Cosmetics Regulation (EC) No 1223/2009 Children · enhanced assessment

Safety Assessment for Children’s Cosmetics

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An enhanced Cosmetic Product Safety Report for cosmetics aimed at children — assessed on children’s body weight, children’s use patterns and children’s tendency to use products in ways no adult would.

Configure your assessment
Choose your formula size — price updates live

Price range: € 250.00 through € 600.00

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 children’s cosmetic specifically — exposure, tests and warnings to match.
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Play sets may need more than cosmetics law. If your product is sold as a toy or in a play set, the Toy Safety Directive may apply alongside Regulation (EC) No 1223/2009. We will tell you if your product sits in that overlap.
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 children’s cosmetic. 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 cosmetics for children

Children are not scaled-down adults, and children’s cosmetics are not scaled-down adult cosmetics. Lower body weight raises the internal dose from the same applied amount; play patterns mean products get used more heavily, more often and in places they were not designed for; and children’s make-up and glitter products carry ingestion risks that the adult equivalents do not.

This is a full CPSR with the toxicological evaluation and exposure assessment rebuilt for a paediatric user, which is why it sits above the standard tier.

What we look at in a children’s cosmetic

  • Body-weight-based exposure for the stated age range, which is what actually drives the margin of safety.
  • Realistic use patterns. Children apply more, more often, and less carefully. The assessment models that rather than an idealised adult routine.
  • Ingestion. Face paints, glitter gels and children’s lip products end up in mouths, and the exposure model has to say so.
  • Sensitisation potential. Fragrance and preservative choices are assessed more conservatively than for an adult product.
  • Glitter and effect pigments, including synthetic polymer microparticles restricted under Regulation (EU) 2023/2055.
  • Toy-cosmetic overlap. Play make-up sets can engage the Toy Safety Directive alongside cosmetics law — two regimes, not one.

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 children’s cosmetic, 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 children’s cosmetic 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 children’s cosmetic 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
Intended age range, stated preciselyAlways
Colorant list with Colour Index numbersIf coloured
Packaging and applicator specificationAlways
Fragrance allergen declaration or IFRA certificateIf fragranced

Why order your children’s cosmetic assessment with Lexora

  • Assessed as a children’s cosmetic, not as a generic cosmetic. Children use cosmetics in ways adults do not, and the exposure model has to reflect the real child rather than a smaller grown-up.
  • 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 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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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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