MoCRA Exemptions Requirements

MoCRA Exemptions 

FDA has established several criteria for MoCRA exemption. The requirements for MoCRA exemption are based on the sales volume and the product type. The requirements for MoCRA Registration and

listing exemptions are based on the risk associated with the product.

 

mocre-exepmtiom

MoCRA Exemption Criteria

  1. Salons and Beaty shops – Saloons and beauty shops are exempted from the MoCRA registration unless they manufacture cosmetic products
  2. Products that are also OTC drugs and cosmetics – Like sunscreen, SPF makeup, SPF lip balm, etc.- are exempted from MoCRA registration.
  3. Small Business – Facilities whose cosmetic products’ average gross annual sales in the US in the previous three years are less than $ 1 million (adjusted for inflation).

 

Small business exemption does not apply to following type of products. 

  • Cosmetics that regularly come into contact with the mucus membrane of the eye when used. Examples – Eyeliner, Eye serums and creams
  • If the product is injected, Examples-
  •      Dermal Fillers
  • If the product is intended for internal use.
  • The products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use. – Permanent hair dyes

 

If You have any questions about MoCRA compliance requirements contact us.