Taiwan Consults on 3 Draft Cosmetic Regulations

Takehome:

On Oct 9, 2018, Taiwan FDA opened the consultation on 3 draft cosmetic regulations: "Administrative Measures for Cosmetic Severe Adverse Event and Hygiene Safety Hazard Notification", "Administrative Measures for Cosmetics Recall" and "Administrative Measures for Cosmetics Supply Source and Flow Information".

The 3 administrative measures are drafted to clarify the management of cosmetic severe adverse events and hygiene safety hazard notification, cosmetic recall and cosmetic supply source and supply chain information in Cosmetic Hygiene Safety Administration Act. The 3 cosmetic administrative measures will be effective when Cosmetic Hygiene Safety Administration Act is in force.

Administrative Measures for Cosmetic Severe Adverse Event and Hygiene Safety Hazard Notification

The measure stipulates the target to notify, the method and content of adverse event notification. If severe adverse events occur or the product is found to be harmful to human health, it shall be notified on the online system established by the central competent authority within 15 days (in an emergency, manufacturers can make a verbal notification on the telephone or in person). The credentials, dossiers or data shall be kept for at least 5 years.

The content of notification:

Notifiers name, address and phone number
Date of adverse event happens
Product name
Product notification number or license number
Severe adverse event and hygiene safety hazard condition
Other dossiers and data stipulated by central competent authority

Administrative Measures for Cosmetics Recall

The measure stipulates cosmetic recall level and associated rectifications measures made by the competent authority, cosmetic manufacturers and importers.

Cosmetic Recall Level

First Level (finish recalling in 1 month, or shorten to 14 days when necessary)	Contain banned ingredients
	Contain ingredients that are harmful to human health
	Manufactured by factory that has not been registered
	Cosmetic’s notification or license that has been revoked or abolished
	Cosmetics from unknown resources
Second Level (finish recalling in 2 months)	Cosmetics didn't complete product notification or establish PIF, and didn't improve within time limit
	Special-use cosmetics that didn't register in TFDA or change registration items without authorization, and didn't improve within time limit
	Supply, sell, display, provide for consumer trials with personal use special-use cosmetics or special-use cosmetics that are exempted from registration, and didn't improve within time limit
	Outer packaging or containers that are not marked as required
	Distributors change product labels, packaging, container or instruction and sell it
	Cosmetics that violate "Standards for Cosmetics Manufactories" or Cosmetic GMP
	Cosmetics with fake, exaggerated or medical marks

Rectification measures of the competent authority:

When municipal or county competent authorities recall cosmetics, they shall notify TFDA and other counties or cities, as well as disclose the following information to the public

Product name

Product notification or license number

Product batch number or sequence number

Manufacturer or importer’s name, address and phone number

Recall reasons

After receiving product recall report, the competent authority should conduct on-site inspections.

Rectification measures by cosmetic manufacturers and importers:

Manufacturers or importers shall establish cosmetics recall procedures;
Manufacturers or importers shall notify distributors to recall products within 7 days of receiving notification from the competent authority. For first level recalled cosmetics, within 3 days;
Manufacturers or importers shall submit a recall plan to the competent authority within 14 days of receiving notification. For first level recalled cosmetics, within 7 days;
Manufacturers or importers shall mark the recalled cosmetics and inventories before the final disposal, and store them separately with the qualified products;
Manufacturers or importers shall submit a product recall report to the competent authority after completing recall.

Administrative Measures for Cosmetics Supply Source and Supply Chain Information

The measure stipulates supply source and flow information shall be established by cosmetic manufacturers, importers and distributors. Cosmetic enterprises shall keep product supply source and supply chain information in the form of a written or electronic document for at least 5 years.

For cosmetic manufacturers and importers:

1. Manufacture or import information and credentials

Product name, notification number or license number, packing specifications and net content or capacity, batch number, product total number, import date and customs declaration number

2. Supply chain information and credentials

Supplier's name, address, contact person and phone number, product name, notification number or license number, packing specification and net content or capacity, batch number, product total number, and delivery date.

For cosmetic distributors:

1. Supply source information and credentials

Supplier's name, address, contact person, and phone number, product name, notification number or license number, packing specification and net content or capacity, batch number, product total number, and receipt date

2. Supply chain information and credentials

Public consultation will last until Dec 9, 2018. Any suggestions can be submitted on Taiwan Public Policy Participation Platform.