B8%84%E0%B8%A7%E0%B8%B2%E0%B8%A1%E0%B8%9B%E0%B8%A5%E0%B8%AD%E0%B8%94%E0%B8%A0%E0%B8%B1%E0%B8%A2/02%20PM%20Requesting%20for%20assessment%20of%20health%20claim.pdf>

[13]<http://food.fda.moph.go.th/law/data/announ_fda/English/1%20Declaration%20of%20Nutrient%20Function%20Claim.pdf>

 [N1]List not found, contacted authorities on 8/02/2018