Understanding the PPE Regulation (EU) 2016/425

 

The workplace can be full of risks. Whether on a construction site, in a busy kitchen or preparing products in a warehouse it’s important to ensure that employees are protected against injury. In line with other methods of risk prevention, PPE that meets the demand of the environment and the user is a method of keeping employees safe at work.

That’s why PPE comes with strict regulations that ensure products are tested and regulated before they are released into the market. However, it can still be taxing to understand what exactly is expected of the products you invest in and whether you can trust that they satisfy legislation.

In this guide, we will analyse the most recently published set of regulations: Regulation (EU) 2016/425.

 

What is Regulation (EU) 2016/425?

The full title is Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on Personal Protective Equipment, repealing Council Directive 89/686/EEC. This regulation came into force in the UK on 21st April 2018 under The Personal Protective Equipment (Enforcement) Regulations 2018.

This regulation replaced the previous directive known as the Personal Protective Equipment Directive 89/686/EEC, which was first enforced in the UK under The Personal Protective Equipment at Work Regulations 1992, and more recently under Personal Protective Equipment Regulations 2002.

A transition period of a year was mandated to manufacturers and as of the end of April 2019, no more PPE can be sold or manufactured that does not comply with Regulation (EU) 2016/425. Whereas under the old directive, employers had to ensure the correct suitability, provision, maintenance and use of PPE, the new regulation makes the whole supply chain accountable.

The regulation lays down requirements for the design and manufacture of personal protective equipment (PPE), which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.

 

Regulation (EU) 2016/425 and the PPE market

As a result of this Regulation, PPE shall only be made available on the market if, where properly maintained and used for its intended purpose, it complies with the criteria set out and does not endanger the health or safety of persons, domestic animals or property.

Regulation (EU) 2016/425 made significant changes to who could be held accountable in the supply chain. Below is a list of key considerations and responsibilities for each authorisation involved in the supply chain apart from the end-user.

 

Who is responsible for PPE under Regulation (EU) 2016/425?

The following information is about the roles of each party in the chain of supply for Regulation compliant PPE. The exhaustive specifications can be found in the Regulations (EU) 2016/425 document published by EUR-Lex, the official website for European Union law.

Manufacturers must:
 

  • Ensure PPE has been designed and manufactured in accordance with necessary health and safety requirements.
     
  • Draw up the technical documentation that provides the following: complete description of the PPE and its intended uses; disclosure of the risks against which the PPE will protect; a list of the essential health and safety requirements that are applicable to the PPE; design blueprints and schemes of the PPE and its components.
     
  • Keep technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market.
     
  • Ensure procedures are in place for production to remain in conformity with this Regulation. Any alterations to the manufacturing of the PPE must be recorded.
     
  • Ensure that PPE placed on the market bears distinct identification, or, where not possible, that the required information is provided on the packaging or supporting PPE documents.
     
  • Indicate on the documentation or PPE their name or affiliation and an address where they can be contacted.
     
  • Ensure that PPE is accompanied by instructions and information; these instructions must be clear, understandable, intelligible and legible.
     
  • Provide the EU declaration of conformity with the PPE in some shape or form.
     
  • Take necessary measures to bring PPE to conformity if they believe that PPE has been placed on the market that is not compliant.
     
  • Be able to provide all the information and documentation necessary to demonstrate the conformity of their PPE with this Regulation.
 

Authorised Representatives must:

 

  • Be appointed by written mandate from an approved PPE manufacturer.
     
  • Perform the tasks specified in the mandate received from the manufacturer.
     
  • Keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the PPE has been placed on the market.
     
  • Be able to provide any authority with the information and documentation necessary to demonstrate the conformity of the PPE.
     
  • Co-operate with the competent national authorities on any action taken to eliminate the risks posed by PPE.
 

Importers must:

 
  • Place only compliant PPE on the market.
     
  • Ensure, before putting PPE on the market, that the manufacturer carried out the appropriate conformity assessments.
     
  • Ensure that the manufacturer has created technical documentation.
     
  • Make sure all PPE bears the CE marking.
     
  • Indicate on the documentation or PPE their name or affiliation and a clear address where they can be contacted.
     
  • Ensure PPE is supplied with necessary instructions and information.
     
  • Ensure that, while the PPE is under their responsibility, it’s not damaged during storage or transport.
     
  • Carry out sample testing of PPE made available on the market, look into and keep a register of complaints, keep lists of non-conforming PPE and PPE recalls, and make distributors informed of these.
     
  • Take necessary measures to bring PPE to conformity if they believe PPE has been placed on the market that is not Regulation compliant.
     
  • Keep technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market.
     
  • Be able to provide all the information and documentation necessary to demonstrate the conformity of the PPE with this Regulation.

 

Distributors must:
 

  • Act with due care in relation to the requirements of this Regulation when putting PPE on the market.
     
  • Verify that PPE bears the CE marking.  
     
  • Verify PPE is accompanied by the required documents and has accompanying instructions and information that can be easily understood by customers and end-users.
     
  • Take necessary measures to bring PPE to conformity if they believe PPE has been placed on the market that is not Regulation compliant. 
     
  • Ensure that, while the PPE is under their responsibility, it’s not damaged during storage or transport. 
     
  • Be able to provide all the information and documentation necessary to demonstrate the conformity of the PPE with this Regulation.
     

 

 

Regulation (EU) 2016/425 — Essential Health & Safety Requirements

Risk Protection and Marketing
 

PPE must:

  • Provide adequate protection against the risks against which it is intended to protect.
     
  • Be designed and manufactured so that, in the foreseeable expectations of its usage, the end-user will be able to perform the risk-related activity normally whilst experiencing the highest level of protection possible.
     
  • Exceed an optimum level of protection that is beyond the constraints PPE delivers.
     
  • Cater for differing foreseeable conditions of use and should be able to counter several levels of the same risk.
     
  • Be designed and manufactured so it does not create risks or nuisances.
     
  • Contain materials that do not adversely affect the health or safety of users.
     
  • Be free of rough surfaces, sharp edges, sharp points and the like which could cause excessive irritation or injuries.
     
  • Be designed and manufactured in such a way as to facilitate its correct positioning on the user. It must remain in place for the period of use and factor in the actions to be carried out and the postures to be adopted.
     
  • Be as light as possible without impairing its strength and effectiveness.
     
  • Be able to ensure simultaneous protection if PPE covers adjacent parts of the body.

 

Design Essentials

 

PPE must:

  • Be created in a way that means perspiration resulting from use is minimised. Otherwise perspiration must be absorbed.
     
  • Minimise all restriction of the user's face, eyes, field of vision or respiratory system.
     
  • Display the month and year of obsolescence unambiguously on each item of PPE.
     
  • Be designed and manufactured in such a way that it cannot be the source of an electric, electrostatic or impact-induced arc or spark, which may cause an explosive substance to ignite.
     
  • Have harmonised pictograms or ideograms if more than one certification is displayed.
     
  • Contain materials and other components that are designed to protect all or part of the body against superficial injuries including abrasion, perforation, cuts or bites.


Protection

 

Footwear:
 

  • Safety footwear must have outsoles designed to prevent slipping. They must be equipped with additional means to ensure adequate grip and be designed with awareness of the nature or state of the surface they will be used upon.
     

Learn more about the safety requirements of protective footwear in our guide to the EN ISO 20345:2011 Standard.

 

Liquids:
 

PPE designed to prevent drowning:

  • Must be able to return to the surface as quickly as possible. Wholly or partially buoyant PPE must be inflated by gas which can be manually or automatically released, or inflated orally.
     
  • Must have a device for attaching the body so the user may be lifted.
     
  • Must be suitable for extended use throughout the activity that exposes the user to the risk of falling into the liquid medium or minimal immersion in it.

 

Noise:
 

  • PPE intended to prevent the harmful effects of noise must be capable of attenuating the sound, so the user’s exposure to noise does not exceed the limits laid down by Directive 2003/10/EC of the European Parliament and of the Council.
     

Discover more about the PPE regulations for ear protection in our comprehensive guide to the EN 352 Hearing Protection Standards.

 

Heat or fire:
 

  • PPE designed to protect all or a part of the body against the effects of heat or fire must possess thermal insulation capacity and mechanical strength appropriate to the conditions of use.
     
  • Where the external surface of those materials and components must be reflective, the reflective power must match the intensity of the heat flux.
     
  • PPE materials and other components, which may accidentally come into contact with flame — and those, used in the manufacture of industrial or fire-fighting equipment — must also possess a degree of non-flammability and thermal protection corresponding to the level of risk.

 

Cold:
 

  • PPE designed to protect all or part of the body against the effects of cold must possess thermal insulating capacity and features appropriate to the foreseeable conditions.
     
  • Materials and components suitable for protection against the cold must possess a coefficient indicating thermal transmissions.
     
  • PPE must attempt to prevent the penetration of such liquids as rain water and must not cause injuries resulting from contact between its cold protective integument and the wearer.

 

Electric shock:
 

  • PPE designed to protect all or part of the body against the effects of electricity must be sufficiently insulated against the voltages.
     
  • Conductive PPE intended for working at high voltages shall be designed and manufactured to ensure there is no difference of potential between the user and the installations on which they are working.

 

Radiation:
 

  • PPE designed to prevent acute or chronic eye damage from sources of non-ionising radiation must be capable of absorbing or reflecting the majority of the energy.
     
  • Eye protective equipment must be manufactured to possess a spectral transmission factor for all strengths of radiation so that the chance of radiation reaching the user's eye in dense amounts is minimised.
     
  • Glasses must not deteriorate or lose their properties as a result of the effects of radiation emitted under the foreseeable conditions.
     
  • Glasses suitable for radiation sources of the same type must be classified in the ascending order of their protection factors and instructions must indicate how to select the appropriate PPE.
     
  • Necessary leak-tightness must be provided by the permeability of the protective integument.

 

Respiratory:

 

  • PPE intended for the protection of the respiratory system must make it possible to supply the user with breathable air when working in a polluted atmosphere or an atmosphere lacking oxygen concentration.
     
  • The breathable air supplied to the user by PPE must be obtained by appropriate means.
 

PPE categorisation under Regulation (EU) 2016/425

As a result of the Regulation, PPE products are now classified into one of three categories, depending upon the level of risk associated with their use. Risks marked in bold are those that have been added since the old PPE Directive 89/686/EEC.

 

Category I (minimal risks):
 

  • Superficial mechanical injury.
     
  • Contact with cleaning materials of weak action or prolonged contact with water.
     
  • Contact with hot surfaces not exceeding 50 degrees Celsius.
     
  • Damage to the eyes due to exposure to sunlight.
     
  • Atmospheric conditions that are not of an extreme nature.

 

Category II:

 

  • Includes any risk not mentioned in Category I or Category III.

 

Category III (risks that may cause very serious consequences such as death or irreversible damage):

 

  • Substances and mixtures that are hazardous to health.
     
  • Atmospheres with oxygen deficiency.
     
  • Harmful biological agents.
     
  • Ionising radiation.
     
  • High-temperature environments the effects of which are comparable to those of an air temperature of at least 100 degrees Celsius.
     
  • Low-temperature environments the effects of which are comparable to those of an air temperature of -50 degrees Celsius or less.
     
  • Falling from a height.
     
  • Electric shock and live working.
     
  • Drowning.
     
  • Cuts by hand-held chainsaws.
     
  • High-pressure jets.
     
  • Bullet wounds or knife stabs.
     
  • Harmful noise.
 

What does Regulation (EU) 2016/425 mean for the PPE industry?

This Regulation means that previous specification for PPE may no longer be appropriate. It is a stricter regulation with more defined specifications of the process of PPE design and manufacture. It many ways, it ensures the end-user has a higher chance of being suitably protected, as stricter guidelines should ensure expectations are met and maintained.

Trusted suppliers of PPE should be prepared to make essential checks to ensure the PPE they are providing to consumers meets appropriate standards and matches all new specifications in the Regulation. Accountability along the supply chain ensures that employees and wearers of PPE are protected against risks that have been properly assessed and measured.

 

Where can compliant PPE be purchased?

WISE Worksafe takes care to stay up to date with the standards and regulations surrounding PPE and protective clothing. This helps us ensure our customers and the end-users of our extensive PPE range are kept safe and comfortable at work. All appropriate products are CE certified and conform to the required British, European or international safety standards.

WISE Worksafe are more than happy to provide guidance and assistance to ensure your employees are kept protected by our certified PPE. After all, PPE might only be for the individual but it’s everyone’s responsibility to make sure its requirements are adhered to.

Even our corporate uniform and workwear is made to support its user through their daily tasks. So boost your safety standards and staff satisfaction today with high quality clothing for a wide variety of jobs.

For more information on staying safe in the workplace, check out our other informative guides to various PPE regulations and safety standards.
 






Author

Glen Smith

Having worked at WISE Worksafe for 16 years, Glen Smith our Marketing Manager has a wealth of experience in corporate branding, company uniforms and functional workwear. He has a passion for making brands stand out from the crowd, and coming up with innovative solutions to support our clients in this process.