The US and EU take fundamentally different approaches: the EU requires pre-market safety assessment and notification through a responsible person, while the US places obligations on facilities and products after market entry under MoCRA. Both require documentation that a manufacturer must supply and a brand must hold. This article covers what each market demands, who is responsible for what, and where launches most often stall.
United States: MoCRA in practice
MoCRA — the Modernization of Cosmetics Regulation Act — shifted US cosmetics regulation from largely post-market reactive to a structured registration regime. The practical obligations:
- Facility registration. Facilities that manufacture or process cosmetic products for US distribution must register with FDA, renewable on a two-year cycle. This obligation sits with the manufacturer, not the brand.
- Product listing. Each marketed product must be listed, identifying the responsible person and the manufacturing facility. This sits with the responsible person — usually the brand.
- Adverse event reporting. Serious adverse events must be reported to FDA within a defined window, with records retained.
- Labeling. Ingredient declaration, net quantity, business identity, and specific requirements for professional-use products and fragrance allergens.
- GMP. FDA is developing mandatory GMP requirements for cosmetics; until finalised, existing good manufacturing practice expectations apply.
What the brand should ask its manufacturer for: the facility registration number, confirmation that the facility is registered for the relevant product category, a Certificate of Analysis per batch, and safety substantiation documentation.
European Union: the responsible person model
The EU requires a responsible person established in the Union, a Cosmetic Product Safety Report prepared by a qualified safety assessor, notification through CPNP, and a Product Information File held available for inspection.
The specific obligations, from the regulation text: a Responsible Person established in the Union is mandatory for market placement (Art. 4(1)); a Cosmetic Product Safety Report must be completed before placement (Art. 10(1) and Annex I); the Product Information File must be retained for ten years after the last batch is placed on the market (Art. 11(1)); and notification must be submitted electronically before market entry, in practice through CPNP (Art. 13(1)).
- Responsible person (RP). A legal or natural person established in the EU who accepts liability. For a non-EU brand, this is usually a appointed EU entity or an authorised representative.
- CPSR. Part A covers product safety information; Part B is the safety assessment itself, signed by a qualified assessor. It draws on formula data, stability results, microbiological quality, and packaging compatibility — all of which the manufacturer supplies.
- CPNP notification. Submission before market placement, including product category, formula framework, and labelling.
- PIF. The full Product Information File, retained for ten years after the last batch is placed on the market, available to authorities on request.
- GMP. Manufacturing must comply with ISO 22716, which is the harmonised standard for the EU cosmetics regulation.
Ingredient restrictions differ by market
A formula that is compliant in one market is frequently non-compliant in another, and this is the most common reason a launch slips.
Examples of divergence a formulator must design around:
- Preservatives — several permitted in the US are restricted or prohibited in the EU, and maximum concentrations differ.
- UV filters — the permitted list differs materially between the two regimes.
- Colourants — the EU positive list is narrower than the US permitted set.
- Fragrance allergens — the EU requires declaration of specific allergens above defined thresholds; the US does not have an equivalent requirement.
- Nanomaterials — the EU requires specific notification and labelling.
This is why the brief should state target markets before the formula is finalised. Retro-fitting compliance into an approved formula means reformulation, which restarts stability testing.
Labeling requirements that catch brands out
The two most common labeling failures are ingredient nomenclature and the responsible person’s address.
- Ingredient names must follow INCI in both markets, in descending order of concentration above 1%, with colourants listed separately in any order.
- The EU requires the RP’s name and address on pack; a US-only address on an EU product is a compliance failure.
- Net quantity must use the correct units and format per market.
- Warnings and usage instructions for professional-use products have specific requirements under MoCRA.
- PAO or minimum durability — the period-after-opening symbol or best-before date, as applicable.
Who is responsible for what
| Obligation | US | EU |
|---|---|---|
| Facility registration | Manufacturer | N/A (GMP instead) |
| Product listing / notification | Responsible person (brand) | Responsible person, via CPNP |
| Safety assessment | Brand (substantiation) | Qualified assessor, via RP |
| GMP | Manufacturer | Manufacturer (ISO 22716) |
| Label compliance | Brand | Brand / RP |
| Adverse event reporting | Responsible person | RP, to competent authority |
| PIF retention | Records retained | RP, ten years |
Where launches actually stall
Three points, repeatedly: missing stability data, missing packaging compatibility data, and a formula that was never screened against the target market’s restriction list.
- Stability data gaps delay the CPSR, because the assessor cannot sign without it. This is a scheduling problem, not a formulation problem — the testing has to start early enough.
- Packaging compatibility is part of the CPSR for good reason: a formula that interacts with its container changes composition over shelf life.
- Restriction screening is cheap before the formula is frozen and expensive afterwards.
What BodyLife Global provides
BodyLife Global supplies the manufacturing-side documentation for both regimes: batch COAs, stability and microbiological data, formulation disclosure for safety assessment, and manufacturing certificates covering GMP and ISO 22716.
The group holds GMP, ISO 22716, ECOCERT and COSMOS certifications, FDA registration, and SMETA audit, and provides CPNP and CPSR documentation support. Facilities have been audited by retail groups in Russia and the United States as well as by ECOCERT within the past year.
Products are shipped to the US, Europe, the Middle East, South America, Canada, Australia, and parts of Southeast Asia, which means the formulation team routinely screens against multiple restriction lists rather than a single market.
Manufacturing runs across two GMP-certified campuses over 60,000 square meters with 20+ production lines and 100 million units of annual capacity; 5,000+ formulations in library; sampling in 7–10 days and first production in 20–30 days.
A note on scope: this article describes regulatory structure, not legal advice. Market-entry decisions should be confirmed with a qualified regulatory consultant or the relevant competent authority for your specific product.
Where launches stall
Missing stability data and formulas never screened against the target market restriction list. Both are cheap to fix before the formula is frozen and expensive afterwards.
Frequently asked questions
Can one formula be sold in both the US and the EU?
Often yes, but not automatically. Preservative, UV filter, colourant, and fragrance allergen rules diverge, so the formula must be screened against both restriction lists. Retrofitting compliance after approval means reformulation and restarted stability testing.
Do I need an EU entity to sell into Europe?
You need a responsible person established in the EU. This can be an appointed representative rather than your own entity, but the obligation — and the liability — must sit with someone in the Union.
Who files the CPNP notification?
The responsible person, or their appointed representative. The manufacturer supplies the technical data the notification draws on, but does not file on the brand’s behalf unless separately engaged to.
Is MoCRA fully in force?
Facility registration, product listing, adverse event reporting, and labeling provisions are in force. Mandatory GMP requirements are still being developed by FDA, so current expectations follow established good manufacturing practice.
Next step
State your target markets when you send the brief. The reply will flag which ingredients in your concept need substitution before the formula is frozen — which is the cheapest possible moment to find out.
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Further Reading
- What to Look for in a Cosmetic Factory Audit
- OEM FAQ: Developing an Effective Organic Shampoo for the US Market
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