August 2024
Taiwan Ministry of Health and Welfare Announced Comprehensive Implementation of Product Notification of Cosmetics
August 2024
Oli Wong and Angel Li
The new cosmetic management system took effect on July 1, 2024. Under the new regulations, cosmetic businesses must complete product notifications prior to sale, giveaway or public display. Failure to comply may result in fines of up to NT$1 million.
Previously, cosmetics in Taiwan were categorized into two types: general cosmetics and specific-purpose cosmetics. Specific-purpose cosmetics, such as sunscreen, hair dye, perm solutions, deodorants, and teeth whitening products, previously announced by Taiwan Ministry of Health and Welfare (MOHW),[1] must apply for inspection and registration according to Article 5, Paragraph 1 of the Cosmetic Hygiene and Safety Act. These products require approvals and permits from the MOHW before manufacture or import (“pre-market registration of specific-purpose cosmetics”). The MOHW announced in June this year that, effective July 1, the pre-market registration requirement for specific-purpose cosmetics would be abolished. Consequently, cosmetics would no longer be categorized and all products would simply be referred to as “cosmetics”. Except for handmade soaps produced in manufacturing facilities exempt from factory registration such as solid handmade soap, all cosmetics would now be managed under the product notification system.[2] To elaborate, prior to the supply, sale, giveaway, public display, consumer trial offer or modification of cosmetics, they must first be registered on the Cosmetic Product Registration Platform System.[3] Violations of these regulations may result in fines ranging from NT$10,000 to NT$1,000,000, with the possibility of repeated fines.[4]
In addition, the MOHW also announced that, starting July 1, 2024, manufacturers and importers of cosmetics for specific-purposes must establish the product information file (PIF).[5] Violations may result in fines ranging from NT$10,000 to NT$1,000,000, with the possibility of repeated fines.[6] Furthermore, manufacturing facilities must comply with the Cosmetics Good Manufacturing Practice Regulations.[7] Facilities that fail to meet these requirements and do not rectify the issues within the specified timeframe could face fines ranging from NT$20,000 to NT$5 million.[8] In cases of severe violations, the most serious penalty may be the revocation of the cosmetic product notification.
[1] On May 30, 2019, the MOHW issued Announcement Wei-Shou-Shi-Zi No. 1081601759, which established the “List of Ingredients and Usage Restrictions for Specific-Purpose Cosmetics.” This announcement was repealed by the MOHW Announcement Wei-Shou-Shi-Zi No. 1131602017 on May 30, 2024. Starting from July 1, 2024, the management of cosmetics is unified.
[2] MOHW Announcement Wei-Shou-Shi-Zi No. 113160439 on June 26, 2024.
[3] Article 4, Paragraph 1 of the Cosmetic Hygiene and Safety Act (“Act”).
[4] Article 23, Paragraph 1, Subparagraph 1 of the Act.
[5] MOHW Announcement Wei-Shou-Shi-Zi No. 1131604608 on June 26, 2024.
[6] Article 23, Paragraph 1, Subparagraph 1 of the Act.
[7] MOHW Announcement Wei-Shou-Shi-Zi No. 1131103147 on June 28, 2024.
[8] Article 22, Paragraph 1, Subparagraph 3 of the Act.
The contents of all materials (Content) available on the website belong to and remain with Lee, Tsai & Partners. All rights are reserved by Lee, Tsai & Partners, and the Content may not be reproduced, downloaded, disseminated, published, or transferred in any form or by any means, except with the prior permission of Lee, Tsai & Partners.
The Content is for informational purposes only and is not offered as legal or professional advice on any particular issue or case. The Content may not reflect the most current legal and regulatory developments. Lee, Tsai & Partners and the editors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The contributing authors' opinions do not represent the position of Lee, Tsai & Partners. If the reader has any suggestions or questions, please do not hesitate to contact Lee, Tsai & Partners.
Oli Wong and Angel Li
The new cosmetic management system took effect on July 1, 2024. Under the new regulations, cosmetic businesses must complete product notifications prior to sale, giveaway or public display. Failure to comply may result in fines of up to NT$1 million.
Previously, cosmetics in Taiwan were categorized into two types: general cosmetics and specific-purpose cosmetics. Specific-purpose cosmetics, such as sunscreen, hair dye, perm solutions, deodorants, and teeth whitening products, previously announced by Taiwan Ministry of Health and Welfare (MOHW),[1] must apply for inspection and registration according to Article 5, Paragraph 1 of the Cosmetic Hygiene and Safety Act. These products require approvals and permits from the MOHW before manufacture or import (“pre-market registration of specific-purpose cosmetics”). The MOHW announced in June this year that, effective July 1, the pre-market registration requirement for specific-purpose cosmetics would be abolished. Consequently, cosmetics would no longer be categorized and all products would simply be referred to as “cosmetics”. Except for handmade soaps produced in manufacturing facilities exempt from factory registration such as solid handmade soap, all cosmetics would now be managed under the product notification system.[2] To elaborate, prior to the supply, sale, giveaway, public display, consumer trial offer or modification of cosmetics, they must first be registered on the Cosmetic Product Registration Platform System.[3] Violations of these regulations may result in fines ranging from NT$10,000 to NT$1,000,000, with the possibility of repeated fines.[4]
In addition, the MOHW also announced that, starting July 1, 2024, manufacturers and importers of cosmetics for specific-purposes must establish the product information file (PIF).[5] Violations may result in fines ranging from NT$10,000 to NT$1,000,000, with the possibility of repeated fines.[6] Furthermore, manufacturing facilities must comply with the Cosmetics Good Manufacturing Practice Regulations.[7] Facilities that fail to meet these requirements and do not rectify the issues within the specified timeframe could face fines ranging from NT$20,000 to NT$5 million.[8] In cases of severe violations, the most serious penalty may be the revocation of the cosmetic product notification.
[1] On May 30, 2019, the MOHW issued Announcement Wei-Shou-Shi-Zi No. 1081601759, which established the “List of Ingredients and Usage Restrictions for Specific-Purpose Cosmetics.” This announcement was repealed by the MOHW Announcement Wei-Shou-Shi-Zi No. 1131602017 on May 30, 2024. Starting from July 1, 2024, the management of cosmetics is unified.
[2] MOHW Announcement Wei-Shou-Shi-Zi No. 113160439 on June 26, 2024.
[3] Article 4, Paragraph 1 of the Cosmetic Hygiene and Safety Act (“Act”).
[4] Article 23, Paragraph 1, Subparagraph 1 of the Act.
[5] MOHW Announcement Wei-Shou-Shi-Zi No. 1131604608 on June 26, 2024.
[6] Article 23, Paragraph 1, Subparagraph 1 of the Act.
[7] MOHW Announcement Wei-Shou-Shi-Zi No. 1131103147 on June 28, 2024.
[8] Article 22, Paragraph 1, Subparagraph 3 of the Act.
The contents of all materials (Content) available on the website belong to and remain with Lee, Tsai & Partners. All rights are reserved by Lee, Tsai & Partners, and the Content may not be reproduced, downloaded, disseminated, published, or transferred in any form or by any means, except with the prior permission of Lee, Tsai & Partners.
The Content is for informational purposes only and is not offered as legal or professional advice on any particular issue or case. The Content may not reflect the most current legal and regulatory developments. Lee, Tsai & Partners and the editors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The contributing authors' opinions do not represent the position of Lee, Tsai & Partners. If the reader has any suggestions or questions, please do not hesitate to contact Lee, Tsai & Partners.
