Cosmetics Regulation (EC) No 1223/2009 Face make-up · shade range

Safety Assessment for Concealer

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A Cosmetic Product Safety Report covering a concealer shade range on one base formula — with the under-eye application that most concealers are actually bought for taken properly into account.

Configure your assessment
Answer three questions — the price updates live

Price range: € 200.00 through € 675.00

Priced by shared base formula, shade count and ingredient count · VAT calculated at checkout
1

Do all shades share the same base formula and differ only in colour pigments (the May Contain +/- system)?

Quantity
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a concealer 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 concealer 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
One assessment can cover a whole shade range.
How it works

From order to signed report

1

Select & order

Answer the three questions above so we scope your shade range correctly, then order online.

2

Document collection

We send a secure intake listing exactly what we need for a concealer. 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 concealer

Concealer follows the same logic as foundation: one base, many shades, one assessment. What sets it apart is where it goes. Concealer is applied under the eye, on the thinnest skin on the body and close enough to the eye that Annex IV eye-area colorant restrictions come into play — even though it is sold as a face product.

You receive a full CPSR covering the base formula and the full shade matrix.

What we look at in a concealer

  • Under-eye application. Thinner skin and proximity to the eye, which pulls the Annex IV eye-area column into scope.
  • Pigment matrix across the shade range against Annex IV, with purity criteria.
  • Preservation where the base is a water-containing emulsion, including challenge testing.
  • Applicator hygiene. Doe-foot and sponge applicators return to the pack after contact with the eye area repeatedly.
  • Heavy metal traces in pigments as technically unavoidable impurities.

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 concealer, 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 concealer 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 concealer 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
Base formula with the full May Contain (+/-) pigment listAlways
Number of shades sharing the baseAlways
Colour Index numbers and pigment purity dataAlways
Applicator specificationAlways

Why order your concealer assessment with Lexora

  • Assessed as a concealer, not as a generic cosmetic. Concealer is sold as a face product and used as an eye-area product. The assessment has to follow the use, not the marketing category.
  • 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.
By how many shades share one base formula, and how many ingredients that combined formulation contains — including every pigment listed under May Contain (+/-). A range of 40 shades built on one base costs far less than 40 separate assessments, which is the whole point.
Then this service is not the right one. Each individually formulated shade needs its own assessment — order the standard Cosmetic Product Safety Report instead, or contact us and we will quote the range properly.
Contact us for a quote. Above 120 shades the pigment matrix usually needs to be reviewed in groups, so a flat online price would either overcharge you or under-scope the work.
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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