In less than a month, your familiar cosmetics regulation in China could be turned over and refresh your perspective totally. It all starts with the new regulation “Management Standards for Cosmetics Registration and Filing Documents” which is about to be implemented on May 1st and brought numerous changes to your cosmetics business. You may read all over the internet to get solid information and prepare for the changes but still can not get it straight. Now we refined the essentials from whole complex regulation articles into SIX key points for members.
1. Unified Dossiers
First of all, thanks to the new regulation unifies the data requirements for special cosmetics and general cosmetics, it lists the necessary dossiers as following:
(1) “Application Form of Cosmetics Registration and Notification” and related materials;
(2) Product Name;
(3) Product Formula ;
(4) The implementation of product standards;
(5) Product label and package;
(6) Testing reports (exempted for general cosmetics);
(7) Product Safety Assessment Report
2. A New Responsible Person Account
According to the new cosmetics regulations, the responsible person shall apply a new account on the new cosmetics notification and registration system which will be online on May 1st as well.
The application documents include “Application Form of Cosmetics Registration and Notification” and related materials;
Instead of the application form, we should pay the most attention to the related materials which the requirements include the most important of the change. New Required materials that are emphasized as follows:
1. Resume of the person who is in charge of quality and safety of products.
The Resume should include educational background, work experience, and other content related to the requirements.
2. Overview of the quality management system
The Overview quality management system includes management systems such as supplier selection, raw material acceptance, production, quality control, and product sample retention. If the registrant and the filing party have both independent production and commissioned production, they shall submit the corresponding version of the overview of the quality management system respectively.
3. Overview of the adverse reaction monitoring and evaluation system.
Overview of the adverse reaction monitoring and evaluation system needs to reflect the key points of adverse reaction monitoring, the settings of each link, and the daily execution management requirements.
The Basic Structure of Quality Management System
| Self-production | Commissioned production |
| ✔ Personnel health ✔ Quality management system configuration (managements for documents, traceability, supplier selection, raw material acceptance, equipment, production process, and quality control, product inspection, retention sample management, product sales, records, quality complaints, product recalls) ✔ Record management ✔ The basic situation of the workshop ✔ Equipment maintenance ✔ Production water ✔ Qualified product release ✔ Sample management ✔ Quality self-examination and error correction | ✔ Formula source ✔ Material purchase ✔ Production enterprise selection and management system ✔ Qualified product release ✔ Independent quality management measures of the production enterprise ✔ Quality self-examination and error correction |
The basic structure of the Adverse Reaction Monitor and Evaluation System
✔ Brand owner: job responsibilities, adverse reaction monitoring system (overall composition and operation mode), evaluation system (completion method, evaluation standard)
✔ Responsible person: job responsibilities, adverse reaction monitoring system (overall composition and operation mode), evaluation system (completion method, evaluation standard), communication mechanism
3. The Raw Material Quality & Safety Information
When registering the products, the applicant should submit each ingredients‘ manufacturer information as well as the raw material’s quality and safety information file issued by the raw material manufacturer.
If the raw material manufacturer has submitted the information file of ingredients in accordance with the “Guidelines of Cosmetic Raw Material Quality and Safety Related Information”. The Cosmetics Registrant and Responsible person can fill in the raw material submission code and related raw material quality and safety information documents.
CosmeticsBridge Analysis:
In most countries, the raw material’s quality and safety information file usually called Certificate of Analysis (COA) which listed the detailed safety control information of the ingredients. Under current regulations, it is only required that substances with high safety risks need to be provided, but all raw materials will need to be provided after May 1st.
4. New Cosmetics Ingredients in Products
For Cosmetics that intended to use newly registered cosmetics ingredients that are still under safety monitoring, the brand or responsible person shall submit the registration application of products only have the grant to use confirmation from the new cosmetics ingredients applicant.
CosmeticsBridge Analysis:
In this means, if you are using a new cosmetics ingredient that is just been registered and under the 3 years monitoring system, you should submit a use authrozation letter from the new cosmetics ingredient registrant.
5. Products Designed specifically for the Chinese market
If your products are specifically designed for Chinese markets, which means it has not been sold in your local, you still can register your products as the following submission.
1. Explaining materials for formula design for Chinese consumers’ skin types, consumer needs, etc.;
2. Chinese consumers should be selected for development in China Consumer testing research or human efficacy test data.
6. Conditions of Animal Testing Free
General cosmetics are exempt from submitting the toxicological test report of the product only if the manufacturer has obtained the relevant qualification certification of the product quality management system (such as GMP )issued by the competent government department of the country (region), and the product safety risk assessment results can fully confirm the product safety, except for the following situations:
1. The product claims to be used by infants and children;
2. The product uses new cosmetic ingredients under safety monitoring;
CosmeticsBridge Note:
Please be aware that the GMP certificate that is mentioned above currently must be issued by the government department of your country (region), otherwise, it is not able to be approved by NMPA.
