Taiwan Finalizes the Amendment to Safety Assessment Report Signer’s Qualification

On November 11, 2021, Taiwan Food and Drug Administration (TFDA) launched a public consultation on the amendment to the safety assessment report signer's qualification in Regulations for Cosmetic Product Information File Management. After a commenting period of 60 days, TFDA introduced the finalized amendment on June 16, 2022. ¹

The finalized amendment is basically the same as the draft version, and only adopts minor changes in terms of wording and content arrangement. Subject to this finalized amendment, the signer of the safety assessment report shall be:

A person who has completed training courses on cosmetic safety assessment that provided by the university in or outside Taiwan which complies with Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education or by the central competent authority, and satisfy one of the following requirements:

1) Graduated from the department of medicine, pharmacy, or department of cosmetic, toxicology and their related departments or graduate schools at the university in or outside Taiwan; 

2) Has more than five years of relevant work experience in cosmetic safety assessment and graduated from the chemistry or chemical engineering department or institute at the university in or outside Taiwan before June 30, 2019.

The content and hours of training courses on cosmetic safety assessment mentioned in the above shall be:

1) Cosmetic management regulations: including cosmetic hygiene management regulations of R.O.C (Taiwan), international cosmetic hygiene regulations, and the system of cosmetic product information file in R.O.C. (Taiwan); at least four hours;

2) Applications and risks of cosmetic ingredients: including the action principles and safety of whitening, sunscreen, antiperspirant, deodorant, hair-dyeing, permanent waving and other ingredients, and common cosmetic adverse effects and violations; at least eight hours;

3) Methods of cosmetic safety assessment: including skin anatomy and physiology, cosmetic percutaneous absorption capacity, skin irritation, the mechanism and symptom of photoaging and photoallergy, the safety assessment of nanomaterials, the safety assessment of natural substance cosmetic, the cosmetic risk assessment, toxicological evaluation methods (skin irritation, skin sensitization, skin corrosivity, eye irritation and genetic toxicity and mutagenicity test), systemic toxicity and margin of safety, and alternative methods of animal testing; at least 36 hours;

4) Concluding the product safety assessment: at least six hours.