Personal Protective Equipment

PPE Regulation (EU) 2016/425

in Personal Protective Equipment

The new Regulation (EU) 2016/ 425 (PPE Regulation) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating personal protective equipment is fully entered into force on the 21st of April 2018 replacing the Personal Protective Directive 89/686/EEC. The PPE Regulation comes into full effect from 21st April 2019.

The PPE Regulation ensures that all personal protective equipment provides a high level of protection of the health and safety of users.

Therefore, the PPE Regulation lays down common standards to provide adequate protection against the risks which is intended to protect.

  • Chapter I: General Provisions (art.1-7)
  • Chapter II: Obligations of Economic Operators (art.8-13)
  • Chapter III: Conformity of PPE (art.14-17)
  • Chapter IV: Conformity Assessment (art.18-19)
  • Chapter V: Notification of Conformity Assessment bodies (art.20-36)
  • Chapter VI: Union Market Surveillance, Control of PPE entering the Union Market and Union Safeguard Procedure (art.37-41)
  • Chapter VII: Delegated and implementing acts (art.42-44)
  • Chapter VIII: Transitional and Final Provisions (art.45-48)
  • Annex I: Risk categories of PPE
  • Annex II: Essential Health and Safety requirements
  • Annex III: Technical Documentation for PPE
  • Annex IV: Internal Production control
  • Annex V: EU Type-examination
  • Annex VI Conformity to type based on Internal Production Control
  • Annex VII: Conformity to type based on internal production control plus supervised product check at random intervals
  • Annex VIII: Conformity to type based on Quality Assurance of the Production Process
  • Annex IX: EU Declaration of Conformity
  • Annex X: Correlation table

Scope

in Personal Protective Equipment

Personal Protective Equipment (PPE) means:

a. equipment designed and manufactured to be worn or held by a person for protection against risks to that person’s health or safety;

b. Interchangeable components for equipment referred to in point (a) which are essential for its protective function (e.g. filters);

c. connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use

The PPE Regulation applies to all sorts of PPE being placed on the EU market except for those:

a. specifically designed for use by the armed forces or in the maintenance of law and order;

b. designed to be used for self-defense, with the exception of PPE intended for sporting activities;

c. designed for private use to protect against:

     i. atmospheric conditions that are not of an extreme nature,

     ii. damp and water during dishwashing;

d. exclusively used on seagoing vessels or aircraft;

e. designed to protect head, face or eye as helmets and their visors used by drivers and passengers of motorcycles and mopeds.


Compliance

in Personal Protective Equipment

There are defined three categories of equipment based on the risk against which the equipment is intended to protect users.

Category I – Minimal risk

In this category, the PPE is designed to protect people from minimal risks:

a) Superficial mechanical injury;
b) Contact with cleaning materials of weak action or prolonged contact with water;
c) Contact with hot surfaces not exceeding 50°C;
d) Damage to the eyes due to exposure to sunlight (other than during observation of the sun);
e) Atmospheric conditions that are not of an extreme nature.

Category II – Intermediate Risk

This category covers risks other than those defined by neither Category I nor Category III

Category III – Serious Risk

The PPE designed to protect people from risks that may cause very serious consequences such as death or irreversible damage to health:

  • Substances and mixtures which are hazardous to health (carcinogenic, mutagenic, reprotoxic, toxic, irritant or sensitizing)
  • Atmospheres with oxygen deficiency
  • Ionising radiation
  • High-temperature environments, the effects of which are comparable to those of an air temperature of at least 100°C
  • Low-temperature environments, the effects of which are comparable to those of an air temperature of -50°C or less
  • Falling from a height
  • Electric shock and live working
  • Harmful biological agents
  • Drowning
  • Cuts by hand-held chain-saws
  • High-pressure jets
  • Bullet wounds or knife stabs
  • Harmful noise

Each risk category of PPE must comply with clearly defined conformity assessment modules prior to being placed on the market.

 

 

 

 

 

 

 

 

 

PPE covered by categories II and III requires the product to be certified by a Notified Body (NB). The Notified Body will issue an EU type-examination certificate following successful evaluation of a manufacturer’s technical file and independent testing report.

Essential Requirements

PPE shall meet certain health and safety requirements (Annex II) to not endanger person and properties as those:

  • general requirements applicable to all PPE, such as ergonomics, absence of inherent risks and other nuisance factor and manufacturer’s instructions and information
  • requirements specific to certain types of PPE, such as PPE subject to ageing or PPE for intervention in very dangerous situations
  • requirements specific to particular risks, such as protection against mechanical impact or in liquids or against ionising and non-ionising radiation.

 

PPE which is in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.

Technical Documentation

The manufacturer compiles the technical documentation, which makes it possible to assess whether the PPE equipment complies with the requirements of the Regulation. It contains at least the elements set out in the Annex III.

Non-Compliance

The non-compliance with the Regulation’s requirements will result in the removal of the equipment from the market and the revoke of the CE marking affixed on it.


Transition to the new Regulation (EU) 2016/425

in Personal Protective Equipment

The PPE Directive 89/686/EEC is repealed with effect from 21 April 2018. The PPE Regulation (EU) 2016/425 shall apply from 21 April 2018.  As of 21 April 2018, manufacturers can place PPE on the European market which are compliant with the PPE regulation.

The article 47 of Regulation  2016/425  foresees a specific transitional regime for PPE:

  • PPE designed and manufactured in accordance with Directive 89/686/EEC can still be placed on the market until 21 April 2019, and in principle EC type-examination certificates in accordance with Directive 89/686/EEC can be issued until the end of the transitional period, unless the classification of the product and/or the essential safety requirements applicable to it have changed (in the new Regulation).
  • PPE may be placed on the market after 21 April 2019 and no later than 21 April 2023 on the basis of an EC type-examination certificate and/or an approval decision in accordance with the PPE Directive. This is not applicable in the following cases:
  1. Higher classification in the Regulation (after 21 April 2019)
  2. Updated version of the Harmonized Standard may result in a non-compliance of the product with the new Regulation
  3. change in design and/or manufacture of the PPE

 


The Directive: PPE 89/686/EEC

in Personal Protective Equipment

PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”.

89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has three modifications 93/95/EEC, 93/68/EEC, and 96/58/EEC.

The introduction establishes the focus of the directive as “safeguarding of public health, improving safety at work and ensuring user protection” and reinforces the European Commissions continuing efforts to create free movement of goods in the European Economic Area through the use
of harmonized standards.

The directive divides PPE into 3 categories; class 1 – simple, class 3 – complex and class 2 – neither of these. For classes 1 and 3 there are comprehensive lists of equipments covered; any equipment not included on either list are classed in the second category. There is also a comprehensive list of equipment excluded from the directive. There are general requirements for all 3 classes, including technical documentation, a CE mark and a Declaration of Conformity. For classes 2 and 3 there are additional requirements.

Current Problems

Awareness and communication continue to be major problems across the EU for the smooth implementation of the directive. Some of the problems identified are:

  • Scope: unclear about applicability to consumer PPE for domestic use; also demarcation between PPE and other directives, e.g. Medical Devices and Toys require clarification.
  • Standards: still not available for all PPE
  • Product Categorization/Conformity
  • Assessment Procedures: require clarification to allow an increased scope for self-certification in order to ease demands on third-party testing and reduce compliance costs
  • Notified Bodies: greater transparency and uniformity is required across member states in the assessment of applicants for Notified Body status in order to increase confidence in their appointment and activities

Scope

in Personal Protective Equipment

The PPE Directive (Personal Protective Equipment Directive) covers any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

This includes:

  • Equipment for protection against falls from a height
  • Head protectors (helmets and other headgear for professional and private use, face protectors for ice hockey players)
  • Protective clothing, gloves (chemical attack, heat)
  • Protective clothing (high visibility, reflecting materials)
  • Reflectors
  • Protective eyewear used in the game of floor ball

 

PPE Directive applies to:

  • A unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks
  • A protective device or appliance combined, reparably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity
  • Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment

 

However the PPED does not apply to:

  • PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.)
  • PPE for self-defense (aerosol canisters, personal deterrent weapons, etc.)
  • PPE designed and manufactured for private use against:PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time
    • Adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.)
    • Damp and water (dish-washing gloves, etc.)
    • Heat (gloves etc.)
  • Helmets and visors intended for users of two- or three wheeled motor vehicles

Compliance

in Personal Protective Equipment

There are general requirements for all 3 classes, including technical documentation,
a CE mark and a Declaration of Conformity.

The manufacturer must create a technical file.

The Technical File shall consist of:

  1. Overall and detailed plans of the PPE accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the basic requirements (Annex II of the PPE Directive). Personal Protective Equipment Directive FAQs 4/4
  2. An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications used to demonstrate compliance with the basic requirements.
  3. Declaration of Conformity

Other technical documentation that should be included, although not strictly part of the ‘Technical File’ is:

  1. A copy of the User Information or Instructions for Use supplied with the equipment
  2. A description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production PPE with the harmonized standards or other technical specification.

If the equipment is to be manufactured in series, an EC type-examination is required. This EC type declaration shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerning the effects of which, when they are gradual, can be safely identified by the user in good time. This category shall cover exclusively PPE intended to protect the wearer against:

  • Mechanical action whose effects are superficial (gardening gloves, thimbles, etc.)
  • Cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)
  • Risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to dangerous impacts (gloves, aprons for professional use, etc.)
  • Atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.)
  • Minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.)
  • Sunlight (sunglasses)

In the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm health, the PPE will be subject to either “EC” quality control system for the final product or system for ensuring EC quality of production by means of monitoring and to an EC Declaration of Conformity.

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the equipment.