Home>Trade Body>BSiF>From the CEO's desk: Personal Protective Equipment Regulation (EU) 2016/425 – The time has come

From the CEO's desk: Personal Protective Equipment Regulation (EU) 2016/425 – The time has come

13 March 2018

The safety and health industry will wake up on the 21st of April 2018 with the Personal Protective Equipment Regulation (EU) 2016/425 in force and the current Directive 89/686 will be repealed.

The Regulation was adopted on the 12th of February 2016 and published on the 31st of March 2016, beginning a two year transition period which comes to its end this April.

End users of PPE need to know that their suppliers are complying with the new Regulation – BSIF makes that simple and straightforward.

The changes will impact across the market, most significantly these will affect the PPE economic operators, but it is important that the end users understand the Regulation.

Based on risk

Within the new Regulation there are some changes that are beneficial to the users. The categorisation of the new Regulation is risk based, not based on the type of PPE. This makes it more straightforward to link selection to the workplace risk assessment. 

Some of the PPE changes from category II to III, the higher risk category and will require more frequent formal quality assurance. This will provide the user with more confidence that the products they are sourcing are fit for purpose. Users should ensure that products which change category from II to III now reflect and comply with the changes. Please note that products already on the market “in distribution” can continue to be sold. Perhaps the most widely used PPE that is changing in risk category are products designed to provide protection against harmful noise – hearing protection.

In addition to hearing protection (harmful noise) other risks that move from category II to III include protection against harmful biological agents, bullet wounds and knife stabs, cuts by hand held chainsaws, high pressure jets and protection from drowning.

The new Regulation also requires that PPE products are accompanied by the Declaration of Conformity (DoC) demonstrating the product’s compliance to the requirements. The DoC can be supplied as part of the product user instructions or through an internet link.

EU – Type testing examination certificates will only be valid for a maximum of five years before requiring renewal by a Notified Body.

When the manufacturer of the product is not based in the EU the address of the importer will be added to the product or to the accompanying documents and “Online” sale will see stricter controls. 

Assures product compliance

Overall from a user’s perspective the Regulation goes a long way to ensure that processes are in place to assure product compliance. The Regulation does this through placing more detailed responsibilities on “economic operators” making up the PPE supply chain. Economic operators include:

Manufacturer: who manufactures the PPE, or has it designed and/or manufactured and markets it under his name or trademark.

Authorised Representative: established within the EU and holds a written mandate from the manufacturer to act on his behalf in relation to specific tasks.

Importer: established within the EU and places PPE from a third country on the EU market.

Distributor: involved in the supply chain, makes PPE available on the market, and is other than the manufacturer or importer. 

Note that distributors and importers who place PPE on the market under their own name or brand take on ALL the obligations of the manufacturer.

All economic operators will have an obligation to: take corrective actions in case of non-compliance and inform the competent authorities where PPE presents a risk. To cooperate with authorities and provide all the information necessary to demonstrate compliance in a language which can be easily understood by that authority. 

  • Manufacturers and authorised representatives must keep the product technical file and the EU Declaration of Conformity available for 10 years after PPE is placed on the market. Importers also need to keep the DoC for 10 years, and ensure the technical file can be made available.
  • Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the PPE Regulation, and manufacturers and importers shall, if necessary, carry out sample testing of PPE made available in the market, keep a register of complaints and keep distributors informed of such monitoring.

Additional obligations on importers are:

  • To only place compliant PPE on the market.
  • To ensure the PPE has the technical documentation available, the conformity assessment has been carried out, the correct markings are available and the PPE is accompanied by the required documents.
  • To indicate on the PPE their product ID and postal address where they can be contacted.
  • To ensure transport and storage do not jeopardize the PPE’s conformity.

From an end user’s point of view their front line relationship is normally with their distributor. It is the distributor who supplies them with their PPE and is normally the first port of call for everyday advice. End users should know that there are further detailed obligations and responsibilities placed on their distributors in order for them to be allowed to sell PPE. 

  • To act with due care.
  • To verify that the PPE bears the correct markings and is accompanied by the required documents in a language that can be easily understood by the consumers.
  • To not make PPE available in the market if the PPE is considered not to meet the essential health and safety requirements.
  • To ensure transport and storage do not jeopardize the PPE’s conformity.

RSSS membership

End users must ensure that their supplier fulfils his obligations under the Regulation! How does an end user achieve this? It is straightforward! An end user of PPE should request proof that his supplier is part of the British Safety Industry Federation’s Registered Safety Supplier Scheme (RSSS). Membership of the RSSS demonstrates an assurance of quality and capability which users should demand.

With the new Regulation now becoming applicable, a BSIF Registered Safety Supplier Scheme member will be able to ensure that he complies by utilising the audited checklists designed to verify that they are managing their “Obligations and Responsibilities”.

This is confirmed by the statement from Trading Standards below:

Statement to Support and Guide UK Commercial Operators from Trading Standards

Being a member of the British Safety Industry Federation Registered Safety Supplier Scheme and abiding by its terms and conditions and adhering to the prescribed and Audited Checklist Protocol will provide to Trading Standards, that you have a due diligence system in place to demonstrate compliance with the Obligations and Responsibilities of economic operators as referenced within the PPE Regulation (EU) 2016/425 pertaining to obligations and responsibilities as an “Importer” and/or a “Distributor”. It does not necessarily provide a guarantee that all products are compliant.

Always look for the Registered Safety Supplier Scheme shield. 

Alan Murray

BSIF chief executive