Safety Assessment for Body Butter
CPSR for an anhydrous body butter — assessed on oxidation and applied quantity, without microbiological tests…
Price range: € 150.00 through € 500.00
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Required for EU market access
Cosmetics
Regulation (EC) No 1223/2009
Anhydrous · leave-on
Safety Assessment for Body Balm
A Cosmetic Product Safety Report for an anhydrous body balm — wax-and-oil chemistry, often with treatment-level actives, assessed without the microbiological tests a water-based formula would need.
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 body balm specifically — exposure, tests and warnings to match.
Anhydrous formula: challenge and microbiological testing usually not required.
Watch the claim line. Balms marketed for eczema, wounds or "healing" can cross from cosmetic into medicinal product territory, which is a different legal regime entirely. If your claims are heading that way we will flag it during the assessment.
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.
Right-sized testing
Anhydrous formulas skip tests they do not need.
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 body balm. 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 body balm
A balm is a wax-structured anhydrous system, frequently sold for dry, damaged or compromised skin. Two things follow. First, no water phase means no meaningful microbial growth and a documented rationale for skipping challenge and microbiological testing. Second, balms are often applied to broken or irritated skin, and the assessment has to consider that the barrier may not be intact.
You receive a full CPSR, Part A and Part B, scoped for an anhydrous leave-on balm.
What we look at in a body balm
- Application to compromised skin, where the barrier is not intact and absorption assumptions change.
- Wax and butter system, its melting behaviour, and packaging compatibility across a realistic temperature range.
- Actives at treatment concentrations — and the line between a cosmetic balm and a product making a medicinal claim.
- Essential oils and fragrance allergens under Regulation (EU) 2023/1545.
- Oxidative stability of the oil phase across the stated shelf life.
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 body balm, 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 body balm is normally anhydrous, and that changes the testing bill. Microbiological and challenge testing exist to address microbial growth, and microbial growth needs available water. We will tell you when you can skip them rather than sell you tests your formulation does not need.
| Test | Usually needed | Why |
|---|---|---|
| Microbiological test (ISO 17516) | Usually not | No water phase — microbial growth is not supported |
| Preservative efficacy / challenge test (ISO 11930) | Usually not | No water phase — there is no available water for microbial growth |
| 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 body balm 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 |
| Wax and butter composition | Always |
| Intended use, including any claim about damaged skin | Always |
| Fragrance allergen declaration or IFRA certificate | If fragranced |
Why order your body balm assessment with Lexora
- Assessed as a body balm, not as a generic cosmetic. Balms are sold for damaged skin, so the assessment cannot assume an intact barrier — that assumption is exactly what a generic report makes.
- 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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Safety Assessment for Body Balm
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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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