Project service

Cosmetic Product Safety Report (CPSR).

The mandatory safety assessment for your product, prepared by CIG and signed by a qualified safety assessor.

Safety assessor reviewing a signed CPSR

What the law requires

A safety report signed by a qualified assessor.

Before a cosmetic product can be placed on the EU or UK market, it must have a Cosmetic Product Safety Report. This is the formal safety assessment of the finished product, set out in Annex I of Regulation (EC) No 1223/2009 and its retained UK equivalent. The report must be completed and signed by a qualified safety assessor, a person who holds a university diploma in pharmacy, toxicology, medicine, or a similar discipline recognised by an EU Member State.

The CPSR sits inside the Product Information File and is one of the documents authorities can ask to see. Under Article 11 the PIF must hold the product description, the CPSR, the manufacturing method with a GMP statement referencing ISO 22716, proof of any claimed effect where that is justified, and data on any animal testing. The file is kept for 10 years after the last batch was placed on the market. A US safety report does not transfer to the EU or UK: the assessment has to be redone in the format the regulation requires, even where existing documentation exists.

A CPSR must be
A formal safety assessment of the finished product, structured as Annex I Part A and Part B.
Completed and signed by a qualified safety assessor holding a recognised pharmacy, toxicology, or medicine diploma.
Held as part of the Product Information File under Article 11.
Available for authorities to inspect, and kept for 10 years after the last batch.

What the report contains

Part A and Part B.

Annex I splits the CPSR into two parts. Part A gathers the safety information. Part B is the assessment and the signed conclusion.

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026

The Cosmetic Product Safety Report is the two-part safety assessment required under Article 10 and Annex I of Regulation 1223/2009, signed by a qualified assessor before any EU or UK sale. CIG produces and signs CPSRs for $450 to $600 per product once your data is complete.

Legal basis: EUR-Lex: Regulation (EC) 1223/2009, ISO 22716.

Annex I of Regulation 1223/2009 on EUR-Lex showing the Cosmetic Product Safety Report structure
Annex I of Regulation (EC) No 1223/2009, the Cosmetic Product Safety Report structure, as published on EUR-Lex, consolidation of 1 May 2026 (02009R1223, EN, 040.001). Captured 26 July 2026. View the official text.
A

Part A: safety information

The data the assessment is built on:

Quantitative and qualitative composition, with the full INCI formula.
Physico-chemical characteristics and stability of the product.
Microbiological quality, including challenge testing (preservation efficacy).
Impurities, traces, and information on the packaging material.
Normal and reasonably foreseeable use, and the exposure that follows from it.
The toxicological profile of the ingredients and any undesirable effects on record.
B

Part B: safety assessment

The assessor's reasoning and decision:

The safety conclusion for the finished product.
Any warnings and instructions for use that belong on the label.
The reasoning, including the Margin of Safety for the substances of concern.
The assessor's name, address, qualification, the date, and the signature.

Part B is the signed judgement. It is what makes the difference between a folder of test data and a legally valid safety report.

How CIG covers it

What is included.

A complete safety report compiled from your product data, with the safety conclusion signed by a named professional.

We compile the full Part A safety information from your formula and product data, covering composition, physico-chemical characteristics, stability, microbiological quality, impurities and traces, packaging, and use and exposure.

We build the toxicological profile ingredient by ingredient and calculate the Margin of Safety for the substances that need it.

A qualified safety assessor reviews and signs Part B. The safety conclusion is always made by a named professional holding a recognised pharmacy, toxicology, or medicine diploma, and the signed report carries that name, qualification, and date.

We set the label warnings and instructions that the assessment requires, so the report and the label agree.

We build it into your Product Information File so the dossier is complete under Article 11.

We keep it current if your formula, your packaging, or the rules change.

What we need from you

The inputs behind the report.

Most of what we ask for is documentation you already hold from your manufacturer or formulator. Where a piece is missing, we tell you what it is and why the regulation needs it, so you can request it from the right source. We do not ask for anything the assessment does not use.

Stability and challenge testing are the two inputs founders most often forget to budget for, and they are the two that most often set the real timeline. Stability testing can take from three to twelve months depending on the method, which is why a new formulation should start long before its planned launch date.

Please have ready
The full formula with INCI names and percentages.
Raw material specifications and safety data sheets.
Stability test results for the finished product.
Challenge test (preservation efficacy) results.
Microbiological test results.
Packaging details and compatibility information.
Artwork and the intended claims for the label.
The manufacturing method and a GMP statement (ISO 22716).

Timelines

How long it takes.

Once the inputs are in, the report itself is not the slow part. The lab work behind it usually is.

When your test data is complete and your formula is settled, we prepare and sign the CPSR without holding your launch back. Where testing is still outstanding, the timeline follows the lab, not the report. Stability testing runs from three to twelve months by method, and challenge and microbiological testing add their own lead times. A new formulation that has not yet been tested should allow several months end to end before it can be sold.

If you send us a product that already has current stability, challenge, and microbiological results, the assessment is a matter of compiling, calculating, and signing rather than waiting. Tell us your launch date when you ask for a quote and we will tell you plainly whether the testing behind the report can realistically be finished in time.

Edge cases

Products that need more.

Some products carry a wider scope. We flag these before they become a problem.

Nanomaterials

A product containing a nanomaterial needs a separate notification to the European Commission under Article 16 of Regulation 1223/2009, six months before it is placed on the market. This sits on top of the standard notification. The nanomaterial and its details must also be declared in the notification for the UK market.

Baby and child products

Products for babies and young children are assessed at a higher scope. Exposure, the toxicological margins, and the warnings are all examined more closely, so the assessment behind the report is more involved than for a standard adult product.

Higher-risk categories

Products such as hair dyes, oxidising and perming products, sunscreens making an SPF claim, and products for the eye area sit in higher-scope territory. Claims like SPF or water resistance also need their own substantiation testing before they can appear on the label.

Restricted and banned substances

Ingredients move between the annexes of Regulation 1223/2009 over time. An ingredient allowed today can be restricted or banned later, which can force a reformulation and a fresh assessment. We check your formula against the current annexes as part of the work.

Across the markets

Where the CPSR is required, and where it is not.

The safety report is one document in a larger compliance chain. What it connects to depends on the market.

EU

A signed CPSR is mandatory under Reg. 1223/2009. It goes into the PIF, the EU Responsible Person verifies it, and the product is notified on CPNP before sale. Nanomaterials need the separate Article 16 notification.

Sell in the EU →

UK

Great Britain kept the CPSR requirement in its own regulation. A UK Responsible Person holds the file and notifies the product through SCPN via OPSS. An EU report does not cover the UK, and a UK report does not cover the EU.

Sell in the UK →

Switzerland

Switzerland follows the annexes of Reg. 1223/2009 and needs a qualified safety assessor behind the PIF. There is no notification portal. A Swiss-address agent holds the compliance data for cantonal inspection, and the PIF is kept 10 years.

Sell in Switzerland →

US (MoCRA)

MoCRA does not use a CPSR, but it does require safety substantiation for every product, kept on file. That obligation applies even to firms that qualify for the small-business exemption. The dossier we build supports it.

Sell in the US →

Who it is for

Any product going on sale in the EU or UK.

Every cosmetic product placed on the EU or UK market needs a signed Cosmetic Product Safety Report before it can be sold. There is no small-business exemption and no turnover threshold: a maker selling a few bars of soap carries the same requirement as a large brand. This service suits brands that need that report prepared and signed, whether as a standalone deliverable or bundled with the Product Information File and notification in a launch pack.

A CPSR is prepared per product. A range of scents or shades built on the same base formula can often be assessed together as a framework, which keeps the cost down across a line. We tell you at quote stage which of your products can share an assessment and which need their own.

Why brands choose CIG for this
Signed by a qualified safety assessor, every time.
Fixed, published pricing.
Prepared and signed once your test data is complete.
A full audit trail behind every conclusion.

Pricing

Fixed, transparent pricing.

A signed safety report per product, or bundled with the Product Information File and notification in the launch pack.

Safety assessment / CPSR: per product, signed by a qualified assessor $450 to $600
EU and UK launch pack: CPSR, PIF and notification per product $1,500

Prices in USD, per product.

See full pricing →

Where this service fits

The safety report in your compliance path.

FAQ

Common questions.

It depends on what the product is for. Anything applied to the skin to clean, perfume, protect or care for it is a cosmetic, so a massage oil or a massage candle whose melted wax goes onto the skin needs a CPSR like any cream. A room spray or an ordinary candle that never touches the body is not a cosmetic and follows other product rules instead. If your product sits on the line, send us the intended use and we will tell you which regime applies before you pay for anything.

A qualified safety assessor reviews and signs your CPSR. Under Regulation 1223/2009 that person must hold a university diploma in pharmacy, toxicology, medicine, or a similar discipline recognised by an EU Member State. The signed Part B carries their name, address, qualification, and the date.

A safety assessment is $450 to $600 per product, signed by a qualified assessor. Bundled with the Product Information File and notification, the EU and UK launch pack is $1,500 per product. These are fixed, published prices. Products built on a shared base formula can sometimes be assessed together, which lowers the per-product cost across a line.

A CPSR is prepared per product. A range of scents or shades on the same base formula can often be assessed together as a framework rather than one report each. We tell you at quote stage which of your products can share an assessment and which need their own.

No. A US report does not transfer to the EU or UK. The assessment has to be redone in the format the regulation requires, following Annex I Part A and Part B. Your existing test data can still feed into the new report, so the work is not started from nothing.

Yes. Under Article 11 the PIF must contain the product description, the CPSR, the manufacturing method with a GMP statement, proof of any claimed effect, and data on any animal testing. We build the signed report into your file, which is kept for 10 years after the last batch.

The main inputs are the full formula with INCI names and percentages, raw material specifications and safety data sheets, stability results, challenge (preservation efficacy) results, microbiological results, packaging details, and the intended claims. Where a piece is missing we tell you what it is and why the regulation needs it, so you can request it from your manufacturer.

Yes. A product containing a nanomaterial needs a separate notification to the European Commission under Article 16, six months before it goes on the market, on top of the standard notification. The nanomaterial also has to be declared for the UK market. We handle this alongside the CPSR.

When your test data is complete, the report is a matter of compiling, calculating the Margin of Safety, and signing. When testing is still outstanding, the timeline follows the lab. Stability testing runs from three to twelve months depending on the method, so a new formulation should start well before its launch date. Tell us your date and we will say plainly whether it is achievable.

Yes. Products for babies and young children are assessed at a higher scope. Exposure, the toxicological margins, and the warnings are examined more closely, so the assessment behind the report is more involved than for a standard adult product.

A change to the formula, the packaging, or the applicable rules can require the assessment to be revisited. We keep your safety report current when that happens, so the dossier held in your Product Information File stays accurate for as long as the product is on the market.

Related

Pairs well with.

Need a signed CPSR?

Tell us your product and we will quote your safety report at a fixed price.

In practice

Compliance, in the real world.

Stability-test samples in a labPart A and Part B report pages
Safety assessor signing a CPSR