Open HSME menu
Subscribe Login

Home / Articles and Press Releases / Press Release / New Regulations, New Responsibilities

CATEGORIES

  • Latest Issue
  • Above The Neck Protection
  • Chemical Protection
  • Confined Space
  • Construction
  • Emergency Procedures
  • Energy, Oil, and Mining Industries
  • Eye Protection
  • Fall Protection
  • Gas Detection
  • Hand Protection
  • Hazardous and Explosive Atmospheres
  • Health and Safety Awareness
  • Hearing Protection
  • Heat
  • Lighting and ATEX
  • Noise Monitoring
  • Personal Protective Equipment
  • Respiratory Protection
  • Safety Footwear
  • Safety Technology
  • Safety Training
  • Slips, Trips, and Falls
  • Wellbeing at work
  • Working at Height
  • Working rights

MORE

  • Press Release
  • Events
  • Videos
  • Webinars
  • Magazines

COMPANY

  • About
  • Advertising
  • Newsletter
  • Contact
Open HSME menu
Subscribe

Home / Articles and Press Releases / Press Release / New Regulations, New Responsibilities

CATEGORIES

  • Latest Issue
  • Above The Neck Protection
  • Chemical Protection
  • Confined Space
  • Construction
  • Emergency Procedures
  • Energy, Oil, and Mining Industries
  • Eye Protection
  • Fall Protection
  • Gas Detection
  • Hand Protection
  • Hazardous and Explosive Atmospheres
  • Health and Safety Awareness
  • Hearing Protection
  • Heat
  • Lighting and ATEX
  • Noise Monitoring
  • Personal Protective Equipment
  • Respiratory Protection
  • Safety Footwear
  • Safety Technology
  • Safety Training
  • Slips, Trips, and Falls
  • Wellbeing at work
  • Working at Height
  • Working rights

MORE

  • Press Release
  • Events
  • Videos
  • Webinars
  • Magazines

COMPANY

  • About
  • Advertising
  • Newsletter
  • Contact

CATEGORIES

  • Safety Signage
  • Heat and Flame
  • Article
  • Press Release
  • Air Pollution
  • Above The Neck Protection
  • Chemical Protection
  • Confined Space
  • Construction
  • Emergency Procedures
  • Energy, Oil, and Mining Industries
  • Eye Protection
  • Fall Protection
  • Gas Detection
  • Hand Protection
  • Hazardous and Explosive Atmospheres
  • Health and Safety Awareness
  • Hearing Protection
  • Heat
  • Lighting and ATEX
  • Noise Monitoring
  • Offshore Platform Safety
  • Personal Protective Equipment
  • Regulations & Legislations
  • Respiratory Protection
  • Safety Footwear
  • Safety Technology
  • Safety Training
  • Slips, Trips, and Falls
  • Wellbeing at work
  • Working at Height
  • Working rights

Press Release

New Regulations, New Responsibilities

By Ansell

| Read Bio

Published: July 30th, 2018

Share this article

Changes to the conditions for the sale of personal protective equipment (PPE) in Europe are fast approaching. The new PPE regulation is more rigorous than its predecessor and designed so that the obligation for the sale of safe products is shared throughout the supply chain.

We spoke with Ansell’s Director of Regulatory Affairs — Guido Van Duren — about the new regulations and what the changes mean for manufacturers, importers and distributors.

First up, what is changing and why?

A new European Union Regulation is being introduced: PPE Regulation (EU) 2016/425. It is a more thorough regulatory system which will ensure that all PPE available for sale in Europe conforms to the latest defined requirements and can therefore be safely placed on the market.

It replaces PPE Directive 89/686/EEC, under which the manufacturer was solely responsible for the sale of compliant PPE products. Regulation 2016/425 is more formalised with respect to certification and compliance and is aligned to a new legislative framework. It clearly outlines the requirements applicable to all economic operators in the supply chain.

Why move from a Directive to a Regulation?

In the EU, a Directive needs to be translated into national law by each individual member state. That makes harmonisation difficult to achieve and leads to discrepancies across the EU. A Regulation becomes law for the entire EU-28 at the same time and without any alteration or loss of integrity.

What are the changes?

There are four key areas of change which I’ll address individually. In short, these are:

  1. Testing and certification
  2. Clearer risk-based category definitions
  3. Enhanced traceability
  4. Broadened supply chain obligations

1. Testing and certification

All PPE to be made available for sale must be re-certified to the latest standards. In some cases, this will mean re-testing.

Products must be supported by a Declaration of Conformity (EU DoC). This declares that the product meets the Regulation, including reference to the risk category as it applies to the product’s intended use.

In the case of products that were tested and previously certified under the existing Directive and against old standards, re-testing and re-certification must be carried out before the existing certificate expires. If no expiry date applies, the cut-off date for re-certification is 21 April 2023.

2. Clearer risk-based category definitions

The Regulation now clearly defines each risk-based category (i.e. Cat I, Cat II & Cat III). Most remain unchanged, although some risks have been reassigned to Cat III — protection against irreversible harm. These include; harmful biological agents, harmful noise, cuts by handheld chainsaws, bullet wounds or knife stabs, high-pressure jets and drowning. PPE designed for these risks must be re-tested and re-certified to meet the new requirements. They will also need a new EU DoC.

3. Enhanced traceability

Enhanced traceability is intended to allow the market surveillance authority to more easily remove dangerous or non-compliant PPE products from the market. Traceability via mandatory product labelling (for example, the marking of a European single point postal address) makes it easier to trace back to operators who may have placed non-compliant products on the market. This means non-compliant PPE manufacturers and distributors are quickly identified, facilitating faster product recalls and encouraging a practice of exhaustive compliance documentation.

4. Broadened supply chain obligation

The manufacturer still retains responsibility for testing, certification and the EU DoC, but the due diligence responsibilities have been broadened to incorporate increased obligation for importers and distributors.

Importers and distributors are now legally bound to ensure they only place fully compliant PPE in the market. This means they must confirm that the appropriate conformity assessment has been conducted by the manufacturer. If there is reason to believe PPE does not comply (and therefore presents a health and safety risk), the importer or distributor must remove it from sale and report it to the relevant market surveillance authority.

The importer and distributor must also guarantee that storage and transport conditions while the PPE is under their responsibility do not jeopardise product conformity.

What are the compliance timeframes and deadlines under the new Regulation?

The new requirements were established and published in March 2016, so there has been fair warning. It is also a transitional process, but there are key dates all supply chain operators should be aware of.

The formal transition period commences 21 April 2018 with a compliance deadline of 21 April 2019, at which point the old Directive will be repealed. This means that between these dates, new products can be supplied to either the Directive or the Regulation. From the 2019 deadline onwards it will only be permissible to sell new products that meet the Regulation.

Figure 1 – A diagram showing the timeline of the transition to the new standard

For existing products tested and declared under the old Directive, re-testing and re-certification must be completed prior to expiration of the existing certificate. If no expiry date applies, the cut-off for re-certification is 21 April 2023.

Share this article

ABOUT THE AUTHOR

Ansell

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. With operations in EMEA, North America, Latin America/Caribbean and Asia, Ansell employs nearly 15,000 people worldwide and holds leading positions in the personal protective equipment and medical gloves market, as well as in the sexual health and well-being category worldwide. Ansell operates in four main business segments: Industrial, Medical, Single Use and Sexual Wellness.

Connect with Ansell

Visit Website

POPULAR POSTS BY Ansell

Ansell

Press Release

Understanding the Risk of Chemical Exposure

Ansell Showcase the Edge 48203

Press Release

Ansell Showcase the Edge 48203

Press Release

Regulatory Standards for Gloves that Protect Against Viruses

Article

Disinfecting Your Home While Caring For Someone Sick With Covid-19

Press Release

Disposal Of Single Use Gloves

Press Release

The New Coronavirus

Get email updates

Sign up for the HSME newsletter

Keep up-to-date through the power of email with the region's only industrial health and safety magazine - delivering the latest news and products to satisfy all your occupational safety needs.
  • This field is for validation purposes and should be left unchanged.

FEATURED ARTICLES

Advertisement

SOCIAL MEDIA

HSME on Facebook

https://www.facebook.com/HSMEMagazine/

Advertisement

SOCIAL MEDIA

HSME on Twitter

hsmemagazine HSME Magazine @hsmemagazine ·
1 Feb

isafe MOBILE announces the immediate availability of the world’s first 5G smartphone for ATEX and IECEx zone 1/21.

The IS540.1 is available immediately, find out more today: https://www.hsmemagazine.com/press-release/is540-1-available-now/

#hsmemagazine #isafeMOBILE #ATEX #IECEx

Reply on Twitter 1620747838971088898 Retweet on Twitter 1620747838971088898 Like on Twitter 1620747838971088898 2 Twitter 1620747838971088898

Advertisement

SUBSCRIBE

Stay up to date with our newsletter

Keep up-to-date through the power of email with the region’s only industrial health and safety magazine – delivering the latest news and products to satisfy all your occupational safety needs.

 

This field is for validation purposes and should be left unchanged.
2

Subscribe

SUBSCRIBE TO HSME MAGAZINE

5 reasons to subscribe to our digital and print package

  • Stay up to date from anywhere in the world, with instant access to the latest issue straight from your phone, tablet or laptop.
  • Trust that you’re getting the best content from our range of internationally accredited authors.
  • Get full access to our archives and see how occupational safety has evolved with us over the years.
  • Enjoy our monthly newsletter curated with up-to-the-minute news and a selection of editor’s top picks.
  • Hot off the press and straight to your door – look forward to your own glossy copy of HSME, delivered five times a year
Subscribe View Subscription levels

STAY SAFE & INFORMED

Subscribe to the best health & safety articles, news, products and regulations

Find out more

Stay up to date with our newsletter

  • This field is for validation purposes and should be left unchanged.

ABOUT

  • About HSME
  • Advertise
  • Contact Us

YOUR ACCOUNT

Sign In Register Account Subscribe to HSME

RESOURCES

Request Media Pack

CONNECT

ACCREDITATIONS

Copyright Bay Publishing 2023. All Rights reserved.

Designed & Built by:
  • Terms & Conditions
  • Privacy Policy
  • Cookie Policy
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Cookie settingsACCEPT
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT