Practical Guidance & Timelines on MoCRA

MoCRA defines a Facility as “any establishment (including an establishment of an importer)

that manufactures or processes cosmetic products distributed in the United States”. It is extremely important to note that the requirement for Facility Registration applies to any Facility meeting the definition, irrespective of geographical location. i.e. this requirement does not only apply to Facilities based in the USA, but all such Facilities around the globe if the products they manufacture or process are distributed within the USA.

Whilst MoCRA does not itself define manufacture or manufacturing, the FD&C defines 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).

Neither MoCRA nor the FD&C define ‘processes’ or ‘processing’ in relation to Cosmetic Products, however MoCRA does include a variety of example exemptions from the definitions. This includes establishments that only perform one or more of the following functions:

1. Labeling
2. Relabeling
3. Packaging*
4. Repackaging*
5. Holding

[*Note that MoCRA provides a further clarification that ‘packaging’ and ‘repackaging’ do not include filling a product container with a cosmetic product.]

Based on the wording of MoCRA, it is our current understanding 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). Any Facility that considers itself exempt from the requirement would have to firmly show how they fit into one of more of the exemption categories that are detailed in Sec. 604, (3), (B) of MoCRA.

Facility Registration will require the following information (Sec. 607, (b), (2)):

• The facility’s:
  • Name
  • Physical address
  • Email address
  • Telephone number
• For any ‘foreign facility’, i.e. based outside of the USA
  • Contact for the United States Agent of the facility
  • If available, electronic contact information
• Facility registration number, if one has been previously assigned during registration
• 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

The deadline for Facility Registration is the 29^th December 2023 for every Facility that is engaged in the manufacturing or processing of Cosmetic Products that are currently available in the USA.

Following this date, any Facility that becomes involved in the manufacturing or processing of Cosmetic Products that are made available in the USA after the 29^th December 2023 must register within 60 days of engaging in said manufacturing or processing.

MoCRA also requires that Facilities renew their registrations every two years (Sec. 607, (a), (2))

~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.

MoCRA requires that the RP submit a ‘Listing’ for each Cosmetic Product that is available on the market in the USA under their name. Such a Product Listing will require the following information to be submitted (Sec. 607, (c), (4)):

• The Facility Registration Number of each Facility where the Cosmetic Product is Manufactured or Processed.
• The name and contact number of the Responsible Person
• Name for the Cosmetic Product, as it appears on the label
• Applicable Cosmetic Category(ies) for the Cosmetic Product
• List of Ingredients, including any
  1. Fragrances
  2. Flavors
  3. Colors
• Product Listing Number, if one has been previously assigned during Listing

The deadline for Product Listing is the 29^th December 2023 for every Cosmetic Product that is currently available in the USA.

Following this date, the RP must list any new Cosmetic Products that enter the USA Market within 120 days of Marketing such product.

MoCRA also requires that RPs update their Product Listings every year (Sec. 607, (c), (2))

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

MoCRA requires that the RP ensures, and maintains records to support, the safety of each Cosmetic Product that is available on the market in the USA under their name. It defines ‘Adequate Substantiation of Safety’ as:

“tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”

Further defining ‘Safe’ as:

“the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.”

A number of key takeaways are relevant here. Firstly that there is no specifically proscribed qualification that is required, and that equally there is no specifically proscribed format or content for a Safety Substantiation under MoCRA. It is expected that current industry best practice, including detailed approaches required by Legislation in other parts of the World (such as the EU or UK) will fulfil this requirement. Relevant complaint to sale ratios are also likely to be considered in relation to the determination of whether mild or transient reactions or irritations are occurring in only some users as compared to a more widespread phenomenon.

Whilst MoCRA does not explicitly prohibit the usage of animal testing data as part of a Safety Substantiation, Section 3507 indicates that “it is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.”

The deadline for RPs to ensure they have suitable Safety Substantiation in place is the 29^th December 2023 for every Cosmetic Product that is currently available in the USA.

Evidence of Safety Substantiation for Cosmetic Products brought to the USA Market after this date is inferred to be required at the time of Marketing.

MoCRA includes a broad definition of an ‘Adverse Event’ as “any health-related event associated with the use of a cosmetic product that is adverse”. In addition to this there is a more detailed definition of what is considered a ‘Serious Adverse Event’ (Sec. 604, (5)). This is an Adverse Event that: 

• Results in
  • Death
  • A life-threatening experience
  • Inpatient hospitalization
  • A persistent or significant disability or incapacity
  • A congenital anomaly or birth defect
  • An infection
  • Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual
• Requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).

Beginning on the 29^th December 2023, an RP must submit a copy of a Serious Adverse Event Report alongside a copy of the label on or within a Cosmetic Product within 15 business days of receiving such a report. In addition, where an RP received new (material) medical information related to a Serious Adverse Event Report within 1 year of the initial report submission they must provide this new information within 15 business days of becoming aware of it. For the purpose of clarity, Serious Adverse Event Reporting and Updating only applies to such events associated with the use of the Cosmetic Product in the USA (i.e. RPs do not have to submit Serious Adverse Event Reports it becomes aware of but which are related to the use of a Cosmetic Product outside of the USA).

A specific system for the submission of Cosmetic Serious Adverse Event Reports is currently being developed. In the interim RPs are being asked to utilise the Safety Reporting Portal (SRP). Access to the SRP can be requested from the FDA by emailing faersesub@fda.hhs.gov

Sec. 609, (a), of MoCRA indicates a requirement that “Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.”

The current understanding of Delphic HSE is that this is to be read as requiring either a domestic address, or domestic phone number, or electronic contact information. This ties in with our understanding that an RP does not have to be based in the USA per se and as such could provide only electronic contact information in relation to receiving adverse event reports.

Note that Sec. 604, (4) of MoCRA defines the RP as “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label…” and the requirement under Sec. 609, (a) is specifically related to the RP being able to receive adverse event reports.

Whilst a foreign Facility does require an Agent in the USA for the Facility Registration (as discussed above), it is not clear at present that this extends to the Agent information appearing on the label in place of the RP. Indeed, as there will be occasions where a Distributor is defined as the RP but does not have any direct Facility Registrations (i.e. they distribute Cosmetic Products under their name, but do not directly own any Manufacturing or Processing Facilities) it is likely that cases will arise where an RP would not have indicated or nominated a USA Agent at any stage of fulfilling its own obligations.

Because of this, Delphic HSE are currently operating with the view that it must be the Contact Information of the RP that appears on the Product Label (even if this is just electronic contact information because they are not based in the USA). Further clarification and guidance from the FDA may alter the consideration of whether an Agent based in the USA (or indeed any other third party) could have their contact information provided on a product label instead of that of the RP for the purpose of receiving adverse event reports.

MoCRA introduces a range of additional Powers & Authorities to the FDA in relation to Cosmetic Products and the enforcement of MoCRA itself. This includes:

• Records Access, including the access to safety records.
• Mandatory Recall Authority, where the FDA believes there is a reasonable probability that a Cosmetic Product is Adulterated, Misbranded or poses a risk of serious adverse health effects to consumers.
• Suspension of a Facility Registration, where the FDA believes there is a reasonable probability that a Facility is Manufacturing or Processing Cosmetic Products in such a way as to pose a risk of serious adverse health effects to consumers.

In addition to the obligations placed on Industry, discussed above, MoCRA includes a requirement for Regulators to provide further proposals on a number of aspects related to Cosmetic Product Manufacturing and Processing as well as the distribution of Cosmetic Products in the USA. This includes:

• Proposal on Asbestos Testing for Talc containing Cosmetic Products (29^th December 2023).
• Proposal on the requirements for Labelling of Fragrance Allergens included a Cosmetic Product (29^th June 2024).
• Proposal on Good Manufacturing Practices (GMP) for Facilities (29^th December 2024)
• Risk Assessment of the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in Cosmetic Products

At this time, the deadlines are for Regulators to generate Proposals or Risk Assessments related to future controls. It is yet to be established what implementation or enforcement timeframes may be associated with these proposals and risk assessments.