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2. Product Listing + Label Review- 30% OFF

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Official Implementation of MoCRA

The official implementation of MoCRA is set for December 29, 2023. On this date, the majority of the new requirements will take effect, including facility registration, product listing, safety substantiation, adverse event reporting, and professional cosmetics labeling.

Key Aspects of MOCRA

Introduction of the U.S. Responsible Person, whose name appears on the label of cosmetic products

Recall of cosmetic products from the market (introduction of the traceability principle)

Allergen labeling

Mandatory GMP regulation

 Registration of facilities (located in the USA or abroad), which must be renewed every two years

Product Registration

Reporting of adverse effects (which introduces cosmetovigilance procedures)

Safety Substantiation (which introduces the concept of safety assessment)

What will we help you with?

Introduction of the U.S. Responsible Person, whose name appears on the label of cosmetic products

Recall of cosmetic products from the market (introduction of the traceability principle)

Allergen labeling

Mandatory GMP regulation

Registration of facilities as your U.S Agent (located in the USA or abroad), which must be renewed every two years

Product Registration & Cosmetic Product Listings & Label Review

Reporting of adverse effects (which introduces cosmetovigilance procedures)

Safety Substantiation (which introduces the concept of safety assessment)

Cosmetic Product Requirements under MOCRA Regulations

Facility Registration Requirements 

  • A US Agent must be appointed
  • Manufacturers and actors in the production chain
  • To be renewed every 2 years on odd numbered years
  • Updates within 60 days

Products and Ingredients Listing

  • Responsible Person
  • Updating annual products and ingredients
  • Registration Number
  • RP References
  • Category
  • Ingredients
  • PLD

Our MoCRA Services

MoCRA Cosmetic Label Compliance

Product Listing

Cosmetic Facility Registration and Renewals

US Agent Service

Safety Substantiation

Cosmetic Good Manufacturing Practices (GMP) Compliance

Frequently Asked Questions

MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the most extensive cosmetic regulation reform in the United States in 84 years. It establishes many new requirements, such as:

  • Facility Registration
  • Product Listings
  • Good Manufacturing Practices (GMPs)
  • Safety Substantiation
  • New labeling requirements
  • Adverse Event Reporting
  • Record Keeping

The FDA will adopt rules under MoCRA that impact every stage of the production and marketing of your cosmetic items. New specifications include:

 

  • Required FDA registration of establishments for cosmetics
  • Required Product Listings for all cosmetics sold in the USA
  • Adherence to Good Manufacturing Practices (GMPs) mandated by the FDA for the Reporting of Adverse Events
  • Keeping records, including those of adverse events and safety justifications
  • Required Recalls
  • Allergen Statement for Fragrances

 

The bill offers general guidance so that cosmetic companies can begin planning for the new FDA Requirements, even though the FDA still needs to develop regulations.

Under MoCRA, the term "facility" includes any establishment that manufactures or processes cosmetic products distributed in the United States. Facilities will need to register and comply with GMPs issued by FDA.

 

The term "responsible person" means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label under section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

The "responsible person" will be responsible for:

  • Cosmetic product listing
  • Adverse events
  • Safety substantiation and regulatory expertise
  • Labeling
  • Fragrance allergen disclosures and records
  • Based in the U.S.A.
    • Single point of contact for authorities
    • Registrations: product listing, facility registration

When choosing a local distributor, be sure to consider factors like data storage capacity, regulatory and scientific competence, experience working with authorities, and confidentiality of product/supplier information.

Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:

  • Come into contact with eyes,
  • Are injected,
  • Are intended for internal use,
  • Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.

Facility registration and product listings are due by December 29th, 2023, for existing facilities. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.

MoCRA allows "flexible listings. "For flexible listings, companies can submit a single listing for cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.

  • A U.S. address,
  • A U.S. phone number, or
  • Electronic contact information for receiving adverse event reports

Cosmetic products containing fragrance allergens must update labels to list these allergens. Professional cosmetic products must prominently indicate that they are to be used solely by licensed professionals and are compliant with existing cosmetic labeling norms.

Within one year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.

Within two years: Labels must include the responsible person's contact information for adverse reporting and identify fragrance allergens determined by the FDA

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