Explanation of the new (EU) 2016/425 PPE Regulation

Written by Michelle Locke

23 March 2017

The below is Centurion’s guidance regarding the new (EU) 2016/425 PPE Regulation (which supersedes the 89/686/EEC PPE Directive).

This outlines the changes and the impact of those changes as a result of the move from the PPE Directive to the PPE Regulation and also provides reference sources for further background reading.

Key changes

  • Change of categorisation from product related to risk related
  • Change of classification for certain product categories; Hearing Protection, now categorized as ‘harmful noise’ (risk) is moving from category II to III (see table below).
  • EC Declaration of Conformity to be provided (or with a web link) with each product
  • 5-year validity / expiry date for new EU Certificates
  • Increased obligations on ‘economic operators’ – being the total supply chain, including manufacturers, importers and distributors

Category Classifications

PPE Category Category Description Activity Above-the-neck PPE Product Examples
Category I Simple PPE
(PPE designed to protect users against minimal risks)
Placing product on the market – manufacturers self-declaration Sweatbands
Cold Weather Hood System
Sun Capes
Category II Intermediate PPE
(PPE not covered within category I or III)
Initial Product approval Safety spectacles
Industrial helmets
Bump caps
Category III Complex PPE
(PPE falling under this category includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health)
On-going surveillance through testing or factory auditing Respiratory PPE
Industrial helmets claiming Molten Metal and Electrical Resistance(EU) 2016/425 PPE Regulation change: Hearing Protection


The timeframe for the new 2016/425 PPE Regulation

There is a two-year transition period from 21st April 2016 for Member States and Notified Bodies to prepare for the new Regulation, so the new (EU) 2016/425 PPE Regulation applies from the 21st April 2018.

Companies can continue to CE mark product to the old 89/686/EEC PPE Directive until April 2019.

The benefits of the new (EU) 2016/425 PPE Regulation

The new legislation can only further help to improve the safety of the PPE on the market, in ensuring that all PPE that is brought into the European market conforms to the (EU) 2016/425 PPE Regulation and is therefore to a relevant and current Standard.

Where products are Category III, this will also ensure that the products continue to meet the requirements of the standard and have not just been tested once when the product was initially submitted for CE approval.

As above, a benefit for clarity and consistency, is that the products in the market will be approved to the latest versions of standards, rather than previous or withdrawn versions.

We at Centurion applaud the changes introduced in the new (EU) 2016/425 PPE Regulation to further improve the safety for our wearers.

From the big stuff to the small stuff at Centurion we’re proud to help and create conditions in which workers can excel. This not only extends to the products that we manufacture – we also believe that we can help the whole industry raise the bar via our interaction and leadership on the committees that write the Standards that govern our chosen sectors.

Q&A’s:
1. What is the difference between a Directive and a Regulation?

Directives lay down certain results that must be achieved but each Member State is free to decide how to transpose directives into national laws.

A Directive is a legislative act that sets out an objective that all EU countries must achieve by a given date. However, it is up to the individual countries to decide how this is done.

Regulations have binding legal force throughout every Member State and enter into force on a set date in all the Member States.

The 89/686/EEC PPE Directive is a fundamental piece of European legislation relating to occupational safety throughout Europe.  It can be described as covering any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards and it is mandatory if a PPE product falls within the Directive

2. What is a European Standard (EN)? 

A Standard is a document that sets out specifically agreed, consistent requirements for an item. Standards facilitate international trade by ensuring compatibility and interoperability of products. They bring benefits to businesses and consumers in terms of enhancing performance and improving safety.

European Standards are documents that have been ratified by one of the three European Standardization Organizations (ESOs), CEN, CENELEC or ETSI.

A European Standard “carries with it the obligation to be implemented at national level by being given the status of a national standard and by withdrawal of any conflicting national standard”. Therefore, a European Standard (EN) automatically becomes a national standard in each of the CEN-CENELEC member countries.

Standards are voluntary which means that there is no automatic legal obligation to apply them. However, laws and regulations may refer to Standards and even make compliance with them compulsory.

3. How are the Standards changing?

The standards themselves are not changing.  However, once standards have been superseded, products can no longer be certified to them within the new regulation (ie from April 2018 when the new Regulation applies or comes into force).

In summary, because the new EU Type Examination (previously CE Type Examination) refers to the standards the product is approved to, they will have to be approved to the latest current standards, not older versions or withdrawn standards.

4. What is the effect of the new (EU) 2016/425 PPE Regulation after England comes out of the EU? How does Brexit affect Centurion and the UK PPE market?

This is currently unknown.  A statement made by the CEO of the BSIF is shown below:

Alan Murray, Chief Executive, British Safety Industry Federation, said: “The Personal Protective Equipment market in the UK has been based on EU directives for a generation. After years of discussion, the new Regulation (EU) 2016/425 came “into force” in April this year. We can only at this stage assume that the market will continue to recognise it. The Federation will work diligently with legislators to be on the inside of any discussions, and we will ensure that members of the BSIF are kept up to date with all pertinent developments.”

5. The new (EU) 2016/425 PPE Regulation is relevant to which countries?(EU) 2016/425 PPE Regulation is a binding legislative act, and it must be applied in its entirety across the EU without the need for separate national legislation.The current 28 members of the European Union are as follows:

Austria – Belgium – Bulgaria – Croatia – Cyprus – Czech Republic – Denmark – Estonia – Finland
France – Germany – Greece – Hungary – Ireland – Italy – Latvia – Lithuania – Luxembourg – Malta
Netherlands – Poland – Portugal – Romania – Slovakia – Slovenia – Spain – Sweden – United Kingdom

6. How are products affected?

The only tangible element of products that are changing is related to instructions and product markings.  The product itself must have reference to the brand and also the postal address for traceability back to the manufacturer if required.

When the (EU) 2016/425 PPE Regulation is in force, the product MUST be approved to the latest standard.

7. How does it impact Centurion’s current product offer?

Ear Defenders are moving from Category II to III within the new (EU) 2016/425 PPE Regulation.

This means that these products will require on-going surveillance through testing or factory auditing (currently as per Article 11A or 11B of the 89/686/EEC PPE Directive and will be under Module C2 (Annex VII) or D (Annex VIII) of the (EU) 2016/425 PPE Regulation).

Centurion’s Ear Defender range will in future be part of the Notified Bodies audit scope during their regular visits, where they assess the technical file against current product and verify our manufacturing processes.  They will also be included in the on-going surveillance schedule (alongside our safety helmets).

8. How is Centurion’s current manufacturing and QA process affected?

Centurion’s current manufacturing and QA process will not change.  We already manufacture and quality control our products in accordance with Category III requirements (the most robust within PPE), regardless of whether they are or are not Category III products.

Helmets with Molten Metal and Electrical Insulation are currently classed as Category III within the 89/686/EEC PPE Directive.  However, helmets without these are classified as Category II.  As Centurion have helmets which are Category III, we have for many years developed and adopted our manufacturing and QA processes accordance with Category III.

Category III process means that we need to have a QA system in place that is accredited by a Notified Body, and that regular surveillance audits are carried out by the Notified Body.  Products that carry the BSI Kitemark (Click here for more information) also have ongoing third party surveillance carried out and are regularly tested, regardless of the Category classification (our non-electrical resistance/molten metal helmets carry the BSI Kitemark and so are treated as Category III products even though they are still classified as Category II)

9. What is Centurion doing to comply with the new (EU) 2016/425 PPE Regulation?

Centurion do not need to change their Ear Defender range as a result of the move from Category II to III.

We do not need to change our manufacturing or QA processes as they all currently comply with Category III requirements.

We will be reviewing our product instructions and markings in advance of April 2019 and implementing these changes prior to enforcement.

10. What is a Declaration of Conformity (DofC) and what is Centurion doing?

A DofC is a declaration that a product that is manufactured is a true representation of the product that was certified and references the certificate number and date of publication and validity.

With the new (EU) 2016/425 PPE Regulation, DofC’s are required to be available for all products that the market has access to.

Centurion will be adding DofC’s for all our products onto our new web site in advance of the PPE Regulation coming into force on the 21st April 2018.

11. How does the new (EU) 2016/425 PPE Regulation affect PPE supply chains?

The previous 89/686/EEC PPE Directive placed responsibility on the manufacturer.  The new (EU) 2016/425 PPE Regulation is now also placing responsibility on the whole supply chain, meaning that anybody involved in the product supply chain is involved, which includes importers of products and also our distributors.  They will also have responsibility to ensure that the PPE product meets the requirements according to the (EU) 2016/425 PPE Regulation as opposed to solely relying on the manufacturer.

Distributors’ obligations

Distributors are required to check that the PPE they sell to their customers has the CE mark, and has the required instructions in the appropriate language where the PPE is being sold.

Distributors also need to ensure that while they are responsible for the PPE, that the storage or transport conditions do not jeopardise the product conforming to the (EU) 2016/425 PPE Regulation.

Distributors also have responsibility to withdraw or recall the product if they consider or believe the product is not conforming to the (EU) 2016/425 PPE Regulation and they have the responsibility to inform the national authorities of the non-conformity and any remedial actions being taken.

Importers’ obligations

Importers obligations are very similar to the distributors obligations but additionally they need to place their company name and postal address on the PPE and ensure that the appropriate conformity assessment procedures have been carried out by the manufacturer.  They are also required to keep a copy of the EU Declaration of Conformity for 10 years after the product has been in the market and provide the technical documentation to the authorities if required.

12. What preparation is required for manufacturers to be compliant?

Preparation involves:
1. Ensuring that reclassified products meet the new classification
 Centurion already manufacture our Ear Defender range in accordance with Category III.

2. Identifying and addressing products that are tested to withdrawn standards
 Centurion’s QA team have already carried out a review of the Standards and all products in the
range will comply to the new (EU) 2016/425 Regulation requirements well in advance of the
timeline required.

3. Working with Notified Bodies leading up to the (EU) 2016/425 PPE Regulation effective date.
 Centurion’s QA Manager and Quality Certification Co-Coordinator are already working with
BSI, our Notified Body to ensure that we are prepared well in advance of the Regulation
coming into force.

13. What is Centurion’s view on head protection not falling into category III?

Centurion would have preferred all Industrial Safety Helmets to be moved to Category III.  We want workers to have the best protection and the task for us as a manufacturer and industry is to provide that by driving safety standards, providing product innovation and user education.

At Centurion, we already treat all our head protection systems as category III (from a process point of view) because we believe it is the right thing to do for the safety of our wearers.  We constantly strive to exceed Standards and Regulations.

We hold the BSI Kitemark (Click here for more information) for all our helmets, which is a clear demonstration to our wearers that they can be confident that the products we manufacture are continually meeting the performance characteristics of the initial sample submitted for type approval.

14. What industry Committees and Associations are Centurion engaged in?

We’re committed and relentless in the standards we set ourselves and are using our expertise, energy, and drive to improve the PPE protection for our wearers, with strong representation in the UK and European Standards committees.

Committees:

CEN TC 158   Chair – Head Protection

BSI PH6          Chair – Head Protection

BSI PH2          Member of Committee

BSIF PH4        Respiratory Member of Committee

BSIF                 Head, eyes, ears – Member of Committee. Founder member of Federation

Useful reference links

BSI-PPE-Whitepaper

BSIF PPE Regs update