Product assessments in 2 minutes
Eyewear manufactured or imported into the EU is subject to various regulations and directives. The specific requirements largely depend on whether the eyewear is considered to be personal protective equipment (PPE), or a medical device.
In this guide, we explain how you can navigate compliance requirements for sunglasses, protective eyewear, prescription glasses, and smart glasses in the European Union.
Covered products
- Sunglasses
- Downhill skiing goggles
- Snowboarding goggles
- Motorcycle goggles
- Sport goggles
- Laser eye-protectors
- Eye protectors for occupational use
- Prescription glasses
- Smart glasses
Content Overview
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Sunglasses and Protective Eyewear
Sunglasses and protective eyewear are generally defined as personal protective equipment (PPE) under the PPE Regulation (EU) 2016/425. This regulation mandates CE marking.
Sunglasses and protective eyewear must also comply with the technical requirements set by applicable harmonised standards. It should also be mentioned that the regulation itself sets requirements specific to eyewear in Annex II:
- 2.3. PPE for the face, eyes and respiratory system
- 3.9.1. Non-ionising radiation
That said, our understanding is that these requirements are addressed by harmonised standards.
PPE categories and standards
The PPE Regulation (EU) 2016/425 divides different types of personal protective equipment (PPE), including sunglasses and eyewear, into distinct categories.
- Category I: Minimal risk
- Category II: Risks other than those listed in Categories I and III
- Category III: Serious risks (i.e., death or irreversible damage to health)
The category also determines which conformity assessment procedure applies, which in turn decides if you can self-declare compliance or if you need to involve a notified body.
The table below lists different types of eyewear and their respective category and conformity assessment procedure. This is based on the PPE regulation guidelines published on the EU website. We also identified relevant harmonised standards.
| Product type | Category | Conformity Assessment Procedure | Notified body | Harmonised standard/s |
| Sunglasses | I | Internal production control (module A) | Not required |
EN ISO 12312-1 – Eye and face protection – Sunglasses and related eyewear – Part 1: Sunglasses for general use EN ISO 12312-2 – Eye and face protection – Sunglasses and related eyewear – Part 2: Filters for direct observation of the sun |
| Ski goggles of all types, except corrective spectacles | I | Internal production control (module A) | Not required | EN ISO 18527-1 – Eye and face protection for sports use – Part 1: Requirements for downhill skiing and snowboarding goggles |
| Eye protectors and filters (unless listed below) | II | EU type-examination (module B) and conformity to type based on internal production control (module C) | Required |
EN 207 – Personal eye-protection equipment – Filters and eye-protectors against laser radiation (laser eye-protectors) EN 208 – Personal eye-protection – Eye-protectors for adjustment work on lasers and laser systems (laser adjustment eye-protectors) EN ISO 16321-1 – Eye and face protection for occupational use – Part 1: General requirements EN ISO 16321-2 – Eye and face protection for occupational use – Part 2: Additional requirements for protectors used during welding and related techniques |
| Eye protectors and filters for use in high-temperature | III |
EU type-examination (module B) and either: a. conformity to type based on internal production control plus supervised product checks at random intervals (module C2), or b. conformity to type based on quality assurance of the production process (module D) |
Required | |
| Eye protectors and filters against ionising radiation | III | Same as above | Required | |
| Eye protectors and filters against electric shock | III | Same as above | Required |
Testing
Third-party testing is generally required to verify compliance with applicable harmonised standards. For example, lenses for sunglasses must meet solar radiation safety requirements as defined under EN ISO 12312-1. Testing is necessary to verify that the lenses meet said requirements.
Other types of eyewear must also meet requirements concerning mechanical safety and other criteria.
Eyewear PPE testing costs generally range from 1000 to 2500 EUR.
Labelling requirements
Below follows an overview of key labelling requirements for sunglasses and eyewear:
| Label | Required for | Information |
 |
All PPE | CE marking must generally be affixed directly to sunglasses and other eyewear. The CE mark is often printed or engraved on the inside of the eyewear frame. |
| Notified body information | PPE category III | Identification number of the notified body |
| Product information | All PPE | PPE type, batch or serial number |
| Manufacturer | All PPE | Manufacturer name and postal address |
| Importer | All PPE | Importer name and postal address (only if there is an EU importer) |
| EN standards | Covered PPE | Some EN standards set additional labelling requirements, such as symbols and pictograms |
| Specific marking and information | Covered PPE | Information listed on Annex II – Essential Health and Safety Requirements for some types of PPE |
Documentation
Here are some key documents required under the PPE regulation for eyewear and sunglasses.
| Document | Required for | Screenshot |
| Declaration of Conformity | All PPE | The manufacturer must create a DoC based on the model structure in Annex IX.
|
| Technical documentation | All PPE | The manufacturer must create technical documentation found in Annex III.
|
| Instructions | All PPE | The manufacturer must create instructions based on the information set out in point 1.4 of Annex II.
|
| EU-type examination certificate | PPE Category II and III | Needed for eyewear and other products classified as PPE category II or III |
Prescription Glasses
Prescription glasses sold in the European Union must comply with the Medical Devices Regulation. Note that medical devices are divided into classes that determine the applicable conformity assessment procedure, and must comply with harmonised standards.
Medical device class
Corrective spectacle frames (that is glasses) and lenses in frames are classified as class I medical devices, according to Rule 1 of the document Guidance on classification of medical devices published on the EU website.
Harmonised standards
EN ISO 12870 – Ophthalmic optics – Spectacle frames – Requirements and test methods
EN ISO 14889 – Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses
Other requirements
✅ CE mark must be affixed and the following labelling:
- The name or trade name of the device
- The lot number or the serial number
- Manufacturer name and postal address
- Importer name and postal address (only if there is an EU importer)
- Unique Device Identification system
- Other information listed in Annex I, if relevant
✅ Declaration of Conformity – Annex IV
✅ Technical Documentation – Annex II
✅ Instructions – Annex I
Smart Glasses
Smart glasses are subject to several EU regulations and directives applicable to electronic devices. Smart glasses are generally battery-powered and communicate with other devices via Bluetooth, which places such products within the scope of several regulations and directives in the EU.
Note that smart glasses must also be CE marked, and generally comply with the following requirements:
- Declaration of Conformity
- User instructions
- Technical documentation
- WEEE symbol
- PPE type, batch or serial number
- Manufacturer name and postal address
- Importer name and postal address
Overview
| Regulation/Directive | Description |
| Radio Equipment Directive (RED) | The Radio Equipment Directive (RED) sets requirements for radio equipment, which includes most smart glasses that communicate via Bluetooth or WiFi. |
| Battery Regulation | This regulation sets safety, documentation, and labelling requirements for batteries. It is relevant to portable batteries contained in smart glasses. |
| EU Cybersecurity Act | This regulation sets cybersecurity requirements concerning the design and manufacturing of products that can be connected to a device or network. Smart glasses often communicate with phones via Bluetooth. |
| RoHS Directive | Restricts heavy metals and chemicals in electronic components, solder, PCBs, etc |
| EMC Directive | Sets EMC requirements for electronic products to ensure smart glasses do not interfere with other devices. |
Substance Restrictions
Materials used to manufacture sunglasses and other eyewear are subject to various chemical restrictions in the European Union.
REACH Regulation
The REACH regulation sets restrictions for various chemicals and heavy metals in consumer products. This includes sunglasses and other types of eyewear.
For example, plastic frames and coatings may contain DEHP or other phthalates, which are restricted under Annex XVII. If such substances are found in concentrations above the set limit, then the eyewear product cannot be sold in the EU.
Metal hinges and other hardware parts can also contain restricted substances, for example lead, cadmium, or nickel.
POPs Regulation
The POPs Regulation sets substance restrictions related to PHAS and other chemicals. These can also be found in eyewear lenses, frames, coatings, and hardware parts.
Substance testing
Third-party lab testing is often required to verify if your eyewear product contains restricted substances above the set limits.
The alternative is to obtain test reports from your supplier, but many companies outside the EU do not have test reports or other substance data for their materials. In my experience, this is also the case in the eyewear industry.
FAQ
Is safety testing required for sunglasses and eyewear in the EU?
Yes, testing is required to verify compliance with the PPE regulation, MDR, and other regulatory requirements in the EU.
Further, test reports must be included in the technical documentation even if the eyewear product is not subject to a conformity assessment procedure which involves a notified body.
How much does testing cost for sunglasses and eyewear?
In my experience, the total cost can range from 1000 to 2500 EUR for testing related to the PPE regulation and MDR.
Substance testing can add another 500 to 1500 EUR, depending on the number of materials and colours. The age group can also be a factor.
Do sunglasses require CE marking?
Yes, sunglasses sold in the EU are subject to the PPE regulation, which mandates CE marking.
Do protective eyewear require CE marking?
Yes, various types of protective eyewear are subject to the PPE regulation and must therefore be CE marked.
Do we need to CE mark prescription glasses?
Yes, prescription glasses fall within the scope of the Medical Devices Regulation, which in turn mandates CE marking.
How do I ensure that the sunglass lenses are compliant?
In my experience, the safest bet is to procure lenses from established brands like ZEISS. They produce lenses that are, for example, technically compliant with EN 166. This can help you reduce testing costs, while also (nearly) eliminating the risk that the lens itself will fail testing.
Note that brands like ZEISS are not only present in the EU but ship lenses to manufacturers in China and elsewhere.
I would even argue that using “brand name” lenses is absolutely critical when importing or manufacturing eyewear of all kinds.
What are the requirements for selling eyewear on Amazon in the EU?
Amazon generally requires that sunglasses and other types of eyewear, when sold on Amazon in the EU, meet regulations and directives applicable in the single market.
As such, sunglasses must meet the PPE regulation and prescription glasses must meet the Medical Devices Regulation.
Eyewear is generally deemed to be somewhat “sensitive”, so Amazon tends to carry out compliance checks.
If a company was looking at importing 4 different frame styles but with only 2 different lens options would I require certification for every separate model or would they be able to be grouped by lens type instead?
hi Ash,
If they are different designs, then they would be treated as separate models although the lenses are similar, hence you will need to test all 4 frame styles, but if they are similar designs with colour of the frame difference then, they could be tested as 1 model. I hope this make sense
thanks
If your sunglasses are under category 1 of PPE, does EU regulation require lab certification or would self-declaration suffice provided the sunglasses standards EN ISO 12312-1 and PPE regulation(EU) 2016/425- which is what’s documented on the self-conformity.
Hello.
What related U.K. and EU regulations apply to sunglasses?
Hi Glenn
The regulation is called PPE Regulation 2016/425 applied to sunglasses.
thanks
Hi
I have a question on Sunglasses, we are a baby/children’s wear
We are currently look at doing sunglasses for 0-3 yrs but as a toy,
SO what labelling would we need and testing?
Thank you
Rav
Hi Mark,
I have a question on Sunglasses, we are a baby/children’s wear
We are currently look at doing sunglasses for 0-3 yrs but as a toy,
SO what labelling would we need and testing?
Hello,
Is it legal to sell distance glasses (prescription) online on the EU market (FR, IT, ES and UK) in particular? I read that it is illegal to do so in France?
If so, are there any disclaimers required?
Also, is legal to sell online in the US – disclaimers?
Which EU and UK regulations on glasses specify this information?
Your feedback will be greatly appreciated!
Thank you.
HI There,
I have a question about the sunglass directive leaflet that comes in all languages of the countries that you sell in. Currently our leaflet is approximately 70 pages and costs a lot off the bottom line. Do you know if you can use a 1-2 page leaflet with a QR code for all of the languages?
Cheers,
Cindy
Hi – Do sunglasses require a UPC number in the US and/or an EAN number in the EU?
Hi there,
I wanted to ask if I have multiple listings with the same type of glasses. Like different colours and quantities but essentially 2 different designs, do I only need a CE mark for the 2 designs?
Hi Joe,
Are these glasses made using the same lenses and materials? I think that is the most important factor here.
Hi there,
Do blue light glasses fall under ppe? Also is it the frame & lenses that are tested for the material or the transmittance of light through the lens? Can SGS test for this in China and provide the technical documentation?
What would the reach certification require for this?
Also for a small alkaline button battery is there any additional work that needs to be done with regards to ce certification? Or does it just need the MSDS and to be packaged well?
Many thanks
Hi
Would selling second hand ray ban sunglasses require me to provide additional documentation relating to testing that the manufacturer had already done for the PPE CE classification?
Or is the CE mark enough for a customs official to be satisfied.
Selling from EU to U.K. and U.K. to rest of the world.
Thanks for your help.
Hi Michael,
It is possible that they will require a DoC and possibly even a test report.
Hi Fredrik,
I need help setting up an RSL and a test program to make sure (Restricted Substances List) factory and producer comply with EU legislation on chemicals.
Do you have a suggestion how to do these best or and example you would use to be sure of these.
Hello AG,
Do I get this right?
1. You want to create a list of regulated substances (and probably also the limits)
2. You want to verify if the products are compliant (this can be verified through lab testing – either on the final product or the different materials and coatings)
Yes correct,
I want to make a RSL list, and plan fo how wee control it in the future – like a document to the factory so they know what we expect from them, and also so our retailers can see what they can expect us (also a demand from bigger retailers). To make sure we have REACH and european and US standard on all products.
But as I’m not Chemist, so I dont know how to make it and not sure what should be in it or where I could find these or get help to get it made.
But surely not the only one, struggling here :-D
Hi AG,
In that case I suggest you contact a lab and ask them to:
1. Provide a list of substance tests (this is part of the standard qutoation)
2. Arrange a lab test with them
You can request a free quote here: https://www.compliancegate.com/lab-testing/
Hi there,
Awesome article and great job with the community.
Do sunglasses need to mandatorily contain place pf manufacture (ex. Made in China) directly on the sunglasses? Because i see alot of models from other brands that dont have. Or is that just for US.
Thanks
Hi Daniel,
Country of origin labeling is mandatory in the USA, not EU
Hello, I make sunglasses by hand using acetate, hinges & lenses sourced from Italy, currently I have a very low production rate making these very exclusive, about 5 glasses made per different design, I’m wondering if I need to test every new model I come up with or if I can stay in business without getting into any sort of trouble..
Your post has been very well written and informative, thank you!
Hi Victor,
Well, technically you’d still need to arrange the DoC and other documentation, but it’s possible that you could use test reports from the material supplier in Italy (which is in the EU)
Hello Mark,
I am importing sunglass clip-on glasses which will have only demo lenses (no prescription). If I understand correctly, there are going to be under the PPE since they are not prescription, and are sunglasses as well. Is this right?
In this case the asian manufactured have the “Attestation Certificate for Medical Device Safety”, which this certification allow me to distribute the sunglass clip-on glasses in EU? Thus not being blocked by the custums?
Thank you, Riccardo
Hi Riccardo,
Attestation Certificate for Medical Device Safety sounds like a bogus “certificate”. Plenty of those going around these days, but there are no workarounds when it comes to CE.
We have imported sunglasses without the CE Mark. The manufacturer claims that the sunglasses PPE are compliant. The goods are held at customs. What are our options? Can we follow the compliance process locally including lab testing? Or is it specific labs appointed by the EU which perform the tests?
Hello,
As the customs if they will accept that you’ll re-label the sunglasses in Europe. Not sure if they accept that though.
Also, if the sunglasses are truly compliant then the supplier can also provide a lab test report and DoC.
Hello, do hay fever glasses fall into PPE and need CE marking?
Hi, how can I find out of a testing lab can release CE certificates of conformity?
Hi Lucio,
Are you referring to a Notified Body?
Find them here: List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system)
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
if you are looking for a lab which can test sunglasses or other eyewear products , you can contact Spectroplus Ltd located in UK which conduct testing on resonable prices.
Hello, what about sunglasses specifically marketed at children, are these also considered PPE?
Thanks!
Hi Tom,
Yes, I cannot imagine that the requirements are lower for children’s sunglasses. If anything it’s the opposite.
Am I correct understanding that *any* kind of eyewear, even fashion items or generally items that are not intended for professional use and don’t claim any protective properties per se, you know, tinted shades and such, are treated as PPE and shall therefore meet all these standards? What about 3D glasses in cinemas?
Hi Marvin,
Sunglasses are covered by PPE. That said, not sure applies to 3D cinema glasses. Probably not classified as PPE.
What are the regulations for non PPE sunglasses?
Hello Mark, what do you mean with “non PPE” sunglasses? Could you explain it a bit more in detail?