The original Cosmetic Hygiene Act was amended and renamed the Cosmetic Hygiene and Safety Act ("Cosmetic Act") on May 2, 2018. To avoid excessive impact on the cosmetic business and give them enough time to adapt their policies and processes to comply with the Cosmetic Act, the Executive Yuan has determined that, except for the labeling requirements, the remaining provisions of the Cosmetic Act shall take effect on July 1, 2019. Below are the key contents of the Cosmetic Act:
1. Amendment to the definition of "Cosmetics" (Article 3)
According to Article 3 of the Cosmetic Act, the term "cosmetics" means products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body. However, this does not apply to those that are regarded as drugs under other laws or regulations. As a result, non-medical toothpaste and mouthwash products shall fall within the jurisdiction of the Cosmetic Act, and their labels, like those of cosmetics, shall disclose all ingredients after July 1, 2021.
2. Completion of product registration and establishment of product information file (Article 4)
According to Article 4 of the Cosmetic Act, cosmetics that are specified by the central competent authority and cosmetics manufacturers and importers of a certain scale that is announced by the central competent authority shall complete product registrations and establish product information files prior to the supply, sale, giveaway, public display, or consumer trial offer of cosmetics. The same applies to modifications of the data in the registrations or product information files. To improve the quality and safety control of cosmetic products after launching to the market, the Cosmetic Act obligates manufacturers and importers to complete product registrations and establish product information files.
3. Amendment to the factory establishment standards for cosmetics manufacturers and introduction of the Good Manufacturing Practice (GMP) Regulations (Article 8)
(1) Article 8(1) of the Cosmetic Act provides that "Manufacturing facilities for cosmetics shall comply with the Establishment Standards for Cosmetics Manufacturers. Except for those specified jointly by the central competent authority and the central competent industry authority as per public announcements, all cosmetic manufacturers shall complete registration."
(2) Article 8(2) further stipulates that, "For cosmetics that are specified by the central competent authority as per public announcements, their manufacturing facilities shall comply with the Good Manufacturing Practice (GMP) for cosmetic products. The central competent authority may inspect the facilities, if necessary." To ensure that all the cosmetics are fit for the intended purpose and improve product uniformity, the Good Manufacturing Practice (GMP) for cosmetic products is introduced at this time.
4. Labeling, promotion, and advertisement of cosmetics (Article 10)
The new rules stipulate that the contents of the labeling, promotion, and advertisement of cosmetics shall not be deceptive or exaggerated, and that no medical efficacy may be stated on the label, promotion, or advertisement of cosmetic products.
5. Requirement on the establishment of the traceability system on direct supply sources and destinations of products (Article 11)
Cosmetics businesses shall establish and maintain data on direct supply sources and destinations of products; however, this obligation does not apply to the data on products directly sold to consumers.
6. Obligation to report and recall defective products (Articles 12 and 15)
The Cosmetic Act stipulates that cosmetic businesses shall report any serious adverse effects of cosmetics under normal or reasonable use or the findings of a product which may pose a hazard to hygiene or safety, and must handle such situation in accordance with the provisions on recalling products as set forth under the Consumer Protection Act. Furthermore, the Cosmetic Act also provides that competent authorities shall immediately initiate investigations, and may order cosmetic businesses to suspend the manufacture, import, or sale, or order their products to be withdrawn from the market or to be sealed and stored if the cosmetics businesses are suspected to have violated the Cosmetic Act, or if the cosmetics are found to be involved with issues regarding expiration, unclear source, or other conditions sufficiently harmful to human health.
7. Whistleblower provision (Article 19)
In addition to the increase of the amount of the fine, to encourage the general public and staff to report any violation of the Cosmetic Act, the whistleblower provision is introduced under the Cosmetic Act.
8. Labeling requirements (Article 7)
Under the new rules, the outer packaging or containers of cosmetics shall conspicuously label information including (i) product name; (ii) function; (iii) usage and storage instructions; (iv) net weight, volume, or amount; (v) full ingredient names (for specific-purpose cosmetics, the specific-purpose ingredients contained therein shall be labeled separately); (vi) precautions for use; (vii) name, address, and telephone number of the manufacturer or importer; country of origin of imported product; (viii) manufacturing date and expiration date; (ix) lot number; and (x) other information required to be labeled as per public announcements of the central competent authority. The information to be labeled as specified above shall be provided in Chinese or internationally known symbols. However, considering that not all ingredients have Chinese translations, the information on ingredient names may be labeled in English. The labeling requirements will come into force on July 1, 2021.
Many provisions in the original Cosmetic Hygiene Act have been amended in the new Cosmetic Act. To avoid receiving administrative penalties, it is advisable that all cosmetic manufacturing, importing or selling businesses shall ensure their operation activities and cosmetics products are compliant with the rules.