To sell gel nail cosmetics legally in the EU you need a designated Responsible Person (RP), a complete Product Information File (PIF) including a CPSR, a valid CPNP notification before market placement, and compliant EU labelling in the required language(s) for the markets where you sell.
Is gel nail “gel polish” a cosmetic in the EU?
Most gel nail products marketed for application to the nail plate to colour, beautify, protect, or keep nails in good condition fall under the EU definition of a cosmetic product. In that case, they are regulated by Regulation (EC) No 1223/2009 and must meet its safety, documentation, notification, and labelling requirements before being placed on the EU market.
What matters is the intended use and how the product is presented (claims, instructions, and typical consumer use), not whether the product is used in salons or at home. The regulation applies to products placed on the market, including those marketed as “professional”.
The 4 pillars of EU compliance
For gel nail cosmetics, EU compliance is best understood as four non-negotiable pillars:
- Responsible Person (RP) established in the EU
- PIF (Product Information File) including a compliant CPSR (Cosmetic Product Safety Report)
- CPNP notification completed before market placement
- EU-compliant label (content + language + traceability)
If any one of these is missing or incorrect, you have a regulatory vulnerability: products can be refused at the border, seized from warehouses/salons, removed from marketplaces, or become the subject of enforcement action.
Responsible Person (RP): who, where, and what they are liable for
The Responsible Person is the legal entity responsible for ensuring the cosmetic product complies with Regulation (EC) 1223/2009. The RP must be established within the EU. For EU enforcement, the RP is the primary point of accountability for authorities.
Who can be the RP?
- The EU manufacturer (if produced in the EU)
- The EU importer (if manufactured outside the EU)
- A third party appointed by written mandate (an RP service provider)
Key RP responsibilities (practical view)
- Ensure a CPSR is completed and kept up to date
- Ensure a complete PIF exists and is accessible at the RP address
- Ensure CPNP notification is done before placing on the market
- Ensure label compliance and traceability (batch/lot)
- Manage serious undesirable effects (SUE) reporting and corrective actions
- Cooperate with competent authorities during inspections
Practical warning for sellers
If you buy gel products from outside the EU and sell them in the EU under your own business, you are often the importer and may be treated as the RP unless a compliant EU RP is clearly designated and shown on the label. “The brand is responsible” is not a safe assumption if the brand has no EU-established RP.
PIF and CPSR: what must be inside (and what sellers often miss)
The Product Information File (PIF) must be kept for each cosmetic product and made readily accessible to competent authorities at the RP address. It must be kept up to date and retained for the required period after the last batch is placed on the market.
Core PIF contents (what authorities expect)
- Product description enabling clear identification
- Cosmetic Product Safety Report (CPSR) (Part A + Part B)
- Manufacturing method and statement of compliance with GMP (commonly ISO 22716)
- Proof of effect for any claimed effects where justified
- Data on animal testing (where applicable under the regulation’s framework)
CPSR (safety assessment): what matters specifically for gel nails
Gel nail products are chemically reactive systems. The CPSR typically needs robust justification around:
- Ingredient identity and restrictions (Annex II prohibited, Annex III restricted, Annex IV colorants, etc.)
- Exposure scenario (amount per application, frequency, target population, professional vs consumer context)
- Impurities and traces (residual monomers, inhibitors, impurities, heavy metals where relevant)
- Photoinitiators and compliance with current restrictions
- Sensitisation risk (acrylates/methacrylates are common sensitizers; label warnings and safe-use instructions matter)
Common PIF/CPSR failures in the gel market
- No real CPSR (only an SDS, or a “certificate”, or a supplier statement)
- INCI list not aligned with actual formula (or not in INCI language)
- Missing range formula logic for colour variants (pigment ranges not clearly controlled)
- Outdated compliance (restrictions change; PIF not updated)
- No clear product traceability (batch/lot control inconsistent)
Important: An SDS can be useful for occupational safety and transport classification, but it is not a substitute for a CPSR and does not fulfil cosmetic compliance requirements in the EU.
CPNP notification: timing, data needed, and common errors
CPNP (Cosmetic Products Notification Portal) notification must be completed before the product is placed on the EU market. CPNP is a notification system (not a pre-approval), but incorrect notification is still a compliance failure.
What you typically need for CPNP
- Product category and name
- RP details and contact
- Country of origin (for imports)
- Presence of certain substances (where required by portal fields)
- Label artwork (often uploaded as part of the notification dataset)
- Frame formulation / ingredient information as required in the portal
Common CPNP issues for gel products
- CPNP submitted with placeholder label or missing languages
- Mismatch between notified product identity and what is actually sold (names, variants, sizes)
- Variant sprawl: many colors treated inconsistently without a controlled approach
- RP not truly established in the EU, or RP details not on the label
Label compliance: mandatory items, language, and practical layout tips
The label is where compliance becomes visible. A compliant PIF and CPNP are necessary, but enforcement often starts with “what’s on the bottle/box”. At minimum, you must ensure all required information is present on the container and/or outer packaging, and that the information is provided in the required language(s) for the Member State where the product is made available to the end user.
Mandatory label elements (typical list)
- Name and address of the Responsible Person (EU established)
- Country of origin for products imported into the EU
- Nominal content (e.g., mL/g)
- Date of minimum durability (if applicable) or PAO (Period After Opening) where applicable
- Precautions for use (including any required warnings)
- Batch number / lot for traceability
- Product function (unless obvious from presentation)
- Ingredients list using INCI names
Language: the practical rule for online selling
If you sell into multiple EU countries, you must ensure the mandatory label information (especially precautions for use) is available in the language(s) required by each destination Member State. For cross-border ecommerce, authorities can treat “selling into” a country as making the product available there, even if you ship from another Member State.
Small packaging: leaflets, tags, and “attached information”
For very small containers, certain information may be provided on an enclosed leaflet, a label tag, or similar means (depending on what is practically feasible), but the approach must be robust: customers and inspectors must still be able to access the mandatory information at the time of supply, and traceability must remain clear. For gel bottles, many sellers use a box label, a wrap label, or a fold-out label to fit the required information.
INCI list for gels: typical pitfalls
- Using non-INCI chemical names instead of INCI
- Omitting photoinitiators or reactive diluents
- Inconsistent naming across shades/variants
- Missing CI numbers where relevant for colorants
Claims, “professional use”, and why SDS is not enough
Claims must be supportable
Any claim you make (e.g., “HEMA-free”, “TPO-free”, “hypoallergenic”, “safe for sensitive skin”) must be truthful, supportable, and not misleading. In the gel category, avoid absolute safety claims; it is better to use verifiable statements (ingredient absence, tested properties, or clear usage instructions).
“For professional use only” is not a compliance shortcut
Labelling a product “professional use only” does not remove the obligations under the Cosmetics Regulation for products placed on the market. You still need RP, PIF/CPSR, CPNP, and compliant labelling. (Separate occupational safety rules may apply for salons, but they do not replace cosmetic compliance.)
SDS: useful document, wrong regulatory category
An SDS is designed for workplace chemical safety and supply-chain communication under chemical legislation frameworks. Cosmetics compliance requires a cosmetic safety assessment (CPSR), labelling per cosmetic rules, and notification via CPNP. In enforcement cases, “we have an SDS” is typically treated as insufficient because it does not demonstrate cosmetic regulatory compliance.
Imports and online cross-border sales: who is the importer and what changes
If the gel is manufactured outside the EU (for example in Korea) and brought into the EU, the entity bringing it in is generally the importer and triggers EU market obligations. If the brand has no EU RP and you import the goods, you may be the de facto responsible economic operator from an enforcement perspective unless an EU RP is properly appointed and clearly indicated on the label.
Key import-specific requirements you must not miss
- Country of origin must be on the label for imports
- RP address must be EU established and shown on label
- CPNP notification must exist before sale
- Border/warehouse checks: non-compliant labelling can lead to seizure or refusal of release
For ecommerce, remember that selling “into” the EU from outside the EU without proper EU compliance can lead to products being seized and destroyed by authorities and platforms can remove listings when compliance is challenged.
Fast compliance checklist for gel nail sellers
- Confirm product classification: marketed as cosmetic for nails.
- Appoint an EU Responsible Person (RP): written mandate; RP details ready for the label.
- Build a complete PIF: product description, GMP statement, claims support, animal testing statement, etc.
- Obtain a compliant CPSR: Part A + Part B, by a qualified safety assessor; ensure formula/INCI/impurities are consistent.
- Verify ingredient compliance: Annex II/III restrictions, allowed colorants, and current photoinitiator restrictions.
- Prepare compliant labels: RP address, origin (if import), nominal content, batch, PAO/durability, function, precautions, INCI list.
- Handle small packaging properly: box/leaflet/tag solution that still delivers mandatory info at point of sale.
- Notify on CPNP: complete notification before placing on the market.
- Set up traceability: batch/lot mapping to invoices, import docs, and inventory.
- Post-market readiness: complaint handling, undesirable effects procedure, corrective action workflow.
FAQ
Do I need CPNP if I only sell to salons?
If you place cosmetic products on the EU market (including B2B supply to salons), the core obligations still apply: RP, PIF/CPSR, CPNP, and labelling.
Is an SDS required for cosmetics?
An SDS is not the core compliance document for cosmetics under EU cosmetics law. For many cosmetic products it is not legally required in the same way as for hazardous chemical mixtures, and it is not sufficient for cosmetics compliance. Your “must have” is the CPSR within the PIF, plus correct labelling and CPNP.
Can I sell a Korean gel with only a Korean label if I add an online ingredients list?
In practice, no. Mandatory label elements (especially precautions and RP details) must be provided according to EU cosmetic labelling rules and in the required language(s) for the market. Online text does not reliably replace mandatory on-pack/attached information.
What is the most common reason gel nail products get flagged?
Missing EU RP on label, missing/incorrect INCI list, lack of valid CPSR/PIF, or products containing restricted/prohibited substances without compliance evidence.