The Modernization of Cosmetics Regulation Act put new, ongoing obligations on cosmetics facilities and products. Aleph tracks facility registration renewals, what each product listing still needs, and safety substantiation status in one place — alongside PFAS test reports for the same catalog. You file with FDA yourself, through Cosmetics Direct.
Facility registration renews every two years, product listings update annually. Miss either and you’re out of compliance with no product change at all — just a date that passed.
The responsible person must ensure, and keep records supporting, adequate substantiation of safety for every product (21 U.S.C. 364d(a)). Tracking which products have it, and which don’t, by hand doesn’t scale past a handful of products.
Cosmetics sold in the US often face Prop 65 exposure questions and, increasingly, state PFAS laws too. Tracking MoCRA in one tool and everything else in another means nothing talks to anything.
Facility registration, product listing, and safety substantiation status live next to the product’s other documents, such as PFAS test reports — not in separate systems.
Record your facility registration and its date, and Aleph works out the two-year renewal date — with an in-app alert before it lapses, not after.
See, for each product, the information an FDA product listing asks for and what’s still missing — including the Responsible Person and the label contact, both easy to lose track of.
Upload the safety assessment, Cosmetic Product Safety Report (CPSR), toxicology reports, and lab results. Aleph’s AI suggests each document’s type for you to confirm, files it under the product, and shows which substantiation documents are still missing.
Facility registration renews every two years; product listing updates are annual (21 U.S.C. 364c). Aleph alerts you in the app before a facility renewal comes due, so it doesn’t run out silently.
A product listing names the Responsible Person, and every cosmetic label must carry contact information for adverse event reports. Aleph flags any product missing either.
Upload your safety assessment, CPSR, tox reports, or lab results — Aleph’s AI reads them and suggests how to file them, and you confirm. Less manual data entry for what’s already on the document.
Cosmetics face more than one regulation. Keep PFAS test reports and supplier statements on the same product as its MoCRA records, with expiry alerts.
Download a substantiation package for a product when FDA asks for records — the documents on file, in one ZIP. Aleph does not submit it to FDA.
MoCRA is a compliance module like FSVP or CPSIA — no separate fee, no add-on, on any plan. It applies to products you mark as cosmetics.