China Cosmetic Regulation Updates in 2022

2022 witnessed a series of significant regulation updates in China. EnterCo has picked out some main updates with in-depth interpretations. The regulation details are as follows:

1. Good Manufacturing Practice for Cosmetics

Publish date: January 7, 2022

Keywords: manufacturing, quality, factory, person in charge of quality and safety

China National Medical Products Administration (NMPA) organized to formulate the Good Manufacturing Practice for Cosmetics, which is issued on January 7, 2022 and shall take effect on July 1, 2022.

From July 1, 2022, the cosmetics registrant, filer, and entrusted production enterprise shall organize the production of cosmetics in accordance with the regulation. Enterprises that have obtained the cosmetics production permit before July 1, 2022, and whose plant facilities, equipment and other hardware conditions need to be upgraded, shall complete the upgrading before July 1, 2023, so as to meet the requirements of the regulation.

It clarifies the requirements and responsibilities of the person in charge of quality and safety once again, and specifies the requirements for the documents, traceability, inspection, sample retention, equipment, materials, production process management, etc. involved in the quality management system of the production enterprise. The registrants and filers shall also refer to this regulation for entrusted production management.

2. Provision for the Administration of Adverse Reaction Monitoring of Cosmetics

Publish date: February 21, 2022

Keywords: post-market supervision, adverse reaction

NMPA organized to formulate the Provision for the Administration of Adverse Reaction Monitoring of Cosmetics, which is issued on February 21, 2022 and shall take effect on October 1, 2022.

The registrant, filer, entrusted manufacturing enterprises, business units, medical institutions, and local drug regulatory departments shall report to the monitoring agency any adverse reactions that may be related to the use of cosmetics. The registrant or filer shall also assign corresponding personnel to monitor adverse reactions and establish a complete recall system.

3. Technical Specification for the Safety of Cosmetics (Edition 2022) (Draft for Comments)

Publish date: March 31, 2022

Keywords: safety, prohibited and restricted ingredients, inspection method

China National Institutes for Food and Drug Control (NIFDC) organized the revision of the Technical Specification for the Safety of Cosmetics on March 31, 2022 and solicited public opinions before April 30, 2022.

Some main revisions:

1) Definitions of relevant terms, and general standards for pH;

2) Standardize the list of prohibited and restricted ingredients and the list of approved raw materials, and add the approved preservative "lauroyl arginine ethyl ester hydrochloride";

3) Add four new physical and chemical test items, eight toxicological methods, anti-freckle and whitening test method, anti-hair loss test method, etc.

4. Technical Guidance for Children's Cosmetics (Draft for Comments)

Publish date: April 11, 2022

Keywords: children's cosmetics, safety

NIFDC organized to draft the Technical Guidance for Children's Cosmetics (Draft for Comments) on April 11, 2022 and solicited public opinions before April 28, 2022.

The text of the Guidance includes the basic requirements for children's cosmetics, product name and relevant data, product formula and raw materials use, product implementation standard, labeling, product inspection report, and cosmetic safety assessment report, etc. The attached table lists 26 allergenic components that may be contained in flavour and fragrance.

5. Administrative Measures for Sampling Inspection of Cosmetics (Draft for Comments)

Publish date: July 24, 2022

Keywords: sampling inspection, post-market supervision

NMPA organized to draft the Administrative Measures for Sampling Inspection of Cosmetics (Draft for Comments) on June 24, 2022 and solicited public opinions from June 24 to July 14, 2022.

The Measures mainly include plan formulation, sampling, inspection and result submission, re-inspection and objection, verification and disposal, information disclosure, etc. The key categories are defined as: children's cosmetics, special cosmetics, cosmetics with new raw materials, products with many problems in daily supervision, products with high failure rate in previous sampling inspection, products with wide circulation range, products with high frequency of use and other products with high safety risks.

6. Technical Guidelines for Anti-freckle and Whitening Cosmetics (Draft for Comments)

Publish date: August 1, 2022

Keywords: anti-freckle and whitening, special cosmetic registration, cosmetic efficacy

NIFDC drafted the Technical Guidelines for Anti-freckle and Whitening Cosmetics (Draft for Comments) on August 1, 2022 and solicited public opinions before August 16, 2022.

The text of Guidelines consists of three parts: 1) The basic principles of anti-freckle and whitening; 2) The definition of anti-freckle and whitening cosmetics; 3) The technical requirements of anti-freckle and whitening cosmetics, including the product basic information, product name, product formula and ingredient use, product implementation standards, packaging labels, product inspection reports, safety assessment data and other related contents.

The Guidelines explain the definition of anti-freckle and whitening cosmetics, and distinguish them from sunscreen products, cleansing products and exfoliating products. It should also be noted, when applying for anti-freckle and whitening cosmetics, enterprises need to submit the use basis of efficacy ingredients.

7. Qualifications for Cosmetic Inspection Institutions (Draft for Comments)

Publish date: August 11

Keywords: inspection institutions

NMPA and the State Administration for Market Regulation (SAMR) jointly formulated the Qualifications for Cosmetic Inspection Institutions (Draft for Comments) on August 11, and solicited public opinions before September 2, 2022.

It contains eight chapters and 28 articles, covering the requirements that cosmetics inspection institutions should meet related to organization, management system, inspection capacity, personnel, facilities and environment, and equipment, etc.

8. Measures for the Supervision and Administration of Cosmetics Online Operation (Draft for Comments)

Publish date: August 17

Keywords: online operation, e-commerce

NMPA organized to draft the Measures for the Supervision and Administration of Cosmetics Online Operation (Draft for Comments) on August 17, 2022 and solicited public opinions from August 17 to September 6, 2022.

The Measures stipulates that the cosmetics e-commerce platform operator shall require the cosmetics operator applying for the platform to submit the identity, address, contact information and other true information, and establish the registration file after check. The information on the platform shall also be consistent with the registration and filing data.

9. NMPA Announcement on the Formal Implementation of the Electronic Cosmetic Registration Certificate

Publish date: August 19

Keywords: special cosmetics, new ingredients

NMPA issued an announcement on the formal implementation of the electronic cosmetic registration certificate on August 19, 2022, which shall come into force as of October 1, 2022.

After the electronic registration certificate for special cosmetics and new cosmetic ingredients is generated, it will be pushed to the space of its legal representative at the Online Service Hall for the registrant (domestic responsible person) at the Online Service Hall. It has such functions as instant service, SMS reminder, certificate authorization, QR code verification, online verification and whole network sharing.

10. NMPA Announcement on the Launch of New Adverse Reaction Monitoring System of Cosmetics

Publish date: September 20

Keywords: adverse reaction, new monitoring system

NMPA had upgraded the National Cosmetic Adverse Reaction Monitoring System since September 20, 2022, and the new system was launched on October 1, 2022.

From October 1, 2022, cosmetic registrants or filing applicants, entrusted manufacturers, cosmetic operators, and medical institutions shall report through the National Cosmetic Adverse Reaction Monitoring System after discovering or learning the adverse reactions of cosmetics.

11. Key Inspection Points and Judgment Principles of Good Manufacturing Practice for Cosmetics

Publish date: October 25

Keywords: manufacturing, quality management, inspection

NMPA organized to formulate the Key Inspection Points and Judgment Principles of Good Manufacturing Practice for Cosmetics, which are issued on October 25, 2022 and shall come into force as of December 1, 2022.

For the enterprises judged as having “defects in the production quality management system” in the inspection, the department responsible for drug supervision and administration shall urge them to complete the rectification and submit the rectification report within the specified time limit, and organize on-site inspection when necessary.

For the enterprise judged as having “serious defects in the production quality management system” in the inspection, the department responsible for drug supervision and administration shall, in accordance with Article 54 of the Regulation on Supervision and Administration of Cosmetics, take emergency control measures such as ordering the suspension of production and operation to control product risks in a timely manner. The enterprise shall complete rectification within the specified time limit and submit rectification report to the department responsible for drug supervision and administration. The department responsible for drug supervision and administration shall conduct on-site re-inspection on the enterprise, and not resume its production or marketing until the rectification meets the requirements.

For the enterprise judged as having “serious defects in the production quality management system” in the inspection, the department responsible for drug supervision and administration shall file an investigation in accordance with Article 60 (3) of the Regulation on the Supervision and Administration of Cosmetics, Article 59 of the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics, and other provisions.

12. NMPA Notice on the Pilot Run of Personalized Service for Cosmetics

Publish date: November 10

Keywords: personalized service, post-market supervision

NMPA decided to carry out the pilot run of personalized service for cosmetics in Beijing, Shanghai, Zhejiang, Shandong and Guangdong provinces (cities). One or three registrants or filers can be selected as the pilot enterprises of personalized service. Each pilot provincial (municipal) Medical Products Administration (MPA) shall submit the first batch of pilot implementation plans and relevant materials to the NMPA for filing before December 1, 2022. The pilot project started in November 2022 and lasted for one year.

The pilot provincial (municipal) MPA were encouraged to innovate the supervision mode under the current regulatory framework of cosmetics, and optimized the supervision mode related to product filing, cosmetic product testing, sample retention, sales management, etc. However, the pilot products should be general cosmetics, excluding children's cosmetics, special cosmetics, and cosmetics with new ingredients.

13. Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities

Publish date: December 29

Keywords: quality and safety, main responsibilities of enterprises

NMPA organized to formulate the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities, which are issued on December 29 and shall take effect on March 1, 2023.

It further standardized the responsibility supervision of the cosmetics quality and safety subject, and refined the post responsibilities, job qualifications and assessment system of the person in charge of quality and safety.

14. NMPA Announcement on Five Information Standards Including the Basic Data Set of Cosmetics Production Permit Management

Publish date: December 30

Keywords: data management

NMPA organized to formulate the Basic Data Set of Cosmetics Production Permit Management, Basic Data Set of General Cosmetics Filing Management, Basic Data Set of Special Cosmetics Registration Management, Basic Data Element of Cosmetics Regulatory Information Part 1: Production Permit, Registration and Filing, and the Value Code of Basic Data Element of Cosmetics Regulatory Information Part 1: Production Permit, Registration and Filing. They were implemented as of the date of promulgation (December 30).?

These regulations have further improved the standards of cosmetics supervision informatization and laid the foundation for the digitalization of cosmetics supervision informatization.