Home Blog Page 9

5 key points of China’s Cosmetics Adverse Reaction Monitoring Measures

On 2022-02-21, the National Medical Products Administration issued the “Measures for the Monitoring and Administration of Adverse Reactions in Cosmetics” (hereinafter referred to as the “Measures”), which will come into force on October 1, 2022.

The monitoring of cosmetic adverse reactions is an important basis for ensuring the safety of public cosmetics. Among them, the cosmetics registrant and filing person shall assume the responsibility of monitoring the adverse reactions of the cosmetics on the market, and take effective risk control measures according to the results of analysis and evaluation. In addition, cosmetic manufacturers and operators are also obliged to monitor adverse reactions. This consolidates the main responsibility of the cosmetic registrant and filing person.

This “Measures” has 7 chapters and 47 articles, and focuses on five aspects: 

01

Improve the adverse reaction monitoring system

Clarify the monitoring obligations of each parties

Establish and improve the national cosmetic adverse reaction monitoring and management system, and establish the cosmetic adverse reaction monitoring and management system. Cosmetics registrants and filing persons, responsible persons, medical institutions, and cosmetics e-commerce platform operators have clarified and refined their respective monitoring responsibilities.

02

Follow the principle of “report if suspicious”,

Improve monitoring records

Report adverse reactions of cosmetics in a true, complete and accurate manner. The registrant, filing persons, entrusted production enterprise, and medical institution shall objectively and truthfully record the activities related to adverse reaction monitoring and form monitoring records.

03

Analysis and evaluation The “adverse reaction”

Testing agency conducts follow-up investigations

to analyze and evaluate the correlation between adverse reactions and products and the severity of adverse reactions. Municipal and county-level monitoring agencies shall conduct follow-up investigations on adverse cosmetic reactions that are serious and may cause greater social impact. The national monitoring agency shall analyze and evaluate the collected adverse reactions of cosmetics across the country, and propose handling suggestions to the NMPA according to the monitoring results and the degree of risk.

04

Strengthen supervision and law enforcement

Take effective risk control measures

Carry out supervision and inspection of cosmetic registrants, filling personnel, domestic responsible persons, entrusted production enterprises, and cosmetic operators involved in adverse reactions according to their duties.

05

Clarify the main responsibilities

Strengthen the supervision of “adverse reactions”.

Cosmetics registrants, filling person, domestic responsible persons, entrusted manufacturers, cosmetics operators, and medical institutions must clarify their respective main responsibilities. The NMPA reports the annual monitoring of adverse reactions of cosmetics to the competent health department of the State Council every year.

  

Annex:

China NMPA Issues the Measures for the Monitoring and Administration of Adverse Reaction of Cosmetics (No. 16, 2022)

Release date: 2022-02-21

In order to standardize the monitoring of adverse reactions of cosmetics, in accordance with the Regulations on the Supervision and Administration of Cosmetics, the Production and Operation of Cosmetics Measures for the Supervision and Administration” and other regulations and rules.

The National Medical Products Administration issuing the “Measures for the Monitoring and Administration of Adverse Reactions in Cosmetics“, which shall come into force on October 1, 2022.

  

Annex:

China Cosmetics Association Holding Free Training on “Cosmetic Production Quality Management Standards” (2022 No. 1)

CAFFCI, China cosmetics association will hold the FREE training about the new GMP standard: ”Cosmetics Quality Production Management Specifications“ on Jan. 14 2022.

The language is in Chinese, if you have business in China, don’t miss it.

T-mall issued the “Requirements for the Display of Cosmetic Products Labels”

In China, “Measures of the Supervision and Administration of the Production and Operation of Cosmetics” will be officially implemented in January 2022. The measures set clear requirements on the details pages of cosmetics sold online.

Article 44 of the “Measures” stipulates that: cosmetics operators on e-commerce platforms and e-commerce operators that operate cosmetics through self-built websites and other network services shall fully, truthfully, and accurately disclose the cosmetics labeling which consistent with the cosmetics registration on the main page of their business activities.

NMPA begin to issue Electronic Certificates for Cosmetics Registration

NMPA made the announcement that, From January 1, 2022, the electronic registration certificate of cosmetics will be implemented on a trial basis. The relevant matters are hereby announced as follows:

1. From January 1, 2022, electronic registration certificates will be issued for special cosmetics and new cosmetic raw materials that have been applied for and approved for registration in accordance with the “Administrative Measures for Registration and Filing of Cosmetics”.

2. From May 1, 2022, the electronic registration certificate will be issued for special cosmetics that have been approved to change or extend the registration certificate.

3. The electronic registration certificate and the paper registration certificate have the same legal effect. The electronic certificate has functions such as instant delivery, SMS reminder, certificate authorization, scanning code verification, online verification, and network-wide sharing. 

4. During the trial period, the electronic registration certificate and the paper registration certificate will be issued in parallel. At the same time when the paper registration certificate for special cosmetics and new cosmetic raw materials is issued, the electronic registration certificate will be automatically pushed to the legal representative space of the online service hall of the registrant (domestic responsible person). The registrant (domestic responsible person) must first register in the online service hall at NMPA, and enter the “My License” column of the online service hall to view and download the electronic cosmetics registration certificate. You can also log in to the “China NMPA APP” to view and download the electronic registration certificate.

5. The time for the formal implementation of the electronic cosmetics registration certificate will be announced separately.

National Medical Products Administration

December 27, 2021

China issued the “Key Points for Acceptance and Review of Special Cosmetics Renewal Application (Trial)”

In accordance with the “Announcement of the National Medical Products Administration on Further Clarifying the Transitional Management of Special Use Cosmetics” (2021 No. 150), the China National Institution for Food and Drug Control issued the “Key Points for Acceptance and Review of the Application of Special Cosmetics Renewal (Trial)” and related documents (see Annex 1-3). 

After review and approval by the National Medical Products Administration, it is hereby released, and it will come into force on the date of release.

China National Institution for Food and Drug Control

January 06, 2022

Attachments and Source: 

China NMPA issued “Cosmetic Production Quality Management Standards” (2022 No. 1)

According to “Cosmetics Supervision and Administration Regulation (CSAR)” and “Cosmetics production operations supervision and management measures”, National Medical Products Administration (NMPA) has issued the “Cosmetic Production Quality Management Standards” (hereinafter referred to as “the Standards”), which is hereby promulgated and shall come into force on July 1, 2022.

Starting from July 1, 2022, cosmetics registrants, filing/notification holders, and entrusted manufacturing factories shall organize the production of cosmetics in accordance with the requirements of “the Standards”. For factories that have obtained cosmetics production licenses before July 1, 2022, if their plant facilities and equipment and other hardware conditions need to be upgraded, they shall complete the upgrading and reconstruction before July 1, 2023 to make their plant facilities and equipment comply with the “the Standard” requirement.

National Medical Products Administration

January 6, 2022

Attachment and Source:

China NMPA Launches Cosmetic Raw Material Safety Information Registration Platform

In order to implement the “Administrative Measures on Cosmetics Registration and Notification”, the China National Medical Products Administration (NMPA) has organized and established a cosmetic raw material safety information registration platform. 

Manufacturers of Cosmetics Raw Materials or their authorized companies can log on to the platform to submit raw material safety-related information. Among them, domestic users directly log in through the “Cosmetic Raw Material Safety Information Registration Platform” module in the Online Office of the NMPA (https://zwfw.nmpa.gov.cn); overseas users need to log in to the “Cosmetic Raw Material Safety Information Registration Platform”. “(http://ciip.nifdc.org.cn) after opening an account.

After the cosmetics raw material safety information registration platform is online, cosmetics registrants, fillers, and domestic responsible persons can still fill in the raw material safety information documents issued by the raw material manufacturer through the cosmetics registration filing service platform, or fill in the raw material submission code which generated by the cosmetics raw material safety information registration platform with the raw material safety information file.

                                                                 

                              National Medical Products Administration

December 30, 2021

China NMPA Issued The Logo of Children’s Cosmetics

On December 1st, 2021, the National Medical Products Administration (NMPA) officially announced the exclusive logo of children’s cosmetics-“Little Golden Shield/小金盾”, as well as the recommended color information, proportional area, and Labeling requirements. In particular, the NMPA pointed out that the use of the shield shape is intended to convey protection and love for children.


According to regulations, children’s cosmetics that apply for registration or filing from May 1 next year must use the children’s cosmetics logo on the product’s labels, and the previous children’s cosmetics must complete the product label update before May 1, 2023.

NMPA stated that the name of the exclusive mark for children’s cosmetics is “Little Golden Shield”, which is intended to express the joint efforts of all parties in society and authorities, to continuously improve the quality of children’s cosmetics Safe, provide a good growth environment for infants and children, guard and care for the healthy growth of children.

Screenshot from NMPA
Children’s cosmetics exclusive logo “Little Golden Shield”

Design Meaning of the Logo

Deep Analysis of the new Children’s Cosmetics Regulation in China

Outline:

  1. The three key date for the implementation of the new regulations
  2. The definition of children’s cosmetics
  3. Allowed efficacy claims of children’s cosmetics
  4. Labeling requirements for children’s cosmetics
  5. The product implementation standards of children’s cosmetics products
  6. Children’s cosmetics safety requirements
  7. Formula Design Principles
  8. Children’s toothpaste Management

On October 8, the National Medical Products Administration (NMPA) issued the latest regulations on children’s cosmetics: “Regulations on the Supervision and Administration of Children’s Cosmetics.” The implementation of this regulation will bring new challenges to the market access of children’s cosmetics. CosmeticsBridge has summarized the key points of the registration of children’s cosmetics new regulations.

1. The three key dates for the implementation of the new regulations

DateDetails
January 1, 2022Implementation”Children’s Cosmetics Supervision and Administration Regulations” for the labeling requirements
May 1, 2022Children’s cosmetics that new applications for registration or Notification must follow the new label requirements of the children’s regulation. 
Before May 1, 2023Children cosmetics that already applied for registration or Notification before May 1, 2022 shall complete the new regulation compliance before May 1, 2023, in accordance with the new regulations labeling requirement. 

2. The definition of children’s cosmetics

According to Article 3 of the “Children’s Regulations”, Children’s cosmetics refer to cosmetics that are suitable for children under the age of 12 (including 12 years old) and have the functions of cleansing, moisturizing, body conditioning, and sun protection. Labels like “applicable to the whole population”, “use by the whole family” and other words or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging, etc. to imply that the product users include children’s products in accordance with the management of children’s cosmetics. ——–At present, adult products are often seen on the market is implied that the products are applicable for children. Such brands should special attention to this regulation now.⚠️.