Personal Protective Equipment (PPE) Regulation: An Essential Guide

The Personal Protective Equipment (PPE) Regulation aims to ensure that PPE sold in the EU is safe to use and protects users from foreseeable risks. The regulation covers equipment that is designed to protect users from different risks (e.g. electric shocks or falls from heights) and in different environments (e.g. workplace or outdoor sports).

The regulation covers products ranging form sunglasses and bicycle helmets to work gloves and protective footwear.

This guide explains what importers and manufacturers must know about the PPE requirements such as harmonised standards, conformity assessments, documentation, and labelling.

What is the PPE Regulation?

The Personal Protective Equipment Regulation covers the design, manufacture, and marketing of products defined as Per. It mandates that manufacturers comply with the regulation’s health and safety requirements, either directly or via relevant harmonised standards.

Besides the above obligations, the regulation also sets labelling, documentation, and testing requirements for PPE that can be used at work, home, or while practising leisure activities that may expose the user to some risks.

It is also important to mention that the PPE Regulation requires CE marking.

What is the definition of PPE?

The regulation defines PPE as:

a. Equipment that is designed and manufactured for holding or wearing by an individual for protection against potential risks to their health or safety.

b. Essential interchangeable components for the equipment mentioned above.

c. Systems designed for connecting a piece of PPE equipment to either a reliable point of anchorage or an external device.

Product examples

The PPE Guidelines provided by the European Commission specify requirements for different types of PPE. Here are some product categories and product examples taken from the guidelines:

• Equipment for eye protection (e.g., safety goggles)
• Equipment for hearing protection (e.g., in-ear protection)
• Equipment for protection against falling from heights (e.g., harnesses)
• Equipment for part or whole face protection (e.g., face shields)
• Respiratory protective equipment (e.g., those for use in diving)
• Equipment for hand and arm protection (e.g., gloves)
• Equipment for protection against electric shock
• Sunglasses

You can find more examples in the guidelines document.

Exempted products

The regulation does not cover PPE that is:

a. Designed for use in the military or law enforcement.

b. Designed for self-defence (except equipment meant for sporting activities).

c. Designed for private use for protecting against mild atmospheric conditions and dampness during dishwashing.

d. Specifically meant for use on aircraft or seagoing vessels.

e. Meant to protect the eyes, face, or heads of users (as specifically intended for motorcycle and moped helmets and visors).

PPE Risk Categories

According to the regulation, there are three PPE risk categories, which are outlined in Annex I.

Category I

Category I PPE protects users against the following risks:

• Superficial mechanical injury
• Extended contact with water, or contact with weak cleaning materials
• Contact with hot surfaces under 50 °C
• Eye damage due to sunlight exposure (other than sun observation)
• Mild atmospheric conditions

Here, we list a few examples of Category I PPE:

• Sunglasses (to protect against natural UV radiation)
• Gloves (with specific UV-protective properties)
• Patches (designed and manufactured to protect the skin against friction)

Category II

Category II PPE protects users against risks other than those listed in Categories I and III. Examples of such products include:

• Swimming armbands (buoyancy aid equipment)
• Racing neck braces (for protection against g-force-induced impacts)
• Anti-avalanche airbags (rescue equipment)

Category III

Category III PPE protects users against specific risks that may result in permanent negative consequences, such as irreversible health damage or even death. Here, we list those risks, as provided in Annex I of the regulation:

• Hazardous mixtures and substances
• Harmful biological agents
• Ionising radiation
• High-temperature environments (that induce effects similar to that of at least 100 °C air temperatures)
• Low-temperature environments (that induce effects similar to that of air temperatures -50 °C or below)
• Falling from heights
• Electric shock and live working
• Drowning
• Cuts via handheld chainsaws
• High-pressure jets
• Bullet wounds or knife stabs
• Harmful noise

Here, we list a few Category III PPE products:

• Life jackets (prevention of drowning)
• Climbing karabiners (for mountaineering)
• Respiratory protective equipment (for diving purposes)

Summary

The table below summarises the different requirements for each of the three PPE risk categories.

	Category I	Category II	Category III
Risk Type	Minimal risks	Risks not listed in Categories I and III	Risks with serious consequences
Conformity Assessment Procedure	Module A	Module B+C	Module B+C2 or Module B+D
Notified Body Required?	No	Yes	Yes
Documentation Requirements	a. Technical documentation. b. Declaration of Conformity c. Test reports d. Instructions	a. Technical documentation. b. Declaration of Conformity c. Test reports d. EU type-examination certificate e. Instructions	a. Technical documentation. b. Declaration of Conformity c. Test reports d. EU type-examination certificate e. Instructions
Labelling Requirements	a. CE marking. b. Traceability information c. Additional markings (if needed)	a. CE marking. b. Traceability information c. Additional markings (if needed)	a. CE marking. b. Notified body’s identification number c. Traceability information d. Additional markings (if needed)

Harmonised Standards

Harmonised standards offer a presumption of conformity with the technical requirements set by the regulation. In practice, this means that if a product complies with relevant harmonised standards, then it can be assumed to comply with the regulation’s requirements. You can download a list of harmonised standards from the European Commission’s website.

Implementing a different compliance solution for PPE products might be technically possible. However, adherence to relevant harmonised standards is usually the easiest way to ensure mandatory compliance with the regulation’s technical requirements.

Here are several examples of standards harmonised under the PPE regulation:

a. EN 136 – Respiratory protective devices – Full face masks – Requirements, testing, marking.

b. EN 166 – Personal eye-protection – Specifications.

c. EN 343 – Protective clothing – Protection against rain.

d. EN 407 – Protective gloves against thermal risks (heat and/or fire).

e. EN 568 – Mountaineering equipment – Ice anchors – Safety requirements and test methods.

f. EN 1080 – Impact protection helmets for young children.

Product Requirements

Article 5 of the regulation mandates that PPE meets the essential health and safety requirements established in Annex II. We list the main points of the requirements in the following subsections.

General requirements applicable to all PPE

Here are the general requirements that cover all PPE:

a. Design principles (e.g. ergonomics).

b. Innocuousness of PPE (e.g. suitable constituent materials).

c. Comfort and effectiveness (e.g. lightness and strength).

d. Manufacturer’s instructions and information.

Additional requirements for certain types of PPE

The regulation includes specific requirements for different types of PPE. Here is a summary:

a. PPE with systems that the user can utilise for adjustment must not accidentally come undone.

b. PPE that encloses body parts must minimise, or absorb, perspiration.

c. PPE that protects the user’s eyes, face, and respiratory system must minimise their restriction.

d. PPE that may age significantly must bear, on the product and the packaging, the date of manufacture (or if possible, when it becomes obsolete).

e. PPE that might catch onto a moving object and endanger the user, must have a breakable or tear-away constituent part that removes this risk.

f. PPE worn in explosive environments must not cause electrostatic sparks that could cause ignition.

g. PPE meant for immediate action must enable rapid putting on and removal.

h. PPE worn for usage in highly hazardous circumstances must include adjustment and functionality information for the user.

i. PPE with adjustable or removable components must allow for easy adjustment or removal.

j. PPE with systems that connect to complementary equipment outside it must have attachments that only permit mounting on relevant equipment.

k. PPE with systems for the circulation of fluids must permit suitable renewal of those fluids.

l. PPE bearing at least one health and safety identification marking or indicator must have them as harmonised ideograms or pictograms.

m. PPE that visually announces the user’s presence must bear at least one means of properly emitting or reflecting bright lights.

n. The design and manufacture of PPE that protects against various, possible, simultaneous risks must meet risk-specific health and safety mandates.

Additional requirements specific to particular risks

There are also additional requirements that PPE must adhere to, that are specific to particular risks. These requirements might apply to PPE that should protect against risks such as:

• Mechanical impact
• Static compression of a body part
• Mechanical injuries
• Drowning
• The harmful effects of noise
• Heat and fire
• Cold
• Electric shock
• Radiation
• Hazardous and harmful biological agents, substances, and mixtures
• Those that diving equipment protects against

Conformity Assessment Procedure

Per Article 19, the conformity assessment procedure differs depending on the PPE risk category.

a. Category I – Internal production control (Module A).

b. Category II – EU type-examination (Module B), followed by conformity to type based on internal production control (Module C).

c. Category III – EU type-examination (Module B),followed by either:

• Module C, plus supervised product checks at random intervals (Module C2), or
• Conformity to type based on quality assurance of the production process (Module D)

In the table below, we summarise the requirements.

	Category I	Category II	Category III
Module A Requirements	a. Technical documentation b. Ensuring compliance with requirements c. Affix CE marking d. Declaration of Conformity	/	/
Module B Requirements	/	a. Application for EU type-examination (must include technical documentation) b. EU type-examination and evaluation report provided by notified body b. EU type-examination certificate (provided by the notified body)	a. Application for EU type-examination (must include technical documentation) b. EU type-examination and evaluation report provided by notified body b. EU type-examination certificate (provided by the notified body)
Module C Requirements	/	a. Ensure the manufacturing process is compliant with the regulation b. Affix CE marking c. Declaration of Conformity	/
Module C2 Requirements	/	/	a. Ensure the manufacturing process complies with the regulation b. Product checks (made by the notified body) c. Test report (provided by the notified body) d. Affix CE marking and notified body’s identification number e. Declaration of Conformity
Module D Requirements	/	/	a. Operate an approved quality system and keep records b. Allow the notified body to access the manufacture, inspection, testing, and storage sites c. Affix CE marking and the notified body’s identification number d. Declaration of Conformity

Documentation

The regulation requires manufacturers to ensure that they draft and provide documentation such as the following:

• Declaration of Conformity
• Technical documentation
• User instructions
• Test report
• EU type-examination

Declaration of Conformity

Per Annex IX of the regulation, the Declaration of Conformity.
must contain the following:

a. The PPE’s numerical identifier.

b. Manufacturer’s name and address.

c. A statement declaring the manufacturer’s responsibility for issuing this document.

d. The PPE’s traceability information (which may include a clear, colour image of the PPE).

e. A statement declaring the PPE’s conformity with the regulation.

f. References to relevant harmonised standards used, and in lieu of that, any technical specifications used.

g. Where applicable, an identifying statement declaring that a notified body performed the Module B conformity assessment and issued the EU type-examination certificate.

h. Where applicable, another statement declaring the PPE’s subjection to either the Module C2 or Module D conformity assessment under the surveillance of the identified notified body.

i. The name, function, and signature of the signee, as well as the date and place the declaration was issued.

Technical Documentation

Per Annex III, the manufacturer must provide technical documentation that specifies how the PPE conforms with the relevant health and safety requirements in Article 5 and Annex II. The technical documentation must include the following:

a. A description of the PPE and how it is meant to be used.

b. Assessment of risks against which the PPE is meant to protect.

c. List of relevant health and safety requirements.

d. Design and manufacturing drawings and schematics of PPE and its components.

e. Descriptions and explanations for those drawings and schematics.

f. References to harmonised standards used, even in the case of partial application of said standards.

g. References to technical specifications used (in lieu of harmonised standards), even if they were partially applied.

h. Outcomes of design calculations, examinations, and inspections.

i. Test reports to verify conformity to relevant health and safety requirements and, where appropriate, to establish the applicable protection class.

j. Description of how the manufacturer ensured the PPE’s conformity with the design specifications.

k. Copy of manufacturer’s instructions and information.

l. Manufacturing instructions for single-unit PPE for individuals.

m. Description of compliance measures for a series of PPE adapted to fit individual users.

Instructions

Per Point 1.4 of Annex II, the manufacturer must, in addition to their name and address, provide instructions regarding the following:

a. Cleaning, disinfection, maintenance, servicing, storage, and use.

b. Performance, as recorded during testing, to check the PPE’s classes of protection.

c. Where applicable, PPE accessories and relevant spare part characteristics.

d. Where applicable, protection classes relevant to different risk levels and corresponding use limits.

e. Where applicable, the date or period of the PPE’s, or its components’, discontinuance.

f. Where applicable, the type of suitable transport packaging.

g. The significance of any markings.

h. The risk that the PPE is designed to protect against.

i. Reference to the PPE Regulation and any other regulations used.

j. Name, address, and identification number of any notified body involved in the conformity assessments performed.

k. References to relevant harmonised standards used (or, in lieu of that, any technical specification used).

l. Internet address to access the Declaration of Conformity.

Test Report

Lab testing is generally necessary to assess product compliance with the PPE Regulation requirements. When a product passes lab testing, manufacturers receive a test report that proves compliance with the regulation’s requirements.

Manufacturers of Category II and III PPE should adhere to Module B’s requirements, which include hiring a notified body to carry out the EU type-examination.

Per Modules C2 and D, the chosen notified body must provide a test report to the manufacturer.

EU type-examination certificate (EC)

PPE products that fall into Category II and III require the notified body to provide an EU type-certificate after it has carried out the EU type-examination and deemed the product to have met the relevant health and safety requirements.

The EU type-examination certificate must contain the following information:

a. The notified body’s name and identification number.

b. The manufacturer’s name and address.

c. The PPE’s type number and a statement of compliance.
d. References to harmonised standards (or parts thereof) used.

e. References to technical specifications used in lieu of harmonised standards.

f. Where applicable, the PPE’s performance levels or protection class.

g. For single-unit PPE for individual users, the range of allowed variations of the applicable specifications based on the basic PPE model.

h. The dates of issue, expiry, and where applicable, renewal.

i. Conditions of the certificate’s issuance.

j. For Category III PPE, a statement reflecting the certificate’s usage in with a conformity assessment procedure.

Labelling requirements

The regulation requires manufacturers to label their products or the packaging with items such as:

• CE marking
• Identification number
• Traceability information
• Additional markings (where applicable)

CE Marking

Article 17 sets rules and conditions for manufacturers affixing the CE marking onto their products. They should ensure that:

a. The PPE, or its packaging and accompanying documents, bears an obvious, clear, and permanent CE marking.

b. They affix the CE marking before placing the PPE on the market.

Identification number

Per Article 17(3), category III PPE must, after the CE marking, bear the identification number of the notified body that performed the procedures outlined in Module C2 or Module D.

Traceability Information

According to Article 8, manufacturers must ensure that their PPE products, or the packaging or accompanying documents, carry the traceability information such as the following:

• Identification number (batch, serial number, or type)
• Their name, registered trade name or registered trademark
• Postal address

Manufacturers should also ensure that their contact details are in an easily-understood language.

Additional Marking Requirements

Annex II of the regulation contains additional marking requirements for several types of PPE. Here are a few examples and a brief summary of their marking requirements.

a. PPE subject to ageing – must bear month and year of manufacture and obsolescence.

b. PPE for intervention in dangerous circumstances – must include user instructions and adjustment procedures.

c. PPE bearing one or more identification markings that directly or indirectly related to health and safety – must carry health and safety identification markings in the form of harmonised ideograms or pictograms.

Lab Testing

Importers and manufacturers must ensure that their PPE complies with the requirements set by the regulation as well as those in relevant harmonised standards. In practice, this means they need to have their products tested to prove that those products comply with the regulation’s technical requirements.

Test methods

Many standards relevant to PPE include test methods. Here we list some examples of these standards (which are harmonised under the regulation):

a. EN 12278 – Mountaineering equipment – Pulleys – Safety requirements and test methods.

b. EN ISO 12401 – Small craft – Deck safety harness and safety line – Safety requirements and test methods.

c. EN 13061 – Protective clothing – Shin guards for association football players – Requirements and test methods.

d. EN 13277-1 – Protective equipment for martial arts – Part 1: General requirements and test methods.

e. EN 13634 – Protective footwear for motorcycle riders – Requirements and test methods.

Lab testing companies

Here are a few companies that offer testing services against the requirements of the PPE Regulation:

• Intertek
• SGS
• TÜV SÜD
• SATRA
• STC

Notified bodies

The European Commission has a list of companies that offer notified body services for the PPE Regulation. Here are a few of those companies and the countries where they offer those services:

• Apave Exploitation France SAS – France
• AENOR INTERNACIONAL, S.A. (Unipersonal) – Spain
• RISE Research Institutes of Sweden AB – Sweden
• Sächsisches Textilforschungsinstitut e. V. – Germany
• SGS FIMKO OY – Finland