On 21 Feb 2022, China National Medical Products Administration (NMPA) issued the “Measures for Monitoring Adverse Reactions of Cosmetics”. It will come into force from 1 Oct 2022.
The Measures defines three adverse reactions types based on the damage caused by the cosmetic products. They include,
- A normal adverse reaction is a reaction to cosmetics that involves lesions of the skin or accessory organs in addition to systemic or partial damage to the body.
- Serious cosmetic adverse reactions refer to the reactions include one of the following damages:
- Causes temporary or permanent loss of function, such as persistent non-healing of skin lesions, scarring, permanent hair loss, obvious changes in damage, etc.;
- Causes systemic damage to the human body, such as abnormal liver and kidney function, anaphylactic shock, etc.;
- Resulting in hospitalization or the medical institution deems hospitalization necessary;
- Causing other serious damage to the human body, endangering life, or causing death.
- Cosmetic adverse reactions that may cause greater social impact, refer to in a certain area, because of using the same cosmetic product, cause serious damages to many people.
The measures require both local companies and overseas companies to establish their own monitoring systems.
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