• Sunglasses & Eyewear Regulations in the European Union: A Complete Guide

    Posted on 29 Comments

    Sunglasses and other eyewear imported, manufactured, or sold in the European Union must comply with a range of safety standards, chemical regulations, and labeling requirements.

    Personal Protective Equipment (PPE) Directive

    Sunglasses and eyewear products are categorized as Personal protective equipment and under-regulated in EU countries. Before placing any sunglasses and eyewear products on the EU market, sit is Mandatory that the products are compliant with the Personal Protective Equipment (PPE) directive.

    Noted that the PPE Directive 89/686/EEC has been repealed and replaced with EU 2016/245.

    PPE Risk Categories

    PPE products are categorized into three categories:

    Category I: Includes PPE product that is intended to protect users.For example:

    • Sunglasses
    • Eye protectors for dust protection

    Category II: Includes risks other than those listed in Categories I and III.

    Category III: Includes PPE products that may cause serious consequences such as death or irreversible damage to health. For example:

    • Eye protectors for use at high temperatures
    • Eye protectors for use at extremely intensive IR radiation

    General Requirement

    Before placing PPE on the market, importers shall ensure the conformity assessment procedure has been carried out by the manufacturer. Also, note that the importer is responsible if they import from outside the EU. Since the different categories of PPE required different mandatory procedures and examinations, it is important to find out which category are you looking for.

    Nevertheless, the CE marking on your PPE products means that it is accompanied by the required documents and that the manufacturer has complied with the requirements set out in the regulation. Therefore, the CE marking is very important and mandatory.

    EN Standards

    Besides of the PPE directive, there are also EN standards that apply to sunglasses and eyewear.

    Although EN standard is voluntary and the directive such as PPE directive is mandatory, as a manufacturer or importer (from outside the EU), it is also important to check with the following EN standards regarding PPE to create a presumption of conformity :

    1. EN ISO 12311: 2013 – Personal Protective Equipment – Test Methods for Sunglasses and Related Equipment.

    2. EN ISO 12312 -1: 2013 – Eye and Face Protection –Sunglasses and Related Eyewear – Part 1 Sunglasses for General Use.

    3. EN 16128:2015 – Reference method for the testing of spectacle frames and sunglasses for nickel release

    Declaration of Conformity

    Importers of PPE products will be responsible for the “EU declaration of conformity”, to indicate that the PPE complies with the regulation and shall not endanger persons and properties. The certain health and safety declaration as follow should be listed:

    • Risk assessment has been carried out
    • Design Principles
    • Levels and classes of protection
    • Ergonomics of the PPE

    Notice that each EU directive has slightly different requirements of the format of the declaration of conformity. For PPE Doc, the following information should be included:

    • Product name
    • Product code
    • Classification
    • Applicable Norms
    • Conformity information

    Technical File

    The technical documentation should be also included in addition to the Doc. It will focus on the technical aspects of the product and the overview information such as the following shall be included:

    1. A complete description of the PPE and of its intended use

    2. The design drawings and schemes of the PPE

    3. Inspection and examinations report that carried out to verify the conformity of the PPE

    4. Copy of the manufacturer’s instruction and information

    Notice that the file must not share with the public like the DoC. Importers will only responsible to share the technical file if requested by the EU or other local authorities.

    CE Marking

    The “CE” marking signify that your products have been assessed to meet high safety, health, and environmental protection requirements as mentioned above.

    The manufacturer shall affix the CE marking to each individual PPE that satisfies the applicable requirements of the regulation. Also, a copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

    Other Labelling Requirements

    Any labeling on PPE should be clear, understandable, intelligible and legible.
    If the PPE products contain any dangerous substances such as toxic and corrosive chemicals, it is also required to label with the warning on the product.

    Each item of PPE must also bear labeling indicating the noise attenuation level provided by the PPE, or it must be fixed to the packaging.

    Moreover, the labeling of PPE products shall be in English, which is easily understood by end-users and market surveillance authorities.

    Laboratory Testing

    As we know lab testing your products is the only way that can ensure the compliance issues. For PPE products, here are some testing that might be required under the regulation depends on a different category:

    • Impact protection testing
    • Chemical resistance testing
    • Biological resistance testing
    • Fall arrest equipment testing

    Here we listed several laboratories that can help with the PPE testing:

    • Intertek
    • TUV SUD
    • Satra
    • Testex
    • BTTG

    Sunglasses

    REACH

    REACH regulated chemicals in products. Sunglasses and eyewear are also regulated under REACH. REACH compliance is mandatory on products produced in or shipped into the European Union (EU) and member countries.

    Lead and cadmium are often regulated and concerned heavy metal under the REACH. However, the EU published two directives (EU 2017/1009 and 1011) and extended the exemptions for optical and filter glass. Exemption such as:

    • Lead in ion colored optical filter glass types
    • Cadmium in striking optical filter glass types
    • Cadmium and lead in glazes used for reflectance standards

    Therefore, we shall always update with new regulations under REACH. Or better, lab testing your products before placing them on the EU market.

    FAQ

    Who is responsible for ensuring compliance if the sunglasses are imported from outside the European Union?

    While the PPE directive often refers to the manufacturer, the importer is considered the ‘legal manufacturer’ if the goods are imported from outside the EU. For example, if you import sunglasses or other eyewear from China, it’s up to you to implement the compliance process:

    1. Book lab testing

    2. Create label files

    3. Create the Declaration of Conformity (DoC)

    4. Create the technical file

    Importing and selling non-compliant sunglasses and other eyewear is illegal, and can result in the goods being confiscated by the customs authorities, or subject to a recall by national market surveillance authorities.

    How do I ensure that the sunglasses lenses are PPE compliant?

    We recommend that you purchase PPE compliant lenses from established brands, such as Carl Zeiss. European and American lens brands are widely available in China and other manufacturing countries – making it easy for you or your supplier to procure compliant lenses.

    The other alternative is to procure Noname lenses from smaller OEM factories. That said, such suppliers can rarely provide test reports, which therefore requires that you book and pay for the necessary lab tests.

    Further, far from all lenses are made to comply with the PPE directive.

    Is the PPE a CE Marking Directive?

    Yes, the Personal Protective Equipment (PPE) Directive is a CE Marking Directive.

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
  • 29 Responses to “Sunglasses & Eyewear Regulations in the European Union: A Complete Guide

    1. Kathy Maynor at 4:43 am

      Hi – Do sunglasses require a UPC number in the US and/or an EAN number in the EU?

    2. Joe at 5:59 am

      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?

      1. Fredrik Gronkvist at 10:59 am

        Hi Joe,

        Are these glasses made using the same lenses and materials? I think that is the most important factor here.

    3. Joe at 11:16 pm

      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

    4. Michael at 6:08 pm

      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.

      1. Fredrik Gronkvist at 10:08 am

        Hi Michael,

        It is possible that they will require a DoC and possibly even a test report.

    5. AG at 9:04 pm

      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.

      1. Fredrik Gronkvist at 3:46 pm

        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)

        1. AG at 6:11 pm

          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

          1. Fredrik Gronkvist at 10:09 am

            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/

    6. Daniel Rahovan at 6:10 am

      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

      1. Fredrik Gronkvist at 12:42 pm

        Hi Daniel,

        Country of origin labeling is mandatory in the USA, not EU

    7. Victor at 4:25 am

      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!

      1. Fredrik Gronkvist at 10:57 am

        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)

    8. Riccardo at 7:19 pm

      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

      1. Fredrik Gronkvist at 11:13 am

        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.

    9. SPT at 10:21 pm

      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?

      1. Fredrik Gronkvist at 6:59 pm

        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.

    10. Satoru Shiga at 12:45 pm

      Hello, do hay fever glasses fall into PPE and need CE marking?

    11. Lucio at 1:02 pm

      Hi, how can I find out of a testing lab can release CE certificates of conformity?

      1. Fredrik Gronkvist at 5:48 pm

        Hi Lucio,

        Are you referring to a Notified Body?

      2. Maksim at 2:08 pm

        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

      3. Ash at 12:22 am

        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.

    12. Tom at 7:27 pm

      Hello, what about sunglasses specifically marketed at children, are these also considered PPE?

      Thanks!

      1. Fredrik Gronkvist at 5:33 pm

        Hi Tom,

        Yes, I cannot imagine that the requirements are lower for children’s sunglasses. If anything it’s the opposite.

    13. Marvin at 3:42 pm

      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?

      1. Fredrik Gronkvist at 9:22 am

        Hi Marvin,

        Sunglasses are covered by PPE. That said, not sure applies to 3D cinema glasses. Probably not classified as PPE.

    14. Mark at 2:08 am

      What are the regulations for non PPE sunglasses?

      1. Ivan Malloci at 3:40 am

        Hello Mark, what do you mean with “non PPE” sunglasses? Could you explain it a bit more in detail?

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