NEW EU REGULATION 2016/425 Changes At A Glance

Every single day, three DuPont brands – Tyvek®, Tychem® and ProShield® provide reliable protection for workers across the globe. In 2018, we’ve harmonised our product identification system and unified the packaging to enable easier identification of our products as well as facilitate garment selection. By this improvement we are not only making it easier to select the right garment for any application but also ensure compliance of our products with the latest EU regulation on Personal Protective Equipment. This white paper explains the DuPont response to the new Regulation (EU) 2016/425.
The new regulation has adopted the scope of the old directive with a few exceptions. The category definition remains unchanged. However, the categorisation of products is slightly modified. Category III has been extended by some specific protection needs such bullet wounds of knife stabs, high pressure jets but also broadened in scope as for example by “substances & mixtures which are hazardous to health”.

With the PPE regulation it becomes a requirement to supply the Declaration of Conformity with product or alternatively to provide a web address in the instructions for use where the document can be downloaded. It shall be translated into the language required by the member state in which PPE is placed on the market or made available. Declarations of conformity have the same validity as EU Type-examination certificates (5 years) and must be retained by manufacturer for 10 years after product introduction on the market.
EU Type-examination certificates validity will be limited to 5 years. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions, together with the technical documentation at the disposal of national authorities, for 10 years after the PPE has been placed on the market. It is the manufacturer’s responsibility for their PPE products to be certified to the latest version of the applicable harmonised standards.
With the introduction of the PPE Regulation the compliance responsibility will be extended to all economic operators in the value chain. The PPE regulation defines “Economic operator” as anyone involved in the supply and distribution of PPE products. It includes manufacturers, authorised representatives, importers and distributors (including online vendors). The regulation requires all economic operators to take full compliance responsibility that products are in conformity with harmonised standards claimed in the certification.

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