Safety Assessment for Children’s Cosmetics
Enhanced CPSR for children’s cosmetics — assessed on children’s body weight and children’s real use patterns,…
Price range: € 250.00 through € 600.00
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Enhanced toxicological assessment
Cosmetics
Regulation (EC) No 1223/2009
0–3 years · enhanced assessment
Safety Assessment for Baby Cosmetics (0–3 Years)
An enhanced Cosmetic Product Safety Report for products intended for children under three — deeper toxicological evaluation and far more conservative exposure calculations than a standard CPSR, because the consumer is not a small adult.
Configure your assessment
Choose your formula size — price updates live
Price range: € 250.00 through € 600.00
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a baby cosmetic specifically — exposure, tests and warnings to match.
Why this costs more than a standard CPSR. The toxicological evaluation is deeper and the exposure calculations are rebuilt on paediatric parameters rather than adjusted from adult ones. It is genuinely more work, not a premium for the label.
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 baby 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 babies (0–3 years)
Cosmetics for children under three are treated differently under Regulation (EC) No 1223/2009, and rightly so. Infants have a higher body-surface-area to body-weight ratio, an immature skin barrier, and developing metabolic and immune systems. The same concentration of the same substance produces a materially higher internal dose than it would in an adult, and the margin of safety calculation reflects that.
Several substances are also explicitly restricted for this age group. Salicylic acid, for example, is not permitted in products for children under three other than in shampoos, and certain preservatives carry the same age restriction under Annex V. These are the entries a standard assessment is least likely to check.
This service delivers a full CPSR built on paediatric exposure assumptions, which is why it is priced above the standard assessment.
What we look at in a baby cosmetic
- Paediatric exposure modelling. Body weight, surface area and application frequency for the actual age band — not adult defaults.
- Age-restricted substances. Annex III and Annex V contain entries specifically excluding children under three. Salicylic acid and certain preservatives are the ones most often missed.
- Immature skin barrier, and the more conservative absorption assumptions that follow from it.
- Fragrance and allergen load. Sensitisation in early life has long consequences; the assessment takes a stricter view than it would for an adult product.
- Nappy-area products, where occlusion under a nappy substantially increases absorption.
- Accidental ingestion, a realistic route for this age group with bath products and creams alike.
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 baby 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 baby 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.
| Test | Usually needed | Why |
|---|---|---|
| Microbiological test (ISO 17516) | Yes | Confirms the finished product meets cosmetic microbiological limits |
| Preservative efficacy / challenge test (ISO 11930) | Yes | Demonstrates the preservative system holds across shelf life and use |
| Accelerated stability and compatibility test | Yes | Supports the shelf life and PAO you print on the pack |
| Certificate of Analysis (physicochemical) | Yes | pH, 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 baby cosmetic safety assessment. You do not need every item on day one — send what you have and we will tell you what is missing.
| Document | Needed |
|---|---|
| Full formulation with INCI names and exact percentages | Always |
| Raw material specifications and technical data sheets | Always |
| Safety data sheets for the raw materials | Always |
| Finished product specification | Always |
| Primary packaging specification (material in contact with the product) | Always |
| Manufacturing method and GMP statement (ISO 22716) | Always |
| Label artwork or draft | Always |
| Stability and packaging compatibility data | Always |
| Intended age range, stated precisely | Always |
| Concentration and supplier data for each active | Always |
| Preservative system with age-suitability justification | Always |
| Ophthalmological tolerance data | For bath and hair products |
| Fragrance allergen declaration or IFRA certificate | If fragranced |
Why order your baby cosmetic assessment with Lexora
- Assessed as a baby cosmetic, not as a generic cosmetic. A standard CPSR uses adult body weight and adult exposure defaults. For a product used on a newborn, those numbers are simply not the right ones.
- 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.
If children under three are within the intended users, yes — the assessment has to cover the most vulnerable user you are selling to. If you market it strictly for adults, the standard assessment applies.
Only under strict conditions. The common criteria in Regulation (EU) No 655/2013 require such a claim to be substantiated, and regulators scrutinise it hardest on baby products. Our Claims Compliance Check covers this.
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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Safety Assessment for Baby Cosmetics (0–3 Years)
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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.
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