New EU regulation for hearing protection
A new European regulation becomes fully applicable in April 2019 that applies to all manufacturers and distributors of hearing protection products.
In 2016 Harmful Noise was officially recognised as an irreversible health hazard, moving it from Personal Protective Equipment (PPE) category II to category III. This puts hearing protection in the same high-risk category as respirators and fall protection.
Hearing protection products – such as ear plugs and ear defenders – are currently subject to PPE Directive 89/686EEC and this will be replaced with the new PPE Regulation (EU) 2016/425 that becomes fully applicable in April 2019.
Manufacturers will be subject to more stringent, on-going quality control procedures – with an annual audit carried out by an approved body – and must apply new CE markings to all packaging and products, where feasible. Technical documentation or a web link must also be provided for each product.
These new CE certificates will be time limited to five years, with all products needing to be re-certified after this time.
The new regulation also gives greater clarity on the role of economic operators, including authorised representatives, importers, re-sellers and distributors. End-users will also need to ensure that all hearing protection products, to protect against both continuous and impulse noise, are correctly fitted and comply with the new regulation.
As distributors, we are obligated to act with due care in relation to the requirements set out in the regulation, verifying that all items of hearing protection bear the CE mark and include instructions in the relevant language.
In addition, we must ensure that storage and transportation conditions do not jeopardise conformity. If products do not confirm, we will need to ensure that these are withdrawn or recalled and inform the manufacturer and market surveillance authorities.
During the transition period, both hearing protection products meeting the old PPE Directive and the new PPE Regulation can be placed on the market, but from April 2019 only those meeting the requirements of the new regulation can be placed on the market. Products already on the market can continue to be sold until 2023.
To guide ourselves and end-users through the transition, 3M has been running a series of workshops for senior health and safety managers.
3M senior technical specialist, Saleem Mohammed, said: “3M has more than 50 years’ experience of developing innovative hearing protection products and we are already complying with the new regulation and going through the process of having our products re-certified to include the new CE marking.
“Our team of technical hearing and regulatory experts are on hand to help our distributors and end-users become fully compliant and we offer a full range of training services including product demonstrations, webinars and fit testing.”
For more information, visit the EU website.