Regulations for Reporting Cosmetics Serious Adverse Effects and Hazards to Hygiene and Safety

Article 1
The Regulations have been established according to Paragraph 3 of Article 12 of the Cosmetic Hygiene and Safety Act (the “Act”).
Article 2
When the regular or reasonable use of cosmetics generated serious adverse effects on the human bodies, or the cosmetics businesses found the products may have hygiene and safety hazards or risks of harm, they shall visit and report to the network system which is established by the central competent authority within 15 days from the day of awareness of the event.
In the case of emergency, the report of the preceding Paragraph shall use oral or other methods to report immediately and shall visit the network system for a correction within the time limit stipulated under the preceding Paragraph.
Article 3
The report of the preceding Article shall include the following information, documents and data:
1. The name, address and telephone number of the reporter.
2. The date that the reporter knew the event mentioned in Paragraph 1 of the preceding Article.
3. The name of the product.
4. Product notification number or license number.
5. The situations of serious adverse effects, hygiene and safety hazards or risks of harm.
6. Necessary documents or information required by the central competent authority.
If contents of the report mentioned in the preceding Paragraph are incomplete and may be corrected, the competent authority shall request for the correction within the time limit.
Article 4
The cosmetics businesses shall keep the certificates, documents or information which could prove content of the report mentioned in Paragraph 1 of the preceding Article at least five years from the day of reporting.
Article 5
The Regulations shall take effect on July 1, 2019.