Cosmetics Regulation (EC) No 1223/2009 Nail care · treatment

Safety Assessment for Nail & Cuticle Care

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A Cosmetic Product Safety Report for cuticle oils, nail treatments, hardeners and strengtheners — assessed as treatments applied to the nail fold and surrounding skin, with restricted hardener chemistry checked properly.

Configure your assessment
Answer three questions — the price updates live

Price range: € 200.00 through € 675.00

Priced by shared base formula, shade count and ingredient count · VAT calculated at checkout
1

Do all shades share the same base formula and differ only in colour pigments (the May Contain +/- system)?

Quantity
Prepared by EU-recognised, VUB-trained Safety Assessors.
Covers Part A (safety information) and Part B (expert assessment).
Written for a nail and cuticle care product 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 nail and cuticle care product 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 nail and cuticle care product. 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 nail and cuticle care products

Nail and cuticle products are applied to the nail plate and the skin around it, often daily, frequently with a brush or pen applicator that returns to the pack. Most are anhydrous oils or solvent systems. The regulatory pressure sits on hardener actives and on the restricted monomers that appear in treatment formats.

Where you sell a range of tinted or scented variants on one base, this service assesses the range rather than each variant separately.

What we look at in a nail and cuticle care product

  • Nail hardener actives, several of which are restricted in cosmetic use and carry mandatory warnings.
  • Methacrylate monomers restricted to professional use under Regulation (EU) 2020/1682.
  • Application to the cuticle and nail fold — living skin, often broken, which is not the same exposure as the nail plate.
  • Essential oils and fragrance allergens in cuticle oils under Regulation (EU) 2023/1545.
  • Applicator hygiene for pen and brush formats returned to the pack after skin contact.

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 nail and cuticle care product, 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 nail and cuticle care product 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 notAnhydrous oil or solvent system — no available water
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 nail and cuticle care product 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
Base formula and any variant listAlways
Hardener or treatment active documentationIf a strengthening claim is made
Applicator specificationAlways

Why order your nail and cuticle care product assessment with Lexora

  • Assessed as a nail and cuticle care product, not as a generic cosmetic. The nail plate is dead tissue; the cuticle is not. The exposure that matters is to the skin around the nail, and that is what we assess.
  • 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 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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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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