Regulation Outline
The "Regulations on Cosmetics Supervision and Administration" stipulates that: Domestic ordinary cosmetics shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality where the filing party is located before being sold on the market.
Legal Accordance
Regulations on the Supervision and Administration of Cosmetics,Administration for cosmetics registration and Record-filing ,Standards for cosmetics registration and Record-filing materials,,Classification Rules and Catalogues of Cosmetics,Evaluation Standards for Cosmetic Efficacy Claims ,Technical Guidelines for Cosmetic Safety Assessment（2021 edition）.
Applicable Cosmetics
Ordinary cosmetics: cosmetics used for hair dying, perming, freckle-remocal, whitening, sun protection, hair loss prevention and other cosmetics claimed to have new efficacies.
Namely:acne removal, nourishing, repairing, cleaning, makeup removal, moisturizing, beauty modification, fragrance, deodorization, anti-wrinkle, firming, soothing, oil control, exfoliation, body refreshing , hair care, anti-broken hair, dandruff removal, hair-color care, hair removal, shaving auxiliary .
Filing Process of Domestic Ordinary Cosmetics
initial declaration → account application → formula confirmation → sample testing → collate other information→submit documents to the NMPA service platform → upload the summary of product efficacy claims on the website designated by the NMPA → complete filing → annually report the production status and compliance , mandatory national standards, and technical specifications to the NMPA responsible for filing.
Data Required for Filing
1. Cosmetics Registration and Filing Information Form and relevant materials .
2. Product name .
3. Product formula((including name and CAS number of raw material ,percentage, purpose of use, safety information).
4. Carried standard for the product.
5. Product label draft and sales package.
6. Product test reports(those who meet the criteria are exempt from toxicology tests).
7. Product safety assessment.
Others
Upload a summary of the basis for product efficacy claims on the website designated by the NMPA at the time of filing (from January 1, 2022).
Annually report the production status and compliance , mandatory national standards, and technical specifications to the NMPA responsible for filing.
Toxicity-free test conditions
Manufacturers of ordinary cosmetics that have obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region), and the product safety risk assessment results can fully confirm the safety of the product, are exempt from submitting the toxicology test report of the product .
Except in the following situations:
1. The product claims to be used by infants and children;
2. The product uses new cosmetic raw materials under safety monitoring;
3. According to the quantitative grading and scoring results, the filing applicant, the domestic responsible person, and the production enterprise are listed as key supervision objects.
If there are multiple production companies, all production companies that have obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) are exempted from submitting the toxicology test report.
Professional Services Provided by ZOOP
Since its establishment in 2010, ZOOP has been focusing on product compliance-related services. The technical staff of the Cosmetics Department are all from medium-sized or above-scale cosmetics manufacturers,and have related professional backgrounds in biology, medicine, cosmetics, and chemistry.
Our advantages :
1. Proven Expertise: Over a decade of regulatory consulting experience, backed by a seasoned and trusted team.
2. Streamlined Process: Our innovative, end-to-end project management ensures timely delivery and cycle guarantee.
3. Local Presence: With offices in Beijing, Guangzhou, Shenzhen, and Shanghai, we ensure seamless communication and local support.
4. Optimal Value: We deliver premium services at competitive pricing, offering you great cost-effectiveness and satisfaction.
5. One-Stop Solution: A comprehensive service portfolio for domestic/imported/special-use cosmetics, imported disinfectants, and medical devices, ensuring efficiency and peace of mind.
6. Global Communication: We support direct communication in English for international clients, eliminating barriers and enhancing collaboration efficiency.
