MoCRA Compliance for European Cosmetic Exporters: The FDA Requirements EU Brands Keep Getting Wrong

Most European cosmetic brands I speak with arrive at the US market conversation with genuine confidence. They’ve got a thorough Product Information File, a safety assessment signed by a qualified toxicologist, EU GMP-compliant manufacturing certified to ISO 22716, and often years of successful sales across multiple European markets. They assume — quite reasonably, it seems to them — that the hard work is largely done.

The Modernization of Cosmetics Regulation Act (MoCRA), signed into US law on December 29, 2022, has made that assumption expensive. For the first time in 86 years, US federal law imposes substantive pre-market obligations on cosmetic manufacturers — including foreign ones. And the requirements diverge from EU Regulation 1223/2009 in ways that create real compliance gaps even in the most carefully managed product lines.

Here is where European exporters are getting tripped up, and what to address before your products face FDA scrutiny.

What MoCRA Actually Changed — And Why EU Brands Underestimate It

Before MoCRA, the US cosmetics market operated under regulatory standards that most EU quality professionals found shockingly permissive. There was no mandatory pre-market safety notification, no formal product registration, and no explicit statutory requirement to document safety substantiation. European brands routinely entered the US market without any FDA interaction at all — label to FDA format, ship, done.

That model is gone. MoCRA created five new mandatory obligations that apply to every cosmetic manufacturer selling into the US, regardless of where they are incorporated or where their manufacturing facility sits:

1. Facility registration — required within 60 days of first marketing in the US, and renewed biennially in every odd-numbered calendar year
2. Product listing — each finished product must be submitted to FDA within 120 days of first being marketed in the US
3. Safety substantiation — documented, adequate, and well-controlled evidence that each product is safe for its intended use, maintained by the responsible person
4. Serious adverse event reporting — events meeting FDA’s threshold must be reported within 15 business days of the responsible person receiving a report
5. GMP compliance — FDA published its proposed GMP rule in February 2024; final enforcement is expected to align substantially with ISO 22716, but the two frameworks are not identical, and US-specific deviations exist

A European brand that entered the US market in 2020 and hasn’t revisited its US compliance posture since then is almost certainly non-compliant on at least facility registration — and probably product listing as well.

Three Mistakes That Show Up Repeatedly in EU-to-US Files

Mistake 1: Treating the PIF as a US safety substantiation

The EU Cosmetics Regulation requires a PIF containing a Cosmetic Product Safety Report (CPSR), signed by a qualified safety assessor. For a well-formulated product, it’s a rigorous and comprehensive document. But the CPSR is not, by itself, FDA’s safety substantiation — and assuming it is creates a documented compliance gap.

FDA’s requirement under 21 U.S.C. §364b is framed differently from the CPSR standard. The safety data must be adequate and well-controlled for the product’s intended use in the US context, including reasonably foreseeable conditions of use by American consumers. The standard allows flexibility — existing scientific literature, SCCS opinions, clinical data, and ingredient-level safety assessments are all legitimate inputs — but the substantiation must be documented specifically for each product as formulated and as marketed in the US.

A CPSR that references EU toxicological thresholds, European consumer use patterns, and SCCS safety opinions alone may not fully satisfy FDA’s standard without supplemental documentation bridging those references to the US regulatory context. This is a manageable gap, but it requires deliberate attention.

Mistake 2: Misreading the cosmetic-versus-drug boundary

The EU draws the cosmetic-versus-medicine distinction primarily on therapeutic effect. The US draws it differently — and in ways that consistently catch European brands off guard, because the US definition captures a wider product range than most EU regulatory teams expect.

In the US, a product is regulated as an OTC drug if it makes a drug claim or contains an ingredient classified as an “active ingredient” under an FDA OTC monograph. This applies regardless of how the product is classified in France, Germany, or the UK. Some common examples:

• Sunscreen products carrying SPF claims are regulated as OTC drugs in the US — every one of them. A French SPF 30 moisturiser that’s a straightforward cosmetic under Regulation 1223/2009 requires OTC drug compliance in the US. That means either conformance with FDA’s sunscreen monograph (21 CFR Part 352 — now under rulemaking) or, in certain cases, a New Drug Application.
• Anti-dandruff shampoos are OTC drugs under the US drug monograph system.
• Teeth-whitening products making specific efficacy claims often cross into drug territory depending on the claim language.
• Products claiming to “reduce wrinkles” may be cosmetics. Products claiming to “rebuild collagen” or “modify skin cell function” almost certainly are not.

Misclassifying a drug as a cosmetic doesn’t just create a labeling problem — it means the product arrived without the required drug approval or monograph compliance. That is a serious import violation, and FDA’s import alert program identifies exactly these situations.

Mistake 3: Assuming the US distributor handles registration

Many EU brands sell through a US importer or distributor and operate on the assumption that the distributor manages all US regulatory formalities. Under MoCRA, the “responsible person” — defined as the manufacturer, packer, or distributor whose name appears on the label — bears the registration, product listing, and safety substantiation obligations.

If your US distribution partner private-labels your product and puts their name on the US label, they are the responsible person. If they sell your product under your EU brand name, you are the responsible person — even with no US legal entity, even with the product manufactured and shipped from France, even if you’ve never attended an FDA inspection.

This distinction causes genuine confusion in distribution negotiations. Before finalising any US distribution arrangement, confirm in writing which party carries the MoCRA responsible person obligations and has completed facility registration. We see this gap in contracts far more often than we should.

Where EU Safety Data Translates — And Where It Doesn’t

The good news for EU exporters is genuine: EU safety assessment frameworks are rigorous, and a thorough CPSR gives you a strong foundation from which to build US substantiation. SCCS opinions on individual ingredients are recognised by FDA toxicologists as credible scientific literature. The EU’s Annex II list of 1,665+ prohibited substances is considerably more restrictive than the US prohibited ingredients framework, meaning EU-compliant formulations rarely contain substances that are prohibited in the US context.

The divergences appear at the edges — but they’re edges that affect a large proportion of products:

Fragrance allergen labelling. MoCRA’s final fragrance allergen rule requires disclosure of 26 specific allergens on the product’s ingredient list when present above specified concentration thresholds. EU Regulation 1223/2009 already requires these same 26 allergens to be listed on rinse-off and leave-on products above their respective EU thresholds. But the US and EU thresholds are not identical for all 26 allergens, and FDA’s formatting requirements for the declaration differ from the EU’s. A label that meets EU allergen declaration requirements will likely need revision before it satisfies MoCRA’s final rule.

Ingredient labelling format. Both markets require INCI nomenclature in the ingredient declaration. But FDA’s regulations under 21 CFR Part 701 add specificity requirements that EU-formatted labels typically don’t meet: declaration strictly in descending order of predominance (with specific rules for ingredients at concentrations of 1% or less), net quantity expressed in both metric and US customary units, and the required “Ingredients:” heading formatted to FDA specification. Almost every EU label we review needs revisions before it meets 21 CFR Part 701.

Color additives. The US maintains its own list of colour additives approved for cosmetic use (21 CFR Parts 73, 74, and 82), and it does not mirror the EU’s approved colourant list. An EU-approved pigment may not appear on FDA’s approved list, or may be approved for different uses — eye area versus non-eye area, for instance — than the EU authorisation permits. This is one of the most consistently overlooked areas in EU-to-US formulation review.

Before Your First US Shipment: The Right Sequencing

Practical order matters as much as the checklist itself. When we work with European brands preparing for US market entry, the sequence looks like this:

Classify every product first. Before registration or labelling review, determine whether each SKU is a US cosmetic or OTC drug. For any product containing a sunscreen active, the answer is always drug. For others, map your specific marketing claims — in English, as they will appear on US-facing materials — against FDA’s drug claim guidance.

Register the facility before listing products. FDA’s Cosmetics Direct electronic submission system handles both, but product listings reference the registered facility. Attempting to list products before facility registration is complete creates submission errors that delay market entry. Foreign facilities require a US authorised agent with a US address — this is a genuine regulatory requirement, not a recommendation.

List every product individually. Each SKU requires a separate product listing submission, including a complete ingredient declaration formatted to FDA requirements. If you plan to launch 35 products in your US debut, that is 35 individual listing submissions.

Review labels against 21 CFR Part 701 and the MoCRA fragrance allergen final rule. Do this before printing US packaging. Label revision after an import hold is significantly more costly than getting it right before shipment.

Document US safety substantiation explicitly. Have a regulatory professional review your existing CPSRs against FDA’s safety substantiation standard and identify gaps. The goal is not to discard the EU work — it’s to build on it deliberately and document the bridge.

The Renewal Window EU Brands Miss

One timing detail that European brands consistently overlook: MoCRA’s biennial renewal cycle falls in odd-numbered years. Facilities that registered in 2023 needed to renew in 2025. A brand that completed initial registration in mid-2024 — perhaps after a delayed US launch — would have faced a 2025 renewal window within months of first registration, then again in 2027.

FDA has not yet launched aggressive enforcement actions specifically targeting expired registrations, but the programme is maturing and import alert risk tied to registration lapses is real heading into 2027 and beyond. The administrative fix is straightforward: verify your current registration status in FDA’s Cosmetics Establishment Registration database, confirm each product listing remains active, and calendar your next renewal now.

MoCRA created an entirely new compliance infrastructure for a market that had operated without it for eight decades. European brands with strong EU compliance programmes are well-placed to meet these requirements — but only if they treat MoCRA as a distinct framework rather than an extension of what they already know. The distance between the two systems is smaller than the FDA website makes it seem, and larger than most EU regulatory teams assume.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe. Learn more about our team

Talk to our team about EU market entry — we handle MoCRA registration, product classification, and label compliance for European brands entering the US market. Contact us

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