Technical Requirements of Cosmetics
The technical requirements cover the positive and negative listings of ingredients, labeling and claims, pre-marketing requirements, and Good Manufacturing Practices (GMP). These technical requirements serve as the guidelines for quality and safety control.
Under the current cosmetic regulation, cosmetics will be classified into two categories: controlled cosmetics and specially controlled cosmetics according to the ingredients used. The use of specially controlled ingredients as part of cosmetic products will have to be registered, whereas the use of controlled ingredients as part of cosmetic products will require the notification of the products to FDA prior to being marketed in Thailand . However, the products containing no specially controlled or controlled ingredients do not fall into these two categories and, thus, are classified as general cosmetics for the time being.
Pre-Marketing Requirements
The pre-marketing requirements need two types of documents according to the pre- marketing activities. The first document will be applicable to the notification of controlled cosmetic products, whereas the second document will be applicable to the registration of specially controlled cosmetic products. The manufacturers or importers are not required to apply for a licence to operate.
Notification
This is applicable to the controlled cosmetics classified in the ministerial notification. Either type of products or ingredients used classify the controlled cosmetics. For instance, products such as talcum powder and liquid talcum are classified as controlled cosmetics as well as those products containing ingredients such as zinc pyrithione or oxybenzone, etc.
Persons who are responsible for the marketing of cosmetic products need to submit a notification to FDA prior to the marketing of their products. The notification process is normally concluded within one working day.
The Requirements for Notification of Controlled Cosmetics
- Application form and attachments
- Master formula certified by authorized person
- Certificate of free sale (for importation of products) duly notarized by the Thai Embassy
- Corporate registration issued by the Ministry of Commerce of Thailand
- Labeling information
Registration
Nonetheless, concerns over the danger from use of the chemicals with higher risk of causing adverse reactions in certain products, if the indications and warnings are labeled improperly, have prompted FDA to continue the registration of cosmetic products using particular ingredients classified as specially controlled ingredients.
This second form of pre-marketing process is called “registration”. Yet, it shares no similarity with the registration of pharmaceutical products. As part of the notion supporting the
enactment of the Cosmetic Act of B.E.2535 (1992), its purpose is to strengthen the standard of manufacture; and the registration of cosmetic products clearly reflects this through the registration requirements. The registration procedure focuses mainly on the manufacturing processes such as production and quality control.
However, the permission for manufacturing or importing sample 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. This step is normally concluded within one working day.
After received the permission for manufacturing or importing the sample, a reasonable quantity of samples could be manufactured or imported; and then such samples shall be submitted as an attachment of the registration application. The required documents for registration are shown in Table 3 below. Basically, the registration of specially controlled is normally concluded within 30 working days.
The Requirements for Registration of Specially Controlled Cosmetics
- Application form and attachment
- Master formula certified by authorized person
- Certificate of free sale (for importation of products) duly notarized by the Thai Embassy
- Corporation registration issued by the Ministry of Commerce of Thailand
- Labeling 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
Labelling Requirements
The labeling requirements endorsed by the Cosmetic Committee stipulate that all cosmetics must be labeled in Thai language covering all aspects of information in compliance with the requirements as shown in Table 3.
The general information of any cosmetic product must be imprinted on the label and/or document attached to the package. This is to ensure that consumers have clear and appropriate information including indications and warning for safe use of the product.
The Labelling Requirements of Cosmetics
| Specially Controlled Products | Controlled Products | |
| 1 | Product name | Product name |
| 2 | Type of product | Type of product |
| 3 | The words “Specially Controlled Cosmetics” | The words “Controlled Cosmetics” |
| 4 | Registration number | – |
| 5 | Name and quantity of Specially Controlled and Active Ingredients |
Name and quantity of Controlled and Active Ingredients |
| 6 | Name and address of manufacturer (importer including country of origin in case of imported products) |
ame and address of manufacturer (importer including country of origin in case of imported products) |
| 7 | Batch number | Batch number |
| 8 | Manufacturing date | Manufacturing date |
| 9 | Instructions for use | Instructions for use |
| 10 | Net contents | Net contents |
| 11 | Statutory warning | Statutory warning |
| 12 | All information shall be imprinted on the pamphlets or leaflets delivered with products except that items 1, 4, and 10 shall be imprinted on the label if the label is smaller than 20 cm 2 | All information shall be imprinted on the pamphlets or leaflets delivered with products except that items 1, 4, and 10 shall be imprinted on the label if the label is smaller than 20 cm 2 |
The labels of cosmetic products may present the claims of use within the scope of cosmetics similar to those claims presented in advertising. The manufacturers or importers must retain the profile of product information including the evidence supporting those claims. Claims must not indicate that the products have any pharmaceutical characteristics or capability to affect or alter human body’s functions or structure. Additionally, these claims must not indicate that those cosmetic products have the capability which, in fact, does not exist (overclaim) or is the cause of misunderstanding in their quality (misleading).