Navi-x

Copyright © 2024 CeWay. All rights reserved.

Home page

Your US MoCra FDA cosmetics
regulatory assistance.

flag

At CE.way, we help you bring your cosmetic products to the market quickly and efficiently. With a combination of our knowhow and in-house lab facility, we can offer all of the necessary regulatory and testing services, and seamlessly navigate you through the registration process of your cosmetic products.

More About Us

MoCRA timeline and requirements

MoCRA (Modernization of Cosmetics Regulation Act of 2022) is the new US cosmetics legislation that cosmetic products placed on the US market need to comply with. MoCRA represents a significant overhaul of the regulatory framework governing cosmetics in the U.S., aiming to enhance product safety, transparency, and accountability within the industry. As a trusted partner, CE.way combines its extensive know-how with state-of-the-art in-house laboratory facilities to ensure your cosmetic products are MoCRA compliant. CE.way's comprehensive regulatory and testing services guarantee the safety, efficacy, and regulatory adherence of your products.

  1. 1

    Enactment of MoCRA

  2. 2

    MoCRA comes into force

  3. 3

    Proposition of a list of fragrance allergens

  4. 4

    Labelling requirements enforced

  5. 5

    Cosmetic GMP Final Rule publication by FDA

serviced
1000+
companies

notified
7000+
products

clients from
38+
countries

MoCRA exemptions

The Modernization of Cosmetics Regulation Act (MoCRA) has introduced a framework aimed at ensuring the safety and efficacy of cosmetic products entering the US market. A significant aspect of this regulation is its approach to small businesses, recognizing the unique challenges they face. MoCRA defines small businesses as those with less than $1,000,000 in average annual gross sales in the US over the past three years, adjusted for inflation. This categorization provides certain regulatory reliefs, aimed at fostering innovation and competition from smaller players in the cosmetics industry.

Under MoCRA, small businesses that fall under this definition benefit from exemptions from specific regulatory requirements, such as Good Manufacturing Practices (GMP), facility registration, and product listing. These exemptions, however, are carefully tailored to ensure they do not compromise product safety and public health. Consequently, exemptions do not apply to facilities that produce products with higher risk factors, including products that:

Come into contact with the mucous membrane of the eye

Are intended for injection

Are meant for internal use

Or have the potential to alter appearance for more than 24 hours

Additionally, the exemptions extend to certain facilities that are regulated under the drug and device requirements, acknowledging the overlapping regulatory oversight these products may already be subject to.

Despite these exemptions, it is crucial for all cosmetic products marketed in the US to adhere to MoCRA's labelling requirements, engage in adverse event reporting, designate a Responsible Person, and be able to substantiate the safety of the cosmetic product for its normal and foreseeable use.

Need help with the cosmetics regulations and testing?

Contact Us

Frequently Asked Questions

RESPONSIBLE PERSON & PRODUCT LISTING

US AGENT AND FACILITY REGISTRATION

EXEMPTIONS UNDER MOCRA

LABELLING REQUIREMENTS

Need help with the cosmetics regulations and testing?

Contact Us