Taiwan to Expand the Scope of Qualification on Safety Assessment Report Signer

Taiwan FDA is now soliciting public consultation on the amended qualification for the signer of the safety assessment report included in product information file (PIF) until Jan. 11, 2022.

According to the amendment, the scope of qualification on the signer will be expanded to two types of persons, instead of being limited to the first type, as shown below:

1. A person who graduated from the department of medicine, pharmacy, toxicology, cosmetic and other related departments or graduate schools at the university in or outside Taiwan which complies with Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education.

2. A person who 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.

Stakeholders with comments can send an email to [email protected] by the deadline.

Current Qualification Requirements for Signer of Safety Assessment Report

According to the Regulations for Cosmetic Product Information File Management, the signer of the safety assessment report shall fulfill the following requirements:

1. A person who graduated from department of medicine, pharmacy, toxicology, cosmetic and other related departments or graduate schools at the university in or outside Taiwan which complies with Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education, and has taken cosmetic safety assessment training courses which are provided by an university in or outside Taiwan, or by the central competent authority.

2. The content and hours of cosmetic safety assessment training courses mentioned in point one shall be:

• 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.

• 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.

• 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.

• Concluding the product safety assessment: at least six hours.

3. The signer shall take at least eight hours courses yearly which are provided by the university in or outside Taiwan, or by the central competent authority, and the courses shall relate to point two.

ChemLinked Comments

1. Safety assessment reports are required for the PIF, but it should be noted that the establishment of PIF is not mandatory at present. The implementation dates for cosmetics are shown below:

• From July 1, 2024: PIF shall be established for specific purpose cosmetics

• From July 1, 2025: PIF shall be established for baby, lip and eye products and unmedical toothpaste and mouthwash

• From July 1, 2026: PIF shall be established for other general cosmetics (solid handmade soap excluded)

Even though, companies are advised to be prepared in advance.

2. For now, the regulatory scheme of the signer is not mature in Taiwan as the authority only accepts the signers who take cosmetic safety assessment training courses in Taiwan. Therefore, overseas safety assessors are not qualified temporarily. But in the future, the situation may change when Taiwan formally implements the PIF requirements.