Your Monthly Regulations Radar: FDA & EU Updates for Cosmetics - January 2025

On this page

• FDA Update Guidance for Facility Registration and Product Listings
  • US Agent Responsibility
  • Can nearby buildings share one FEI number?
  • Do free samples or gifts require product listing?
• Is Your Cosmetic Product Compliant with EU REACH and POPs Regulations?
  • ECHA Recommendations

As we step into 2025, we're excited to continue our journey with Christine Thiffault, our trusted expert in regulatory updates for the beauty industry. This month, she's diving into two critical topics: the FDA's updated requirements for facility registration and product listings, and an examination of whether your cosmetic products align with EU REACH and POPs regulations, based on recent ECHA findings. Stay ahead of the curve with Christine's insights!

FDA Update Guidance for Facility Registration and Product Listings

Since issuing the first Guidance in December 2023, the cosmetics industry began listing cosmetic products and registering their facilities as mandated by the Modernization of Cosmetics Regulation Act of 2022, also known as MoCRA, with a deadline of July 1st, 2024. However, there were still many remaining unanswered questions such as what are the responsibilities of the US Agent? Does each building associated with the manufacturing or processing of cosmetic products require a separate FEI (FDA Establishment Identifier) number? And what about product listings for free samples/gifts?

This new Guidance, issued on December 11th, 2024, helps respond to many of these questions and provides key information about who must register, what information is required, how and when to submit information, and available exemptions. The updated guidance builds upon earlier guidance, with the addition of new registration and listing FAQs. 

US Agent Responsibility

Foreign facilities require the use of a "U.S. Agent" for registration purposes. The U.S. agent is the person, which includes an individual or business entity, that resides in the U.S. or maintains a U.S. place of business and is physically present in the U.S. The U.S. agent should not be a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's agent is not physically present.

The responsibilities of the U.S. Agent are as follows:

• Assist the FDA in communications with the foreign establishment;
• Respond to questions about the foreign establishment's products imported into the US; 
• Help the FDA schedule inspections of the foreign establishment;
• Receive information or documents from the FDA on behalf of the foreign establishment when direct contact is not possible.

Can nearby buildings share one FEI number?

Multiple buildings within three miles of one another can share one FEI number if they are part of the same business, are under the same local management, and can be inspected together. The cosmetic product facility registration system allows one registration per FEI number, even if it includes multiple buildings.

Do free samples or gifts require product listing?

The answer is yes, generally. A product listing must be submitted for each cosmetic product, including free samples or gifts e.g. given at a trade show. Exemptions apply for samples provided for research and development or within the industry, not intended for consumer use. 

Is Your Cosmetic Product Compliant with EU REACH and POPs Regulations?

As part of a pilot program, the European Chemicals Agency (ECHA) evaluated 4478 cosmetic products for the presence of Persistent Organic Pollutants (POPs) substances listed in Annex I of Regulation (EC) No 2019/1021 and Substance of Very High Concerns (SVHCs) listed in Annex XCII of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006 and amendments. The pilot program was launched between November 2023 and April 2024 in 13 Member States. The inspections were mainly done by checking the ingredients or INCI names listed online or on the packaging against the restricted substance lists. It is important to highlight that, in many cases, the selection of products was not random, but based on a risk-based approach.

Of the 4478 products evaluated, 6.4% were non-compliant. According to the report, the most non-compliant and restricted substances identified were perfluorononyl dimethicone (siloxane polymer with a C9 perfluorinated side-chain related to perfluorooctanoic acid (PFOA) and perfluoroalkyl carboxyl acids (PFCA)) and listed in Annex I of POPs and Annex XVII of REACH) and cyclopentasiloxane (D5) (listed in Annex XVII of REACH). The latter were found in wash-off cosmetic products (e.g., hair conditioner). Other banned or restricted substances included POPs and/or SVHCs cyclomethicone (a blend of cyclotetrasiloxane (D4), D5 and cyclohexasiloxane (D6)), D4, perfluorooctylethyl triethoxysilane, and perfluorononylethyl carboxydecyl PEG-10 dimethicone. These substances have been historically used in cosmetic products for their smooth, shiny, silky texture and their ability to enhance the feel and appearance of products. 

Enforcement authorities have taken measures to remove the non-compliant products from the market and issued written advice to help suppliers comply with the law. 

ECHA Recommendations

In their report, ECHA recommends that the Industry implement the following:

1. "...Cosmetic products... have to follow not only the provisions of the Cosmetic regulation but also those of POPs and REACH..."
2. "Industry should use substance identifiers (e.g. CAS, EC) that reflect accurately the composition of their manufactured substances. This is especially relevant for UVCBs."
3. "Companies selling cosmetic products are recommended to use ECHA CHEM to help them in identifying whether their products contain restricted substances."
4. "Industry should be aware that the definition of placing on the market differs between the regulations (POPs/REACH and Cosmetics)."

💡 Christine's Takeaways: 2025 beings with much needed clarification with respect to facility registration and product listings under MoCRA. The new Guidance offers three FAQs including (1) defining the US Agent responsibilities, (2) whether nearby buildings can share the same FEI number, and (3) the requirements for the listing of cosmetic samples.

In addition to the European Cosmetics Regulation (EC) No 1223/2009, the Industry must make sure that they understand what other regulations they must comply with and include REACH and POPs. Cosmetic products that do not comply with the required regulations may be subject to recall which can have a devastating impact on your brand. 

👉 If you want to know more about how to comply with the cosmetic regulation in the USA, Canada and Europe and your regulatory and safety obligations as a manufacturer don’t hesitate to reach out to Christine Thiffault, PhD DABT ERT at cthiffault@toxessential.com, Toxicology Expert at ToxEssential, or visit the website: toxessential.com

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