Cosmetic Safety Assessment: Process, Costs and Tools
No cosmetic product may be sold in the EU without a safety assessment. The Cosmetic Product Safety Report (CPSR) under Art. 10 of the EU Cosmetics Regulation is mandatory — regardless of whether you make a face cream, a shampoo or a lip balm. Even so, the process is a black box for many small and medium-sized cosmetics manufacturers in the DACH region: what exactly is assessed? Who is allowed to do it? What does it cost? And which documents must be assembled beforehand?
This guide explains the CPSR process step by step. You will learn how a safety assessment is structured (Part A and Part B), what qualifications the assessor must have, what costs you should budget for and which preparation mistakes most frequently lead to delays or objections. At the end you will find a checklist that helps you assemble all the documents in a structured way.
What is a safety assessment (CPSR)?
The safety assessment — officially the Cosmetic Product Safety Report (CPSR) — is a mandatory document under Art. 10 in conjunction with Annex I of the EU Cosmetics Regulation (EC) No 1223/2009. It documents the toxicological safety of a cosmetic product under normal and reasonably foreseeable conditions of use.
The CPSR is a mandatory part of the Product Information File (PIF). Without a complete CPSR the PIF is incomplete — and the product may not be placed on the market. How the PIF is structured overall is described in our PIF practical guide.
Why the CPSR is so critical
The CPSR is the document most frequently examined by market surveillance authorities. If it is missing or incomplete, you risk a recall, a fine and a RAPEX alert (the EU rapid alert system for dangerous consumer products). In Germany the responsible authority is the BVL, in Austria the AGES and in Switzerland the BAG.
Who is allowed to carry out the safety assessment?
Art. 10(2) of the EU Cosmetics Regulation sets out the qualification requirements for the safety assessor. Not every chemist or pharmacist may produce a CPSR — the requirements are clearly defined:
- A university degree in pharmacy, toxicology, medicine or a comparable discipline recognised by the Member State
- Practical experience in experimental or clinical toxicology and/or dermatology
- Specialist knowledge of cosmetic chemistry, cosmetics law and regulatory risk assessment
In practice these are toxicologists, specialised pharmacists or dermatologists with cosmetics experience. In the DACH region, both freelance safety assessors and specialised service providers (e.g. Biorius, Diapharm, KOSI, Certified Cosmetics) offer CPSR preparation as a service.
Tip: Before commissioning an assessor, check their academic degree and professional experience. Ask for references in similar product categories. An assessor with experience in decorative cosmetics is not automatically the right choice for a leave-on skincare product.
The CPSR process: Part A and Part B
The CPSR consists of two clearly separated parts. Part A is prepared by the manufacturer; Part B is produced by the safety assessor on the basis of that data. Together, the two parts form the complete safety assessment.
| Component | Responsible | Content |
|---|---|---|
| Part A | Manufacturer / RP | Formulation, raw material specifications, stability data, challenge test, packaging, exposure data |
| Part B | Safety assessor | Toxicological evaluation, Margin of Safety (MoS), risk assessment, conclusion, signature |
Part A — Safety information (supplied by the manufacturer)
- Complete formulation: all ingredients with INCI names and concentrations in percentage by weight. The correct INCI breakdown is explained in our INCI guide.
- Toxicological profiles: for each individual ingredient, data on systemic toxicity, skin sensitisation, irritation and, where relevant, phototoxicity (sources: CosIng, SCCS opinions, raw material supplier)
- Stability data: accelerated stability test (40 °C / 75 % RH, min. 3 months) and, where applicable, real-time data
- Microbiological quality: challenge test in accordance with ISO 11930 (preservative efficacy test)
- Impurities: heavy-metal analysis (Pb, As, Cd, Hg, Ni) and further trace analyses where applicable
- Packaging: material specification, compatibility testing and, where applicable, migration tests
- Exposure data: product category (leave-on vs. rinse-off), frequency of application, contact area, expected amount applied
Part B — Safety assessment (produced by the assessor)
- Toxicological evaluation: systemic and local evaluation of each ingredient on the basis of the data supplied
- Margin of Safety (MoS): calculation of the safety margin for each relevant substance (a MoS ≥ 100 is considered safe)
- Risk assessment: an overall consideration that takes interactions and cumulative exposure into account
- Conclusion: a clear statement on the safety of the product under normal and reasonably foreseeable use
- Signature: the assessor's name, address and qualification, and the date of the assessment
Costs and timeframe in the DACH region
The cost of a CPSR depends above all on the number of ingredients and the complexity of the product. The following table gives a rough guide for the DACH region (as of 2026):
| Product complexity | Ingredients | Price range |
|---|---|---|
| Simple | up to 9 ingredients | 400–500 € |
| Standard | 10–15 ingredients | 500–650 € |
| Complex | 16+ ingredients | from 650 € |
| Variant | only fragrance/colour differs | 200–250 € |
Turnaround time: once all documents have been supplied in full, expect 10–15 working days with the safety assessor. In practice the biggest time factor is gathering the data: missing raw material certificates or outstanding laboratory tests often delay the process by weeks.
Additional costs: laboratory tests are charged separately. Challenge tests cost approx. 200–400 €, heavy-metal analyses 70–100 € per test, and stability tests 150–300 € depending on their scope.
Practical example: face cream with 18 INCI ingredients
A small natural-cosmetics manufacturer in southern Germany wants to bring a face cream with 18 individual ingredients (including 3 essential oils, 1 UV filter and preservatives) to market.
Cost breakdown:
- CPSR (complex, 16+ ingredients): approx. 700 €
- Challenge test (ISO 11930): approx. 300 €
- Stability test (3 months accelerated): approx. 250 €
- Heavy-metal analysis: approx. 80 €
- Total cost: approx. 1,330 €
Timeframe: 4 weeks of data gathering + 2 weeks of CPSR preparation = approx. 6 weeks from commissioning to finished assessment.
Common mistakes when preparing a CPSR
The following mistakes regularly lead to delays, queries from the safety assessor or — in the worst case — an incomplete assessment that is objected to during market surveillance:
1. Incomplete raw material breakdown
The formulation is supplied at raw material level rather than at individual-INCI-ingredient level. The assessor, however, needs the complete breakdown of every raw material into its individual components with exact concentrations.
2. Missing stability data
No accelerated stability test is available, or only real-time data covering a few weeks. Without proof of stability the assessor cannot make a valid statement about shelf life.
3. Incorrect exposure calculation
The amount applied, frequency of application or contact area are estimated unrealistically. A leave-on cream has a completely different exposure profile from a rinse-off shampoo — this has to be modelled correctly.
4. Impurities not identified
Heavy metals, solvent residues or trace components in raw materials are not analysed. Especially with natural extracts, a heavy-metal analysis is indispensable.
5. IFRA certificates not enclosed
Fragrance raw materials are supplied without an IFRA conformity certificate. Without an IFRA certificate the assessor cannot fully evaluate the fragrance allergens.
6. CPSR not updated after a formulation change
The formulation has been changed (different supplier, adjusted concentration), but the CPSR is still based on the old version. This is a common audit finding.
Practical example: lip balm with an outdated CPSR
A contract manufacturer has been producing a lip balm since 2023. In 2024 the shea butter supplier was changed — the new raw material has a slightly different composition (a higher proportion of unsaponifiable matter). The CPSR is still based on the original formulation.
During a spot check by the regional authority, it emerges that the raw material specification in the PIF does not match the CPSR. Result: an objection and a 30 day remediation deadline during which the product may not be shipped.
Lesson: every formulation change — including a change of supplier for the same type of raw material — requires a check of whether the CPSR is still valid.
Checklist: preparing your CPSR documents
Use this checklist to assemble all the documents for your safety assessor. The more complete the data at the point of commissioning, the faster and cheaper the process will be.
CPSR document checklist (as of 2026)
- Complete formulation with all INCI names and concentrations (percentage by weight)
- Raw material specification data sheets for every raw material used
- Toxicological profiles for all individual ingredients (from CosIng, SCCS opinions, supplier data)
- Stability data: accelerated stability test (40 °C/75 % RH, 3 months) and, where applicable, real-time data
- Challenge test (preservative efficacy test) in accordance with ISO 11930
- IFRA certificate for every fragrance raw material with an allergen breakdown
- Packaging specification: material, migration testing, compatibility
- Exposure data: product category, frequency of application, contact area, retention on the skin
- Heavy-metal analysis of the finished product (Pb, As, Cd, Hg, Ni)
- Any existing laboratory test results (patch test, in-vitro irritation, pH value)
The foundation for a smooth CPSR is a cleanly documented formulation with a complete INCI breakdown and all raw material specifications. Managing this data centrally saves considerable time with every safety assessment and every audit. How to build up GMP-compliant documentation is explained in our GMP guide to ISO 22716.
Note: CPSR groundwork with INCIkit
The integrated CPSR assistant in INCIkit guides you step by step through the groundwork for Part A: formulation with INCI breakdown, raw material specifications, preliminary MoS calculation and exposure data. The assembled documents can be handed over directly to the safety assessor — this reduces queries and typically shortens the turnaround time by several weeks.
Further resources
Creating a PIF — guide & template
The CPSR is part of the PIF. This guide shows all 5 mandatory components under Art. 11 of EU Regulation 1223/2009.
GMP for cosmetics in accordance with ISO 22716
GMP-compliant documentation is the basis for a smooth safety assessment.
Creating an INCI list correctly
The INCI breakdown is the basis for Part A of the safety assessment.
Want to document your cosmetics with full compliance?
INCIkit builds PIF, INCI list and batch records from your formula data — ready for the authority check.
INCIkit Editorial
Cosmetics Compliance Desk
More articles
Making and Selling Soap: Everything You Need to Know
Want to sell your homemade soap? This guide explains all the rules, from the EU Cosmetics Regulation through the safety assessment and INCI list to the CPNP notification. With a practical example and cost table.
Selling Homemade Cosmetics Legally: The Complete Beginner's Guide
Want to sell your handmade cosmetics? This guide explains the 5 steps from business registration through the safety assessment to the CPNP notification — with concrete costs, real-world examples and a checklist.
Contract Manufacturer Guide: Compliance Requirements and Digital Tools
Contract manufacturers carry their own compliance obligations under EU Cosmetics Regulation (EC) 1223/2009. This guide explains GMP requirements, multi-client management and batch traceability, and shows how digital tools simplify documentation.