Important changes are underway for Personal Protective Equipment (PPE). The repeal of Directive 89/686/EEC and adoption of Regulation (EU) 2016/425 on April 21, 2018, will have a major impact on the PPE industry in the European Union. In order to better understand the changes, we start with the history of PPE regulations.
To promote a single European market for goods, the European Union (EU) began what is referred to as the New Approach. The idea of the New Approach was that all products should be required to meet consistent basic health and safety requirements for PPE, both throughout the EU and among trade partners of the European Economic Area. The original PPE Directive was adopted by the European Council in 1989 and implemented into UK law as the Principal Regulations, effective January, 1993. This directive helped harmonise standards for PPE as well as removing barriers to trade. That was 25 years ago. It is worth noting that the PPE Directive is now a Regulation. This is a significant change. A Directive declares a goal for all EU countries to achieve by a certain date. A Regulation, however, is a binding legislative act, applied across the European Union without any separate national legislation.
Why make changes?
Changes in the requirements are intended to maximise consumer safety. Regulations needed to be adapted in order to incorporate new, rapidly developing technologies. The changes will also reflect new developments in production techniques and the ways PPE is brought to the market.
Industry leaders were concerned about the adequacy and consistency of coverage and conformity assessments.
Key changes in the new PPE Regulation
The new PPE Regulation (EU) 2016/425, imposes a number of new requirements on the manufacturers and suppliers of PPE in the EU. There are also changes in the requirements for the different categories of PPE. Category I is Simple PPE, intended to protect users from minimal risks, such as superficial injuries. Category II includes PPE products such as industrial helmets and high visibility clothing. Category III, or complex PPE, includes high risks leading to irreversible damage to the individual or even death, such as falls from a height, electric shock, or harmful biological agents. Under the new Regulation, some products change category. Hearing protection, for example moves from Category II to Category III.
In addition, the Regulation specifies new and clarified responsibilities of importers and distributors. This important change means that all companies or organisations involved with PPE will have the same responsibilities as the manufacturer. Entities involved in production, importation, supply, distribution, marketing and sales are affected. They will need to obtain product approval, ensure conformity to the Regulation, and keep technical files and records. Such changes will help to keep counterfeit products or those with sub-standard specifications out of the EU market.
Other changes include:
• Products intended for private use, such as oven gloves, are now PPE.
• A detailed assessment of the risks to be protected by PPE.
• A mandatory maximum five-year certificate validity.
• Instructions for use must include the internet address to allow the EU Declaration of Conformity to be accessed.
• The Regulation provides for changes in product marking, such as manufacturer name, registered trade name or registered trade mark, and postal address.
Preparing for the transition
Everyone in the PPE industry needs to prepare for the change in order to maintain compliance with the new Regulation. Here are the important dates:
• April 21, 2018 – New products on the market must conform to Regulation 2016/425
• April 21, 2019 – Existing products which are currently on the market must obtain proper certification for Regulation 2016/425
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