The Ministry of Health and Welfare (MOHW) of Taiwan published the Proposed Regulations for Reporting Cosmetics Posing Serious Adverse Effects and Hazards to Hygiene and Safety (預告「化粧品嚴重不良反應及衛生安全危害通報辦法」草案) (the Proposal) on 9 October 2018. Once adopted, the proposal would clarify the scope of safety incidents that might trigger a mandatory reporting by cosmetic manufacturers, importers and sellers. In addition, the responsibilities of private companies that are subject to the mandatory reporting requirements have been specified in the Proposal. Public consultation on the Proposal is open until 10 December 2018.
Verisk 3E Analysis
Specifically, the Proposal would regulate the following aspects in relation to a mandatory reporting requirement imposed under the Cosmetic Hygiene and Safety Act (化粧品衛生安全管理法):
Timelines for companies to report a cosmetic product that might cause adverse effects. Specifically, companies that engage in the manufacture, import or sale of cosmetics and are subject to the mandatory reporting requirements under the Cosmetic Hygiene and Safety Act would need to submit this report to the MOHW within 15 days of becoming aware of or should have been aware of this incident;
Information that needs to be reported, including the name, address and contact information of the reporting company, identifiers of concerned cosmetic products as well as a description of the adverse effect that might occur; and
Record-keeping requirements for companies submitting an adverse effect and hazard report. All required documents for this report must be kept on file by the reporting company for at least five years.
Pursuant to the Cosmetic Hygiene and Safety Act, private entities engaged in the manufacture, import or sale of cosmetics are required to report the serious adverse effects caused by their products under normal or reasonable usage conditions. Findings on potential issues of a cosmetic product that might pose a threat to hygiene and safety or a risk of harm must also be reported.
Serious adverse effects include the following conditions:
- Life-threatening situations;
- Temporary or permanent disability/incapacity;
- Congenital anomaly/birth defect of fetus/infant;
- Hospitalization of users for treatment.
The Proposal was issued to provide further detailed implementation guidelines for this requirement.
Companies that engaged in the manufacture, import or sale of cosmetics in Taiwan should note that a regulation has been proposed to provide further implementation details for the reporting requirement prescribed under the Cosmetic Hygiene and Safety Act. Affected companies are recommended to review the Proposal and submit their comments to the MOHW by 10 December 2018 via one of the following methods: