Dissecting MOCRA- The Modernization of Cosmetic Regulations Act
Luke Grocholl Ph.D., Head of Regulatory
The Modernization of Cosmetic Regulations Act, or MoCRA, was signed into law in the USA in 2022 and is the first major update to US cosmetic regulations in over 80 years. This ambitious law will spawn multiple regulations intended to help ensure the safety of cosmetics in the US. Under MoCRA, the FDA has expanded authority to monitor cosmetic safety, and implement measures to address safety concerns. Many of the measures in MoCRA are similar to FSMAii, the Food Safety Modernization Act, which was enacted in 2011. Like FSMA, however, it may take quite some time for full execution. Some of the MoCRA elements are already in place as the FDA actively works on implementing further aspects of this far-reaching law.
MoCRA requirements will be phased in over several years, with details on the rule requirements provided by the FDA through guidance documents and specifications. Some important elements of MoCRA are already in place or will be enforced in the near future.
EXEMPTIONS IN MOCRA
Small businesses are exempt from many elements of MoCRA, including GMP requirements, facility and product registration, and the record-keeping of adverse events for six years. Under MoCRA, a firm is classified as a small business if its average annual revenue over the past three years is less than $1 million (the Act does allow for increasing this small business cap to reflect inflation). However, due to the risks associated with certain cosmetic products, any firm, regardless of size, that produces cosmetics that are injected, intended for internal use, or are reasonably expected to come into contact with the mucous membranes of the eye (such as mascara, liquid eyeliner, and eyelash adhesives) is subject to MoCRA. Additionally, cosmetic companies that produce products intended to alter appearance for more than 24 hours and are not normally removed by the consumer are subject to MoCRA regardless of their annual income. This specialized category of cosmetics includes eyebrow/eyelash dyes, acrylic or gel fingernails, and gel nail polish.
There is also a MoCRA exemption for firms that produce cosmetics that are also considered drugs, such as special shampoos intended to treat a medical condition. Such manufacturers are subject to pharmaceutical regulations rather than cosmetic requirements.
REGISTRATION REQUIREMENT
All non-exempt facilities that manufacture or process cosmetic products must now be registered with the FDA as a cosmetic facility. Those firms that manage only raw materials for cosmetics are not required to register. Therefore, a company involved in fragrance raw materials or fragrance formulation, where the formulation is provided to another organization for further processing into a cosmetic product, need not register as a cosmetic facility. Registration is mandatory for any facility involved in the manufacturing or processing of the cosmetic product itself. For example, a fragrance facility that processes perfume or cologne must register as a cosmetic facility, even if the final product is sent to another facility for packaging or labeling.
This is because, in addition to raw material manufacturers, MoCRA establishes other exceptions to the registration requirement. The Act exempts downstream establishments. Downstream establishments are those entities involved with only labeling, packaging, or distribution. In addition, beauty shops, health care firms, and retailers are considered downstream establishments. Finally, operations such as airlines or hotels that offer complimentary cosmetics also fall within the downstream establishment exemption.
Apart from facility registration, non-exempt firms are required to provide a complete listing of all their cosmetic products. The list must be updated (or at least confirmed if there are no changes) at least annually. The ingredient list must include all ingredients, including flavors, fragrances, and colors. Fragrance allergens must be declared. The FDA continues to finalize rules on fragrance allergens.
ALLERGEN LABELLING
Labeling of fragrance allergens will be required under MoCRA. The FDA is actively reviewing and establishing allergen testing standards for the cosmetic industry. Although the federal standard has not yet been finalized, products sold in California must disclose fragrance allergens. California defers to the identified skin-contact allergens in EU Regulation (EU) 1223/2009 Annex III. This includes the additional substances and natural extracts added to the EU regulation in 2023, bringing the total number of fragrance allergens that must be disclosed to 82. It is likely the federal rules will closely resemble the California requirements, and once the FDA fragrance allergen standard is established, there will be greater alignment between California and federal requirements.
LOOKING FORWARD
MoCRA is the biggest change to federal cosmetic regulatory authority in eight decades. These sweeping laws will require years of implementation to establish rules, roll out requirements, and issue guidance. In order to ensure adherence to the requirements in the Act, cosmetic producers must monitor FDA updates on MoCRA and adopt policies and procedures to meet MoCRA requirements. The FDA is being diligent in its mission to help ensure cosmetic safety, and all who work in the cosmetic industry or its supply must be aware of their role in meeting MoCRA requirements.
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