Safety Assessment for Lip Oil
CPSR for a lip oil or glossy treatment — anhydrous and tinted, with ingestion exposure and…
Price range: € 150.00 through € 500.00
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Required for EU market access
Cosmetics
Regulation (EC) No 1223/2009
Lip · ingestion route
Safety Assessment for Lip Balm
A Cosmetic Product Safety Report for a lip balm — anhydrous, so no challenge test, but assessed against ingestion because lip products are swallowed in use.
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 lip balm specifically — exposure, tests and warnings to match.
Anhydrous formula: challenge and microbiological testing usually not required.
Good to know. A safety report is mandatory, but it is not the whole job. To place your lip balm 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 lip 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 lip balm
Lip products are eaten. Not deliberately, but a measurable proportion of what is applied to the lips is ingested, and that changes the safety assessment fundamentally. The exposure calculation uses an oral route, colorants must be permitted for lip use, and heavy metal traces in pigments are assessed against limits that assume swallowing.
Because a lip balm is normally anhydrous, the microbiological side falls away and the file documents why — you are not buying tests a wax-and-oil stick does not need.
What we look at in a lip balm
- Ingestion exposure. The assessment uses an oral route for a proportion of the applied amount, which tightens acceptable levels considerably.
- Colorants against Annex IV, restricted to those permitted for lip application, with their purity criteria met.
- Heavy metal traces in pigments and mineral ingredients, assessed as technically unavoidable impurities.
- UV filters if the balm carries an SPF claim, which brings Annex VI into scope.
- Flavours and sweeteners, and fragrance allergens under Regulation (EU) 2023/1545.
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 lip 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 lip 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 | Anhydrous wax and oil system — no available water |
| 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 lip 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 |
| Colorant list with Colour Index numbers and purity data | If coloured |
| Heavy metal analysis for pigments | If coloured |
| Flavour composition | If flavoured |
| SPF test report | If an SPF claim is made |
Why order your lip balm assessment with Lexora
- Assessed as a lip balm, not as a generic cosmetic. Lip products are assessed against an ingestion route. Applying a standard skin-exposure model to a lip balm is simply the wrong calculation.
- 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.
Because in practice everyone does. Established exposure models assume a proportion of a lip product is ingested, and EU assessments are built on that assumption. It is what makes lip colorant rules stricter than skin ones.
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 Lip Balm
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