3D printers, filaments and resins

• Regulation (EU) 2023/1230 — Machinery
• Directive 2014/35/EU — Low Voltage
• Regulation (EC) No 1272/2008 — CLP for resins
• Regulation (EU) 2023/988 — GPSR
• Regulation (EU) 2017/745 where printed items are medical devices

Who has to appoint one

Manufacturers and sellers outside the Union placing 3D printers and consumables on the EU market. The printer is machinery with moving parts and heated elements; photopolymer resins are classified mixtures with sensitising properties requiring full CLP treatment.

Thresholds and exemptions

None. Consumer desktop printers are machinery in the same way as industrial ones, with the risk assessment scaled to the hazards.

What must appear on the label

CE marking, manufacturer and EU representative details, type and serial number, year of construction, rated electrical data, and hot surface and moving part warnings. Resins carry CLP pictograms, hazard and precautionary statements, the UFI code and the supplier's EU details.

Marketplace fields

Marketplaces check the responsible person and remove resin listings without CLP labelling in the images. Resins are also subject to transport restrictions that constrain fulfilment.

Documentation you must hold

EU declaration of conformity, technical file with the machinery risk assessment covering entrapment, burns and emissions, electrical test reports, and for resins the classification file, safety data sheet and poison centre notification.

Standards and testing

EN 60335-1 or EN 61010 depending on classification, EMC testing, emission testing for ultrafine particles and volatile organic compounds where the printer is enclosed for consumer use, and CLP classification testing for resins including skin sensitisation.

Language requirements

Instructions, warnings and safety data sheets in the language of each member state of sale.

When it applies

Before placing on the market.

How long records are kept

Ten years.

What happens if you do not comply

Withdrawal, fines and Safety Gate alerts. Resin sensitisation cases have driven attention to labelling and to the adequacy of the protective equipment advice given.

Who enforces it

Market surveillance authorities, chemicals authorities, poison centres and customs.

Where the boundary lies

Printing an object does not transfer regulatory responsibility to the printer maker, but a business printing and selling items becomes the manufacturer of those items, with the regime of whatever it printed — including the medical device regime for anatomical models or aligners.

Questions we are asked

Are printed parts regulated?

The person placing the printed part on the market is its manufacturer, with the obligations of the applicable regime for that product.

Do resins need a UFI?

Yes, classified mixtures require poison centre notification and the UFI on the label.