MoCRA registration is the single biggest compliance change in the US cosmetics market in decades, and it moves the burden of documentation from a voluntary practice to a legal requirement. A brand launching in the US now needs a facility registration, a product listing, records of safety substantiation and an adverse event procedure, and the obligations split between the manufacturer and the brand in ways that are often misunderstood.
1. Facility registration
Every facility that manufactures or processes a cosmetic for US distribution must register with the FDA and renew every two years. The registration is the manufacturer’s obligation, not the brand’s, and a brand should obtain the registration number as part of its supplier qualification. A filler that cannot produce a registration number is not a compliant source for the US market, whatever the price.
2. Product listing
Each product has to be listed with the FDA, with the responsible person, the ingredients and the facility. The listing is the brand’s obligation as the responsible person, and it has to be updated when the formula or the pack changes materially. A listing is not an approval: it is a notification, and the FDA does not review it before the product is sold.
3. Safety substantiation
MoCRA requires adequate safety substantiation for each product, and the standard is a reasonable basis – which in practice means a safety assessment, a toxicological review of the ingredients at the use levels, and stability and microbial data. The file belongs to the responsible person. A brand that buys a stock formula still owns the obligation to hold a substantiation file for its own product, even if the underlying data came from the supplier.
4. Adverse event reporting
Serious adverse events have to be reported to the FDA within 15 business days, and the brand has to keep records for six years. That means a complaint intake process, a severity classification and a named responsible person. A brand selling through a marketplace often has no visibility of the complaint, which is a structural risk rather than a paperwork one.
5. Fragrance and allergen disclosure
MoCRA introduced fragrance allergen disclosure on the label for a defined list of allergens, and it applies to fragrance ingredients above a threshold. A brand using a compounded fragrance needs an allergen declaration from the fragrance house, in writing, before the artwork is finalised. This is the requirement that most often delays a US launch at the last minute.
6. Small business and the exemptions
Small businesses have relief from some requirements, but the definition and the scope are narrow, and the relief does not cover safety substantiation. A brand should assume it has the full obligation and treat any relief as a bonus rather than a plan.
7. The document set to collect
Ask the filler for four documents before the purchase order: the facility registration number, a certificate of conformity, the safety assessment or the summary that the brand’s assessor will build on, and the fragrance allergen declaration where applicable. A supplier that answers all four within a week is set up for the US market. A supplier that answers two is a supplier whose other customers are not selling into the US, and that tells you more than any audit report.
8. Commercial profile
US-bound launch with a stock formula, 12 to 16 weeks including listing and safety file. See the skincare set range and the EU notification guide for the parallel European path.
