EU Cosmetics Regulation, US MoCRA, UK OPSS, APAC registration - global cosmetics compliance is more demanding than ever. TGC's dedicated team handles Responsible Person designation, label reviews, PIF and CPSR preparation, ingredient compliance, and market-specific registration so your products launch legally and stay on shelves.
EU Safety Gate alerts
in 2024 - cosmetics
the #1
flagged category
Source: European Commission, April 2025
Cosmetic compliance sits at the intersection of ingredient safety, labelling law, documentation, and registration - and every major market has its own framework. The EU Cosmetics Regulation, US MoCRA, UK OPSS, and the fragmented APAC landscape all impose different obligations, with different Responsible Person requirements, different ingredient annexes, and different enforcement timelines.
In 2024, cosmetics were the most frequently flagged product category in the EU Safety Gate Rapid Alert System - accounting for 36% of all 4,137 alerts, a record high. Of the chemical risk alerts for cosmetics, 97% involved the banned fragrance ingredient BMHCA - a substance prohibited since March 2022 that continues to appear in products placed on the EU market without adequate compliance checking. The enforcement environment is intensifying, and 2026 brings a wave of new ingredient deadlines across EU, UK, and US simultaneously.
TGC provides specialist cosmetic compliance support for brands, manufacturers, and importers operating across multiple markets. We combine regulatory expertise with practical product experience - covering everything from pre-launch ingredient screening and label review through to ongoing safety monitoring, Responsible Person services, and crisis response when compliance issues emerge.
We provide Label Reviews for INCI compliance and claims substantiation, Expedited Compliance Audits for urgent gap assessments, and Full Product Compliance management for brands entering multiple markets simultaneously.
2025 and 2026 represent one of the most active regulatory periods for cosmetics in decades. Key changes are active or approaching across all major markets.
Contact information requirements on labels took effect December 29, 2024. cGMP final rule pending publication.
A further 15 CMR substances proposed for January 2027. SCCS opinions on Butylparaben, CBD, and Titanium Dioxide ongoing.
Formaldehyde-releaser warning threshold drops from 0.05% to 0.001% from July 2026.
Australia TGA scrutiny increasing for products with anti-ageing or therapeutic claims.
The enforcement dates driving reformulation, documentation updates, and label changes for brands selling cosmetics in the EU and UK.
EU Safety Gate alerts in 2024 β a record high, with cosmetics the most flagged category for the second year running
Binding EU ingredient annex updates since September 2025, with two more in force before mid-2026
FDA recall authority under MoCRA β a safety substantiation gap can now escalate to a forced recall, not just voluntary action
A structured overview of the core compliance obligations in each major market β covering Responsible Person, registration, safety assessments, labelling, and 2026 deadlines.
| Requirement | EU (EC 1223/2009) | UK (OPSS) | US (MoCRA / FDA) |
|---|---|---|---|
| Responsible Person | Mandatory β EU-established entity | Mandatory β separate UK-based entity | Manufacturer / packer on label |
| Product Registration | CPNP notification before market placement | SCPN notification (separate from CPNP) | FDA Cosmetics Direct listing (enforced Jul 2024) |
| Safety Assessment | Mandatory CPSR by qualified assessor | Equivalent UK CPSR required | Safety substantiation records required |
| Key 2026 Deadline | Omnibus VIII β May 1, 2026 | 4-MBC & 16 CMR bans β Jul/Aug 2026 | cGMP final rule pending |
Our cosmetic compliance work spans the full product lifecycle - from pre-launch ingredient screening and safety documentation through to market registration, label review, and ongoing regulatory monitoring across all your markets simultaneously.
We provide EU-based and UK-based Responsible Person services, manage product notifications through CPNP (EU) and SCPN (UK), and maintain the associated regulatory records. For US brands entering the EU or UK for the first time, we handle the full RP appointment and notification process.
We review cosmetic product labels for INCI nomenclature accuracy, ingredient declaration order, mandatory warnings, allergen disclosure (including new Annex III thresholds), claims substantiation, and jurisdiction-specific format requirements. Our reviews cover EU CLP, UK OPSS, US MoCRA, and APAC labelling frameworks simultaneously where required.
We coordinate the preparation and maintenance of compliant Product Information Files and Cosmetic Product Safety Reports for EU and UK markets - working with qualified safety assessors where required. We audit existing PIFs for completeness, identify gaps against current regulatory requirements, and manage updates triggered by formulation changes or annex updates.
We screen cosmetic formulations against EU Annex II (prohibited), Annex III (restricted), Annex IV (colorants), Annex V (preservatives), and Annex VI (UV filters) - as well as UK equivalents and US prohibited ingredient lists. For brands affected by 2025-2026 ingredient bans, we advise on compliant alternatives and manage the reformulation compliance process.
For brands entering the US market or managing ongoing MoCRA compliance, we support FDA facility registration, product listing through Cosmetics Direct, adverse event reporting system setup, safety substantiation documentation, and label compliance for MoCRA's contact information requirements - including support for foreign brands establishing their US responsible person relationship.
When a product launch is approaching, a compliance issue has been flagged, or a retailer or regulator has raised concerns, TGC's expedited audit service delivers a rapid, prioritised assessment of your cosmetic compliance status - identifying gaps, recommending immediate actions, and producing a clear remediation roadmap within days.
Discovered at customs, not in advance
One of the most common Safety Gate triggers
Authorities can request it at any time
Two jurisdictions, two portals, two legal entities
FDA enforcement exposure for unlisted brands
Each market draws the line differently
Answers to the questions we hear most often from cosmetic brands, manufacturers, and importers preparing for market entry or reviewing existing compliance programmes.
Under the EU Cosmetics Regulation (EC 1223/2009), a Responsible Person (RP) is a legal or natural person established within the EU who is designated for each cosmetic product placed on the EU market. The RP is legally accountable for compliance, including the Product Information File, safety assessment, labelling, and adverse event reporting. Non-EU manufacturers must appoint an EU-based entity as their Responsible Person before placing any product on the EU market.
The UK operates a separate, parallel system - a UK-based Responsible Person is required for Great Britain through OPSS. One entity cannot act as both EU RP and UK RP simultaneously, as each must be established in the respective jurisdiction. Brands expanding from EU into UK - or vice versa - must arrange separate RP appointments for each market.
MoCRA (Modernization of Cosmetics Regulation Act of 2022) is the most significant expansion of FDA cosmetics authority since 1938. Key requirements currently in force include: facility registration with the FDA (mandatory since July 1, 2024, renewed every two years); product listing for each marketed cosmetic through Cosmetics Direct; mandatory adverse event reporting (serious events within 15 business days); safety substantiation records; and contact information on all cosmetic labels (effective December 29, 2024).
As of January 2025, there were 9,528 active facility registrations and 589,762 product listings in the FDA system. MoCRA also grants FDA mandatory recall authority. The FDA published draft guidance on mandatory cosmetic recalls in December 2025, signalling an increasing enforcement posture.
A Product Information File (PIF) is a mandatory dossier required for every cosmetic product placed on the EU market. It must be kept by the Responsible Person and must include: a Cosmetic Product Safety Report (CPSR) prepared by a qualified safety assessor; the product description and formula; evidence of good manufacturing practice (GMP); details of any claims and supporting evidence; and records of adverse effects.
The PIF must be kept for 10 years from the date of last sale and made available to authorities on request. It must be updated whenever formulations change, when safety opinions are updated, or when ingredient regulations change - for example, when an ingredient is added to a restricted list. Failing to maintain a current PIF is one of the most common compliance failures identified in EU market surveillance. The UK has equivalent PIF requirements enforced by OPSS.
The EU cosmetic regulatory framework has been highly active. Omnibus VII (Regulation EU 2025/877), effective 1 September 2025, banned 22 CMR substances including TPO (used in UV-cured nail products) with no transition period. Omnibus VIII (Regulation EU 2026/78), published January 2026, applies from 1 May 2026 and adds further CMR bans including perborate derivatives.
A Commission proposal (WTO notification May 2025) would ban 15 further CMR substances including Triphenyl Phosphate, with application from January 2027 and sell-through until July 2028. Brands must also monitor ongoing SCCS opinions on Butylparaben (children), CBD, and Titanium Dioxide in oral care products - all of which are likely to drive further restrictions in 2026-2027.
Great Britain operates its own cosmetics regulation managed independently by OPSS, broadly retained from EU Cosmetics Regulation (EC 1223/2009) but updated via UK Statutory Instruments. Key differences: a separate UK-based Responsible Person is required; product notifications go through the UK SCPN portal (not EU's CPNP); and ingredient annex updates follow UK-specific timelines that increasingly diverge from the EU.
Key 2026 UK deadlines include the ban on 4-MBC UV filter (15 July 2026), stricter formaldehyde-releaser labelling (15 July 2026), and 16 new CMR substances banned from 15 August 2026. Northern Ireland continues to follow EU cosmetics rules under the Windsor Framework, meaning brands selling into Northern Ireland use EU requirements - not UK SI requirements.
Cosmetics were the most frequently flagged product category in the EU Safety Gate Rapid Alert System in 2024, accounting for 36% of a record 4,137 alerts - up from 32% in 2023. The primary driver is a single ingredient: BMHCA (2-(4-tert-butylbenzyl)propionaldehyde), a synthetic fragrance banned in the EU since March 2022, which accounted for 97% of chemical risk alerts for cosmetics in 2024. This indicates that many products - particularly those originating from China, which accounted for 40% of all Safety Gate alerts - are still entering the EU market containing this banned substance.
Other common failures include: prohibited or restricted ingredients above permitted limits; missing or incorrect INCI labelling; incomplete Responsible Person information; non-compliant cosmetic claims; and failure to update formulations following new Annex II/III restrictions. Source: European Commission 2024 Safety Gate Annual Report.
EU · UK · US · APAC specialists
Gap assessment in days, not weeks
Global regulatory infrastructure
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