Sunglasses and non-prescription eyewear

• Regulation (EU) 2016/425 — PPE
• Regulation (EU) 2023/988 — GPSR
• Regulation (EU) 2017/745 — MDR for corrective eyewear

Who has to appoint one

Manufacturers and sellers outside the Union placing sunglasses on the EU market. Sunglasses are personal protective equipment against sunlight, normally Category I, so CE marking and a declaration of conformity are required even for fashion frames sold at low prices.

Thresholds and exemptions

None. Category I applies to ordinary sunglasses; equipment protecting against intense radiation such as welding or solarium goggles is Category II or III and needs notified body involvement.

What must appear on the label

CE marking. Manufacturer name and address and the EU representative's address. The filter category from 0 to 4 and its meaning. A warning that the glasses are not suitable for direct observation of the sun or for driving where the filter category prohibits it — category 4 may not be used for driving. Model identification and the address where the declaration of conformity can be found.

Marketplace fields

Marketplaces check for CE marking and the EU responsible person, and remove listings claiming UV400 protection without documentation. Blue-light filtering claims are treated as advertising claims requiring evidence.

Documentation you must hold

EU declaration of conformity, technical documentation, risk analysis, and test reports for UV transmittance, luminous transmittance, filter category classification and mechanical robustness.

Standards and testing

EN ISO 12312-1 for sunglasses for general use, covering UV transmittance, spectral requirements, refractive power, robustness and, where a driving claim is made, traffic signal recognition. EN ISO 12311 sets the test methods.

Language requirements

Warnings, filter category information and instructions in the language of each member state of sale.

When it applies

Before placing on the market.

How long records are kept

Ten years from placing on the market.

What happens if you do not comply

Withdrawal, Safety Gate alerts and fines. Sunglasses with a dark tint but no UV filter are a recurring alert, because the pupil dilates while the retina is unprotected.

Who enforces it

National market surveillance authorities and customs at import.

Where the boundary lies

Non-prescription readers are a general consumer product, while corrective spectacles and contact lenses are medical devices under the MDR, including plano coloured contact lenses. Children's sunglasses attract additional scrutiny on small parts and mechanical strength.

Questions we are asked

Are fashion sunglasses really PPE?

Yes. They protect the eyes against solar radiation, which puts them in Regulation 2016/425 as Category I. Self-declaration is possible, but the CE marking, the declaration and the EU operator are mandatory.

Is a UV400 claim enough?

Only if you can produce the transmittance test report. An unsupported claim is both a documentation failure and a misleading commercial practice.