Application for Permission Relating to a Product
Type 1 hazardous substance
Manufacturer or importer of hazardous substance must declare details regarding the hazardous substance in accordance with the HS/PH 5 Form to the competent official prior to the first manufacturing or importation of such hazardous substance. The declaration may be made at the Food and Drug Administration, in the case where the place of manufacturing or storage is in Bangkok, or at the public health office of such province, where the place of manufacturing or storage is located.
Product distributed in Thailand must have a correct label in accordance with the Notifications relating to the labeling of hazardous substance products and must specify its “declaration receipt no.” on its label.
Types of products which fall within type 1 hazardous substance
1. Products used for the termination, prevention, control, repelling, or elimination of insects and other animals, only those which have citronella oil as one of the active ingredients or the sole active ingredient.
2. Products used for the cleaning of floors, walls, sanitary wares, or other materials, or the declogging of pipes or drains which have a chemical belonging to the following chemical groups as an active ingredient:
- anionic surfactants (except for laundry detergent powder);
- nonionic surfactants, except for chemicals belonging to the nonylphenol ethoxylate group (except for laundry detergent powder);
- amphoteric surfactants;
- amine oxides.
3. Products used for the disinfection or deodorization of pools which have one the following substances as an active ingredient
- calcium hypochlorite;
- sodium hypochlorite;
- dichloroisocyanuric acid and its salts;
- trichloroisocyanuric acid and its salts.
4. Products used in households or in the field of public health for the purpose of adhering or attaching of materials’ surfaces which have alkyl cyanoacrylate as an active ingredient.
5. Products used in households which contain methanol or methyl alcohol as a solvent, except for correction products in the form of correction tapes or correction pens.
Documents required for detail declaration
- Detail declaration form (HS/PH 5 Form)
- List of ingredients which indicates their chemical names and ratio of active ingredients and all other ingredients in the product, as well as the role of each ingredient; the ratio shall be identified in the form of % weight by weight (%w/w) or % weight by volume (%w/v)
- Additional documents (as the case may be) as specified in the HS/PH 5 Form.
Type 2 and type 3 hazardous substance
Manufacturer or importer of type 2 or type 3 hazardous substance must obtain a registration certificate before applying for facility permission, except for products used for the termination, prevention, control, repelling, or elimination of insects or other animals or products used for deodorization which have one of the following chemicals as an active ingredient:
- naphthalene, which is a type 2 hazardous substance;
- p-dichlorobenzene or 1,4-dichlorobenzene, which are type 3 hazardous substances.
In such case, the applicant may proceed to apply for the facility permission without having to obtain a registration, since these hazardous substances are exempted from registration according to the Notification of the Ministry of Public Health published in 2006 (B.E. 2549)
Where the hazardous substance falls within those which require submission of a result of efficacy test or active ingredient quantity analysis, an application for permission to manufacture/import sample must also be made before applying for the registration.
Product distributed in Thailand must have a correct label in accordance with the Notifications relating to the labeling of hazardous substance products and must specify its “registration no.” on its label.
Examples of products which fall within type 2 or type 3 hazardous substance
Products which fall within type 2 or type 3 hazardous substance may be divided into the following broad categories:
1. Products used for the termination, prevention, control, repelling, or elimination of insects or other animals, except for products with the following conditions:
- products having essential oils which are derived from plants or animals as active ingredients; or
- products having parts of plants which may have undergone any processing method, such as cutting, grinding, chopping, or slicing, as the main ingredients; or
- products having substances derived from plants or animals which have undergone the boiling, fermenting, distilling, extracting, burning, or any other kind of processing methods which do not involve an addition of any other substance with a view to creating a chemical reaction, as active ingredients;
such products must not have synthetic chemicals as active ingredients;
2. Products used for rodent control; except for products with the following conditions:
- products having essential oils which are derived from plants or animals as active ingredients; or
- products having parts of plants which may have undergone any processing method, such as cutting, grinding, chopping, or slicing, as the main ingredients; or
- products having substances derived from plants or animals which have undergone the boiling, fermenting, distilling, extracting, burning, or any other kind of processing methods which do not involve an addition of any other substance with a view to creating a chemical reaction, as active ingredients;
such products must not have synthetic chemicals as active ingredients;
3. Products used for the disinfection, cleaning of floors, walls, sanitary wares, or other materials, or the declogging of pipes or drains, except for products with the following conditions:
- products having enzymes as active ingredients; or
- products having parts of plants which may have undergone any processing method, such as cutting, grinding, chopping, or slicing, as the main ingredients; or
- products having substances derived from plants or animals which have undergone the boiling, fermenting, distilling, extracting, burning, or any other kind of processing methods which do not involve an addition of any other substance with a view to creating a chemical reaction, as active ingredients; such products must not have synthetic chemicals as active ingredients;
4. Products used for laundry bleach or the disinfection or deodorization of pool;
5. Products used for dry cleaning, correction, or used as correction fluid solvents, except for those in the form of correction tapes or correction pens.
Whether a product is type 2 or type 3 hazardous substance depends on its active ingredient as specified in the Notification of the Ministry of Industry Re: Hazardous Substance Lists (List 4 Hazardous Substances under the Responsibility of the Food and Drug Administration).
Where the product contains more than one type of hazardous substances, the product shall be classified based on the type of its most hazardous substance.
Documents required for registration of hazardous substance
- Registration form (HS/PH 1 Form)
- Label of the product to be put on sale
- List of ingredients
- Manufacturing, packaging and labeling processes
- Physical and chemical properties
- SDS: Safety data sheet with hazard classification in accordance with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
- Result of efficacy test (in the case of products used for the prevention or elimination of insects and other animals/disinfectant products and laundry bleach products)
- Result of active ingredient analysis (in the case of products consisting of hazardous substance in the list of hazardous substances which require submission of active ingredient quantity analysis)
- Utility, quantity and usage recommendation, or information regarding usage recommendation according to the claims of the finished product
- Copy of hazardous substance registration certificate of the technical grade raw material or semi-finished material used in the manufacturing of the hazardous substances wished to be registered (where the products are used for the prevention, control, repelling, or elimination of insects or rodents)
- Certificate of Free Sales from the country of the manufacturer or any other country where the products are not sold in the country of the manufacturer (where the products are used for the prevention or elimination of insects and rodents), in the case where the products are to be imported into the country for sale
- Photograph of the product or its container, or the wrapping or banding of its container
- Other relevant documents, evidence, or other explanatory notes
Type 4 hazardous substance
The law prohibits any person from manufacturing, importing, exporting, transiting, or possessing type 4 hazardous substance, except for a case-by-case-basis authorization by the responsible agency for the hazardous substance to be used as a reference standard in the conducting of laboratory analysis in accordance with the prescribed rules and conditions.
Examples of products which fall within type 4 hazardous substance:
- Products having active ingredients which temporarily interfere with the bodily functions for the purpose of self-protection or causing damage to others;
- Products used for spraying or sprinkling and products of which the use requires coming into contact with skin or food which contain methanol or methyl alcohol as a component;
- Products used for the sanitization or cleaning of floors, walls, sanitary wares, and other materials, having formaldehyde or methanal as an active ingredient;
- Other type 4 hazardous substance products with chemical names, Chemical Abstracts Service number (CAS No.), and conditions in accordance with the Notification of the Ministry of Industry Re: Hazardous Substance Lists (List 4 Hazardous Substances under the Responsibility of the Food and Drug Administration).
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