- Regulation (EU) 2023/988 — GPSR
- Regulation (EC) No 1907/2006 — REACH Annex XVII, entries 23, 27, 63
- Directive 2014/53/EU where the watch is connected
Who has to appoint one
Sellers and brands outside the Union placing watches, straps and metal accessories on the EU market, including private-label and print-on-demand operations. A connected watch moves into the radio and data protection regimes as well, which is a different and heavier set of duties.
Thresholds and exemptions
None. Nickel release limits apply to any article in prolonged contact with skin, regardless of price or quantity.
What must appear on the label
Manufacturer name and address, EU responsible person with an electronic contact, model or batch reference, and care information where the material requires it. Where the item contains a battery, the crossed-out wheelie bin symbol and the battery producer obligations.
Marketplace fields
Watches and straps are among the categories most tested for nickel release, and marketplaces suppress listings without the responsible person block. Claims such as 'hypoallergenic' or 'surgical steel' are treated as substantiable claims.
Documentation you must hold
Technical documentation with the risk analysis, supplier declarations and test reports for restricted substances, and traceability records identifying the supplier of each batch.
Standards and testing
EN 1811 for nickel release from items in prolonged skin contact and EN 12472 for items with a coating, after simulated wear and corrosion. Lead and cadmium limits under REACH entries 63 and 23. Where a leather strap is used, chromium VI testing under entry 47.
Language requirements
Care and warning information in the language of each member state of sale.
When it applies
Before the listing goes live, since GPSR Article 19 attaches to the offer.
How long records are kept
Ten years for technical documentation and traceability records.
What happens if you do not comply
Withdrawal and Safety Gate alerts, which for this category almost always concern nickel release above the limit. Fines follow nationally, and repeat findings lead to marketplace account action.
Who enforces it
National market surveillance authorities and customs at import.
Where the boundary lies
A smartwatch is not this category: it is radio equipment with a data protection dimension and, if it makes health claims, potentially a medical device. A plain analogue watch with a battery is a consumer product plus a battery producer obligation in every country you ship to.
Questions we are asked
- Is a supplier declaration on nickel enough?
- Only if you can stand behind it. Authorities test the article after simulated wear, and a coating that passes when new can fail after abrasion.
- Does a watch battery need registration?
- Yes. Battery producer registration is national and applies to button cells inside the product as well as to loose batteries.
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