China registration
CSAR
Cosmetic Supervision and Administration Regulation
CSAR definition of cosmetics: Daily chemical products intented to be applied on human skin, hair, nails, lips, mouth by spreading, spraying or other similar ways for cleansing, protecting, beautifying or grooming purposes.
Cosmetic categories
ORDINARY Cosmetics:
Product claims excluded from the functional cosmetics
FUNCTIONAL Cosmetics:
Hair dyes
Hair perming products
Freckle-removing (whitening) products
Sunscreens
Anti-hair loss products
Cosmetics with new efficacy
COSMETIC DOMESTIC RESPONSIBLE AGENT
protectionist concept
Only imported cosmetics are concerned.
The Domestic Responsible Agent (DRA) is mandatory to apply for a NMPA Product Registration in China and must be established in China. NMPA is carrying out rigorous on-site inspections and grading of DRA. Unqualified candidates will not be permitted to act as DRA.
WHO?
Distributor
+ : take care of everything
- : in case of dispute, difficult to regain rights if you want to change: stop of products selling
Consultant
+ : professional regulatory compliance service with low cost; special service menu to meet your individual requirements; more flexible when you choose a local distributor
- : strong inspection from NMPA
Branch Office
+ : 100% under control, professional team to follow up the local regulations.
- : high cost
REGISTRATION
list of ~ 8900 ingredients
Before
→ every 4 years: test and validate products for safe use
→ could not add an ingredient other than those on the list
From May 2021 → lifetime filing certificate
→ if ingredient pre-market registration procedure is approved by NMPA*: "new cosmetic ingredient trial use certificate”
→ if no adverse effects after 3 years = ingredient will be added to IECSC**
→ smoother regulation, allows inspection of ingredients & finished product
→ regulation on animal testing
→ annual report showing the use and safety status of the new raw materials to NMPA through the information service platform within 30 working days before expiration.
*National Medical Product Administration
**Inventory of Existing Chemical Substance
ANNUAL REPORT
In case of new ingredient declaration
In the period of 3 years after the new cosmetics raw materials are registered and put into use, the registrant of the new raw materials shall report the use and safety status of the new raw materials to NMPA every year.
During the safety monitoring period, the registrant shall timely collect and sort out the relevant information in accordance with monitoring requirements, and prepare the annual safety monitoring report accordingly.
Requirements:
Basic information & production status of new cosmetics raw materials.
Cosmetic product information: supervision, inspection & recall information of the cosmetics containing the new raw materials.
Description of risk monitoring & evaluation system applied by the cosmetics manufacturers & the related measures that are taken.
The new material registrants shall describe their adverse reaction monitoring systems, statistical analysis & the measures that are taken.
For the new cosmetics raw materials that are used at home or abroad for the 1st time, the test data of long-term preservation should be provided in the monitoring period.
EFFICACY CLAIM OF COSMETIC PRODUCTS
When applying for the registration of a cosmetic product, the applicant should upload an abstract of the efficacy claim.
A product classification code based on:
The efficacy claim
Application site
User group
Dosage form
Usage method
The advertising copy should not be out of the range of product classification and misleading the consumers.
NEW REGULATIONS
Animal testing
China tests on animals at two stages:
Pre-Market Animal Testing: Tests done on products in order to be proven “safe” for consumers before they hit the market.
Post-Market Animal Testing: Tests done after products hit the market. Products can be chosen at random and removed from shelves for “confirmatory” animal testing to ensure that the product on sale to customers is same as formulation approved for sale.
2 preconditions:
General cosmetic manufacturers must have obtained the GMP* certificates issue by the competent authority of the country (region) where they are located.
Safety assessment results must fully confirm the safety of products.
*Good Manufacturing Practice
3 exceptions:
Products claim to be used for infants and children
Products use new cosmetic ingredients during their 3 years of required monitoring
The responsible person /manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by NMPA
Foreign imported ordinary cosmetics (non-special use)
(NEW) there will NOT be any mandatory pre-market animal testing on Non-SU cosmetics !
But keep in mind, these products can still be subjected to post-market animal testing incase of customer complaints or product recalls.
ADVERSE REACTION REPORT
within 20 working days when they discover the cosmetic adverse reaction
If the cosmetic applicant discovers any risk of their products through the self inspection of adverse reaction, a written report should be submitted to the provincial NMPA and monitoring organization in local.
Stop the production and sales of relevant products
Notify the OEM factory and dealer to stop the production and sales of relevant products
Implement the product recall
Release the risk alert
Proceed a self audit of production quality management system and rectify the problems
Modify the label and instruction
Improve the production process
Update the registration or filing of relevant products as requirement
Other necessary risk control actions
REGULATIONS
Ordinary cosmetics:
Appoint a responsible agent in China
Product dossier
The “Cosmetic Registration and Notification Information Form” and related documents
Information on the product name
Product formula
Product executive standard;
Product label sample manuscript
Product testing report
Product safety assessment documents
Submit dossier to NMPA for administrative review
Technical review
Registration certificate
Importation
FUNCTIONAL COSMETICS (special use):
Same steps as ordinary cosmetics
+ The responsible agent applies for NMPA account
+ E-filing certificate
INGREDIENTS
Responsible agent information:
Responsible registrant person
name, address, contact information
New cosmetic ingredient R&D report
Research documents on the NCI* preparation techniques, stability and quality control standards
Safety assessment documents for NCI
Technical requirements (available for public)
High risk NCI:
teratogenicity test
chronic toxicity/carcinogenicity combined
test
the long-term human trial safety test
*New Cosmetic Ingredient
Labeling
A complete list of ingredients must be reported on all cosmetic product labels.
Must be in Chinese:
Product name
Name and address of the manufacturer
Net weight/volume
Product INCI list
Shelf life/expiration date
Manufacturer license, product standard or administrative approval
Safety marks and product literature, recycle symbols
Prohibited expressions:
exaggerated descriptions
medical results