Cosmetic brands entering the EU, UK, and US for the first time frequently underestimate how different the three regulatory frameworks are in practice. The EU's Cosmetics Regulation (EC) 1223/2009 imposes a mandatory Responsible Person, a pre-market notification via CPNP, and a prescribed safety dossier structure. The UK has retained an equivalent framework post-Brexit but operates it independently — requiring a separate UK Responsible Person, a separate SCPN notification, and UK-specific documentation. The US Modernisation of Cosmetics Regulation Act (MoCRA), in force since 2022, has introduced mandatory product listing and facility registration obligations that did not previously exist at federal level.
These are not minor administrative differences. They create genuinely separate compliance programmes for each market. The table below maps the eight most operationally significant dimensions of cosmetic compliance across all three jurisdictions, with the key 2025–2026 changes highlighted in the final row.
At a Glance: EU vs UK vs US Cosmetics Compliance
| Requirement | EU (EC 1223/2009) | UK (OPSS) | US (MoCRA / FDA) |
|---|---|---|---|
| Responsible Person | Mandatory — EU-established legal or natural person; holds PIF and is accountable for safety | Mandatory — UK-based (GB) RP required separately from EU RP; OPSS enforced | "Responsible person" = manufacturer, packer, or distributor whose name appears on label |
| Product Registration / Listing | Notification via CPNP portal before placing on market | Notification via SCPN portal (separate from CPNP); mandatory before GB market placement | Product listing via FDA Cosmetics Direct portal — enforced from July 1, 2024 |
| Facility Registration | Not required under EU Cosmetics Regulation | Not required under UK Cosmetics Regulation | Mandatory under MoCRA — each manufacturing/processing facility must register with FDA |
| Safety Assessment | Mandatory CPSR (Cosmetic Product Safety Report) by qualified safety assessor; part of PIF | Equivalent UK CPSR required; separate from EU CPSR | Safety substantiation records required; format not as prescribed as EU/UK |
| Product Information File (PIF) | Mandatory — includes CPSR, formula, GMP evidence, claims justification; kept 10 years | Equivalent UK PIF required — separate document maintained by UK RP | No equivalent PIF requirement; safety substantiation records must be maintained |
| Labelling — Key Requirements | INCI ingredient list (descending order); EU RP name & address; warnings; function; net contents | UK RP name & UK address; country of origin; INCI list; compliant warnings under UK SI | Ingredient list (INCI, descending order); RP contact information (from Dec 29, 2024) |
| Adverse Event Reporting | Serious Undesirable Effects (SUEs) reported to competent authorities within 20 days | SUEs reported to OPSS | Serious adverse events reported to FDA within 15 business days under MoCRA |
| Key 2025–2026 change | 1 May 2026: Omnibus VIII (Regulation EU 2026/78) applies; further CMR bans from Jan 1, 2027 | 15 Jul 2026: 4-MBC ban (UK SI 2026/23); 16 CMR substances banned Aug 15, 2026 | cGMP final rule pending; ongoing MoCRA facility registration enforcement build-out |
The Responsible Person: Three Separate Appointments
The single most operationally significant difference between the EU, UK, and US frameworks is how they define and assign the "Responsible Person." In the EU, the Responsible Person must be established within the EU — they hold the Product Information File, are responsible for safety compliance, and bear liability for the product in the EU market. Following Brexit, the UK operates an identical but entirely independent RP obligation for the GB market: a UK-based Responsible Person is required, holds the UK equivalent PIF, and is separately accountable to OPSS. These are not the same appointment and cannot be fulfilled by a single entity unless that entity has legal presence in both jurisdictions.
The US framework under MoCRA uses "responsible person" to mean something different — the manufacturer, packer, or distributor whose name appears on the label. This is not a compliance appointment in the EU/UK sense. However, MoCRA does impose facility registration and product listing obligations directly on the responsible person, and adverse event reporting obligations that did not previously exist at federal level. Brands entering the US market for the first time should treat MoCRA as a new compliance system requiring its own programme — not simply a lighter version of EU obligations.
Substance Restrictions: Rolling Amendments vs Statutory Schedules
EU substance restrictions are managed through the Commission Regulation amendment process, which adds substances to Annexes II (banned), III (restricted), IV (colourants), V (preservatives), and VI (UV filters) on a rolling basis. The Omnibus programme has added CMR and other substances annually since 2019. Each amendment triggers a market placement deadline and a sell-through period — meaning brands must continuously track the Official Journal for changes affecting their formulations. The UK's post-Brexit position is to maintain an equivalent but independently administered substance list, which is beginning to diverge from the EU list — the UK's SI 2026/23 additions are similar to but not identical to EU Omnibus VII and VIII.
The US currently has no statutory list of prohibited cosmetic ingredients equivalent to EU Annex II. The FDA can take enforcement action against unsafe products under the FD&C Act, and California's Cosmetics Act includes some substance restrictions, but the federal framework does not impose the same pre-market substance assessment system. This creates a material asymmetry: formulations approved for EU and UK markets are not automatically compliant in the US, but the absence of a comprehensive US restriction list means separate US-specific substance review is less common in practice.
Planning for Multi-Market Cosmetic Compliance
Brands targeting EU, UK, and US simultaneously should plan for three distinct compliance programmes rather than one programme with regional adaptations. The CPNP and SCPN notifications are separate pre-market steps. The EU and UK PIFs must be maintained as separate documents under separate RP appointments. The MoCRA product listing and facility registration must be completed and kept current in the FDA Cosmetics Direct portal. Adverse event reporting timelines differ across the three jurisdictions. And the substance restriction calendars diverge annually.
The most effective approach is to use the EU Cosmetics Regulation as the baseline — given its prescriptive requirements — and then layer on the UK-specific differences and the MoCRA-specific obligations as additional tracks. This reduces duplication while ensuring that each market's specific requirements are met by someone accountable for them.
Selling Cosmetics in Multiple Markets?
TGC manages multi-market cosmetic compliance across EU, UK, US, and APAC — from Responsible Person appointments and CPNP/SCPN notifications to PIF maintenance and substance restriction monitoring.
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