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FDA MoCRA Modernization of Cosmetics Regulation Act
About

MoCRA (Modernization of Cosmetics Regulation Act) is the FD&C Act that makes every company which manufactures or processes cosmetics in the US market register mandatorily. This is the most significant expansion to regulate cosmetics including access to records, recall and etc.

Every company needs to register facility and list products as follows:

  • Facility Registration: Manufacturers or processors of cosmetics register their facilities, update content if there is any change, and renew every 2 years.
  • Product Listing: The responsible person must submit and register cosmetics including ingredients and update annually.
Necessity and Expected Outcomes of the Certification
  • Requirement for export to US
  • Enhancement of corporate and brand image.
  • Establishment of product safety and reliability through FDA certification.
  • New business opportunities
Certification Process
Certification Requirements

Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US

Cosmetics Category Lists

  • Baby products
  • Bath preparations
  • Eye makeup preparations
  • Children’s eye makeup preparations
  • Fragrance preparations
  • Hair preparation (non-coloring)
  • Hair coloring preparation
  • Makeup preparation (not eye) (other than makeup preparations for children)
  • Makeup preparations for children (not eye)
  • Manicuring preparation
  • Oral products
  • Personal cleanliness
  • Shaving preparations
  • Skin care preparations (creams, lotions, powder and sprays)
  • Suntan preparations
  • Tattoo preparations
  • Other preparations

GSC is doing our best to support customers' global corporate activities by getting the latest information and expertise through the US FDA U.S Agent that can respond in real time.