Cosmetics Compliance in 2025: A Practical Roadmap for EU, UK, and US Brands

Cosmetic regulation tightened considerably over the past few years, and 2025 is very much a "show your work" moment. Whether you operate in the EU, UK, or US, authorities now expect clear evidence that you know what's in your products, how they're made, and how you monitor safety once they're on the market.

Below is a concise, jurisdiction-by-jurisdiction playbook, with the essential documents and actions you should have in place.

Man Filling Out Compliance Paperwork.

European Union (EU)

EU cosmetics are governed by Regulation (EC) No. 1223 / 2009. Three pillars matter most day-to-day: the Responsible Person (RP), the Product Information File (PIF), and the Cosmetic Product Safety Report (CPSR). The regulation requires an RP established in the EU, a PIF available to authorities, and a CPSR (Annex I) before placing products on the market. Notification via the CPNP portal is mandatory.

What to maintain:

• CPSR (Annex I): Part A (safety information; formula, impurities, exposure, etc.) and Part B (the safety assessor's conclusion and justification).

• PIF: CPSR, product description, GMP statement (ISO 22716 is the usual route), evidence of claimed effects (where appropriate), and data on animal testing. National authorities such as Ireland's HPRA echo these expectations and provide practical layouts for CPSR and PIF content.

• Notification: Each product must be notified on the CPNP before sale in the EU.

ISO 22716 is the globally recognised cosmetic GMP guideline and is routinely referenced to demonstrate compliance; ISO confirms the standard remains current (reviewed 2022).

United Kingdom (UK)

Post-Brexit, the UK mirrors the EU framework with local twists: you need a UK Responsible Person (RP) established in the UK and must notify products to the Submit Cosmetic Product Notification (SCPN) service before placing them on the GB market. UK guidance also points to ISO 22716 for GMP and requires a UK-held PIF and CPSR equivalent to the EU model.

Your UK checklist:

• Appoint a UK RP (can be the manufacturer, importer, or an appointed third party).

• Notify each product via SCPN; keep the PIF accessible in English in the UK.

• Manufacture under ISO 22716-aligned GMP.

Authorities and industry guidance in GB continue to recognise ISO 22716 as the relevant GMP benchmark.

United States (US)

The Modernisation of Cosmetics Regulation Act of 2022 (MoCRA) fundamentally changed the US landscape. As of 2025, the FDA expects facilities to register, products to be listed, and companies to maintain adequate safety substantiation for each product.

FDA's Cosmetics Direct portal is the mechanism for facility registration and product listing. FDA has also issued draft guidance on safety substantiation and continues to update MoCRA resources.

MoCRA essentials to have buttoned up:

• Facility registration & product listing via Cosmetics Direct (keep details current).

• Safety substantiation files: ingredients, toxicology, exposure, margin-of-safety rationale; FDA's materials explain the kind of evidence the y expect.

• Adverse event handling: maintain procedures to capture, evaluate, and (where serious) adverse events to FDA.

• GMP: While a cosmetics-specific GMP rulemaking is in progress, FDA already expects manufacturing under appropriate, documented controls; ISO 22716 remains the practical benchmark many US brands use while FDA finalises its framework.

What to Put in Your Technical Dossiers (Wherever Your Operate)

Although labels and portals differ, the backbone looks similar across regions:

• Full formula & raw-material data (INCI names, grades, impurity profiles, allergens).

• Toxicological profiles for ingredients / impurities and an exposure-based safety rationale (this becomes CPSR in the EU/UK and Safety Substantiation under MoCRA).

• GMP evidence (ISO 22716 procedures, training, equipment maintenance, batch records).

• Claims support (where "evidence of effect" is relevant under EU rules).

• Post-market surveillance: adverse-event logs and trend reviews; escalation/notification rules (EU vigilance via RP; US serious adverse events to FDA).

  
  

Overcoming these challenges is rarely easy but creates stronger, more efficient, and more resilient organisations.

Pitfalls to Avoid in 2025

Two gaps still trip brands up. First, thin or outdated CPSRs/PIFs: if exposure, impurities, or packaging interactions change, the safety assessment must be updated, don't treat the CPSR as a one-time document.

Second, notifications that lag the product: if your formulation, label, RP, or manufacturer changes, your CPNP/SCPN/Cosmetics Direct entries and internal files must be aligned.

A third, perennial risk is "paper GMP", policies without proof. Regulators look for trained people following controlled procedures and leaving an auditable trail.

Building a System that Scales

If you sell in multiple jurisdictions, standardise your core set of documents and then bolt on country specifics. Many brands create a master technical dossier (formula, specs, tox evidence, packaging data, stability, claims support, GMP records) and then generate jurisdiction-ready packs:

• EU/UK Pack: CPSR (Annex I), PIF, label artworks, notification proof (CPNP/SCPN), RP details.

• US Pack: Safety substantiation file, facility registration and product listing confirmations, adverse-event SOPs, and manufacturing controls aligned with cosmetic GMP.

A short monthly governance meeting (Regulatory, Safety, Quality, and Supply Chain) keeps dossiers synchronised with real-world changes: reformulations, supplier switches, new claims, adverse-event trends, or label updates.

Final Thoughts

Regulators in the EU, UK, and the US are converging on the same expectation: show, don't tell, how your cosmetics are made safely, under control, and with evidence to back every claim.

If your dossiers (PIF/CPSR or US safety substantiation), GMP records, and notifications are current and traceable, you're already most of the way there. The brands that win in 2025 aren't the ones with the slickest labels; they're the ones with clean files, disciplined manufacturing, and a post-market system that actually learns.

📌Ready to level up?

If you want a fast, practical way to close gaps, Pharmalliance Consulting Ltd offers the cGMP Fundamentals Program: Cosmetics. We walk your team through ISO 22716-aligned GMP, PIF/CPSR essentials, MoCRA expectations, and the day-to-day controls that stand up to inspection.

Get in touch with Pharmalliance Consulting today to discuss how we can support your GMP journey!