The Modernization of Cosmetics Regulation Act (MoCRA) has introduced an array of new requirements for the cosmetics industry. The act aims to standardise the regulatory framework of the cosmetics industry. Notably, MoCRA has transformed and modernized the US FDA cosmetics regulations prioritising consumer safety. Cosmetics facility registration, product listing, product labelling, GMP compliance, adverse event reporting are some of the major tenets of MoCRA. Thus, the consumer health will be safeguarded upon the implementation of MoCRA. In this blog, we will focus on the MoCRA cosmetics facility registration requirements and guidelines. Notably, this requirement will be applicable to both existing and new facilities. Additionally, timely cosmetics facility registration and renewal of registration are crucial for MoCRA compliance.

What is a cosmetics facility?

Per MoCRA, a cosmetics facility is any establishment that manufactures or processes cosmetic products to be distributed in the US.

What is MoCRA?

MoCRA stands for Modernization of Cosmetics Regulation Act. It aims to modernise the cosmetics regulations and regulatory guidelines to ensure safe and high-quality products enter the cosmetics industry. MoCRA strengthens the oversight of cosmetics regulations. Notably, it aims to increase the accountability of the cosmetics manufacturers. The scope of the act is extensive and applies to cosmetics manufacturers, importers, distributors, and marketers. Furthermore, it covers all types of cosmetics products and ingredients used in them. Moreover, it is applicable to the manufacturing facility and methods used to produce them. The major provisions of the act are as follows:

1. Cosmetics facility registration
2. Cosmetic product listing
3. Cosmetics good manufacturing practices
4. Safety substantiation
5. Cosmetics product labelling guidelines
6. Record keeping requirements
7. Fragrance allergen disclosure
8. Adverse events reporting

The act has strengthened the requirements for record keeping and reporting to improve transparency and accountability. Moreover, as per MoCRA guidelines, the manufacturers will be required to register their facility as well as cosmetics products with the FDA. Additionally, they will be required to annually update the list of products. All these requirements increase the responsibility of manufacturers towards consumer safety. Thus, compliance with the MoCRA guidelines is mandatory for marketing cosmetics products in the US.

MoCRA cosmetics facility registration guidelines for cosmetics industry

According to MoCRA guidelines, cosmetics facility registration and product listing have become mandatory. MoCRA cosmetics facility registration requirements have laid down guidelines and regulations for registering cosmetics facilities. If your facility manufactures or processes cosmetic products intended to be marketed in the US, you are required to register your cosmetics facility with the US FDA. Moreover, these guidelines apply irrespective of whether your facility is located in the US or abroad. Additionally, there is a requirement for renewing cosmetics facility registration.

Who must comply with MoCRA cosmetics facility registration requirements?

• Cosmetic product facility: Any entity that manufactures or processes cosmetics products intended to be distributed and marketed in the United States is required to comply with MoCRA cosmetics facility registration requirements.
• Cosmetics contract manufacturers: Cosmetics contract manufacturers are also required to register their facility with the US FDA, as per MoCRA guidelines.

What are the MoCRA cosmetics facility registration guidelines?

MoCRA cosmetics facility registration guidelines are slightly different for new and existing cosmetics facilities. 

• New facilities: New cosmetics facilities are required to register with the FDA within 60 days of marketing their products.
• Existing facilities: All existing facilities that manufacture and process cosmetics have to be registered with the US FDA within December 29, 2023.

Therefore, timely cosmetics registration is vital for MoCRA compliance in order to market your cosmetics product in US. Furthermore, if the facility poses a risk of serious adverse event, the FDA may suspend the registration of this facility. In addition to facility registration requirements, cosmetics product listing is also a mandatory requirement under MoCRA guidelines.

The responsible person will have to provide a list of all marketed cosmetics products within 1 year of MoCRA’s enactment. The responsible person could be the distributor, packer, or manufacturer of a cosmetic product whose name appears on the product’s label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. Furthermore, for products marketed after the MoCRA’s enactment, a complete list of the new products has to be submitted to the FDA within 120 days of marketing. Additionally, the cosmetics product list has to be annually updated.

MoCRA cosmetics facility registration renewal guidelines

The MoCRA also mentions registration renewal requirements for cosmetics facilities. As per MoCRA cosmetics facility registration guidelines, the facility registration has to be renewed every 2 years.

Exemption from cosmetics facility registration requirements

MoCRA guidelines have provided provisions for exemption from mandatory MoCRA cosmetics facility registration and product listing requirements. Certain small businesses have been exempted from this mandatory cosmetics facility registration and product listing requirement. Notably, MoCRA has provided a well-defined definition of the type of businesses who can take advantage of this exemption provision.

Any business whose average gross annual cosmetic products sales for the previous 3 years is less than USD 1 Million in the US will be consider a small business. To be eligible for the exemption, these businesses should not be involved in manufacturing/processing cosmetic products that can be injected. The product manufactured should not come into contact with the eye’s mucus membrane. Furthermore, they should not be intended for internal use. Additionally, the products should not alter appearance for more than 24 hours without consumer removal.

How to register cosmetics facility with the FDA?

Cosmetics facilities will have to be registered online on the FDA’s Cosmetics Direct portal. This electronic submission portal has been developed to streamline the submission of facility registration details and product listing information. The facility registration has to be submitted in the structured product labelling (SPL) format. Notably, a fee need not be paid to register a cosmetics facility or submit a product listing to FDA.

Moreover, the responsible person will be expected to submit the cosmetics product listing using the FDA’s Cosmetics Direct portal. Notably, the cosmetic product listing information must include the facility registration number of the facility where the product is being manufactured or processed. Hence, the facility registration process should be completed prior to cosmetic product list submission. This is necessary to have the facility registration number handy while submitting the cosmetics product listing.

Pharmadocx Consultants: Your trusted ally for all your US FDA cosmetics regulatory needs

Implementation of the Modernization of Cosmetics Regulation Act or MoCRA is significant moment in US cosmetics regulatory history. It increases manufacturer’s accountability and responsibility and promotes transparency in order to safeguard consumer health. MoCRA has prioritised consumer health by regulating the quality of cosmetics entering the market. Moreover, it aims to ensure safe cosmetics reach the consumers and spurious substandard products do not enter the market. Thus, consumers tend to prefer MoCRA compliant cosmetics manufacturers and companies. Hence, compliance with MoCRA guideline is not only a regulatory requirement but also it improves brand reputation.

In this blog, we have discussed MoCRA cosmetics facility registration requirements. This is one of the many requirements, cosmetics companies will have to comply with. The transition from the existing cosmetics regulatory guidelines to the MoCRA guidelines can be challenging for cosmetics businesses. The MoCRA guidelines are extensive and elaborate. A US FDA agent with expertise in MoCRA guidelines can guide you through this transition. To avail our all-encompassing US FDA cosmetics regulatory service, simply drop an email at [email protected] or call/Whatsapp on 9996859227.