The new PPE Regulation (EU) 2016/425 was listed in the Official Journal of the European Union on 21st April 2016, and started a two year transition period for Member States and Notified Bodies to prepare. This Regulation supersedes the PPE Directive 89/686/EEC and is mandatory, covering every type of product which falls within its scope.
Therefore if you're in the Personal Protective Equipment (PPE) industry, it's a legal obligation to comply. Previously, the PPE Directive only impacted manufacturers placing products onto the market, but the new PPE Regulation involves the entire supply chain. This means importers, distributors, retailers and any other parties involved in the supply, distribution, marketing and sale of PPE have a duty to ensure it meets requirements and complies with the Regulation.
With less than a week to go until the new PPE Regulation applies, we're taking you on a quick crash course to ensure you're up to speed with the changes.
Why Is the PPE Directive Changing?
The implementation of the new PPE Regulation is being made for various reasons:
- To reflect modern methods of bringing PPE to market, in addition to changes in production and technology techniques
- To improve consumer safety
- To guarantee fair competition between companies
- To keep it up to date with other recently revised Directives
- To re-implement the old Directive as a Regulation, meaning it's now a binding legislative act and must be applied across the EU without the need for separate national legislation
- To improve the effectiveness of market surveillance
What Are The Main Changes?
- New responsibilities detailed for distributors and importers
- Compulsory issuing of a Declaration of Conformity with each PPE product, or a web link to where it can be obtained
- Mandatory maximum five-year validity period for EU Type Certificates, leading to continually reviewed and improved products. This may also help to reduce counterfeit or illegal products and remove outdated/inferior products from the market.
- Moving hearing protection from Category II (Intermediate) to Category III (Complex) PPE
- Moving life jackets from Category II (Intermediate) to Category III (Complex) PPE
- All items that can be used on or in conjunction with other manufacturers' equipment have to be certified to do so safely and effectively
- Bespoke PPE is covered in the new Regulation
What PPE Applies To The New Regulation?
- Equipment designed and manufactured to be worn or held by the user for protection against one or more risks to their health or safety
- Interchangeable components for equipment referred to in point 1, which are vital for its protective function
- Connexion systems for equipment referred to in point 1, that aren't held or worn by the user, that are designed to connect that equipment to an external device or to an anchorage point, that are not designed to be permanently fixed and that don't need fastening works before use
What PPE Doesn't Apply To The New Regulation?
- Equipment designed for use by armed forces or in the maintenance of law and order
- Equipment designed for self-defence, with the exception of PPE intended for sporting activities
- Equipment designed for private use to protect against atmospheric conditions that aren't an extreme of nature, damp, and water during dishwashing
- PPE use on seagoing vessels or aircraft
- Helmets and their visors for drivers and passengers of motorcycles and mopeds
- Any PPE for use at trade fairs, exhibitions or demonstrations, so long as a visible sign indicates the PPE doesn't comply to the new Regulation
What Do I Need To Do?
- Review existing product ranges to ensure they comply with the latest product specifications
- All products currently certified to old withdrawn standards will need to be tested to the latest current versions
- Be aware of products that are changing categories (life jackets, hearing protection) and what this change will mean (e.g. the need for an on-going surveillance system)
- If you are a distributor, you now have a duty to ensure any PPE you sell complies with the new Regulation
- 21st April 2018 - PPE Directive 89/686/EEC is repealed and superseded by the new PPE Regulation (EU) 2016/425. After this date, all PPE will have to be certified to the new Regulation
- 21st April 2019 - Member States won't impede on the making available on the market of products covered by the old PPE Directive before this date.
- 21st April 2023 - EC Type-Examination Certificates issued under the old PPE Directive are valid until this date unless they expire before this date.
Keep In Mind...
- Provisions on Notified Bodies will apply six months after the new PPE Regulations comes into force
- Manufacturers need to submit their application for certification at the earliest 12 months and at the latest 6 months prior to the expiry date of the certification. This is so Notified Bodies have enough time to fulfil their re-certification tasks
Will Brexit Affect Anything?
This is not yet known.
"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."
- Alan Murray, Chief Executive, British Safety Industry Federation
Who Can Help?
We highly recommend getting in contact with a Notified Body, such as BSI. They can assist you through the changes and keep you up to date on information released from the European Commission in relation to the new PPE Regulation.
Stay Ready and Aware
The new PPE Regulation will have a big impact on the industry, but we realise it's a lot to wrap your head around.
That's why we've created a completely free guide for you to download, so you can read about the changes in further detail when it's convenient for you.