What does EU Regulation 2016/425 mean for importers of PPE?

The ins and outs of European rules for importing personal protective equipment (PPE)

EU regulations and conformity assessment in sourcing

If you are involved in sourcing in China or other Asian countries and want to import personal protective equipment (PPE), you will inevitably come across EU Regulation 2016/425. This regulation ensures a standardization of safety standards for PPE products within the European Union. But what exactly does this regulation entail, and how do you, as an importer, go through the conformity assessment?

a close up of a working glove (PPE) holding equipment

Why is EU Regulation 2016/425 so important?

This regulation is essential because it protects both consumers and workers. It ensures that all PPE products sold in the EU meet strict safety standards. This goes hand in hand with quality control and traceability, so that both manufacturers and importers can be held accountable.

The requirements of EU Regulation 2016/425 in detail​

  1. Conformity assessment: This step is crucial. It is a thorough process of checking whether a product meets the relevant EU standards. This includes not only testing, but also inspections and certification.
  2. CE marking: Once a product has passed the conformity assessment, it must be provided with the CE marking. This marking is confirmation that the product meets all stated requirements.
  3. User information: A good manual with extensive information about correct use, storage and possible risks is not only a requirement but also an ethical responsibility.
  4. Traceability: Every product must be able to trace its origin back to the original manufacturer. This is important for both quality control and liability questions.

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The indispensable role of the sourcing agent

A sourcing agent is often an extension of your company on location. Particularly if you are sourcing in China or other Asian markets, a sourcing agent can help you select reliable suppliers and ensure quality controls.

 Do you need help importing PPE from China or Asia?

At Westwood we offer expert support and guidance when sourcing PPE from Asia. Contact us to find out how we can help you import high-quality protective equipment from China and other countries in Asia. 

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