Taiwan Cosmetic Regulation: Pending Amendments to Cosmetics Hygiene Standards

Recently Lin Yijie, an official from "Taiwan Food and Drug Administration" confirmed with ChemLinked that Taiwan is planning to revise the “Statute for Control of Cosmetic Hygiene”. Lin also stated that the development of the new legislation is still in the incipient stages. A release made by Korean Cosmetic Association has revealed that the new hygiene standard will contain significant changes.

The amendments are as follows:

1 The scope of cosmetics is extended to oral products.

2 For cosmetics containing medical, poisonous or potent drugs, pre-market application is replaced by notification of key product information and preparing evaluation dossiers for inspection.

3 Labelling requirements are revised.

4 Experts or pharmacists in cosmetic manufacture companies are required to comply with GMP requirements and are subject to administration and supervision.

5 Where a product advertisement violates related requirements, the manufacturer will be ordered to rectify the advertisement and the according information will be subsequently filed.

6 Manufacturers are required to keep information about raw material suppliers and other links downstream in the supply chain.

7 Considering that cosmetics may cause hygiene and safety problems, the competent authority has the power to conduct tests and inspection when cosmetics are imported.

8 Any individuals reporting illegal activities will be rewarded while violators will be fined.

Required Labelling Information

According to the statute, Essential information such as the name and address of the manufacturer; the name of the cosmetic; the number of license/permit; the ingredients, usage, weight or volume, and the lot number or the manufacturing date shall be indicated.

The revised labelling information required to be indicated includes:

1 Name, address and phone number of manufacturer/importer; Name, address and phone number of factory

2 Product name

3 License number and lot number

4 Date of Manufacture and shelf life

5 Name of ingredients, usage, storage method, weight or volume and precautions for use

ChemLinked’s Perspective

Lin spoke to ChemLinked stating that, “the focus of the amendment would be the strengthening of manufacturers/importer self-management and products post-market surveillance.” The main shift in focus will see the pre-market approval system replaced with a simplified notification system and a move towards a self-regulating market. At present official guidance documents detailing the new regulatory requirements and new compliance obligations have not been released, so it remains to be seen whether or not the new system will align with the notification systems implemented in the member states of ASEAN.