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  • Writer's pictureDaniel Jiménez

MoCRA - How affects the Modernization of Cosmetics Regulation Act

Last December, the US Congress passed The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which creates federal standards for cosmetic cosmetic safety and compliance.

How cosmetic companies around the World will be affected?

Here a list of the main points to considerate to be in compliance with new regulations:

1. Registration and Product Listings

Cosmetic companies have to to register their facilities and submit product listings to FDA. It also requires the Responsible Person (i.e., a “manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product) to submit to FDA the cosmetic product’s listing, including the ingredients of any fragrances or flavours.

The registration shall be done no later than one year after the enactment date. Companies must renew a product listing annually with any updates.

2. Safety Substantiation

Requires manufacturers to maintain records demonstrating adequate substantiation of the safety of a cosmetic product, such as reputable “tests or studies, research, analyses, or other evidence or information… sufficient to support a reasonable certainty that a cosmetic product is safe.”

It means that Cosmetic Product Safety Report shall be done before the product marketing.

3. Good Manufacturing Practice

FDA is going to promulgate good manufacturing practice (GMP) regulations for cosmetics manufacturing and processing facilities with the intention of protecting the public health and ensuring that cosmetic products distributed in the United States are not adulterated.

In developing this guidance, FDA incorporated elements from the International Organization for Standardization’s standard for cosmetic GMPs (ISO 22716:2007). It may therefore be useful to track any developments in ISO 22716:2007 going forward because these will likely form the basis of any GMPs promulgated by FDA.

4. Adverse Event Reporting

The Responsible Person shall maintain records of health-related adverse events associated with the use of its product for six years (or three years for small businesses), and to report to FDA any serious adverse events within 15 business days of learning about the event.

5. Recalls

FDA has been authorized for requesting a voluntary recall of a cosmetic product if the agency determines that there is a reasonable probability that the product is adulterated or misbranded.

If the responsible person does not comply with that request, FDA may order a mandatory recall (subject to requirements for an informal hearing). It means that the Responsible Person has the opportunity to recall the product, but if refused, FDA, by order, can call for the immediate cease distribution and recall the product.

Considerations which may help cosmetics companies may include:

  • Consider to hire a specialized professional to ensure full compliance with new standards;

  • Careful creation of not only processes and procedures for implementing all MoCRA requirements but also training of employees on the importance of compliance and the dangers of non-compliance, as well as careful documentation practices;

  • Timely and complete registration and product listing disclosures to FDA;

  • Review of safety substantiation tests and data sources for each product to ensure they are scientifically supported and can be defended, including the test methods utilized themselves in addition to their results;

  • Updating or establishing new Standard Operating Procedures to ensure compliance with forthcoming GMPs.

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