Safety Assessment for Baby Cosmetics (0–3 Years)
Enhanced CPSR for products used on children under three — paediatric exposure modelling and the age-restricted…
Price range: € 250.00 through € 600.00
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Enhanced toxicological assessment
Cosmetics
Regulation (EC) No 1223/2009
Pregnancy · enhanced assessment
Safety Assessment for Pregnancy Cosmetics
An enhanced Cosmetic Product Safety Report for cosmetics marketed to pregnant and breastfeeding customers — a targeted review of the substances that matter in pregnancy, plus an honest read on what you may and may not claim.
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 cosmetic for use during pregnancy specifically — exposure, tests and warnings to match.
An honest word on claims. EU law has no "pregnancy-safe" category, and a claim implying medical reassurance can be challenged. What we can do is assess your formulation against the substances of concern and help you word the position defensibly. If a claim will not stand up, we will say so.
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 cosmetic for use during pregnancy. 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 marketed for pregnancy
There is no legal category of "pregnancy-safe cosmetic" in EU law. What exists is a set of substances where developmental or endocrine concerns are documented, and a customer group that reads labels more carefully than any other. This service does two things: it assesses your formulation with those substances specifically in scope, and it tells you plainly which claims you can defend.
The toxicological work is deeper than a standard CPSR — reproductive and developmental endpoints are examined explicitly rather than taken as read — which is why the price sits above the standard tier.
What we look at in a cosmetic for use during pregnancy
- Retinoids. Vitamin A derivatives are the first thing this customer group looks for, and Regulation (EU) 2024/996 has already set limits on them in cosmetics.
- Salicylic acid and other BHAs, at the concentrations used in leave-on treatment products.
- Substances with endocrine-activity concerns, including phytoestrogens such as genistein and daidzein addressed by the same 2024 amendment.
- Essential oils traditionally flagged in pregnancy, and their constituents at your finished concentration.
- Dermal absorption assumptions, examined conservatively where systemic exposure is the concern.
- The claim itself. "Safe for pregnancy" is a claim like any other and has to satisfy the common criteria of Regulation (EU) No 655/2013.
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 cosmetic for use during pregnancy, 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 cosmetic for use during pregnancy 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 cosmetic for use during pregnancy 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 |
| Concentration and supplier data for each active | Always |
| Draft marketing claims and label copy | Always |
| Essential oil composition | If essential oils are used |
| Fragrance allergen declaration or IFRA certificate | If fragranced |
Why order your cosmetic for use during pregnancy assessment with Lexora
- Assessed as a cosmetic for use during pregnancy, not as a generic cosmetic. This customer group buys on the claim, and the claim is where the legal risk lives — so the assessment covers the wording as well as the formula.
- 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.
It is risky as an unqualified claim. It has to satisfy the common criteria in Regulation (EU) No 655/2013, must not imply a medical benefit, and must not suggest that competitors are unsafe. We will help you find wording that is both accurate and defensible.
Yes. It is a full CPSR plus a targeted reproductive and developmental review, and an assessment of the pregnancy-related claims you intend to make.
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.
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