Cosmetics Regulation (EC) No 1223/2009 Anhydrous · leave-on

Safety Assessment for Body Butter

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A Cosmetic Product Safety Report for an anhydrous body butter — assessed on oxidation and applied quantity rather than on preservation, so you are not buying microbiological tests your formula does not need.

Configure your assessment
Choose your formula size — price updates live

Price range: € 150.00 through € 500.00

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 body butter specifically — exposure, tests and warnings to match.
Anhydrous formula: challenge and microbiological testing usually not required.
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Good to know. A safety report is mandatory, but it is not the whole job. To place your body butter 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.
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 butter. 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 butter

A true body butter has no water phase. That removes the microbiological question almost entirely — microbial growth needs available water — and moves the assessment onto different ground: oxidative stability of the butters and oils, the very large quantity applied to the whole body, and packaging that stays sealed against a product people scoop out with their fingers.

You receive a full CPSR, Part A and Part B, with an anhydrous testing rationale documented in the file rather than tests bought for form’s sake.

What we look at in a body butter

  • Oxidative stability. Unsaturated plant oils go rancid; the antioxidant system and the shelf life have to be justified.
  • Applied quantity over the whole body, which keeps the exposure figure high even though the format is simple.
  • Any water introduced in use — wet fingers in an open jar. Where that risk is real we document it rather than ignore it.
  • Essential oils and their allergen content under Regulation (EU) 2023/1545; natural body butters routinely exceed the declaration threshold.
  • Botanical oils with their own restrictions, and the supplier documentation that proves identity and purity.

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 butter, 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 butter 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.

TestUsually neededWhy
Microbiological test (ISO 17516)Usually notNo water phase — microbial growth is not supported
Preservative efficacy / challenge test (ISO 11930)Usually notNo water phase — there is no available water for microbial growth
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 body butter 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
Oil and butter composition with supplier specificationsAlways
Antioxidant system and rationaleAlways
Packaging type (jar, tube, stick)Always
Fragrance allergen declaration or IFRA certificateIf fragranced

Why order your body butter assessment with Lexora

  • Assessed as a body butter, not as a generic cosmetic. The anhydrous rationale has to be written into the file properly — done right it removes two laboratory tests legitimately.
  • 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.
For a genuinely anhydrous formula, normally not — and we document why in the report so it stands up to scrutiny. If your formula contains any water, or is packed in an open jar used with wet hands, we will say so and reassess.
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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Complete your compliance

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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