MoCRA (Sec. 612) exempts certain small businesses from GMP, facility registration and product listing. Small businesses are defined as businesses with average gross annual sales of cosmetic products in the USA for the previous 3-year period of less than $1,000,000 (adjusted for inflation). However, this exemption does not apply to facilities producing cosmetic products that:
- Regularly come into contact with mucus membrane of the eye under conditions of use that
are customary or usual
- Are injected (e.g., tattoos).
- Are intended for internal use (e.g., mouthwash).
- Are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not art of such conditions of use that are customary or usual.
Exemptions also apply to certain facilities that are subject to requirements for devices and drugs.
In case you are not sure if you fall under the exemption, we recommend you still perform registration of facility and list your products.
Small businesses that fall under the definition for small businesses exemption as defined under MoCRA, are exempted only from the following sections of MoCRA:
- Section 606. Good manufacturing practice
- Section 607. Registration and product listing
However, they must still comply with the rest of the sections:
- Section 605. Adverse Events
- Section 608. Safety Substantiation
- Section 609. Labeling
- Section 610. Records
- Section 611. Mandatory Recall Authority
This means that the responsible persons of small business still have a lot of obligations under the new regulation for which they have to prepare in time. If you need help to prepare for the new requirements, please don’t hesitate to contact us.