- Regulation (EC) No 1223/2009 — Cosmetics
- Regulation (EC) No 1272/2008 — CLP
- Directive 2014/35/EU for UV lamps
- Regulation (EU) 2023/988 — GPSR
Who has to appoint one
Manufacturers and sellers outside the Union placing nail products on the EU market. Gels and polishes are cosmetics with a responsible person, safety report and CPNP notification; the curing lamp is an electrical product with its own conformity route.
Thresholds and exemptions
None. Several acrylates used in gels have been restricted or banned for consumer use following sensitisation cases, and professional-only restrictions apply to some substances.
What must appear on the label
Full cosmetic labelling with the responsible person, INCI list, batch, durability and precautions, including sensitisation warnings. HEMA and di-HEMA TMHDI containing products carry a professional use restriction. Lamps carry CE marking and photobiological information.
Marketplace fields
Marketplaces have removed consumer nail gels containing restricted acrylates, and this was one of the most enforced cosmetic restrictions of recent years.
Documentation you must hold
Product Information File with the safety report signed by a qualified assessor, CPNP notification, formulation records evidencing the restricted substance concentrations, and for lamps the declaration of conformity and photobiological assessment.
Standards and testing
Stability, compatibility and preservative efficacy, analytical verification of restricted acrylates, and for lamps IEC 62471 photobiological testing given the UV emission.
Language requirements
Precautions and warnings in the language of each member state of sale.
When it applies
CPNP notification before the first sale.
How long records are kept
Ten years after the last batch.
What happens if you do not comply
Withdrawal and fines, with sensitisation cases attracting particular attention because the harm is permanent and widespread.
Who enforces it
Cosmetics competent authorities, market surveillance authorities and customs.
Where the boundary lies
Products containing HEMA above the permitted limits may only be supplied for professional use, and selling them to consumers online is the recurring infringement. The lamp and the gel are two different regulated products in one kit.
Questions we are asked
- Can we sell HEMA gels to consumers?
- Not where the substance is restricted to professional use. The restriction followed widespread allergic sensitisation from home use.
- Does the UV lamp need its own documentation?
- Yes, as an electrical product with photobiological assessment, separate from the cosmetic notification.
Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom