Cosmetics Regulation (EC) No 1223/2009 Leave-on · emulsion

Safety Assessment for Face Cream

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A Cosmetic Product Safety Report for a face cream or moisturiser — an emulsion left on facial skin daily, where preservation, emulsion stability and any SPF claim all have to hold together.

Configure your assessment
Choose your formula size — price updates live

Price range: € 150.00 through € 500.00

Priced by number of ingredients · VAT calculated at checkout · digital delivery
Quantity
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a face cream specifically — exposure, tests and warnings to match.
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Good to know. A safety report is mandatory, but it is not the whole job. To place your face cream on the EU market you also need a CPNP notification and an EU Responsible Person — we handle both.
EU-recognised assessors
Signed by qualified, VUB-trained Safety Assessors.
Part A + Part B
Structured exactly to Annex I of Regulation (EC) No 1223/2009.
Test-backed file
Microbiological, challenge and stability data built in.
Transparent pricing
Priced by formula size — published upfront.
How it works

From order to signed report

1

Select & order

Choose your formula size above and order online — no consultation call required.

2

Document collection

We send a secure intake listing exactly what we need for a face cream. The checklist below is the usual set.

3

Assessment & testing

Your assessor reviews the formulation against Annexes II–VI and calculates exposure. If tests are missing we arrange them with our partner laboratories.

4

Signed report

You receive the signed CPSR digitally, ready to go into your Product Information File.

Safety assessment for a face cream

A face cream is an emulsion, and emulsions fail in ways that anhydrous products cannot: the water phase supports microbial growth, the preservative can partition into the oil phase and stop working where it is needed, and separation over shelf life changes the dose the consumer actually applies. A safety assessment under Regulation (EC) No 1223/2009 has to account for all three.

You receive a complete CPSR, Part A and Part B, with the exposure assessment based on daily leave-on application to facial skin.

What we look at in a face cream

  • Preservative system in an emulsion. Which preservatives are permitted under Annex V, at what concentration, and whether the system still works at your finished pH.
  • UV filters. The moment a face cream carries an SPF claim it enters Annex VI, and nano forms of titanium dioxide or zinc oxide bring their own approval and (nano) labelling requirements.
  • Retinol and other restricted actives against the limits set by Regulation (EU) 2024/996.
  • Emulsion stability and packaging compatibility — the data behind the shelf life and PAO you print on the pack.
  • Fragrance allergens above the leave-on threshold under Regulation (EU) 2023/1545.

What you receive

A complete Cosmetic Product Safety Report in two parts, prepared and signed by a qualified Safety Assessor:

  • Part A — safety information. Composition, physicochemical characteristics and stability, microbiological quality, impurities and packaging, the exposure assessment for your face cream, the toxicological profile of every substance, and any undesirable effects.
  • Part B — safety assessment. The assessor’s reasoned conclusion on whether the product is safe, together with any warnings or usage restrictions that must appear on the label.

Which laboratory tests you actually need

A face cream normally contains a water phase, so the microbiological side of the file matters. The list below is the usual starting point — we confirm it against your actual formulation.

TestUsually neededWhy
Microbiological test (ISO 17516)YesConfirms the finished product meets cosmetic microbiological limits
Preservative efficacy / challenge test (ISO 11930)YesDemonstrates the preservative system holds across shelf life and use
Accelerated stability and compatibility testYesSupports the shelf life and PAO you print on the pack
Certificate of Analysis (physicochemical)YespH, viscosity, density, appearance and odour for the CPSR

Testing is arranged through our partner laboratories. If you already hold valid reports, we use yours — you are not asked to repeat work.

Typical required documents

This is what we normally ask for to start a face cream safety assessment. You do not need every item on day one — send what you have and we will tell you what is missing.

DocumentNeeded
Full formulation with INCI names and exact percentagesAlways
Raw material specifications and technical data sheetsAlways
Safety data sheets for the raw materialsAlways
Finished product specificationAlways
Primary packaging specification (material in contact with the product)Always
Manufacturing method and GMP statement (ISO 22716)Always
Label artwork or draftAlways
Stability and packaging compatibility dataAlways
Emulsion type and phase compositionAlways
pH of the finished productAlways
SPF test reportIf an SPF claim is made
Fragrance allergen declaration or IFRA certificateIf fragranced

Why order your face cream assessment with Lexora

  • Assessed as a face cream, not as a generic cosmetic. An emulsion left on the face daily is assessed on preservation and stability as much as on its actives — a generic assessment tends to under-weight both.
  • EU-recognised assessors. Signed by qualified, VUB-trained Safety Assessors.
  • No unnecessary testing. We tell you which tests your formulation genuinely needs and which it does not.
  • Transparent pricing. Published upfront and scaled to your formula — no hourly surprises.
  • End-to-end route to market. Pair it with CPNP notification and an EU Responsible Person and you are done.
Considerably. An SPF claim brings Annex VI UV filters into scope, requires substantiated SPF testing, and adds labelling rules. Tell us at intake so it is scoped from the start.
Almost always yes. A water-containing emulsion needs evidence that its preservative system controls microbial growth across shelf life and consumer use — that is the ISO 11930 challenge test.
By the number of ingredients in your formula. Select the matching tier above (1–9, 10–24, 25–39 or 40+) and the price updates automatically.
A qualified Safety Assessor — a toxicologist, pharmacist or equivalent professional, EU-recognised and trained at Vrije Universiteit Brussel (VUB), as Annex I of the Regulation requires.
No. The CPSR is mandatory but not sufficient on its own. You also need a complete Product Information File, a CPNP notification and an appointed EU Responsible Person. We provide all three.
It depends on the size of the formula and how complete your documentation is. Once your intake is in we confirm a timeline — and if laboratory testing is still outstanding, that is usually what sets the pace.
Yes. The safety report is one component of the PIF. We can assemble the whole dossier, or review the one you already hold.

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Complete your compliance

Every EU cosmetic needs an EU Responsible Person

A safety report proves your product is safe. To legally place it on the EU market you also need an appointed EU Responsible Person — a role we can take on for you.

View EU Responsible Person →
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