Frequently asked questions about MoCRA

Q: I believe I’m the RP for Cosmetic Products distributed in the USA, but I use Third-party/Contract Manufacturers or Outsource Design Manufacturers (ODMs) to physically produce the products. Do I have to ensure they Register their Facilities?

A: Yes, MoCRA requires any Facility that manufactures or processes Cosmetic Products distributed in the USA to be registered – irrespective of where those Facilities are based or whether they themselves would be the RP of the Cosmetic Product. As a first step, ensure that the manufacturers you utilise are aware that you distribute the products in the USA and enquire as to their preparations regarding MoCRA. Delphic HSE can act as a USA-based Agent for any manufacturers not located in the USA. Additionally, Delphic HSE can support USA-based Facilities through the Facility Registration Process.

Q: I’m a Third-party/Contract Manufacture, or Outsource Design Manufacturer (ODM), do I have to register my Facility(ies) multiple times for each RP I Manufacturer or Process Cosmetic Products for.

A: No, MoCRA requires only a single registration for a Facility irrespective of how many RPs it Manufacturers or Processes Cosmetic Products for. This is explicitly addressed in Sec. 607, (a), (3) of MoCRA. You will be required, within that Registration, to list all Brand Names and Product Categories of all the Cosmetic Products you Manufacture or Process that are distributed in the USA.

If your Facility(ies) are based outside of the USA, you will need a USA-based Agent to include in the Facility Registration(s). Delphic HSE can act as your USA-based Agent, as well as provide a range of other support to you and your clients. Please see information in our xx-yy-zz document for details of our full remit of services.

Q: We Manufacture or Process the same Cosmetic Product at Multiple Facilities, does each one need to be Registered?

A: Yes, as above MoCRA requires any Facility that manufactures or processes Cosmetic Products distributed in the USA to be registered. If more than one Facility Manufactures or Processes the same Cosmetic Product, each of those Facilities must be registered. When completing a Product Listing, the RP must also provide the Facility Registration Number of each Facility involved. Delphic HSE can act as a USA-based Agent for any manufacturers not located in the USA &/or support USA-based Facilities through the Facility Registration Process.

Q: Following Facility Registration, am I likely to be contacted or inspected by the FDA?

A: MoCRA provides some remit for the FDA to access records and suspend Facility Registrations, where they have reasonable concerns over the safety of individual Cosmetic Products or Cosmetic Products Manufacturer or Processed by specific Facilities. Eventually, MoCRA will introduce GMP requirements and whilst it is unknown what form this will take, it is perceivable that this may require GMP Inspection or Certification by the FDA or FDA-approved entities. It is too early to know how likely this is, and more information will be available when the FDA have to release their proposals for GMP Requirements (29th December 2024 at the latest).

Q: I’m the RP for Cosmetic Products Distributed in the USA. Whilst I understand I cannot fully transfer my role as RP or the Obligations associated with it, can I use external support to help fulfil those Obligations.

A: Yes. Whilst the RP retains the ultimate Responsibility and Liability for compliance with MoCRA, it can use third parties to Support its compliance and provide Services to meet its Obligations. For example, an external expert to provide and document Safety Substantiation or to complete Product Listings on its behalf. Delphic HSE offer a large range of services to support RPs, Facilities and the wider supply chain with the Obligations of MoCRA – please see information in our xx-yy-zz document or contact us at aa-bb-cc to learn more.

Q: Does MoCRA prohibit animal testing of Cosmetic Products or Ingredients.

A: No, MoCRA does not contain explicit prohibitions on the use of animal testing to Substantiate the Safety of Cosmetic Products or Ingredients. However, Section 3507 indicates that animal testing should be phased out with the exception of ‘appropriate allowances’. There is, certainly, no requirement to utilise new animal testing to support the Safety Substantiation.

Delphic HSE have been conducting Safety Assessments/Substantiations of Cosmetic Products without the need to rely on novel animal testing data since our founding in 2007. We have an internal team of over 20 Toxicologists specialised in desk-based and non-animal Safety Assessment of Cosmetic Products based on existing data on the safety of Cosmetic Ingredients. This includes individuals with a range of Professionally Recognised Qualifications, such as the Diplomate of the American Board of Toxicology (DABT), UK and European Register of Toxicologists (UKRT/ERT) as well as other internationally recognised bodies.

Q: Can I use another company or expert to help me with Serious Adverse Event Reporting?

A: MoCRA makes it clear that Serious Adverse Event Reporting is the responsibility of the RP, as opposed to say the USA-based Agent of a Facility. However, the legislation does not explicitly prohibit the use of third parties to assist with the review of Serious Adverse Event or their Reporting. Delphic HSE have extensive experience in ‘Causality Assessment’ of Adverse Events, and our in-house team of Toxicologists can review incidents reported by consumers along with medical reports and documentation. Additionally, we expect to be able to provide support to RPs for completion and submission of Serious Adverse Event Reports if they require it.