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.
This is covered
- PPE Directive
- EN Standards
- Declaration of Conformity
- Technical file
- CE Marking
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Noted that the PPE Directive 89/686/EEC has been repealed and replaced with EU 2016/245.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:
- 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
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 category of PPE required different mandatory procedures and examination, 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.
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
- Applicable Norms
- Conformity information
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.
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.
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:
- TUV SUD
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.
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.