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 |