Cosmetic Products Regulation in Taiwan
The Cosmetic Hygiene and Safety Act was enacted in Taiwan in 2019. Several dates were set and since July 2021 three new requirements have been enacted. General cosmetics notification is now mandatory and there are new requirements regarding the cosmetic products' labelling.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate

TAIWAN’S LEGAL FRAMEWORK ON COSMETIC PRODUCTS

In 2019, Taiwan implemented the Cosmetic Hygiene and Safety Act, its national cosmetic regulation. Along with this Act and according to the implementations dates set, in July 2021 there were three new cosmetic regulatory systems implemented at national level.

According to the Cosmetic Hygiene and Safety Act, “Cosmetics” means the substance(s) for external use on the human body to freshen the hair or skin, to stimulate the sense of smell, to cover body odour, or to improve facial appearance. Cosmetic products are regulated based on their functions, distinguishing general cosmetics and specific purpose cosmetics. Specific purpose cosmetics include sunscreens, hair dyes, hair perms, deodorants, teeth whitening products and cosmetics with other purposes.

Since 2019, animal testing in Taiwan is not allowed unless approval by the central competent authority is granted and one of the two following conditions is met: the ingredient is widely used and its function cannot be replaced by other ingredients; or there is evaluation data that demonstrates a potential for harming human health.

The Cosmetic Hygiene and Safety Act stipulated that new management systems (regarding general toothpaste and mouthwash products, notification system, labelling requirements, etc.) would be implemented from July 2021 onwards in order to fully and thoroughly satisfy the provisions of such Act.

Currently, manufacturers and importers need to notify general cosmetics to the Taiwan Food and Drug Administration (TFDA), otherwise they will be regarded as illegal.  Solid handmade soaps produced by cosmetic manufacturing sites which are exempt from factory registration are exempt from this notification.

The cosmetic product notification must be made online, in the “Cosmetic Products Notification Platform System”, before their supply, sale, giveaway, public display, or consumer trial offer. Before notifying the cosmetic product, the applicants need to contact the TFDA in order to get an account and password to access the system. Relevant information needs to be provided at the moment of notification, like the name of the product, precautions and full components of products, just to name a few. This notification functions as a record to help TFDA to assign liability in case there is a safety problem.

For now, specific purpose cosmetics are still subject to a registration based process, but from July 2024 onwards, they will also be subject to notification procedures.

General toothpaste (unmedicated) and mouthwash products are now classified as general cosmetics and, consequently, the labelling, ingredients, quality, hygiene and safety, and manufacturing facilities of such products have to comply with cosmetic regulations.

From this date onwards, there are also new requirements on cosmetic labelling, prohibited ingredients and permitted colourants. The new regulations provide clear rules for the labelling, including standardization of the display order of ingredients and font sizes of items which are mandatory in the label. The function, manufacturing date and expiration date, for example, are now mandatory informations that the label must contain. The objective is to help consumers identify and acknowledge the product’s information, strengthening their rights.

There are several mandatory requirements still to be implemented, like Good Manufacturing Practices compliance for both manufacturers and importers. For general cosmetics, the expected implementation date is set for July 2024.

Entering different markets and being in compliance with cosmetics regulation can be a hard task. Our company has team of regulatory experts that can help you throughout this process. Do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Taiwan Cosmetic Hygiene and Safety Act. 2018. Taiwan Food and Drug Administration. Available from: https://cosmetic.chemlinked.com/expert-article/ebook/taiwan-cosmetic-hygiene-and-safety-act
  2. New Cosmetics Management System to be Enforced from July 2021. 2021. Food and Drug Administration, Ministry of Health and Welfare. Available from: https://www.mohw.gov.tw/cp-115-58834-2.html

further
reading

cosmetic products

Citral under review: SCCS’s Preliminary Opinion

The SCCS was tasked by the European Commission to evaluate if the safety levels for Citral, determined through QRA2 based on skin sensitization induction, are sufficient to safeguard consumers. A preliminary opinion was released.

Read More »
cosmetic products

Are sunscreens with Benzophenone-4 safe?

Benzophenone-4 is commonly known as a UV-filter in cosmetic products. Learn what the final opinion of SCCS states about Benzophenone’s safety profile as a UV-filter in cosmetic products.

Read More »
cosmetic products

Is Aluminium in cosmetics safe for human health?

The Scientific Committee on Consumer Safety (SCCS) published its Final Opinion on the safety of Aluminium in cosmetic products. This follows a lengthy review process that began in 2013 when the SCCS was first mandated to evaluate the potential health risks of Aluminium (Al) and its compounds in cosmetics.

Read More »
cosmetic products

Silver in Cosmetics: SCCS preliminary opinion.

Ingredients: SILVER

The recent preliminary opinion from the Scientific Committee on Consumer Safety (SCCS) regarding silver in cosmetics is crucial for consumers and manufacturers. This article breaks down the key points, making it easier to understand the implications and stay informed.

Read More »
news & updates

EU Ecolabel adoption and recognition are on the rise

The Ecolabel certification is a comprehensive program focused on fostering sustainable practices. It evaluates products based on life cycle assessments, where every phase of said life cycle must abide by strict standards to attain the Ecolabel certification. The overarching objective of this certification is minimizing environmental harm from production or consumption activities.

Read More »
cosmetic products

UK proposes ban of wet wipes containing plastic 

The UK has proposed, on April 24, 2024, a regulation titled The Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2024, to the World Trade Organization (WTO). The regulation aims to eliminate the supply and sale of plastic-containing wet wipes, including cosmetic ones. The public can offer comments on the draft until June 23, 2024, with adoption expected in September of the same year.

Read More »
news & updates

SCCS preliminary opinion on Citral sensitization endpoint

Ingredients: CITRAL

Date of publication: 27/03/2024

On March 27 2024, the Scientific Committee on Consumer Safety (SCCS) published the Preliminary Opinion on the safety of Citral in cosmetic products. The deadline for comments is set to June 2, 2024.

Read More »
medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »