Breaking News: China Finalises the Long-Awaited Cosmetic Supervision and Administration Regulation

On June 29, the new fundamental cosmetic legislation-Cosmetic Supervision and Administration Regulation (CSAR), was officially published by the Chinese State Council to replace the existing Cosmetics Hygiene Supervision Regulations (CHSR), which was firstly released in 1989. The new regulation is scheduled to be effective on January 1, 2021.

Encompassing 6 chapters with 80 articles, the new CSAR is designed to overhaul the outdated regulatory framework and address issues revolving around cosmetic pre-market and post-market management in new situations, such as cosmetic classification, new ingredient management, efficacy evaluation, safety assessment, online cosmetic supervision, accountability system, and punitive measures.

Compared with the obsolete CHSR, the major changes of the CSAR include:

1. 5 Key Amendments to the Existing Provisions

Changed items	Types	CHSR	CSAR
Cosmetic definition	Amendments	It refers to chemical products for the daily use intended to be applied on any external part of the human body (such as skin, hair, nails, lips, etc.) by spreading, spraying or other similar ways to keep the body clean, eliminate unpleasant odor, protect the skin, and improve appearance and beauty.	It refers to daily chemical products intended to be applied to the external part of the human body, such as skin, hair, nails, lips, etc. by spreading, spraying, or other similar ways for the purpose of cleansing, protecting, beautifying and modifying.
Cosmetic definition	New	–	Under the CSAR, toothpaste shall be managed in line with general cosmetics. Efficacy claims (such as “anti-caries,” “inhibit plaque,” and etc.) of toothpaste products are permitted to be used after conducting efficacy evaluation following the national or industrial standards by toothpaste filer. Soaps are outside the scope of this regulation, except for those with the efficacy of special cosmetics.
Ingredient management	New	–	Cosmetic ingredients are classified into new ingredients and used ingredients. New ingredients with high risk shall conduct registration while other cosmetic new ingredients are subject to filing management.
New ingredient application	Amendments	The manufacture of cosmetics using new ingredients must be approved by the health administrative department under the State Council.	Ingredients with high risk such as new preservatives, sunscreens, colorants, hair dyes, whitening agents shall register with NMPA and obtain approval, while other new ingredients shall file with NMPA before use. The following dossiers shall be submitted for new ingredients filing/registration: Name, address and contact information of registration applicant or filer; R&D report; Research materials on manufacturing process, stability, and quality control standards; Safety assessment dossiers.
Usage report of new ingredients	New	–	The registration applicant or the filer shall report the usage and safety information of the new cosmetic ingredients to the NMPA every half a year for three years. Only the new ingredient without safety problems before the expiry of a 3-year observation period will be included in IECIC.
Cosmetic classification	Amendments	Special use cosmetics: hair growth, hair dye, hair perming, depilating, breast beauty, slimming, deodorant, whitening (anti-spot) products, and sunscreen products; Non-special use cosmetics: skincare, hair care, nail (toe) care, make-up, fragrance products.	Special cosmetics refer to hair dye, hair perm, whitening, sunscreen, anti-hair loss products, and products with new efficacy and are subject to registration. The general cosmetics are defined as all other cosmetics excluded from special use cosmetics and shall conduct filing.

2. New Provisions

Changed items	Types	CHSR	CSAR
Safety assessment	New	–	Both the registration applicant and filer of new ingredients and cosmetics should carry out safety assessment by itself or by entrusting a professional institution prior to registration and filing. The personnel engaged in safety assessment should have professional knowledge related to cosmetics quality and safety and have more than five years of relevant work experience.
Efficacy claim	New	–	Cosmetic efficacy claims shall have sufficient scientific evidence that can be relevant literature, research data, or efficacy evaluation documents and shall be exposed to the public on NMPA’s website for social supervision.
GMP and COFS	New	–	Imported cosmetics also require submission of certifications relating to manufacturing quality control of the overseas manufacturers abroad and supporting documents that prove those products have been put into market in the country (region) where those products are manufactured or originally made shall also be submitted. For those products specially produced for China market without the supporting documents, the applicant shall submit related research and test data for China consumers.
Required registration dossiers of special cosmetics/ Required filing dossiers of general cosmetics	New	–	Name, address and contact information of registration applicant or filer; Name, address and contact information of manufacturer; Product name; Product formula or a full list of ingredients; The standards adopted; Sample manuscript of the label; Testing report; Safety assessment dossiers; Other documents required to prove product safety.

Transitional Policies

Given the new CSAR put forward a number of new requirements for cosmetics enterprises, a five-year grace period was granted for already registered hair growth, hair removal, breast beauty, slimming, and deodorant cosmetics from the date of implementation of this regulation to ensure a smooth transition. The production, import, and sale of these products are prohibited after the transition period.

Reference Links：Chinese State Council