Personal Protective Equipment (PPE) Regulation: Guide For EU Importers

Posted on 2 Comments

Personal Protective Equipment

The Personal Protective Equipment (PPE) Regulation establishes safety standards and requirements to ensure the safety of users wearing protective equipment, either at their workplace or in another situation that might require its use. The scope of the PPE Regulation covers a wide range of products, including sunglasses, work gloves, and protective masks.

In this article, we explain the basic requirements of the PPE regulation, including product classification, standards, documentation, labeling, and lab testing.

  • We Help Brands & Importers With Product Compliance (US & EU)

    • Book a free consultation call today with Ivan Malloci to learn how we can help you with:
    • Product Requirements Lists
    • Product Certification
    • Product & Packaging Labeling
    • Lab Testing

    BOOK A FREE CONSULTATION

Product Scope

The PPE Regulation covers personal protective equipment that is intended to protect users from potential hazards both at their workplace, in public places, and, in some cases, at home.

Here we list some examples of personal protective equipment that is covered by the regulation:

The regulation classifies PPE into three categories depending on the risks associated with the usage.

In the next sections of this guide, we introduce the product scope, standards, documentation, and lab testing requirements for each category.

PPE Category I

Category I equipment is designed to protect against minimal risks that, as specified in Annex I of the regulation, include:

  • Superficial mechanical injury
  • Contact with hot surfaces (max 50°C)
  • Sunlight exposure (and the relative risk of damages for the eyes)
  • Non-extreme atmospheric conditions
  • Contact with cleaning materials that aren’t considered too aggressive

Product Scope

PPE Category I products designed to protect against the above-mentioned risks might include:

  • Sunglasses
  • Gardening gloves
  • Cleaning gloves
  • Cut-resistant gloves

EN Standards

Importers and manufacturers can adhere to relevant harmonized EN standards to comply with the technical requirements mandated by the regulation.

Note that, even if in some cases harmonized standards are voluntary, they provide technical specifications that are considered to be sufficient to satisfy the compulsory technical requirements of the regulation.

Thus, although it could be technically possible to implement a different solution, often following the relevant harmonized standards is the easiest way to achieve the mandatory technical requirements.

Here are we list some harmonized standards that might be applicable for PPE Category I:

EN ISO 12312 – Eye and face protection sunglasses and related eyewear

This standard applies to most protection sunglasses and eyewear including general use (EN ISO 12312-Part 1) and direct observation of sun use (EN ISO 12312-Part 2).

The standard provides material reference, general transmittance, robustness, and solar radiation resistance requirements.

EN 379 – Personal eye-protection automatic welding filters

This standard provides a general provision on welding filters with switchable scale numbers. It specifies information such as switching time, power-off test, scale number setting, and other applicable requirements.

EN 388 – Protective gloves against mechanical risks

This standard covers protective gloves against mechanical risks, such as heavy rubbing, cutting, or tearing. It provides characteristics guidelines including abrasion resistance, cut resistance, impact protection, and other requirements for importers or manufacturers.

Documentation

For PPE classified under Category I, importers and manufacturers shall follow the internal production control (module A) set out in the regulation.

Below you find an overview of the required documentation.

User Manual

The user manual shall include a description of the PPE and its intended use. It provides assistance to use the device properly. Importer and manufacturers shall include information such as:

  • Product installation (if any)
  • Instructions on how to use and/or wear the product
  • Safety instructions and potential hazards
  • Instructions on how to correctly dispose of the products (especially in case of disposable products)
  • Relevant compliance marks (eg. CE mark)

Technical File

The technical file allows relevant authorities, distributors, and consumers to access information such as product material, design, and labels. It might also include the results of the design calculations, inspections, and examinations for the conformity with the PPE Regulation.

Here is an overview of the information that shall be included in the technical file:

  • Bill of materials
  • Design drawing
  • Label files
  • Risk assessment
  • Packaging files
  • Quality inspection record

Test Report

Importers and manufacturers shall be able to prove compliance with relevant technical requirements. Oftentimes, this comes down to providing a valid test report against relevant EN standards.

Declaration of Conformity (DoC)

Retailers, authorized organizations, or government bodies often require the DoC to assess product compliance. Below we list some information that shall be included in the DoC:

  • Product description
  • User instruction
  • Importers contact information
  • List of applicable regulations and/or directives (i.e. PPE)
  • List of harmonized standards
  • Place and date of issuing the DoC
  • Relevant test reports/certificates

Authorized Representative

If you are a foreign manufacturer or importer, and you do not have a company in the EU, then you can appoint an Authorized Representative in the EU that might act on your company’s behalf.

Authorized Representatives must be legally established in one of the EU countries, and they are responsible for the following:

  • Affix the CE marking and draft the DoC
  • Keep a copy of the DoC and technical file for 10 years
  • Provide such documentation to the relevant authorities, when required
  • Cooperate with the authorities to reduce risks, when required

Lab Testing

Most importers and manufacturers do not have the technical ability to perform the testing procedure necessary to assess compliance with relevant EN standards or other relevant standards.

Testing companies such as TUV, SGS, or Intertek can provide lab testing, quality monitoring, and other relevant compliance services.

PPE Category II

Category II PPE carries intermediate risks between category I and III. For example, category II PPE might cause physical, electrical, and chemical injuries that are not sufficient to cause death or irreversible damage to users.

Product Scope

PPE classified under Category II might include:

  • Protective footwear
  • High-visibility clothing
  • Bump caps
  • Bicycle helmets
  • Safety goggles for skiing and snowboard

EN Standards

Here a list of harmonized EN standards that might be applicable:

EN 511- Protective gloves against cold

This standard sets out the requirements and test methods for protective gloves, which are intended to protect against convective and conductive cold up to -50°C. The standard provides guidelines for cold resistance classification and water permeability.

EN 381-7 – Protective clothing for users of hand-held chainsaws

Part 7 of this standard provides the typical design of hand-held chainsaws protection gloves. It describes the protection requirements on the back of the gloves and the fingers part.

EN 175 – Personal protection equipment for eye and face protection during welding and allied processes

This standard explains the safety requirements and test methods for welding protection against optical radiation and other specific risks. It also covers ergonomic, fire, mechanical, and electrical aspects of the equipment. Notice that welding protection for special applications is not covered in this standard.

EN 1077 – Helmets for alpine skiers and snowboarders

This standard serves as the safety standard for most snow sport helmets. The standard provides safety requirements for impact testing, product classification, product design, helmet’s retention system, and shock absorption.

EN 174 – Personal eye-protection – Ski goggles for downhill skiing

This standard sets out the requirements for spectacle lenses, goggles materials, performance testing, and optical measurement. Further, EN 174 emphasizes the resistance requirements on fogging, surface damage, ultraviolet coefficient, and ignition.

Documentation

For PPE that falls under Category II, importers and manufacturers shall still prepare the following documentation:

  • User Manual
  • Technical File
  • Test Report
  • Authorized Representative Written Mandate (if needed)

However, in this case, importers and manufacturers shall follow the conformity assessment procedures outlined in EU type-examination (Module B) and internal production control (module C).

The main difference, compared with the conformity assessment procedures necessary for the compliance of Category I PPE, is that for Category II PPE the involvement of a Notified Body is necessary.

EU type-examination certificate (EC)

The Notified Body shall assess the conformity of the product against all the requirements of the regulation. This can be based on a review of the documents submitted by the manufacturer or importer, including existing lab test reports and the technical file.

Besides, it shall issue the EU type-examination certificate, if it deems the product to be compliant. The certificate shall include information such as:

  • Notified Body name and identification number
  • Manufacturers/Importer name and address
  • Product identification (Type or batch number)
  • Technical specifications
  • List of applicable harmonized standards
  • Test reports

Declaration of Conformity

Once the Notified Body has issued the certificate, the manufacturer or importer can draft the Declaration of Conformity.

In this case, the document shall also include information concerning the Notified Body such as:

  • Notified Body Name
  • Notified Body Number
  • EU type-examination certificate reference number

Assessment and Lab Testing

As said, for PPE classified under Category II PPE, importers and manufacturers will need the involvement of a Notified Body designated by an EU country.

Notified Bodies are responsible for different procedures for conformity assessment, including:

  • Assess the technical documentation
  • Examine the user manual and labeling
  • Production process conformity
  • Perform the required tests (or evaluate testing reports provided by other testing company, if any)
  • Issue the certification

If you want to find a Notified Body in your country, you can check this list.

PPE Category III

PPE classified under Category III protects users from serious consequences such as death or irreversible damage to health. These risks include:

  • Contact with hazardous substances
  • Contact with harmful biological agents
  • Electric shock
  • Harmful noise
  • High-temperature environments (comparable with an air temperature of at least 100°C)

Product Scope

PPE classified under Category III might include:

  • Fire-protective clothes
  • Electrical insulating protective helmets
  • Safety goggles (for use in presence of hazardous substances)
  • Respirators (for use in presence of hazardous substances)

EN Standards

EN 397 – Industrial safety helmets

This standard provides guidelines for mandatory tests such as shock absorption tests, resistance to penetration tests, and resistance to a flame test. It also provides some optional tests such as lateral deformation and electrical properties.

EN 142 – Respiratory protective devices (mouthpiece assemblies)

This standard establishes requirements for respiratory protective devices including filtering devices and breathing apparatus. Manufacturers can refer to the design, materials, ergonomics, flammability, and testing requirements in this standard at the design stage.

EN 143 – Respiratory protective devices (Particle filters)

This standard serves as a complementary standard for respiratory protective devices. This standard focuses on particle filters and describes the lab testing requirements with applicable standards. It also classifies particle filters into three categories based on filter efficiency.

EN 407 – Protective gloves against thermal risks (heat or fire)

This standard specifies most test methods for thermal risk protection gloves. It sets out the fire properties of the material and specific labeling requirements.

Documentation

As for PPE classified under Category II, PPE classified under Category III requires the following documentation:

  • User Manual
  • Technical File
  • Test Reports
  • EU type-examination certificate
  • DoC (including information about the Notified Body)
  • Authorized Representative Written Mandate (if needed)

Besides the above-mentioned requirements, PPE classified under Category III requires the implementation of either Module C2 or Module D, which might require additional test reports also after obtaining the certificate from the Notified Body.

Assessment and Lab Testing

As said in the previous section, besides the lab testing that might be necessary to get the initial EU type-examination certificate, if importers or manufacturers choose to perform supervised product checks (Module C2), then the Notified Body shall conduct appropriate tests at least once per year.

If the importers or manufacturers choose to comply with the regulation via the quality assurance process (Module D), then it shall comply with the requirements of the QMS of its choice, including periodic testing, if needed.

Note that the Notified Body might decide to conduct its own tests, either during the QMS evaluation or at any time it deems necessary.

Let’s describe the two procedures more in detail.

Supervised product checks at random intervals (Module C2)

If the manufacturer or importers choose to carry out supervised product checks, it shall give a mandate to the Notified Body to perform random yearly product checks.

These checks, which must be conducted using adequate statistical samples, are necessary to verify the homogeneity of production during the year, within acceptable limits.

Note that the first check shall be performed within a year from the day of issuance of the EU type-examination certificate.

The Notified Body shall then provide a test report to the manufacturer or importer.

If the test fails, for instance, because the production is not homogenous and thus doesn’t comply anymore with the essential requirements, the Notified Body shall take the appropriate actions, such as inform the relevant authorities.

Quality assurance of the production process (Module D)

Quality assurance is an alternative conformity assessment, with respect to supervised product checks.

In order to comply with module D, manufacturers shall establish an approved quality system for production, final product inspection, and testing as required by the regulation.

Manufacturers shall submit an application for assessment of their quality system with a Notified Body of their choice. They shall also prepare the quality system documentation including:

  • The quality objectives and organizational structure
  • The quality assurance techniques
  • Applicable tests and examinations
  • Inspection reports and test data

Then, the Notified Body shall perform the quality assurance process’s evaluation and assessment to determine whether it meets the requirement of the regulation.

Also, manufacturers shall inform their notified body before making any changes that could affect their quality system. Further, they shall allow the Notified Body to access the production facility for periodic audits, which shall be carried out at least once per year, and might include testing as well.

Once the auditing is completed, the Notified Body shall provide an audit report to the manufacturer.

Note that the regulation doesn’t mention any specific QMS (quality management system). Thus, according to the product, different QMS such as ISO 9001 or ISO 13485 might be more appropriate.

The Notified Body of your choice shall be able to advise you on the most appropriate QMS for your case.

Labeling

CE Marking

CE Mark

The CE mark shall be permanently affixed on the product, product packaging, and the official accompanying documents (e.g user manual).

Note that, if the product is too small and can’t fit CE Mark, then it suffices to affix it in the product packaging and relevant documentation.

Finally, if the compliance procedure requires the involvement of a Notified Body, then its identification number shall be added near the CE mark as well.

CE Mark File

Importers shall not expect their supplier to provide a correct format CE label file. Instead, they shall prepare a digital CE label file preferably in .ai or .eps format, and instruct their supplier before mass production.

Also, importers shall specify the followings:

  • Dimension
  • Location
  • Color
  • Print type

Product Traceability

The regulation also requires importers and manufacturers to affix a permanent traceability label on the product or its packaging. The label might include information such as:

  • Product identification number
  • Importer / manufacturer address
  • Importer / manufacturer contact information
  • (USA & EU)

    We Help Brands & Importers With Product Compliance (US & EU)

    • Product Requirements Lists
    • Product Certification
    • Product & Packaging Labeling
    • Lab Testing

    BOOK A FREE CONSULTATION


    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.
  • 2 Responses to “Personal Protective Equipment (PPE) Regulation: Guide For EU Importers

    1. Anssi at 1:48 am

      Hello Fredrik and team, this is Anssi from Spain. Great article!
      I would like to contribute with some information that might be of your interest and for your clients interested in developing this kind of products. The Regulation 2016/425 according EN 149 is the main part when it comes to product compliance for PPE, but also note that articles like masks and gloves can also be considered Medical Devices which are regulated by the EEC 93/42 Directive (En 14683:2019+AC:2019) as class I MD products. The main difference is that PPE Regulation needs involvement of Notified Body while MDD (as it is class I) does not (but has to wear CE marking), in other hand PPE products don´t need a special licence obtained by the importer or comunications to authorities while MDD products may need (in Spain at least it works like this).

      Also there is the so called DUAL products (mainly by manufacturers interest) that are compliant with both PPE and MDD. This is not mandatory, but as you may guess if you are compliant with 2 in stead of 1, it´s a better market oportunity and impression towards a trained importer if you (as manufacturer) can proove these.

      Hope this information is usefull for you.

      Regards
      Anssi Tynjala

      1. Fredrik Gronkvist at 2:45 pm

        Hello Anssi,

        Thank you! Your comments are very valuable.

    Leave a Reply

    Your email address will not be published.