Since the amendment of the Cosmetic Hygiene and Safety Act passed on May 2, 2018, the Taiwan Food and Drug Administration of the Ministry of Health and Welfare (hereinafter referred to as the “TFDA”) began drafting regulations and ordinances for implementing the newly amended provisions. On October 9, it announced, in accordance with the authorization granted in Article 12 Paragraph 3, Article 17 Paragraph 4, and Article 11 Paragraph 2 of the Act, the draft for the “Regulations on Reporting Severe Adverse Reactions for Cosmetics Products and Health Hazards”, draft for the “Regulations on Cosmetics Products Recycling”, and draft for the “Regulations on Information on the Source of Supplies and Destination of Cosmetics Products” to provide specific implementation measures for reporting, recycling, and follow-up tracking.

The draft for the “Regulations on Reporting Severe Adverse Reactions for Cosmetics Products and Health Hazards” mainly regulates the recipients of reports, reporting methods, reporting period, report content, and the retention period for related documents and information for cosmetics with severe adverse reactions as well as principles for processing personal information. The draft for the “Regulations on Cosmetics Products Recycling” assigns different ratings for the recycling of cosmetics products and the schedule, processing methods, and procedures for recycling cosmetics products of different ratings. The draft for the “Regulations on Information on the Source of Supplies and Destination of Cosmetics Products” requires manufacturers and importers to control the sources and destinations of products and specifies the retention period for related documents and information.

In addition, the TFDA also announced, in accordance with the authorization granted in Article 9 Paragraph 2, Article 5 Paragraph 6, Article 5 Paragraph 3 Subparagraph 1, and Article 4 Paragraph 2 of the Act, the draft for the “Regulations on the Qualifications and Training of Professional Technical Personnel for Cosmetics Products”, draft for the “Regulations on Special Authorization for Import of Cosmetics Products for Specific Purposes”, draft for “Limitations on the Exemption of Inspections and Registration of Imported Cosmetics Products for Specific Purposes for Personal Use”, and draft of the “Regulations on Cosmetics Products Registration”.

The draft for the “Regulations on the Qualifications and Training of Professional Technical Personnel for Cosmetics Products” is mainly provided in response to the requirement in the new legislation for domestic cosmetics producers to appoint pharmacists or professional technical personnel for cosmetics to oversee production. Therefore, regulations are provided for their qualifications, required pre-job training, on-the-job training, and duties. The draft for the “Regulations on Special Authorization for Import of Cosmetics Products for Specific Purposes” is based on the import of cosmetics products for specific purposes (known as cosmetics that contain drugs in the previous legislation) by cosmetics operators and academic research institutions for inspections and registration or research experiments. These products may be imported with a special application and approval from the TFDA and regulations are therefore required for the qualifications, usage, required documents and information, and required quantities. The TFDA is also granted the power to abolish and revoke applications with false documents or usage that is inconsistent with the usage specified in the application. It may also refuse to accept applications from violators for two years. The draft for “Limitations on the Exemption of Inspections and Registration of Imported Cosmetics Products for Specific Purposes for Personal Use” focuses on the quantity of cosmetics products citizens may bring from foreign countries and be approved for passage by customs. Regulations are provided for the import channels, restrictions on quantities, and methods for processing excessive amounts. The draft of the “Regulations on Cosmetics Products Registration” is based on the TFDA’s requirement for the completion of product registration for categories of cosmetics products for cosmetics producers and importers exceeding a certain scale. Therefore, regulations are provided for items, contents, procedures, changes, validity periods, abolishment, and revocation and other compliance items required for product registration.

Each draft announcement is provided with a 60-day notice for comment period to collect information from all sectors as reference for the TFDA’s amendments before the drafts are finalized. The TFDA plans to officially announce and promulgate related regulations in mid-2019. Violators of related regulations may be fined a maximum fine of NT$1 million in accordance with Article 23 and Article 24 of the Cosmetic Hygiene and Safety Act and may be fined successively for each violation. In case of severe violation, business operations may be suspended or terminated and the product registration or permit may also be restricted. Therefore, operators are advised to duly understand the contents of the drafts and the scope of their obligations and express their opinions on the feasibility of practical operations to the TFDA.