Who is a cosmetic safety data signatory?

I. Introduction

A Safety Assessor (SA) is a professional who specifically signs cosmetic safety data files. What are their qualifications?

Cosmetic Product Information Archive Management Regulations

Article 4 Anyone who has completed a cosmetic safety assessment training course offered by a domestic university or a foreign university that complies with regulations for recognizing foreign academic qualifications (hereinafter collectively referred to as domestic and foreign universities) or a central competent authority, and meets one of the following conditions, may serve as a signatory for safety data under paragraph 16 of the preceding article: 1. Graduated from a domestic or foreign university’s medical, pharmacy, or related fields such as cosmetics, toxicology, etc. 2. Graduated from a domestic or foreign university’s chemistry or chemical engineering department before June 30, 2019, and has more than five years of relevant work experience in cosmetic safety assessment. The content and duration of the aforementioned safety assessment training course are specified as follows: I. Cosmetic Management Regulations: Including Taiwan’s Cosmetic Hygiene Management Regulations, international cosmetic management regulations, and Taiwan’s Cosmetic Product Information Archive System; at least four hours. II. Application and Risks of Cosmetic Ingredients: Including the mechanisms of action and safety of whitening, sunscreen, antiperspirant, deodorant, hair dye, perming, and other ingredients, as well as common adverse reactions or violations of cosmetic regulations; at least eight hours.

III. Methods for Cosmetic Safety Assessment:

Including skin physiology and anatomy, transdermal absorption capacity of cosmetics, skin irritation from cosmetics, mechanisms and clinical symptoms of photoaging and photosensitivity, nano-safety assessment, safety assessment of natural cosmetics, cosmetic risk assessment, toxicological assessment methods (skin irritation, skin sensitivity, skin corrosivity, eye irritation, and genotoxicity and mutagenicity testing), systemic toxicity and safety thresholds, and alternative methods for animal testing; at least thirty-six hours.

IV. Preparation of Product Safety Assessment Conclusions: At least six hours.

Article 5 Personnel signing safety data shall receive at least eight hours of training annually from domestic or foreign universities or central competent authorities in courses related to paragraph 2 of the preceding article.

If the original documents in the preceding paragraph are not in Chinese or English, a Chinese or English translation should be provided. For cosmetic manufacturers that produce in segments, the name and address of the manufacturing plant in paragraph 1, subparagraph 1, should include all manufacturing plants involved in the process and the processes they execute.

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