Safety Assessment for Lip Balm
CPSR for a lip balm — anhydrous, so no challenge test, but assessed against ingestion with…
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 Lipstick, Lip Gloss & Lip Liner
A Cosmetic Product Safety Report covering a full lipstick, gloss or liner range on one base formula — assessed against ingestion, with lip-permitted colorants and heavy metal limits checked across every shade.
Configure your assessment
Answer three questions — the price updates live
Price range: € 200.00 through € 675.00
1
Do all shades share the same base formula and differ only in colour pigments (the May Contain +/- system)?
This service is not the right fit. It is intended only for cosmetic ranges built on a common base formulation with a May Contain (+/-) ingredient declaration.
If each shade has its own individual formulation, please order our standard Cosmetic Product Safety Report, or contact us for a quotation covering the range.
Please contact us before ordering. Whether your shades share one base formula decides both the scope and the price, so we would rather check it with you than sell you the wrong assessment.
This range needs a tailored quote. Above 120 shades, or with 40+ ingredients in the combined formulation, the pigment matrix is reviewed in groups. A flat online price would either overcharge you or under-scope the work.
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a lipstick 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 lipstick 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
One assessment can cover a whole shade range.
How it works
From order to signed report
1
Select & order
Answer the three questions above so we scope your shade range correctly, then order online.
2
Document collection
We send a secure intake listing exactly what we need for a lipstick. 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 lipstick, lip gloss and lip liner
Lip colour combines the two things that make an assessment demanding: an ingestion exposure route, and a large pigment matrix. A forty-shade lipstick range is normally one base plus pigments under May Contain (+/-), so it is one assessment — but every one of those pigments has to be permitted for lip use under Annex IV and has to meet the purity criteria that come with it.
You receive a full CPSR covering the base formula and the whole shade range.
What we look at in a lipstick
- Ingestion exposure. Lip products are swallowed in use, so the exposure model uses an oral route and acceptable levels tighten accordingly.
- Annex IV colorants permitted for lip application, checked shade by shade across the May Contain list.
- Heavy metal traces in pigments, assessed against limits that assume ingestion.
- Synthetic polymer microparticles under Regulation (EU) 2023/2055, where lip and make-up products have a transitional period that new formulations should be planned around.
- Liquid lipsticks and glosses containing water, which need preservation and challenge testing that a wax bullet does not.
- UV filters if any shade carries an SPF claim.
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 lipstick, 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 lipstick 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 lipstick 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 |
| Base formula with the full May Contain (+/-) pigment list | Always |
| Number of shades sharing the base | Always |
| Colour Index numbers and pigment purity data | Always |
| Heavy metal analysis for pigments | Always |
Why order your lipstick assessment with Lexora
- Assessed as a lipstick, not as a generic cosmetic. Every shade in the range is eaten in small amounts, so every pigment in the matrix has to clear the lip-use column — not just the ones in your bestsellers.
- 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.
Yes. A water-containing liquid lip product needs a preservative system, challenge testing and microbiological testing. Tell us at intake and we scope it as a water-containing formula.
By how many shades share one base formula, and how many ingredients that combined formulation contains — including every pigment listed under May Contain (+/-). A range of 40 shades built on one base costs far less than 40 separate assessments, which is the whole point.
Then this service is not the right one. Each individually formulated shade needs its own assessment — order the standard Cosmetic Product Safety Report instead, or contact us and we will quote the range properly.
Contact us for a quote. Above 120 shades the pigment matrix usually needs to be reviewed in groups, so a flat online price would either overcharge you or under-scope the work.
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 Lipstick, Lip Gloss & Lip Liner
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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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