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Shanghai FDA Issues Notice on 2017 Cosmetic Sample Inspection

Shanghai FDA released its 2017 cosmetic inspection plan. The plan includes: 1) uncovering new problems; 2) clamping down on the use of illegal ingredients or ingredients outside of regulated scope/dosage 3) timely discovery of security risks...

Take home:

Shanghai FDA released its 2017 cosmetic inspection plan. The plan includes: 1) uncovering new problems; 2) clamping down on the use of illegal ingredients or ingredients outside of regulated scope/dosage 3) timely discovery of security risks.

As an important method of post-market surveillance, Shanghai sample inspection is of particular importance to stakeholders involved in filing management of imported non-special use cosmetics. Shanghai FDA has already outlined its plans to reinforce post-market surveillance including the use of sample inspection on imported non-special use cosmetics in support of the new filing management system. (See more detail: CL)

For 2017, Shanghai FDA will focus inspection on 6 categories of cosmetics: 1) sun-protection, 2) facial mask, 3) spot removing/whitening, 4) acne removing, 5) hair dyeing, 6) children cosmetics. Among the total quantity of samples inspected, imported products will account for no less than 20%.

Cosmetic enterprises should take note of the following: all samples should have full packages and complete labels, and the validity time of samples should exceed 6 months. Enterprise should provide authorities with 3x the total number of actual inspected samples and submit them to the inspection office of shanghai FDA (who will maintain samples).

Appendix: Requirements for cosmetic sample inspections

Catogories of Products

Sample Quantity

(Imported cosmetics can’t be less than 20%)

Inspection Item

Finish Time

Sun Protection products

70

Sun screener

Mar.31

Facial Mask

120

Hydrargyrum(for product claiming to remove spot or whiten skin)

May 31

Glucocorticoid

Fluocinolone Acetonide

Spot Removing/Whitening products

100

Hydrargyrum

Jul.31

Glucocorticoid

Acne Removing products

80

Antibiotics (6 kinds) and metronidazole

Jul.31

Ofloxacin, ketoconazole

Hair Dyeing products

50

Hair dye

Sep.31

Children Cosmetics

30

microbe

Sep.31

 

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