Selling Cosmetics in the US and EU: MoCRA vs. CPSR¶

Q: Can I use the same safety assessor for both the EU CPSR and US MoCRA substantiation?

The same toxicological data can support both, but the EU CPSR must be signed by a qualified safety assessor meeting EU criteria. A CPSR alone does not satisfy the MoCRA obligation to maintain separate safety substantiation records.

Q: Do I need a US Responsible Person if my brand is not US-based?

Yes. For imported cosmetics without a US entity on the label, the US importer is the Responsible Person and must handle FDA registration, product listing, and adverse event reporting under MoCRA.

Q: Is INCI labeling mandatory in the US?

The FDA strongly encourages INCI but has not mandated it by regulation. Almost all cosmetic brands use INCI on US labels for consistency with EU labeling. Non-INCI labeling is discouraged by industry practice.

A cosmetic brand selling in both the United States and the European Union must comply with two regulatory frameworks that are structurally similar but operationally distinct — and neither framework accepts the other's documentation. The US system, modernized in 2022 by MoCRA, emphasizes manufacturer self-declaration of safety. The EU system, established under the Cosmetic Products Regulation (EC) 1223/2009, requires a qualified safety assessor to prepare a formal Cosmetic Product Safety Report (CPSR) and mandates notification to the EU's Cosmetic Product Notification Portal (CPNP) before the product reaches the market.

For brands selling in both markets, the compliance cost is additive — you need both a MoCRA safety substantiation and an EU CPSR. But the ingredient data and toxicological assessments that support one can inform the other, and building both in parallel from the same product data is significantly more efficient than treating them as separate compliance projects.

The Two Frameworks Side by Side¶

Requirement	US (MoCRA)	EU (EC 1223/2009)
Facility registration	FDA registration required, renewed every 2 years	No facility registration; Responsible Person identified
Product notification	FDA product listing (ingredients, category, label image)	CPNP notification before first market placement
Safety assessment	Self-declared safety substantiation	CPSR by qualified safety assessor (Annex I)
Responsible Person	Manufacturer, packer, or distributor on label	Legal entity established in the EU
GMP	FDA proposed rule (not yet final)	ISO 22716 compliance required
Adverse events	Report serious events to FDA within 15 days	Report serious undesirable effects to competent authority
Ingredient labeling	Common or usual name	INCI nomenclature
Fragrance allergens	FDA proposed list (2024)	Annex III list of 26 (expanding)
Animal testing	Not federally banned; some state restrictions	Full marketing ban on animal-tested cosmetics
Recall authority	FDA mandatory recall (new under MoCRA)	Competent authority can order withdrawal
Penalties	Warning letters, civil/criminal enforcement	Product withdrawal, fines, criminal penalties

The Safety Documentation Split¶

This is where dual-market brands lose time and money. A US MoCRA safety substantiation and an EU CPSR are different documents satisfying different regulators:

MoCRA safety substantiation: No prescribed format. Must demonstrate that qualified experts evaluated the product and concluded it is safe under labeled conditions of use. FDA does not pre-approve. The manufacturer maintains the records.
EU CPSR: A specific, structured document defined by Annex I of Regulation 1223/2009. Must be prepared by a qualified safety assessor with a diploma in pharmacy, toxicology, medicine, or equivalent. Divided into Part A (cosmetic product safety information — ingredient data, physicochemical properties, stability, microbial quality) and Part B (safety assessment — the assessor's conclusion, labeled warnings, reasoned statement).

The toxicological data that underpins both documents is largely the same — ingredient safety profiles, exposure assessments, concentration limits. Brands that commission a CPSR for the EU can use the underlying toxicological data to prepare the MoCRA safety substantiation for the US. But the EU CPSR itself, as a formatted document, does not satisfy MoCRA — and vice versa.

Ingredient Listing: INCI vs. Common Names¶

The US and EU use different ingredient nomenclature:

EU: The International Nomenclature of Cosmetic Ingredients (INCI) system — Latin binomial names for botanicals, standardized chemical names.
US: Historically allowed common names, but the FDA strongly encourages INCI and most brands now use INCI on US labels to maintain consistency with EU labeling.

If a brand uses INCI on both US and EU labels, the ingredient list can be identical — which simplifies manufacturing and labeling for dual-market products. The product listing required under MoCRA, however, requires separate submission to the FDA's electronic portal regardless of label format.

Fragrance Allergen Labeling: Both Markets Are Moving¶

Both the US and the EU are expanding fragrance allergen disclosure requirements beyond what has historically been required:

EU: Annex III currently lists 26 fragrance allergens that must be individually labeled when present above 0.001% in leave-on products and 0.01% in rinse-off products. The European Commission has adopted an expansion to add more allergens based on the SCCS opinion.
US: MoCRA required the FDA to issue a proposed rule identifying fragrance allergens that must be individually disclosed on cosmetic labels. The FDA published its proposed list in 2024. The final rule, when issued, will end the practice of listing "fragrance" as a catch-all ingredient for products sold in the US — bringing US requirements closer to the EU standard.

Brands should track both the EU's expanded allergen list and the FDA's proposed rule to avoid reformulating product labels twice.

The CPNP vs. FDA Product Listing Difference¶

The EU's CPNP notification and the FDA's MoCRA product listing serve the same regulatory purpose — a government registry of cosmetic products on the market — but have different operational implications:

CPNP: Required BEFORE the product is first placed on the EU market. The Responsible Person must be established in the EU. The notification includes the product formulation (quantitative), the CPSR, the label, and the Responsible Person's details. Toxicological data is uploaded to the CPNP.
FDA listing: Required within 120 days of first marketing for new products. The US Responsible Person submits the ingredient list, product category, and label image. Toxicological data is NOT uploaded to the FDA — it is maintained by the Responsible Person and produced on request.

The CPNP is a pre-market notification with toxicological data. The FDA listing is a post-market registration without toxicological data. The timing and data requirements are different, and brands selling in both markets must manage both portals.

Practical Dual-Market Cosmetics Compliance Checklist¶

EU CPSR — Commissioned from a qualified safety assessor before EU market placement. Covers every SKU formulation.
CPNP Notification — Filed before first EU market placement. Responsible Person established in an EU Member State.
MoCRA Facility Registration — Every manufacturing facility registered with FDA. Renewed every 2 years.
MoCRA Product Listing — Filed within 120 days of first marketing for new products. Submitted through FDA's electronic portal.
Safety Substantiation (US) — Documented safety assessment maintained by the US Responsible Person. Uses toxicological data from CPSR where applicable.
US Responsible Person — A US-based entity identified on the product label or as the importer of record.
Ingredient Labeling — INCI nomenclature maintained across both markets. Fragrance allergen labeling tracked against both the EU Annex III expansion and the FDA proposed rule.
GMP Compliance — ISO 22716 compliance for EU production. FDA GMP final rule tracked for US production.
CA TPPA Packaging — Packaging for products sold in California and 19 other states complies with heavy metal limits.

How Sustalium Simplifies Dual-Market Cosmetic Compliance¶

Running two regulatory frameworks in parallel for the same product catalog — EU CPSR and CPNP on one side, FDA MoCRA product listing and safety substantiation on the other — creates duplication, version control problems, and audit gaps.

Sustalium centralizes cosmetic compliance across both markets:

Unified Ingredient Database — Enter your formulation once, structured by INCI name and concentration. Sustalium maps the data to both EU (CPSR Part A, CPNP) and US (MoCRA product listing, safety substantiation) documentation formats.
EU CPSR Integration — Link your safety assessor's CPSR to your product profile. The toxicological data feeds your MoCRA safety substantiation, eliminating duplicate assessment.
Dual Portal Support — Structured data export formatted for CPNP notification and FDA product listing submission. Two regulators, one data source.
Packaging Compliance — Generate CA TPPA Certificates of Compliance for your product packaging, linked to your cosmetic SKUs.

One Product, Two Markets, One Compliance Platform

Running separate EU and US cosmetic compliance programs doubles the administrative overhead without adding safety. Manage your CPSR and MoCRA documentation from a single product profile.

With Sustalium, build your dual-market cosmetics compliance dossier for just €10 per document.

Start Your Cosmetics Compliance Now →

Frequently Asked Questions¶

Can I use the same safety assessor for both the EU CPSR and US MoCRA substantiation?

The EU CPSR must be signed by a qualified safety assessor meeting the EU qualification criteria. The MoCRA safety substantiation does not prescribe specific qualifications for the assessor, only that qualified experts conducted the evaluation. The same toxicological data can support both, but the CPSR is a specific EU-regulatory document, and a CPSR alone does not satisfy the MoCRA obligation to maintain safety substantiation records for FDA review.

Do I need a US Responsible Person if my brand is not US-based?

Yes. MoCRA defines the Responsible Person as the manufacturer, packer, or distributor whose name appears on the product label. For imported cosmetics where no US entity appears on the label, the US importer is the Responsible Person and must handle FDA facility registration, product listing, and adverse event reporting.

Is INCI labeling mandatory in the US?

The FDA strongly encourages INCI nomenclature, and almost all cosmetic brands have adopted it for US labels to maintain consistency with international labeling. The FDA has not mandated INCI by regulation, but labeling with non-INCI common names creates inconsistency with EU labels and is discouraged by industry practice.

Last updated: July 13, 2026