EU & UK regulatory guide

Cosmetic Product Safety Report (CPSR): what it is, what it contains, and who can sign it

The CPSR is the scientific dossier that proves your cosmetic is safe, and the document the law demands before a single unit is sold in the EU or UK.

A cosmetic product safety report being compiled for EU and UK market entry
CM
Written and reviewed by Cassandra Maddocks
Chemist & biochemist · cosmetic safety assessor · LinkedIn · last reviewed 22 August 2026
TL;DR: A Cosmetic Product Safety Report (CPSR) is the mandatory technical document required before any cosmetic is placed on the EU or UK market, under Article 10 of Regulation (EC) No 1223/2009. It applies to every product and every seller, including home businesses. It has two parts: Part A (the safety data) and Part B (the assessment, signed by a qualified assessor). Without a valid CPSR the product cannot legally be sold; enforcement runs from withdrawal to criminal prosecution.

What is a Cosmetic Product Safety Report?

The formal document proving a cosmetic is safe for human health under intended and reasonably foreseeable use. Not a certificate or a lab result: a structured scientific dossier built from raw-material data, toxicological profiles, exposure calculations and microbiological evidence, concluded with a signed assessment. It lives inside the Product Information File.

No CPSR, no legal sale: that is the rule in both the EU and the UK. The CPSR is the evidence that your product belongs on a shelf rather than in a recall notice.

Is a CPSR legally required?

Yes, unambiguously. Article 10 of Regulation (EC) No 1223/2009 allows a cosmetic on the EU market only after a safety assessment has been performed and a CPSR drawn up per Annex I. The retained UK Cosmetics Regulation carries the identical requirement for Great Britain, enforced by OPSS. No turnover threshold, no small-brand exemption, no grace period.
Article 10 of Regulation 1223/2009: safety assessment and CPSR required before placing on the market
Article 10 in the consolidated Regulation (EC) No 1223/2009: the safety assessment and CPSR come before the market, not after. From our evidence library.

Both regimes also require the CPSR to be kept current: new safety data, a formula tweak or an ingredient status change reopens the document. A CPSR written at launch is not one-and-done.

The change protocol in practice: any formula change, however small, goes back to the assessor before it goes into production. Minor changes within already-assessed limits usually need only a documented delta review and an updated Part B conclusion; a new ingredient or concentration outside the assessed range means new exposure calculations and, where relevant, new testing. The PIF is updated, the CPNP or SCPN record is updated to match, and if the INCI list changed, the label changes with it. Reformulating first and telling the assessor later inverts the legal order of operations.

The requirement covers product types including:

  • soaps
  • shampoos
  • conditioners
  • bath bombs
  • body butters
  • lip balms
  • perfume balms
  • hair oils
  • cleansers
  • toners
  • serums

What does a CPSR contain? Part A and Part B

Part A is the safety information: full quantitative formula, physico-chemical data and stability, microbiological quality and challenge-test data, impurities and packaging, exposure calculations, toxicological profiles, undesirable-effect data and claim evidence. Part B is the assessment: the safety conclusion, label warnings, scientific reasoning and the named assessor’s credentials and signature.

Part A without Part B is incomplete; Part B without Part A is unverifiable. Both must sit in the PIF before the first sale. The full input checklist is in our guide to what a CPSR needs from you.

Who can sign a CPSR?

A named individual holding a university diploma in pharmacy, toxicology, medicine or a similar discipline, per Article 10(2). A company cannot sign Part B. Chemistry or biochemistry can qualify as a similar discipline where the member state or UK authority recognises it as equivalent.
Article 10(2) of Regulation 1223/2009: assessor must hold a diploma in pharmacy, toxicology, medicine or a similar discipline
Article 10(2): the qualification bar for who may sign Part B, highlighted in the official consolidated text.

Credentials are the floor, not the bar: regulators also look for demonstrable experience in cosmetic safety assessment. A CPSR signed by an unqualified consultant, or generated by software with no named assessor, does not survive enforcement scrutiny.

When a CPSR fails scrutiny, it fails for predictable reasons. The ones we see first: a Part B with no named, qualified signatory; a Part A formula that does not match the INCI list printed on the artwork (the assessed product and the sold product must be the same product); a water-based formula with no challenge-test data behind the microbiological section; and template toxicological profiles pasted in with no product-specific exposure calculation. Any one of these turns the report from evidence into liability.

My take, from the assessor’s desk

The delay is almost never the assessment; it is the data pack. The same three gaps stall most files that reach us: a formula given in ranges instead of exact percentages (Part A needs the real numbers, and so do the exposure calculations), no challenge test on a water-based product (that is a 28-day study you cannot compress), and claim evidence that does not exist for claims already printed on the artwork. Brands that assemble Part A properly get Part B back in days. Brands that send a folder of supplier brochures wait weeks and think the assessor is slow.

How does the CPSR relate to the PIF?

The CPSR is one component of the Product Information File, alongside the product description, GMP evidence (ISO 22716) and claim substantiation. The Responsible Person keeps the PIF for 10 years after the last batch and produces it to authorities on request.

Think of the PIF as the file and the CPSR as the most scrutinised document inside it. An inspector checking compliance opens both.

CPSR for the UK vs the EU: one document or two?

The Annex I structure is identical, and the core Part A science can usually be shared. But each market needs its own jurisdiction-specific CPSR, its own Responsible Person, its own notification (CPNP for the EU, SCPN for GB) and its own label address block.

The lists are also diverging: the GB restriction schedule has been amended independently of EU updates since 2024, so an ingredient compliant in one market can be restricted in the other. Treating the two CPSRs as one unchanged document is an accumulating risk, and the ingredient review must run against both lists.

Post-Brexit, a single CPSR drafted to the stricter standard (EU Reg 1223/2009 + UK BPR) is accepted in both markets; CIGREG’s assessors draft to both simultaneously.

My take on the divergence

For the first years after Brexit, one CPSR quietly served both markets and nobody noticed. That window is closing: since the GB restriction schedule started moving independently in 2024, every EU amendment is a fork, and a file that was compliant on both sides drifts out of date on one of them without anyone touching the formula. This is where running the EU and UK dossiers under one roof pays off: when either list moves, both CPSRs get the delta review at the same time, instead of the UK file being remembered a year later during a retailer audit. If your EU and UK paperwork live with two different providers, ask each of them who is watching the other list. The honest answer is usually nobody.

Can you sell cosmetics from home without a CPSR?

No. A kitchen-made lip balm on Etsy, a serum at a craft fair, a shampoo sold through Instagram: all are cosmetics placed on the market, all need a CPSR, a Responsible Person, a notification and compliant labelling before the first sale. Handmade and natural create no exemption.

The real consequence of skipping it is not missing paperwork; it is an unassessed product on real skin. When something goes wrong, the legal and reputational exposure lands without the one document that would have defended you.

How long does a CPSR take, and what does it cost?

With a complete data pack: 3 to 6 days for simple and standard formulas, 6 to 10 days for SPF, children’s and high-active products. Where testing is still outstanding the clock changes: a challenge test alone runs 28 days, and that time is the data; it cannot be compressed. Budget the CPSR at development stage, not the week before launch.

Market prices range from roughly £55 for the cheapest simple-formula reports to £700+ for complex products, and the cheap end is where unqualified signatures live. Our own CPSR service is fixed at $450 to $600 per product, signed by a qualified assessor, with the timeline stated before any work begins. Full cost drivers are in CPSR cost and timeline.

What happens if you sell without a valid CPSR?

In Great Britain it is a criminal offence under the Cosmetic Products Enforcement Regulations 2013: market withdrawal, recall at the brand’s cost, seizure, and prosecution with fines up to £20,000, up to 12 months’ imprisonment, or both. EU member states enforce equivalent outcomes.

The public record compounds it: a recall notice is visible to every retailer and customer you approach afterwards. The CPSR is the foundation market access rests on; without it there is no foundation.

This is visible enforcement, not a paper threat: the EU’s Safety Gate rapid alert system publishes cosmetics pulled from member-state markets every week, and missing or inadequate safety documentation is a recurring ground, while UK trading standards prosecute under the 2013 Regulations. The pattern in those alerts is small brands and imported products: exactly the sellers who assumed they were too small to be checked.

How to get a CPSR: the five inputs your assessor needs

The five inputs your assessor needs:

  • full ingredient list (INCI)
  • usage instructions
  • manufacturing process
  • stability data
  • challenge test results

FAQ

Common questions.

A Cosmetic Product Safety Report: the mandatory scientific document demonstrating a cosmetic is safe under its intended conditions of use. Part A holds the safety information compiled by the Responsible Person; Part B is the assessment signed by a qualified assessor. Required before any EU or UK sale.

Yes. Every cosmetic placed on the Great Britain market needs a valid CPSR regardless of business size, sales channel or production method, home sellers included. It sits in the PIF and must be complete before the first sale.

Part A can be compiled by the Responsible Person or a consultant. Part B must be written and signed by a named individual holding a degree in pharmacy, toxicology, medicine or a recognised equivalent, with credentials documented in the report.

Market prices run from roughly £55 for the simplest formulas to £700+ for complex products. Our fixed price is $450 to $600 per product including the signed Part B. Be wary of the cheap end: an unqualified signature makes the report a liability, not an asset.

The core Part A science can usually be shared, but each market needs its own jurisdiction-specific CPSR, Responsible Person, notification and label. GB and EU ingredient lists have diverged since 2024, so the ingredient review must run against both.

There is no fixed expiry. It stays valid while the formula, ingredient status, packaging and use conditions are unchanged and no new safety data emerges; any change triggers a review. The PIF holding it is kept 10 years after the last batch.

It is a signed scientific report, not a framed certificate or a badge.

Need a CPSR signed by a qualified assessor?
Fixed $450 to $600 per product. Part A compiled, Part B signed, timeline stated upfront.
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