Expert Guidance on Technical Review of Special-use Cosmetics

Background

Technical review is an essential phase in the notification of special-use cosmetics under the current certification system--“Administrative Permit”. The review is carried out by an expert committee summoned by CFDA that constitutes four panels of experts, known as formula unit, toxicological unit, label unit and hygiene & chemical unit respectively and with a sole purpose of preventing any threat to human safety from cosmetics. This article will look at the technical review and provide first hand guidance from a former member of the expert committee He Dingyuan.

Formula Unit: Universal Quality Control

The main responsibility of the formula unit is thoroughly reviewing formula and manufacturing techniques of the notifying cosmetics so as to ensure every aspect during the production is in compliance with Chinese standards.

The basic checklist includes formula Chinese name, INCI name, concentration, colorant CI number and intended use. For notifications involving extracts of animal viscera and blood products the review will place emphasis on the origin of formula, quality specification and a certificate to prove the extract is allowed to be used in the country of its origin. If the formula contains hydrocarbons derived from oil and coal tar, attention will be directed at whether the corresponding CAS number has been noted in the formula list.

Another important mission is to conduct a rigorous and comprehensive risk assessment of a type of substance known as a “safety risk substance” which is substance intimately linked with the production of the cosmetic and poses a risk of residual contamination.

Toxicological Unit: Consumer Safety Outweighs Animal Welfare

Despite sharp criticism by some foreign companies, the animal testing results summed up in the testing report of human safety and efficacy assessment is a priority assessment criterion of the toxicological unit. There are dozens of testing to be carried out, in line with requirements from “Cosmetic Technical Review Guidance” and “Cosmetic Hygiene Standard”. The entire review by the toxicological unit is centered on ensuring no products being placed on the market can cause widespread problems in consumers.

Label Unit: Zero Tolerance on Ambiguous Terminology

For experts in the label unit, the key principle to judge whether the language on a label is proper is the conciseness and clarity of terminology used. Incompliance with Chinese language requirements is also a major factor why many products fail at label review.

The label unit is highly alert at any expression used in a product label that is extremely eye-catching to consumers. An example of the strictness in assessing labels can be seen in a previously failed notification of a perfume claiming to be capable of clearing all body odor while, under Chinese classification of cosmetics, only those capable of removing underarm odor is classified as deodorant cosmetic

Hygiene & Chemical Unit

The review of physical, chemical and microorganism testing reports lies with the hygiene & chemical unit. This unit is tasked with assessing if testing items are complete and there is no presence of prohibited substances, restricted substances exceeding limits, microorganisms exceeding the safety standard and that the ingredient concentrations corresponds with that in the formula. For new ingredients, its origin, physical and chemical property, chemical structure, molecule formula, molecule weigh and testing methods are important.

A good example of a failed notification at the hygiene & chemical review step is from notification of a certain brand of hair perm, which reported a 7% concentration of mercaptoacetic acid compared with 9% found after testing. With over 20% deviation in accordance with “Cosmetic Technical Review Guidance”, the notifier was asked to amend the formula and had to wait in a long queue of notifiers for a second review.

Only through the review process, can the quality and safety of the notifying cosmetic be established. However, the fast development of technology and emergence of new ingredients have posed challenges to the review work conducted by authorities and is forcing authorities to change and update their assessment methods.