Are you Ready for the new EU PPE Regulation?

There’s a new regulation in the European Union for personal protective equipment (PPE). Learn about the latest requirements before they take effect on April 21, 2018.

Manufacturers, distributors, and importers of PPE will soon have to follow a new set of requirements under Regulation (EU) 2016/425. With a new definition for PPE, re-classification of products, additional responsibilities for economic operators (i.e. the entire PPE supply chain), and new testing & certification requirements – we break down everything you need to know to help you stay compliant.

WHAT’S CHANGED?

Since the regulation will replace a 20-year-old directive, there are a number of significant changes to PPE requirements that are intended to enhance consumer safety and ensure fair competition in the market. Moreover, the last twenty years have witnessed many technological breakthroughs and given way to new processes for bringing PPE products to market – triggering a need for updated requirements to align with other relevant standards around the world.

The biggest change is that the regulation is binding. The preceding directive laid out objectives that gave each EU member state flexibility in how they would plan to achieve those objectives. In this case, each member state will now be required to include this regulation in their own laws.

Under the new regulation, PPE is defined as:

1. Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;
2. Interchangeable components for equipment referred to in point (a) which are essential for its protective function; and
3. Connection systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and do not require fastening works before use.

In addition to the new definition, PPE products have been re-categorized based on risk level instead of by product type. There are three categories, with category I representing products for the lowest health & safety risks and category III representing products for the most serious risks. With this change, some products that fell under category II in the previous directive, such as hearing protection and life jackets, have moved to category III.

PPE products covered by categories II and III require certification by a notified body (NB). The certificates issued by the NBs are valid for a maximum of five years, upon which the manufacturer must re-apply for renewal. Category III manufacturers must also undertake ongoing assessments to check compliance.

The new regulation also introduces new requirements for economic operators, such as record retention rules. Manufacturers, importers, and distributors must hold copies of technical files, product type examination certificates, and declarations of conformity for at least 10 years. They must also provide user instructions with each product in the correct language and ensure that transport and storage do not harm the PPE’s efficacy or conformity. As an added safety measure, distributors and importers who place PPE on the market under their own name take on ALL of the obligations of the manufacturer.

THE TRANSITION PERIOD

To ensure a smooth transition to the new regulation, member states must not prevent any products from being made available if they are covered by, and conform to Directive 89/686/EEC, and are placed on the market before April 21, 2019.

EC Type Examination Certificates issued under Directive 89/686/EEC will remain valid until April 21, 2023, unless they expire before that date.

HOW A NOTIFIED BODY CAN HELP

The European Commission defines a notified body as an organization designated by an EU country to assess the conformity of certain products before they are placed on the market. NBs carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.

The European Commission publishes a list of notified bodies – a valuable resource for manufacturers planning to sell their products in Europe. CSA Group – a standards development organization and global provider of testing, inspection, and certification services – is listed as a notified body in the UK to test and certify PPE products for the European market.

LEARN MORE

With these requirements taking effect soon, it is important that all players in the PPE market – manufacturers, distributors, and importers – get up-to-speed on the new regulation and prepare for the impact on their business.

In addition to our in-depth knowledge of the latest PPE requirements, we can help you access over 140 country marks for fast market access.

Contact CSA Group today to find out how to get your PPE products to European markets.