Personal Protective Equipment (PPE) is defined as ‘any device to be worn or held by an individual for protection against one or more health and safety hazards’.
Previously the PPE Directive focused on manufacturers placing products onto the EU and EEA market, but the new Regulation covers the whole supply chain. This includes importers, distributors or anyone involved in the supply and distribution of PPE. They should take appropriate measures to ensure that PPE meets standard requirements and that they make available on the market only products which comply with the Regulation as well as keep relevant documents for at least 10 years. Here you can read more about PPE certification with the CE marking for Europe.
The PPE Regulation is mandatory – covering any type of product that falls within its scope.
What does the PPE regulation cover?
The PPE definitions used in the Regulation are as follows:
PPE can include items such as safety helmets, gloves, eye protection, hazmat suits, high-visibility clothing, safety footwear, safety harnesses, ear plugs, ear defenders and respiratory protective equipment (RPE). In appropriate situations disposable PPE may be provided; eg single-use coveralls. Employers have duties concerning the provision and use of personal protective equipment at work.
The PPE Regulation does not include:
- Ordinary working clothes or uniforms not designed to provide for the health or safety of workers;
- Clothing provided for food hygiene purposes;
- Equipment used for protection while travelling on a public road (ie motorcycle or bicycle helmets);
- Equipment used during competitive sport competitions (but other protective equipment used by sports instructors would be included eg life jacket worn by canoe instructor);
- An offensive weapon used as self-defence or as deterrent equipment. For example, truncheons or CS gas canisters as used by the police or military (but helmets, body armor and other PPE used to protect staff from physical violence, is included);
- Portable devices for detecting and signaling risks and nuisances, such as badges for detecting radiation, or personal gas detectors.
The regulation classifies PPE into three categories depending on the risks associated with the usage.
PPE Categories
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
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)
- Short text where to find the DoC, at which internet address.
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
- Assembly drawing
- Label files
- Packaging files
- Risk assessment
- 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)
The following information can be included in the DoC:
- Object of declaration
- Manufacturer contact information
- List of applicable regulations and/or directives (i.e. PPE)
- List of harmonized standards
- Place and date of issuing the DoC
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
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
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
Declaration of Conformity
Once the Notified Body has issued the certificate, the manufacturer or importer can issue 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
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 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)
Documentation
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
Besides 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.
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.
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
Labeling
The CE mark shall be permanently affixed on the 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.
For the UK market:
UKCA marking is effective in Great Britain (England, Scotland and Wales) from 1 January 2021, so if you place Personal Protective Equipment (PPE) on the market in Great Britain you will need to affix the UKCA marking (although CE marking will also be recognized for most products until the end of 2021).