New EU PPE legislation - Regulation EU 2016/425 – provides requirements for the design and manufacture of personal protective equipment in order to ensure the health and safety of users. This is creating a fundamental shift in the industry, as the rule changes define clearer responsibilities for every economic operator in the supply chain – from manufacturers, to importers, to distributors. There is a strong sense of urgency to comply with these enhanced EU regulation requirements, particularly when failure to do so might result in penalties and a “call for action” for less qualified players.
Ansell, is acknowledged as a global leader in protection solutions and an authority on the certification of regulated products, with considerable experience in navigating effectively through complex rules, regulations and standards around the world.
The PPE legislation implemented through Regulation EU 2016/425 will make it easier to remove dangerous PPE and improve traceability, while reinforcing control of the market and ultimately making it more efficient. The regulation came into force on 21 April 2018 and the industry is currently benefitting from a one year transition period before all products must comply and the old PPE directive is repealed.
Ansell’s decision to act early – the final deadline for recertifying products to the new Regulation is 21 April 2023 – is designed to reassure its customers that they will be well informed and well protected. Offering a safe pair of hands to the industry, Ansell is acting on the key driver behind the new regulation, improving trust within the PPE market.
Determined to be well ahead, Ansell is on track to certify all of its products before April 2019, and in addition all new products produced as of then will have the new labelling on all PPE and also will be marked with the latest state of the art standards by that date. With an established network of 23 different labs around the world – including seven that are ISO 17025 accredited – Ansell is well equipped to lead the transition to the new compliance requirements and to ensure continuous compliance.
The new regulations also stipulate that all economic operators need to act with due care. To help Ansell’s distributors, Ansell will supply mini technical files for all its PPE. Traceability is another crucial part of the new legislation, and Ansell provide an assurance that it will mark all its products with a six-digit and a ten-digit lot number, indicating the month and year of production.
"the PPE legislation implemented through Regulation EU 2016/425 will make it easier to remove dangerous PPE and improve traceability, while reinforcing control of the market and ultimately making it more efficient"
Risk management – the process for checking all PPE is correctly categorised and follows the right state of the art harmonized standards - is also a vital element of the new regulation, requiring proof that this has been undertaken by the manufacturer. Ansell already performs this process during its extensive new product development. Ansell also has initiatives in place to deal with any complaints, recalls and other post-market surveillance activities to ensure Ansell products on the market can be trusted.
Ansell is ahead of the game, but sees the process as much more than applying the latest rules to stay compliant, or indeed, doing so to just to help its partners and customers to be compliant, too. Ansell views this new legislation as a driver to improve the industry as a whole, making things safer for the people who use and rely on PPE. Ultimately, it reinforces Ansell’s core mission: to build a safer workplace for all.
Guido Van Duren, Ansell’s Director of Regulatory Affairs summarises the company’s strategy when he says: “Our customers can trust us to provide effective leadership, preparedness and ultimately, solutions that fit for the industry. Ansell’s considerable experience in lobbying and influencing new standards, regulations and legislation globally has consistently resulted in sustainable compliance and in facilitating long- term relationships which drive successful enterprises.”