Introduction

The regulatory landscape for cosmetic products in the United Kingdom and the European Union has undergone profound changes since the UK’s departure from the EU. This transition has not only initiated separate regulatory systems but has also set the stage for increasing divergence—especially concerning the preparation, requirements, and recognition of Cosmetic Product Safety Reports (CPSRs). With an escalation in ingredient bans, labelling changes, notification portal divergence, and differing post-market obligations, compliance professionals are facing growing pressure to reassess the feasibility and sufficiency of a single, harmonized CPSR for both markets. The central question now confronting regulatory compliance professionals is whether the practical and legal differences between the UK and EU requirements necessitate the creation of two distinct CPSRs to maintain market access and ensure uninterrupted product compliance.

This report offers a meticulous evaluation of the current and evolving regulatory divergence between the UK and EU regarding CPSRs. Drawing extensively on the most up-to-date legislation, agency guidance, industry analysis, and case studies, it dissects key regulatory differences, recent amendments, and the real-world impact on product developers and compliance teams. The report will present a detailed comparative table of UK and EU CPSR requirements, critically assess the operational and cost implications of dual certification, and provide strategic recommendations and practical best practices for global brands and their advisors.

1.1. CPSR and Its Regulatory Basis

A Cosmetic Product Safety Report (CPSR) is a mandatory, science-based assessment that demonstrates product safety under normal and foreseeable conditions of use. For both EU and UK cosmetics regulations, the CPSR is the linchpin of the Product Information File (PIF), acting as the core proof of safety for market entry¹²³⁴.

The CPSR consists of two parts:

• Part A: Cosmetic Product Safety Information – Collates data on ingredients, manufacturing, stability, impurities, microbiological quality, conditions of use, and adverse effect history.
• Part B: Cosmetic Product Safety Assessment – Provides the safety assessor’s scientific conclusion, justification, labelling requirements, and safety assessor’s credentials.

Under EU Regulation (EC) No 1223/2009, Annex I, and the assimilated UK Schedule 34 (‘UK Cosmetics Regulation’), a compliant CPSR (for each formula) is compulsory prior to marketing⁵⁶⁷.

1.2. Scope of UK and EU Cosmetics Regulations

• EU: Regulation (EC) 1223/2009 as dynamically amended.
• UK: The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34, with further amendments and guidance post-Brexit⁶.
• Northern Ireland: Remains aligned with EU Regulation (per Windsor Framework).

Both frameworks apply to all cosmetic products intended for external parts of the human body, including skin, hair, nails, lips, and external genital organs.

Core Regulatory Differences: UK versus EU CPSR

2.1. Legislative and Institutional Divergence

Since Brexit, the UK has established its independent regulatory oversight (OPSS and SAG-CS), notification portals (SCPN versus CPNP), and, critically, its own process for updating chemical and cosmetic substance regulations⁸⁹⁶. While structurally similar, the synchronization of amendments is by no means guaranteed, and independent UK scientific opinions and ministerial decisions have led to growing divergence¹⁰.

2.2. Responsible Person and Product Notification

• EU: Cosmetics must have an EU-based Responsible Person (RP). Notification is through the centralized Cosmetic Products Notification Portal (CPNP), serving all EU/EEA member states.
• UK: A separate UK-based RP is required, and notification must be submitted via the Submit Cosmetic Product Notification (SCPN) portal. Dual notification is now required for products marketed in both regions¹¹¹²¹³.

2.3. Safety Assessor Recognition

• UK: The safety assessor must hold a diploma from a UK university or equivalent recognized by UK authorities. The UK automatically recognizes EU diplomas, but the EU does not automatically recognize UK diplomas.
• EU: The safety assessor must have a diploma from an EU university or equivalent recognized by an EU Member State. Critically, EU authorities do not automatically accept UK qualifications, posing barriers to cross-border single-assessment practice¹⁴¹⁵.

2.4. Ingredient Restrictions: Emerging Divergence

While both jurisdictions rely on Annexes II-VI of the original EU Cosmetics Regulation, active divergence is rapidly increasing:

• Implementation Lag: The UK lags behind the EU implementation of new restrictions (e.g., for titanium dioxide, DHA) or adopts them on a delayed proprietary timeline¹⁶⁹.
• Active UK Divergence: UK-specific bans or limits (e.g., BHT in leave-on oral care, methyl salicylate, certain microplastics) do not always match the EU’s approach⁹⁸.
• EU Only Bans/Restrictions: The EU regularly adds new substances to Annex II/III under "Omnibus Acts” based on its ongoing Adaptation to Technical Progress (ATP) of the CLP regulation. Some of these substances are not matched in UK law (see Omnibus Acts VII and VIII, for example), creating ingredient mismatches between CPSR submissions^1718192021.

2.5. CPSR Structure and Data Requirements

The core structure (Parts A and B, with defined data headers) is nearly identical, reflecting the original EU regulation assimilated into UK law¹⁵⁶. However:

• Ingredient Compliance: Each jurisdiction requires proof that ingredients meet current local regulatory status (i.e., must not be banned, are used below established maxima, and with correct label warnings per jurisdiction).
• Formulation: The same formulation may need CPSR adjustments and revalidation if its acceptability in terms of restricted/prohibited ingredients splits between regimes.

2.6. Notification Portal Differences

• CPNP (EU): Centralized; serves all member states; accepts only EU RPs and assessment; supports integrated reporting and EU Poison Centres.
• SCPN (UK): Separate; requires more detailed notification (i.e., pH range, photos, nanomaterial data), operates in English only, and does not allow cross-editing of existing notifications¹¹¹³.
• Dual notification is irreversible for new-to-market products; each notification is legally required before product launch in the respective jurisdiction.

2.7. Labelling and Packaging

Both regimes require:

• RP name (UK RP for UK; EU RP for EU).
• RP address
  • UK RP for UK (Uk does not allow the use of a PO box).
  • EU RP for EU.
• Country of origin (not just “Made in EU”; the specific country is required for UK).
• Compliance with annexed lists for warnings, ingredients, and claims.

However, differences in transitional provisions (e.g., “UKCA” marking for aerosols, “Made in [country]” for GB versus “Made in EU” is not acceptable), and ingredient labelling nuances must be anticipated on a per-market basis⁶.

Recent Regulatory Updates and Divergence Drivers

3.1. Recent EU Regulatory Changes Affecting CPSR

Ingredient Bans and Restrictions via Omnibus Acts

• Omnibus Act VII (EU 2025/877): From 1 September 2025, bans over 20 additional CMR substances (Category 1A, 1B, 2) in all cosmetics. No market sell-through allowed; shelf stock must be withdrawn instantly on deadline. Substances such as trimethylbenzoyl diphenylphosphine oxide (TPO) and tetrabromobisphenol-A become strictly prohibited.^19171820
• Annex III/VI Updates: New restrictions on fragrance allergens, aluminium, benzyl salicylate, hair dyes, and more, including prescribed warning statements for vitamin A and formaldehyde-releasers, plus new labelling requirements for fragrance allergens, with transition phases through 2028²¹.

Cosmetic Claims and Safety Documentation

• Ongoing updates to labelling and claims substantiation expectations (Annex claims harmonized by Regulation (EU) No 655/2013 and its UK equivalent)²².
• Expanded labelling requirements for 56 new fragrance allergens by July 2028²¹.

SCCS Opinions and Scientific Guidance

• SCCS opinions on key substances (tea tree oil, DHHB, benzyl salicylate, octocrylene, etc.) leading to updated restrictions or guidance in the EU, with UK often lagging or following selectively²¹⁹.

3.2. Recent UK Regulatory Changes Affecting CPSR

SAG-CS Opinions and New Domestic Restrictions

• Scientific Advisory Group on Chemical Safety (SAG-CS): Developed UK-specific ingredient restrictions (e.g. for butylated hydroxytoluene (BHT), methyl salicylate, formaldehyde-releasing preservatives), occasionally diverging from SCCS conclusions⁸²³⁹.
• BHT: New limits on use in leave-on oral care and other categories (effective 2025), not completely aligned with the EU⁹.
• Methyl Salicylate: Lower use limits for children's products compared to the EU⁹.
• Microplastics and PFAS: Slow or as yet absent regulatory movement relative to the EU.

Notification, Labelling, and Transition Deadlines

• Extended labelling compliance deadline to 31 December 2027 for transition to full GB labelling (including UK RP, country of origin, UKCA for aerosols)⁶.
• Harmonised Extended Producer Responsibility for packaging, similar to EU, but with locally specific registration and data requirements.

Active Ingredients

• Deliberate or slower adoption of certain EU restrictions (e.g., for dihydroxyacetone, DHA, and microplastics). Some SCCS opinions are not automatically translated into UK rules, requiring fresh SAG-CS reviews and sometimes leading to different risk assessments and limits¹⁶⁹.
  Comparative Table: UK vs EU CPSR Requirements (October 2025)

Table discussion: While the format and structure for CPSRs are nearly identical, differences in ingredient lists, warnings, responsible person, and notification infrastructure mean that using a single, unchanged CPSR for both EU and UK markets is likely non-compliant or leads to audit/corrective action risks. The divergence is particularly pronounced in the area of ingredient restrictions and the legal standing of CPSR signatories. Recent regulatory changes continue to push these regimes further apart¹⁶⁹¹⁹.

Practical Compliance Implications for Teams

5.1. Daily Workflow Complexity

Compliance teams operating across both the UK and EU must now:

• Monitor two sets of legislative updates and scientific opinions on ingredient safety.
• Maintain separate notification procedures and data for CPNP and SCPN.
• Appoint and coordinate with two separate Responsible Persons and, often, two safety assessors.
• Adapt labelling and documentation for separate address, country of origin, ingredient restrictions, and warnings.

Cross-market product launches now require substantially more project management—a “single-dossier, multi-market” strategy is largely obsolete or fraught with legal risk.

5.2. Cost and Operational Burden of Dual CPSRs

Developing and maintaining two CPSRs (plus supporting documents) for every product/formulation is associated with increased:

• Direct Costs: Each market requires independent professional safety assessment and sign-off. Fees, especially for complex or high-risk products, compound quickly (CPSR costs in the UK typically range £99–250 per formulation for basic products, additional for each variant, and higher for specialist or multi-ingredient blends).
• Indirect Costs: Additional label designs, packaging SKUs, notification management, tracking ongoing divergences, and the need to reassess if ingredient status changes in either jurisdiction.
• Time to Market: Sequential—not simultaneous—regulatory review/distribution is increasingly common, risking launch delays.
• Risk Exposure: Inadequate documentation in either market exposes the manufacturer/importer/distributor to withdrawal orders, fines, reputational harm, and permanent delisting in the worst cases. Numerous case studies document audit failures due to template CPSRs lacking market-specific compliance²⁵.

5.3. Ingredient Divergence: Formulator and Developer Implications

Product formulators must:

• Scrutinize both markets’ banned/restricted ingredient lists; do not assume mutual recognition of new substances or restriction thresholds (e.g., BHT, formaldehyde-releasers, certain dyes, DHA)¹⁶⁹.
• Ensure that safety documentation for “shared formulations” accurately reflects each market’s applicable regulatory situation.
• Plan for periodic review and update of safety and technical data files in response to new SCCS or SAG-CS opinions (and related law).
• For each fragrance or color cosmetic variant, assess whether different allergen declarations, risk warnings, and safe-use thresholds trigger the need for additional CPSRs (per variant, per market)²⁶.

5.4. Notification Portals and Workflows

Notification is not a “rubber stamp” acceptance, errors in one system are not transmitted or flagged to the other. Each portal (CPNP and SCPN) could require additional supporting evidence or new technical formats on notification changes, leading to duplication of effort. Notably, changes to notifications in the UK cannot be directly copied over from CPNP submissions, adding yet another layer of complexity to ongoing change management¹²¹³.

5.5. Vigilance and Post-Market Reporting

Product safety surveillance (cosmetovigilance) obligations remain strict in both jurisdictions but require separate local reporting and response systems. This means that investigations and corrective actions must occur in parallel per market, with separate regulatory authority engagement, tracking, and compliance documentation²⁷²⁸²⁹.

Real-World Case Studies of Dual CPSR Implementation

6.1. Case Study: Cosmetic Product not allowed entrance into GB

R&R Luxury Limited Skincare Shea Butter Body Balm: a Shea butter “body balm” from Ghana, supplied in a green tube. The labelling stated ‘Lemongrass, 100% natural. The authorities indicated

“The product presents a serious chemical risk as it contains 12,900 mg/kg of Citral which is higher than the safe limit for this ingredient in cosmetics.”

The product did not meet the requirements of Regulation 1223/2009 or the Cosmetic Products Enforcement Regulations 2013. Hence, the import was rejected at the border. ⁴

6.2. Case Study: Regulatory Audit Failure from Non-Compliant CPSR GB

Product Recall for Bubble Up Mermaid You Look The Bath Bomb (OnBeyond Shops) presenting a serious chemical risk.

The authorities deemed that the product presented serious chemical risk as it contained butylphenyl methylpropional (BMHCA), which is prohibited in cosmetic products. BMHCA may harm the reproductive system, may harm the health of the unborn child and may cause skin sensitisation.

The product was recalled from end users. Users who purchased the product from a One Beyond store were advised to return it to their nearest store for a full refund on September 2025 as the product does not meet the requirements of Regulation (EC) 1223/2009 or the Cosmetic Products Enforcement Regulations 2013.²⁴

6.3. Case Study: Brilitas EU – Risk of “Template” CPSRs

Brilitas EU documented a case where a German cosmetics brand relied on a contract manufacturer’s “template” CPSR, which failed to:

• Include certified European toxicologist sign-off
• Provide relevant exposure scenarios or valid supporting data
• Match the ingredient status post-Omnibus Act VII ban.

Result: The defective documentation led to regulatory intervention, withdrawal from the market, forced remediation, and considerable cost and reputational damage. The use of lowest-cost, copy-paste CPSRs was found to be a false economy when true compliance risks are factored in²⁵.

6.4. Case Study: children’s Henna Cones – Excessive Heavy Metals (UK/EU)

• Issue: Henna cones marketed for skin decoration were found to contain excessive levels of lead and arsenic, not identified in the CPSR. Labels also failed to warn against use on children.
• Action Taken: Multiple recalls across the UK and EU; products were banned from sale.

6.5. Case Study: Efficient Dual-CPSR Practice

A global beauty company harmonized its compliance process by grouping products by identical base formula and intended use, but always prepared a distinct CPSR (and notification) for each jurisdiction. Variants (e.g., different fragrances) were assessed for their individual ingredient and allergen profile per market, and the company maintained a regular rolling review to monitor divergence in ingredient status. While costlier upfront, this robust process avoided audit penalties, recalls, and gave greater agility in adapting to rapid regulatory changes.

Expert Recommendations & Best Practices

7.1. When Is Dual CPSR Creation Essential?

Based on current and emerging divergence, two separate, jurisdiction-specific CPSRs are now strongly recommended for all products placed on both UK and EU markets. Relying on one harmonized CPSR exposes the brand to unacceptable legal, commercial, and reputational risk.

Dual CPSRs are essential in the following scenarios:

• Any change in ingredient restriction/ban between the UK and EU relevant to your formula or product category.
• When the safety assessor’s credentials do not satisfy both markets’ recognition rules.
• Where formulation (or pack ingredients) is varied to comply with only one market’s regulatory requirements.
• If local labelling, warnings, or RP contact information differs.
• For new product introductions post-2022, as mutual grandfathering no longer applies for most notification/approval processes.

7.2. Best Practice Compliance Strategy

• Maintain a Master Dossier PIF for Each Market: Use a unified approach for core data but ensure every field is reviewed, updated, and certified for market-specific regulations.
• Appoint Dual Responsible Persons and Assessors: Choose compliance partners with robust local experience in both the EU and UK.
• Monitor Both Jurisdictions for Ingredient Updates: Invest in regulatory watch tools or services that flag ingredient status movement, SAG-CS and SCCS opinions, and transition deadlines.
• Prepare for Variant-Specific CPSRs: Each new scent, colour, or functional variant with a different toxicological or allergen profile may trigger new or amended CPSR(s) for each jurisdiction²⁶.
• Use Professional Safety Assessors: Avoid “template” or low-cost providers without recognized qualifications or in-depth ingredient data analysis; inadequate safety reports are a frequent cause of product recalls²⁵²⁴.
• Centralize Documentation Control: Build a single digital documentation hub backed by strict version control so that UK/EU changes can be efficiently managed but clearly tracked by market and by formulation/variant.
• Plan for Labelling and SKU Complexity: Take a pragmatic view on unified versus market-specific labelling (e.g., use dual-address labels where legal, but do not cut corners that breach market-specific requirements).

7.3. Ongoing Surveillance and Continuous Review

• Implement Market-Specific Cosmetovigilance: Ensure your company has distinct internal procedures for SUE/UE reporting per the requirements of MHRA and relevant EU authorities (CPNP).
• Annual Review of All Safety Documentation: Schedule annual reviews of PIF and CPSR for all products in both markets; more frequent review may be necessary for high-risk categories or rapid-changes sectors such as hair dyes, fragrances, and children’s personal care.

7.4. Engage with Regulatory Updates and Industry Forums

• Monitor Official Bulletins: Subscribe to regular updates from CTPA, Cosmetics Europe, and official government notifications.
• Consult Professional Advice: Where divergence or ambiguity exists, seek legal and regulatory advice, especially in the areas of ingredient threshold interpretation, post-market vigilance requirements, and the evolving UK-EU recognition of professional qualifications.
  
  Conclusions

The period of regulatory convergence between the UK and EU in cosmetics compliance is over. As of late 2025, the steady and increasing divergence in ingredient restrictions, notification processes, recognition of professional qualifications, and post-market obligations has made a dual-CPSR approach the essential standard for compliance in both markets. Compliance teams must now adapt to a dual-system paradigm, with careful attention to ingredient status, local assessor credentials, notification requirements, and documentation controls for each jurisdiction.

The operational and cost implications of this structural divergence are significant, but so are the risks of inaction, ranging from regulatory interventions and enforced product withdrawals to reputational damage and market exclusion. For compliance agents and product developers, proactive planning, real-time regulatory intelligence, dual-market documentation, and rigorous local safety assessments are now the best strategies for protecting both consumer safety and business continuity.

Crucial Takeaway: The regulatory divergence between the UK and EU for CPSRs is an established and accelerating reality. All brands wishing to sell in both the UK and the EU must—without exception—prepare and maintain separate, fully compliant CPSRs for each market. Streamlining documentation is advisable where possible, but legal and practical differences make “one report for two markets” a risky and outdated practice.

For further expert guidance and bespoke regulatory solutions, brands and compliance professionals should maintain robust engagement with both local counsel and expert regulatory service providers in each market, and develop agile strategies capable of rapidly aligning with ongoing regulatory evolution.

References (29) Available on demand.