Your Quick Guide to US MoCRA

Your Quick Guide to US MoCRA

If you are a manufacturer or processor of cosmetic products for sale in the United States, or a contract manufacturer, packer, or distributor of cosmetics in the US, the US Modernization of Cosmetic Regulation Act (MoCRA) is a regulation of which you should at least be aware. The US laws for cosmetics have changed; they are now more comprehensive and similar to other regulations under the US Food and Drug Administration (FDA).

Facility Registration

To start, facility registration has become a major requirement for all manufacturers and processors of cosmetics, including companies outside the United States. The process includes obtaining an FEI Number and completing the registration process with the FDA. A US agent is required for cosmetic facility registration with the FDA if the establishment is located outside the United States. The US agent can act on behalf of the manufacturer or processor of a foreign cosmetic to register their facility with the FDA.

Responsible Person

Cosmetic product labels may have the name of the manufacturer, packer, or distributor on them. The entity whose name appears on the product label is considered a 'Responsible Person'. The main obligations of the Responsible Person include:

• Listing products on the FDA portal
• Ensuring compliance with each product's formula and label
• Completing safety substantiation
• Having an adequate adverse event recording system in place
• Reporting any serious adverse events to the FDA

Good Manufacturing Practices

In 2013, the FDA published a draft GMP guidance for the cosmetics industry. This document has been in use since then as a GMP compliance standard in the industry. It incorporates many of the requirements of ISO 22716 for global harmonization purposes. GMP requirements under MoCRA are expected to be available for review sometime during 2024. Compliance should be seamless for facilities that are already compliant with the 2013 guidance or that are ISO 22716 certified, or both.

In addition to the above, the FDA is also expected to publish requirements for labeling fragrance allergens and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

Where to Start if You Are a Manufacturer or Processor of a Cosmetic Product:

1. Get a US agent if you are located outside the United States.
2. Register your facility with the FDA.
3. Identify the Responsible Person(s) for your products.
4. The Responsible Person should complete the required tasks for product listing, safety substantiation, and adverse events.

Do you need help and are not sure how to proceed? We are here to help. Contact SGS, and we will be happy to support you with any of the following services for MoCRA:

• Finding you a US agent
• Registering your facility with the FDA
• Listing your products on the FDA portal
• Getting you ready for GMP compliance
• Making sure your cosmetic products, ingredients, and labels comply with US regulation
• Helping you with product safety substantiation - Toxicology risk assessment, testing, and others

SGS is your MoCRA compliance partner every step of the way.

By Hank Karayan, Global Head of Cosmetics and Pharma at SGS North America Inc.