Safety Assessment for Body Lotion
CPSR for a body lotion — the largest applied quantity of any leave-on cosmetic, which tightens…
Price range: € 150.00 through € 500.00
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Required for EU market access
Cosmetics
Regulation (EC) No 1223/2009
Leave-on · high frequency
Safety Assessment for Hand Cream
A Cosmetic Product Safety Report for a hand cream — applied more often than any other leave-on cosmetic, frequently to damaged skin, and with a genuine route to ingestion that the exposure model has to account for.
Configure your assessment
Choose your formula size — price updates live
Price range: € 150.00 through € 500.00
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a hand cream specifically — exposure, tests and warnings to match.
Good to know. A safety report is mandatory, but it is not the whole job. To place your hand 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 hand 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 hand cream
Hand cream is unusual because of how often it is used. Several applications a day, on skin that is washed repeatedly and is often cracked or irritated, and on the part of the body that handles food. Each of those raises the exposure figure or loosens the assumptions a standard assessment would make.
You receive a full CPSR, Part A and Part B, with frequency-of-use figures appropriate to a hand product.
What we look at in a hand cream
- Frequency of application. Daily exposure is driven by how often, not only how much — and hand cream is the most frequently reapplied leave-on product there is.
- Application to compromised skin, since hand creams are bought precisely when skin is cracked or irritated.
- Secondary ingestion through hand-to-mouth contact, which is a real exposure route for hand products.
- Urea and other actives at treatment strength, common in repair formats.
- Fragrance allergens under Regulation (EU) 2023/1545, where high reapplication frequency raises the total.
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 hand 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 hand 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.
| 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 hand cream 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 frequency of use | Always |
| pH of the finished product | Always |
| Fragrance allergen declaration or IFRA certificate | If fragranced |
Why order your hand cream assessment with Lexora
- Assessed as a hand cream, not as a generic cosmetic. Reapplication frequency is what makes a hand cream different, and it is the number a generic leave-on assessment gets wrong.
- 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.
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