Compliance services and software for the

cosmetic industry.

Get your cosmetic business regulation-ready with Registrar Corp’s industry-leading services and software solutions, so you can deliver safe and effective products.

Services

As cosmetic regulations change, Registrar Corp is here to help you meet them. Our tech-enabled services for cosmetic and personal care businesses range from FDA facility registration and product listings to label review and adverse events.

Facility Registration

Under the New Modernization of Cosmetics Regulation Act of 2022 (MoCRA), U.S. FDA requires most facilities that engage in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility. Additionally, non-US cosmetic facilities are required to designate a U.S. Agent for FDA communications.

We can help you register your facilities with FDA and act as your U.S. Agent if your facilities are located outside the U.S.

Product Listings

U.S. FDA requires that, for most cosmetic products, the manufacturer, packer, or distributor whose name appears on the label must submit a cosmetic product listing, FDA cosmetic listings can be difficult and time-consuming.

We can help make listing your products quick and easy.

Adverse Event Reporting Software

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days. FDA will also have access to adverse event reports during an inspection.

We provide Adverse Event Reporting Software to help assure compliance.

Label and Ingredient Review

The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits any distribution of misbranded cosmetic products with false or misleading labeling claims, labels with missing information, or containers made or filled in a deceptive manner. The Modernization of Cosmetics Act (MoCRA) imposes additional labeling requirements that must be met, including an adverse event contact and allergen labeling.

We can help assure that your Cosmetic Product Labels are compliant.

California Safe Cosmetics Act Reporting

The California Safe Cosmetics Act (2005) requires manufacturers, packers, and/or distributors marketing products in the state of California to report any of over 3,000 potentially harmful ingredients. Our team of regulatory specialists can assist you to determine which of your products’ ingredients require reporting and submit them to the California Department of Public Health (CDPH) on your behalf.

Import Alerts

Get professional support in case of a Detention Without A Physical Examination (DWPE). Registrar Corp guides you through the process of determining potential noncompliance, documenting corrective action, and submitting a complete and accurate petition for removal.

Detention Assistance

If your cosmetics shipment has been detained due to misbranding, adulteration, or not appearing to comply with regulations, Registrar Corp can help. Our team of professionals will work with you to identify potential noncompliance issues and establish a corrective plan of action.

Software

Registrar Corp’s innovative cosmetic formulation software empowers cosmetic brands to produce compliant shipments for U.S. and international markets.

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Cosmetri

Our cosmetic formulation and regulatory platform enables cosmetics manufacturers and R&D labs to produce safe, compliant personal care products efficiently. Manage production orders, oversee quality control and testing, and collaborate with your team on formula development on one platform. Assure compliance by following built-in GMP guidelines for product production, control, shipment, and storage.

Online Training

Become experts in FDA cosmetic compliance under MoCRA. Registrar Corp’s Online Training platform allows you to train yourself, and your team, to gain the skills required to remain FDA compliant.

Cosmetic GMP Best Practices

Understand all Good Manufacturing Practices (GMPs) covered in ISO 22716, the GMP standard widely accepted across the entire cosmetic industry. Our course covers every guideline from raw materials and personnel hygiene to manufacturing sites and documentation.

MoCRA eLearning Library

Discover everything you need to know to assure FDA compliance for your cosmetic business. From FDA facility registration and U.S. Agent designation to product listings and labeling, our course library will keep you updated on what MoCRA will require of your company.

Better cosmetic compliance with Registrar Corp.

After 20 years in regulatory compliance, we’ve seen it all. Let us support your compliance efforts as cosmetic regulations change.

Deepen Your Understanding of MoCRA

The Complete Guide to MoCRA: Cosmetic Regulations 101

Navigate the new regulatory landscape & keep yourself MoCRA compliant. This guide provides comprehensive information about FDA’s governance of cosmetics.

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Frequently Asked Questions

p-faq

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

  • Facility registration
  • Product listings
  • Good Manufacturing Practices (GMPs)
  • Safety substantiation
  • New labeling requirements
  • Adverse event reporting
  • Record keeping

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 in accordance with 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 
  • Labeling 
  • Fragrance allergen disclosures and records  

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. 

For existing facilities, facility registration and product listings are due by December 29, 2023. 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 with respect to colors, fragrances or flavors, or quantity of contents. 

Contact Registrar Corp to determine which responsibilities your company will need to complete to be compliant.  

Product labels must be updated to include: 

  • A U.S. address, 
  • A U.S. phone number, or 
  • Electronic contact information in which a responsible person can receive adverse event reports.  

Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements. 

When do the new labeling requirements go into effect?

Within 1 year: Professional cosmetic product labels must include all required information and state that only licensed professionals may use the product.

Within 2 years: Labels must include responsible person’s contact information for adverse reporting and must identify fragrance allergens determined by FDA.

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