The Modernization of Cosmetics Regulation Act (MoCRA) introduces a range of new roles, responsibilities and obligations for those across the supply chain. Whilst much focus is being given to the introduction of a ‘Responsible Person’ within MoCRA, it is just as important to understand the impact on other parts of the supply chain – and in particular what MoCRA refers to as a ‘Facility’:

“any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States”

This is a wide-ranging definition, and MoCRA itself does not include any definition for ‘manufactures’ or ‘processes’ within it. However, the Food ,Drug and Cosmetic (FD&C) Act does define the ‘manufacture of a cosmetic product’ as

“the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.” (21 C.F.R. § 700.3).

With respect to ‘Processing’, our current understanding is that any Facility which undertakes processes (including manufacturing) that would expose a Cosmetic Product to the external environment (thus potentially leading to contamination or adulteration) is likely to require registration (which would include moving a finished product from bulk containers to final packaging or from one unit of packaging to another).

MoCRA does provide a list of exemptions from being considered a Facility, and our recommendation is that unless it can be clearly shown that one of the exemptions apply, organisations should consider themselves likely to be covered by the definition of ‘Facility’. These exemptions are (Sec 604, (3), (B)):

Beauty shops and salons (unless they manufacture or process cosmetic products on site).
Cosmetic product retailers, including individual sales representatives, direct sellers, retail distribution facilities, and pharmacies (unless they manufacture or process cosmetic products on site).
Hospitals, physicians’ offices, and health care clinics.
Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
Trade shows and other venues where cosmetic product samples are provided free of charge.
An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
An establishment that solely performs one or more of the following with respect to cosmetic products: Labeling, Relabeling, Packaging*, Repackaging*, Holding, Distributing.
1. * ‘Packaging’ and ‘Repackaging’ do not include filling a product container with a cosmetic product.

How Can Delphic Help?

Delphic HSE will be able to operate as the USA-based Agent for overseas Facilities, in addition to supporting Facilities in the USA with their registrations should they require it. Utilising our Offices in Nevada, just south of Las Vegas, we will be able to:

Be listed as your USA Agent for Facility Registration
Support with the Registration Process
Support with the Renewal of Registrations (every 2 years)
Assist in Liaising with the FDA on matters such as:
- Questions on the Facility(ies)
- Questions on the Cosmetic Products that you Manufacture or Process
- GMP Certification & Inspection

In addition, Delphic HSE will be able to review your existing GMP Status, advise on possible gaps in relation to current International Standards (such as ISO 22716) and ensure you are kept up-to-date about the requirements of GMP under MoCRA as they are implemented.

~At the time of writing, the system for Facility Registration is not currently available from the FDA. Facilities should ensure they monitor the progress and availability of the required systems to ensure they can meet the required timelines.

Service	Description
Facility Registration	Delphic HSE will act as your USA-based Agent and help with completion of your Facility Registration, including all Products that need to be included within this and determining the appropriate Categories for them.
GMP Gap Analysis	Delphic HSE will review the current GMP Certification/Status of each Facility and provide information on potential gaps compared to ISO GMP Standards.
MoCRA GMP Implementation Monitoring	In addition, we will keep you updated as the MoCRA GMP Requirements are released and advise on implementation to meet any requirements.
Authority Liason	As your USA-based Agent, Delphic HSE will liaise with the FDA on an ‘as needs’ basis.

To receive a formal MoCRA specific proposal which includes more detailed information and costs or if you have any further questions on MoCRA, please contact us.

Additional information

Facility Registration

The key Obligation placed on Facilities under MoCRA at this time is that of Registration, Sec 607, (1) and (2). This requires that:

“Every person that, on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after date of enactment of such Act.”

AND

“Every person that owns or operates a facility that first engages, after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity.”

In other word, any Facility that is involved in Manufacturing or Processing Cosmetic Products that are distributed within the USA must:

Register with the FDA on or before 29^th December 2024 where products are already being distributed in the USA at this time
Register with the FDA within 60 days of first becoming involved in this if products are not already being distributed in the USA

It is extremely important to note that this requirement applies to every Facility, not just those based in the USA. Overseas Facilities must also register with the FDA!

The Registration process will require provision of the following information to the FDA upon registration (Sec 607, (B), (2):

The facility’s:
1. Name
2. Physical address
3. Email address
4. Telephone number
For any ‘foreign facility’, i.e. based outside of the USA
1. Contact for the United States Agent of the facility
2. If available, electronic contact information
All brand names under which cosmetic products manufactured or processed in the facility are sold.
The product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.

Upon Registration, each Facility will be issued a ‘Facility Registration Number’. This number will be required to be utilised in future communications with the FDA, including re-registration of the Facility(ies) that is required every two years.

Also note, that each Brand and Responsible Person (including your own brands if your Facility manufactures or processes own brand items) will be required to provide the Facility Registration Number when completing their Product Listing.

This is essential and means that no Brand you Manufacture or Process for will be able to complete their legally required Product Listing without the Facility Registration Number you will receive on completion of your registration!

Good Manufacturing Practice (GMP)

Although no immediate GMP Requirements are placed on Facilities at this stage, MoCRA requires the FDA to produce GMP Standards for Facilities by 29^th December 2024. Following this, although the timeline for implementation is not yet specified Facilities will have to ensure they comply with these GMP Requirements. It is anticipated this may include GMP Certification by the FDA or FDA-approved Bodies.

MoCRA – Facility FAQ

Q: I’m a Facility that Manufactures products distributed in the USA, but my Facility is not in the USA – do I still need to Register?

A: Yes, all Facilities involved in Manufacturing or Processing of Cosmetic Products Distributed in the USA need to register, even if they themselves are not based in the USA.

Q: As a Contract Manufacturer/Outsource Design Manufacturer/Third-party Manufacturer, I produce Cosmetic Products for a number of different Brands – do I have to register for each of them?

A: No, such entities are only required to register once, Sec 607, (A), (3). If you are not based in the USA you will be required to appoint a USA-based Agent as part of Registration, which is something Delphic HSE can provide for you.

Q: Once Registered, is that it?

A: No, aside from re-registration every two years the FDA have indicated that it is likely you will received questions from them regarding the Facilities and the Cosmetic Products you Manufacture or Process. In addition, GMP Criteria will be released in December 2024 – which will require compliance with at a future date.

Q: Do I have to Register my Facility(ies) in order for the Brands I work with to continue selling in the USA?

A: Yes, the USA Responsible Person has to List all the Products they are distributing in the USA. As part of this, they will be required to provide the Facility Registration Number. Without it, they cannot List the products and hence cannot continue to sell them.

Q: Will I have to provide my USA-based Agent with a list of all Brands and Product Names?

A: Yes, your USA-based agent will need the full list of all Brands, Product Names and Product Categories as part of the Facility Registration.

Q: We utilise multiple Facilities to produce some Cosmetic Products, do we have to Register each of them?

A: Yes, any and all Facilities involved in the Manufacture or Process of Cosmetic Products Distributed in the USA require Registration. If you produce the same product in multiple locations (Facilities) they will all have to be Registered. Also note that, when completing their Product Listing, the Responsible Person will have to provide a Facility Registration Number for each Facility.

Q: Can Delphic HSE help us with anything other than MoCRA?

A: Yes! Delphic HSE Offer a range of Safety and Compliance Services throughout the Cosmetic Supply Chain and covering all major Cosmetic Markets. This includes Service Packages for Safety and Regulatory Compliance on a per product basis, as well as testing and claims substantiation through trusted 3^rd parties, enabling you to offer a ‘full service’ to clients who need it or when tendering for Product Ranges.

Delphic HSE is delighted to announce our latest global expansion

We are honoured to welcome Delphic HSE Solutions LLC, located in the United States, into the Delphic Group.
3753 Howard Hughes Parkway, Suite 200 - 1277, Las Vegas.

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