China Cosmetics Substances Compliance Assessement Service
Highlights on China REACH
China Cosmetics : “Cosmetics Supervision and Administration Regulations” (CSAR).
The main regulatory body for cosmetics in China is the National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA).
NMPA is under the governance of the State Administration for Market Regulation (SAMR), which was established in 2018.
Regulatory system in China is founded on the Regulations Concerning the Hygiene Supervision over cosmetics, which is in force since 1990 but has been under revision since 2013.
The revised regulation has been renamed to “Cosmetics Supervision and Administration Regulations” (CSAR) and enters into force on 1 January 2021.
In addition, there are many standards that need to be followed.
The most important standard is the Safety and Technical Standards for Cosmetics 2015, which provides requirements for product quality and safety, including the lists of prohibited and restricted substances for use in cosmetics.
Some measures under China Cosmetics
Classification of cosmetics in China :
Cosmetic products in China are divided into two categories:
- non- special use cosmetics (non-SUC)
- and special use cosmetics (SUC)
Non-SUC include: Hair care products, nail care products, skin care products, perfumes and make-up.
SUC include: Depilating products, breast beauty products, hair growth products, hair dyes, hair perming products, slimming products, deodorants, sunscreens and whitening products.
The latest draft of CSAR introduced reclassification of cosmetics into general cosmetics and special use cosmetics.
The latter includes only five products categories: hair perming products, hair dyes, sunscreens, whitening products and other cosmetics that claim new efficacies.
The remaining four categories, which are currently considered SUC, will be classified as either general cosmetics or drugs.
Approval process of cosmetic products in China :
Cosmetics sold in China have to be approved by NMPA.
Imported SUC, domestic SUC and new cosmetic ingredients require a pre-market registration while imported non-SUC and domestic non-SUC are subject to pre-market filing.
Imported non-SUC need to have a Chinese Responsible Person (RP), who must be the importer and needs to have a cosmetic business licence. They are responsible for the filing as well as the quality and safety of the product.
For non-SUC a product dossier needs to be prepared, which includes also the product specifications obtained during the product testing at one of the NMPA approved laboratories.
This dossier is submitted to NMPA or to a provincial Medical Products Administration, depending on where the RP is based.
The dossier undergoes only an administrative review at this time, where the completeness of the documentation is checked, as well as compliance with the format requirements.
NMPA will then grant a filing certificate, which doesn’t have an expiry date, and non-SUC products can be imported.
Technical review of the filing documents is carried out within 3 months after obtaining the filing certificate, but the products can be already on the market during that time.
Imported SUC require a Chinese Responsible Agent (RA) who can be any legal entity registered in China, and who is only responsible for product registration.
The product dossier and testing requirements are more stringent for SUC than for non-SUC products, but the biggest difference comparing to non-SUC products is, that SUC can be imported only after the technical review is finished and NMPA issues an administrative licence, which is valid for four years.
Despite an increasing number of approved alternative methods to animal testing, cosmetics in China still require testing at the NMPA approved laboratories, which perform test on animals.
Only domestic non-SUC and cosmetics sold through Cross-border E-commerce (CBEC) are able to avoid animal testing.
Products Compliance Assessement Service with Regard to China Cosmetics
Service Pack: Products assessment & Classification
- ¤ Review and consolidation of the Chinese regulation at the date of the study (core regulations and amendments)
- ¤ Classification of the products, in the relevant regulatory categories
- ¤ Identification of the regulatory requirements and adequate compliance procedures for each item (or item category when relevant)
- ¤ Identification of mutual compliance requirements with actors up and down the supply chain
- ¤ Identification of the resulting full set of regulatory obligations, if any
- ¤ Evaluation of compliance strategies and associated timelines deliverables
- ¤ Products Assessment Deliverable :
- • The deliverable for this service pack is a study report detailing the above obligations with relevant regulatory references and compliance deadlines
- • This report will include, when possible and relevant, qualitative and quantitative evaluations of the necessary compliance undertakings and strategies
China-Cosmetics Full Services Portfolio ...
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