Stricter regulations here and now

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On 21 April 2018 the PPE Regulation (EU) 2016/425 of the European Parliament and of the Council will replace the old PPE Directive 89/686 EEC and all the transition requirements relating to the new regulation come into force.

Bryan Lawrie, director at Arco, took a moment to tell Safety Management what the change means for British employers.

Iris Cepero (IC): Who is affected by these

Bryan Lawrie (BL) Anyone who is involved in specifying, sourcing or purchasing PPE. They need to ensure that their PPE suppliers are able to meet the new regulation obligations, which are stricter than the old PPE Directive. If they don’t, users could be facing issues with continuity of supply. This could leave their workers exposed in hazardous situations or productivity could be impacted if production must stop due to issues with the supply of the correct PPE.

IC: What are the main changes

BL The rules of the new PPE Regulation now apply to the whole supply chain rather than just manufacturers. Now, everyone involved in the manufacture, supply and distribution of PPE, which the new Regulation refers to as ‘Economic Operators’ must ensure that their PPE meets with the standard requirements.

The PPE regulation clearly defines that an importer or distributor who markets a product in Europe under their own name, brand or trademark becomes liable for the full manufacturers obligations.

Therefore, the responsibility of proving product compliance falls to the manufacturer, importer, or quasi manufacturer of own brand products. However they may not have the resources in place to ensure the regular testing this will involve.

Another important change to be aware of is the reclassification of some risks from Category 2 (Intermediate) to Category 3 (Complex). This means that these risks are now subject to the strictest conformity assessment procedure and ongoing surveillance. For example, all types of hearing protection against harmful noise have been reclassified to Category 3 (Complex).

Purchasers of PPE should make sure they are working with a trusted supplier. Photograph: iStock

IC: What this means for companies

BL Identifying true product compliance is difficult for the purchaser and for the end user.

It is important that those purchasing PPE understand how the transition requirements will affect product certification. In general, products can be placed on the market until 21 April 2023 using a current EC type Examinations certificate as long as the product meets the requirements of the new regulation. However, this is not the case if the expiry date of the certificate is earlier than that. There are also three other exceptions to this, which they should familiarise themselves with. They must also be clear on the responsibilities of their suppliers.

IC: What is the advice to health and safety or procurement managers

BL We would advise purchasers of PPE to make sure that they are working with a trusted supplier and ask their suppliers to do three things:

  • Provide a declaration of conformity that shows original certification for the PPE you are purchasing
  • Define their process for ongoing sample testing to ensure safety products continue to meet the required standards
  • Define their process of quality assurance at the manufacturing facility to ensure the products are being manufactured as they were originally certified.

IC: What is the importance of these changes

BL These changes are important as they focus on raising standards of PPE and are major opportunities to raise standards of protection, drive product innovation and eliminate inferior products from the market.

However, even once the new regulation becomes effective, with the UK’s competent authorities for market surveillance of PPE under increasing pressure due to reduced budgets, the regulation needs proactive support from the industry to ensure its full impact is felt.

IC: Anything else considered relevant

BL Arco has been highlighting for some time now procedural weaknesses within the EC type approval and CE marking process that is of serious concern to us, and which are resulting in the sale of substandard products accompanied by legitimate CE Certificates.

We advise those purchasing PPE to not only rely on CE certification for certain product types, but to check the product assurance processes of their suppliers also. We are hopeful that the new emphasis on supply chain accountability will go some way towards addressing these serious issues.

New PPE regulation available here


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