Was ist ein Kosmetikproduktsicherheitsbericht (CPSR) und wie funktioniert er?

Every cosmetic product legally sold in the UK or the EU must be backed by a Cosmetic Product Safety Report the CPSR. It is the single most important compliance document a brand holds, and no product may reach the market without one. This guide explains what a CPSR is, what goes into it, how the assessment works, and where it fits in the wider compliance picture.

Whether you are launching a first product or scaling a range across several markets, understanding the CPSR is foundational. This is our pillar guide; it links out to detailed articles on Part A, Part B, who can sign it off and how to obtain one.

What a CPSR actually is

A CPSR is a formal, documented assessment that concludes whether a cosmetic product is safe for human health when used normally or in a reasonably foreseeable way. It is required under Regulation (EC) No 1223/2009 in the EU and under the equivalent retained UK Cosmetics Regulation in Great Britain. In both regimes, the obligation is the same: the report must exist, and be held on file, before the product is placed on the market.

Crucially, a CPSR is not a certificate a brand simply buys, nor a pass/fail stamp issued by an authority. It is an expert evaluation carried out by a qualified safety assessor, who reviews the product's full composition and supporting data and reaches a reasoned conclusion. The output is a structured document in two defined parts, which we examine below.

Why the CPSR exists

The regulation places the burden of proving safety on the business that markets the product, not on a government body approving it in advance. There is no pre-market approval system for cosmetics in the UK or EU in the way there is for medicines. Instead, the responsibility sits with industry: brands and manufacturers must demonstrate, through the CPSR and its underlying data, that each product is safe before it is sold.

This self-responsibility model is why the CPSR matters so much. It is the evidence that a business has done its due diligence. If a product is later questioned by a market surveillance authority, the CPSR and the file it sits within is the first thing that will be examined. A robust, well-constructed report is both a legal requirement and a form of protection.

The two parts of a CPSR

The regulation prescribes a specific structure. A CPSR is divided into Part A, the cosmetic product safety information, and Part B, the cosmetic product safety assessment. The two serve distinct functions: Part A gathers the evidence, and Part B interprets it and reaches a conclusion. Both are mandatory, and a report missing or thin on either part is not compliant.

Understanding this division is the key to understanding how the CPSR works. Part A is largely about data collection and characterisation; Part B is where a qualified professional applies judgement. We look at each in turn.

Part A: the safety information

Part A assembles all the information needed to evaluate the product. It includes the quantitative and qualitative composition (the full formula), the physicochemical characteristics and stability of both the raw materials and the finished product, its microbiological quality, information on impurities, traces and packaging material, the product's normal and reasonably foreseeable use, and the exposure it gives rise to both exposure to the product and to each substance in it.

It also captures the toxicological profile of the substances, any undesirable effects and serious undesirable effects data, and any other relevant information. In short, Part A is the evidence base: the compiled, documented facts about what the product is, what is in it, how it will be used, and how much exposure results. The quality of Part A determines what Part B has to work with. Our Part A guide breaks each element down.

Part B: the safety assessment

Part B is the reasoned assessment itself. Drawing on the information in Part A, the safety assessor sets out the assessment conclusion (whether the product is safe), any warnings and instructions for use that must appear on the label, the reasoning behind the conclusion, and the assessor's credentials and approval their name, qualification, and signed sign-off.

This is where professional judgement is applied. The assessor weighs the exposure against the toxicological data for each ingredient, considers the product as a whole and its foreseeable use, and determines whether it can be considered safe and under what conditions or warnings. Part B is signed by a qualified assessor, which is what gives the CPSR its legal weight. Our Part B guide explains the assessor's reasoning in depth.

Who carries out the assessment

The safety assessment must be performed by a suitably qualified professional typically someone holding a university-level qualification in pharmacy, toxicology, medicine or a comparable discipline, as set out in the regulation. This requirement is strict: a CPSR signed by an unqualified person is not valid, regardless of how thorough the underlying work appears.

This is one reason brands engage specialist providers rather than attempting the assessment in-house. The assessor's qualification is a legal precondition, not a formality, and it is checked if the report is ever scrutinised.

Where the CPSR fits: the wider compliance set

The CPSR does not stand alone. It sits at the heart of the Product Information File (PIF) the dossier the Responsible Person must hold for each product and make available to authorities on request. The PIF contains the CPSR alongside a product description, manufacturing information, evidence of any claimed effects, and data on animal testing. The CPSR is the safety core of that file. Our guide to what goes into a PIF covers this in full.

Beyond the PIF, a compliant product also needs a designated Responsible Person, notification to the relevant portal (SCPN in Great Britain, CPNP in the EU), and compliant labelling. The CPSR is the anchor that much of this depends on. Our guides to what a Responsible Person does and SCPN vs CPNP notification explain how the pieces connect.

What the CPSR is not

Several misconceptions are worth clearing up. A CPSR is not a laboratory test it is an assessment that may draw on test data, but the report itself is an expert evaluation, not a bench result. It is not government approval no authority signs it, and holding one is not an endorsement. And it is not a one-size document it is specific to a single product and formula.

It is also not optional or a nice-to-have. Placing a cosmetic on the market without a valid CPSR is a breach of the regulation, exposing the business to enforcement action, product withdrawal and reputational damage. Treating the CPSR as a genuine safety exercise, rather than a box to tick, is what separates a resilient compliance position from a fragile one.

One product, one CPSR with some nuance

As a rule, each distinct product needs its own CPSR, because the assessment is tied to the specific formulation and its exposure. However, closely related products for example a range of shades or scents built on the same base formula can sometimes be assessed together or through a framework approach, provided the differences are limited and well understood. The assessor determines what can reasonably be grouped.

This nuance matters commercially. A brand launching a large range should plan its assessments strategically, since how products are grouped affects both cost and timelines. Getting this right early with input from the assessor avoids duplicated work and unnecessary expense.

How long a CPSR lasts and when it changes

A CPSR does not simply expire on a fixed date, but it is only valid for the product as assessed. If the formulation changes, the supplier of a raw material changes in a way that affects the product, the packaging changes, or new safety information emerges about an ingredient, the assessment may need to be reviewed and updated. The Responsible Person is expected to keep the CPSR current.

Regulatory change is a particular trigger. When an ingredient becomes newly restricted or banned as happens regularly through EU and UK amendments products containing it must be reassessed and, often, reformulated. Keeping the CPSR aligned with the current regulatory position is an ongoing obligation, not a one-off task at launch.

What separates a strong CPSR from a weak one

Not all CPSRs are equal. A strong report rests on complete, accurate data a precise formula, full ingredient documentation, and appropriate testing and shows clear, substance-by-substance reasoning in Part B, including proper margin-of-safety analysis where relevant. It reflects the product's real, foreseeable use, specifies the warnings the label genuinely needs, and is signed by a properly qualified assessor. Such a report stands up to scrutiny.

A weak report, by contrast, may rely on thin or missing data, apply generic reasoning that does not engage with the specific product, overlook an ingredient limit, or specify inadequate warnings. It might be cheaper and faster, but it offers little real protection and can collapse the moment an authority examines it. For a brand, the difference is not academic: the CPSR is only as valuable as it is robust, which is why the choice of assessor and the quality of the input data matter so much.

The practical lesson is to treat the CPSR as a genuine safety exercise rather than a document to acquire as cheaply as possible. A well-built report is an asset evidence of due diligence, a foundation for market access, and a safeguard against enforcement and liability. Investing in getting it right pays back many times over if a product is ever questioned.

The CPSR at a glance

Frequently asked questions

References: Regulation (EC) No 1223/2009, Articles 10–11 and Annex I (EUR-Lex); UK Cosmetics Regulation as retained (legislation.gov.uk); OPSS guidance. General information only, not legal advice.