Taiwan to Implement a Series of Supplementary Measures for Cosmetic Hygiene Safety Administration Act

On 22^nd and 28^th May, 2019, Taiwan FDA released the final version of 10 cosmetic administrative measures which will enter into force on 1^st July, 2019. The measures will aid implementation of Cosmetic Hygiene Safety Administration Act^[1] which is likely to enter into force on 1^st July, 2019. The detailed information of the 10 administrative measures are listed in Table 1, and Table 2 and Table 3 respectively specify cosmetics recall level and fee standards for different administrative items.

Table 1:

Name	Summary	Note	Detailed Content
Administrative Measures for Cosmetics Recall^[2]	Cosmetic recall level and associated rectifications measures made by the competent authority	Compared with the previous draft, the recall level changes from 2 levels to 3 levels	Refer to CL News [5]
Administrative Measures for Cosmetics Supply Source and Supply Chain flow information^[3]	Supply source and flow information which shall be established by cosmetic manufacturers, importers and distributors	/
Administrative Measures for Severe Adverse Event and Hygiene Safety Hazard Notification ^[4]	Action which should be taken when adverse events happen	/
Administrative Measures for Cosmetics Certificate Issuance ^[6]	Application requirements, review procedures and standards, validity period, cancellation of cosmetic certificates	/	Refer to CL News ^[7]
Administrative Measures for Specific Purpose Cosmetics Certificate Issuance ^[8]	Application requirements, review procedures and standards, validity period, cancellation of specific purpose cosmetics certificate	/	Refer to CL News ^[9]
Administrative Measures for Registration Exemption Application of Imported Specific Purpose Cosmetics ^[10]	Applicant qualifications, dossiers necessary, maximum number, inadmissible conditions, withdrawal and abolition of registration exemption application of imported specific Purpose- cosmetics.	/	Refer to CL News^[11]
Regulations for Self-change of Cosmetics Registration Information ^[12]	Registration Information which can be changed by manufacturer or distributors themselves without notifying TFDA.	The regulation will enter into force on 1st July 2019 except the tenth part of Article 2 which will be effective on 1st July 2021.	/
Limitation of Imported Specific Purpose Cosmetics^[13]	Specific purpose cosmetics accompanying passengers entering Taiwan for personal use, each category of which shall not exceed 12 bottles, totaling no more than 36 bottles, can be exempted from registration at TFDA	/	Refer to CL News ^[14]
Amendment to Cosmetics Categories and Scope ^[15]	Non-medicated toothpaste and non-medicated mouthwash are re-designated as cosmetics and subject to cosmetic regulatory compliance requirements.	The Amendment will enter into force on 1st July 2019. But non-medicated toothpaste and non-medicated mouthwash will be classified as cosmetics on 1st July 2021.	Refer to CL News ^[16]
Fee-charging Standards for Cosmetic Administrative Items^[17]	Fee charging standards for cosmetic notification, animal testing application, specific purpose cosmetics registration, GMP on-site inspection, etc.	Old name: Fee-charging Standards for Registration of Cosmetic Products and Cosmetic Colorants. Compared with the previous draft, there are some price changes and newly added fee-charging items	Refer to CL News^[18]

Table 2: Cosmetic Recall Level:

First Level (Finish recalling in 1 month, or shorten to 14 days when necessary)	Contain banned ingredients such as Lead
	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
	Cosmetics didn’t establish or changed information about storing time limit, method and place, 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
	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
Third Level (Finish recalling in 6 months)	Outer packaging or containers that are not marked as required

Table 3: Main administrative items fee standards:

Administrative Items		Fee (TWD)
Cosmetic notification	Cosmetic notification	600
	Change of notification information
	Extension of cosmetic notification
Cosmetic animal testing	Animal testing application of cosmetic product or ingredient	40000
Cosmetic animal testing	Reissue or replacement of animal testing approval letter	4000
Specific-purpose cosmetic registration	New special-use cosmetics registration	36000
	Special-use cosmetics registration	12000
	Change of specific purpose cosmetics registration (product name, packaging, usage, or manufacturer)	3500
	Change of specific purpose cosmetics registration information (ingredient or category)	5000
	Extension of specific purpose cosmetics license	3500
	Reissuance of specific purpose cosmetics license or approval letter of label and instruction	3500
	Judgment of cosmetic management attribute	2500
	Registration for exemption application of imported specific purpose cosmetics	3000
	Application for specific purpose cosmetics license	4000
	License	1500
GMP on-site inspection for cosmetic enterprises	GMP on-site inspection of Taiwan cosmetic factories	60000
	GMP on-site inspection of foreign cosmetic factories	600000
	Registration of information change of GMP documents	6000
Cosmetic related certificates and approval letters	Review of application for Cosmetic production and sales certificate, sales certificate or manufacturing factory certificate	2000
	Cosmetic production and sales certificate, sales certificate or manufacturing factory certificate in Chinese	Original: 1500 Copy: 200
	Cosmetic production and sales certificate, sales certificate or manufacturing factory certificate in English	Original: 1500 Copy: 200
	Good Manufacturing Certificate in Chinese	1500
	Good Manufacturing Certificate in English	1500
	Reissuance of Good Manufacturing Certificate	1800