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Guangdong FDA Implements Supervision and Inspection Plan for Cosmetic Manufacturers and Distributors

In order to strengthen cosmetics post-market surveillance and guarantee the quality and safety of cosmetics, the Guangdong FDA is implementing a comprehensive supervision and inspection plan for cosmetic manufacturers and distributors in the province...

Takehome:

The Guangdong FDA is implementing a comprehensive supervision and inspection plan for cosmetic manufacturers and distributors in the province.

 In order to strengthen cosmetics post-market surveillance and guarantee the quality and safety of cosmetics, the Guangdong FDA is implementing a comprehensive supervision and inspection plan for cosmetic manufacturers and distributors in the province.

(1)Routine Inspections

According to the risk of manufacturing and distribution in the “List of Cosmetics Risks and List of Responsibilities for Risk in Guangdong Province” (see the annex list), the Guangdong FDA shall fully implement direct supervision and routine inspections of D-level risk cosmetics manufacturers and distributors. Routine inspection contents are as follows:

 Manufacturers:

  • Cosmetics registration and filing;
  •  Whether the used ingredient is consistent with the ingredient for registration and filing;
  • Cosmetic labels;
  • The traceability of the cosmetics quality, etc.

Distributors:

The focus of routine inspections of distributors is on the implementation of quality and safety management responsibilities of the wholesale market promoters, which mainly include:

  •  Review the legitimacy of cosmetic distributors in the wholesale market;
  • Establish a review system for the legitimacy of cosmetics on the market;
  • Inspect and record cosmetic distributors in the wholesale market regularly;
  • Handle and record the illegal cosmetics in accordance with the regulations;
  • Establish the rules and regulations for cosmetic distributors’ management and reporting of emergencies, etc.

(2)Unannounced Inspections

The Guangdong FDA will conduct unannounced inspections on 100 enterprises which: were previously found to have unqualified products during sampling tests, were notified by the regulatory authorities, subject of a complaint/report, problems found during risk monitoring process. The major targets of the inspection are on freckle eliminating, sunscreen, hair dye, acne and mask products. Unannounced inspection contents are as follows:

 Manufacturers:

  • Illegal production, illegal addition and illegal product labeling;
  • Whether the manufacturing process meets the requirements of the “Key points for Inspection of Cosmetics Production Licensing” ;
  • Evaluate the traceability of the cosmetics quality from ingredients purchase records, product records, inspection and sales records, etc.

 Distributors:

The focus of inspections on distributors is the legitimacy and traceability of cosmetics, which mainly include:

  • Cosmetics production licenses and approval certificates (filing certificates) ;
  • Whether cosmetic labels are consistent with approval certificates;
  • Illegal advertising;
  • Whether to fulfill the request for invoices;
  • The responsibility of the ledger management, etc.

 The routine inspections will be carried out in a grid supervision mode, which consists of provincial, municipal, county (district) supervisors and technical staff. The unannounced inspections are mainly based on double randomization. Enterprises are randomly selected from the list of supervised enterprises and inspectors are randomly selected from the list of inspectors.

 Problems found in routine and unannounced inspections are, in principle, followed up by the prefecture-level regulatory authorities at the place where the enterprise is located and the results should be reported within one month. Sampling test shall be carried out on suspicious products found during the inspection.

Annex list 1: Pre-judgment of Manufacturers Behavioral Risk in 2018 

No.

Name

Description

Event

Degree

Measure

SC-01

Enterprise Access

Ultra-range production

Product over-range varieties

significant risk

Key inspection

SC-02

Product Access

Unregistered;

Illegal production

Unregistered;

Illegal production

Key risk

special rectification

SC-03

Ingredient Usage

Use prohibited and restricted ingredients

 

Detection of prohibited ingredients or

restricted ingredients excess

 

Key risk

special rectification

SC-04

Manufacturing Process

Microbial contamination;

No production records

Microbial excess;

Product quality is not traceable

Significant risk

Key Inspection

SC-05

Product Inspection

Untested products

Untested products

General risk

Random Inspection

SC-06

Labels

Illegal product labeling

Illegal product labeling

Significant risk

Key Inspection

SC-07

Product Sales

Product quality is not traceable

No sales records

Significant risk

Key Inspection

SC-08

Quality Traceability

Adverse events

Conceal adverse events

General risk

Random Inspection

SC-09

Sub-contract Production

Illegal sub-contract production

Unregistered products

Significant risk

Key Inspection

Annex List 2: Pre-judgment of Distributors Behavioral Risk in 2018

No.

Name

Description

Event

Degree

Measure

JY-01

Enterprise Access

No business license

unlicensed business activities

General risk

Random Inspection

JY-02

Product Purchase

Unregistered products;

Product quality is not traceable

No receipt of invoices and vouchers

Key risk

Special rectification

JY-03

Product Storage

Unqualified storage conditions

Quality Problem

General risk

Random Inspection

JY-04

Product Sales

Illegal business

Expired products on sale;

Wholesale without a ledger

General risk

Random Inspection

JY-05

Quality Traceability

Conceal adverse event

Severe adverse event

General risk

Random Inspection

Annex List 3: Pre-judgment of Illegal Behavioral Risk in 2018

No.

Name

Description

Event

Degree

Measure

FF-01

Illegal production

Product without license

Underground dens

Key risk

special rectification

FF-02

Illegal addition

Use prohibited ingredients;

restricted ingredients excess

Detection of prohibited ingredients or

restricted ingredients excess

Key risk

special rectification

FF-03

Illegal operation

Illegal product sales

Illegal product sales

Key risk

special rectification

FF-04

Illegal product labeling

Illegal product labeling

Illegal product labeling

Key risk

special rectification

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