CSAR Subsidiary Regulations: China to Implement a Cosmetic Sampling Inspection Scheme

On Sep. 28, 2020, China NMPA released the Standards for the Management of Cosmetic Sampling Inspection for public consultation ^[1]. Any suggestions can be mailed to ChemLinked ([email protected]) before Oct. 14, 2020, and we will submit to the NMPA. 

Specifics of the Standards

To strengthen the supervision of domestic cosmetic manufacture and operation, local MPAs will organize the regular sampling inspection according to their annual sampling inspection plans or occasional sampling inspection for cosmetics with quality and safety risks.

Special personnel will be assigned to carry out the sampling by the ways of on-site sampling or online product sampling, and recognized testing institutions will be responsible for the sample testing. The whole process of sampling inspections are shown below: 

1. Focus of Sampling Inspection

The sampling inspection will mainly focus on the following cosmetics:

(1) Cosmetics with a large circulation and high frequency of usage

(2) Cosmetics for special groups of people such as children

(3) Cosmetics with wide media coverage and high consumer's attention

(4) Cosmetics that may have quality and safety risks found in complaint reporting, supervision and inspection, adverse reaction monitoring, and risk monitoring

(5) Cosmetics with a high unqualified rate in previous sampling inspections

(6) Other cosmetics deemed necessary to be included in the sampling inspection plan

2. Obligations of Responsible Entities

Cosmetic manufacturers, operators, domestic registrants/notifiers, domestic responsible persons and e-commerce platform operators are the targets of the sampling inspection. They are required to fully cooperate in the sampling inspection, such as providing required documents for examination, taking actions in accordance with the sampling inspection results, etc.

For on-site sampling, the above-mentioned responsible entities will be examined in the aspects as below:

• Product registration license or notification certificate

• Production license and delivery inspection qualification certificate/label (for domestic cosmetics only)

• Certification of entry inspection and quarantine of goods (for imported cosmetics only)

• Information consistency between the cosmetic label and product registration license/notification certificate, and compliance of cosmetic labeling and claims

• Establishment and implementation of a purchase inspection record system

While for online product sampling, online information relating to the cosmetic manufacturer/operator and product description will be recorded for examination.

For products deemed as disqualified after sampling inspection, the manufacturers and operators shall stop the manufacture and operation, and the registrants/notifiers of domestic cosmetics or domestic responsible persons of imported cosmetics shall fulfill the following obligations:

• Implement product recalls and release recall information

• Carry out comprehensive self-inspection, analyze reasons, and conduct the risk assessment of the quality management system

• Take necessary risk control measures based on the self-inspection and assessment results

*English Translations of  the Standards will be uploaded to ChemLinked soon. So keep updated on any CSAR updates by following ChemLinkeds' dedicated CSAR Homepage.

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[English Translation]

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