What conditions and qualifications do whitening face cream processing and customized manufacturers need
1、 Basic qualification requirements
Cosmetics Production License
It is necessary to obtain a "Cosmetics Production License", and the production scope must include "skincare" and "special cosmetics" (freckle removal and whitening).
The production site must comply with the "Quality Management Standards for Cosmetics Production" (implemented from July 1, 2022) and undergo on-site verification through production permits.
Special Cosmetics Registration Certificate
Whitening products need to be approved by NMPA and obtain the "Registration Certificate for Domestic Special Purpose Cosmetics" (now known as the "Registration Certificate for Spot Removing and Whitening Cosmetics").
Product formula, efficacy evaluation report, safety assessment materials, etc. need to be submitted, and the approval cycle is about 1-2 years.
business license
The business scope should clearly include the production, processing, or sales of cosmetics.
2、 Production environment and facilities
GMPC certification
The factory building must comply with the requirements of the "Quality Management Specification for Cosmetics Production" and meet the 100000 level clean room standard (higher standards are recommended for special cosmetics).
Equipped with quality control facilities such as microbiology laboratory and physical and chemical laboratory.
Environmental Protection and Safety
Obtained environmental impact assessment approval and fire safety acceptance certificate, meeting the requirements for wastewater and exhaust gas treatment.
3、 Product compliance requirements
Raw material compliance
Use ingredients listed in the 'Catalogue of Used Cosmetics Ingredients'.
Whitening ingredients (such as arbutin, vitamin C derivatives, etc.) need to provide safety evidence.
Efficacy evaluation
It is necessary to demonstrate the whitening effect through human efficacy evaluation tests or consumer testing (according to the "Cosmetic Efficacy Claim Evaluation Specification").
Labels and claims
The label must comply with the "Management Measures for Cosmetics Labels" and indicate the full ingredients, registration certificate number, production license number, etc.
False advertising is prohibited, such as phrases like "medical effect" and "absolute whitening".
4、 Additional conditions for cooperative manufacturers
OEM/ODM qualification
If the manufacturer is engaged in OEM manufacturing for a brand, they must have the qualification of cosmetics OEM and provide brand authorization filing services.
Quality control system
Provide complete raw material quality inspection, production process records, and finished product inspection reports (including microbiological, heavy metal, and other testing).
R & D capabilities
Capable of formula development, able to assist customers in adjusting product formulas and obtaining registration and filing.
5、 Filing and Supervision
Filing submission: Product filing information must be submitted through the cosmetics registration filing information service platform before production.
Post supervision: Accept flight inspections from drug regulatory departments to ensure compliance throughout the production process.
precautions
New regulation change: After 2021, whitening products will be included in the management of "special cosmetics" and need to be registered separately (not extended from the old version of "special certificate").
Cross border cooperation: If exporting, it must comply with the regulations of the target country (such as EU EC 1223/2009, US FDA registration, etc.).
It is recommended to prioritize manufacturers with successful experience in filing whitening products and sign a confidentiality agreement to protect the intellectual property rights of the formula. Before cooperation, the manufacturer can be requested to provide past customer cases and copies of registration approvals to verify qualifications.