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Information On New PPE Regulation (2016/425)

CleanSpace Technology Pty Ltd holds respiratory protection approvals (EN12942) which previously fell under the PPE Directive (89/686/EEC). On 1 April 2019, this Directive changed to a Regulation (see explanation below). CleanSpace has completed the transition of our European registered approvals to the new Personal Protective Equipment (PPE) Regulation (EU) 2016/425.

The purpose of the new regulation is to bring PPE in line with the New Legislative Framework (NLF) under which many common Directives now fall. The NLF more directly outlines the responsibilities of Economic Operators and makes Risk Assessments an explicit legal requirement as well as introducing a common approach to the structure of the legislation. The new Regulation has been shaped to enhance consumer safety and ensure fair competition between companies. The changes also mean that the old Directive is being re-implemented as a Regulation rather than remaining in its current status. This means that the new Regulation will not have to be transposed into each Member State’s national law. (A Directive is a legislative act that sets out an objective that all EU countries must achieve by a given date. However, it is up to the individual countries to decide how this is done. In contrast a Regulation is a binding legislative act, and it must be applied in its entirety across the European Union without the need for separate national legislation.)

Please find the CleanSpace Certificates and Declaration of Conformity’s for our CE and UKCA Certification in the links below:

New PPE Regulation (EU) 2016/425 Old PPE Directive 89/686/EEC
CE Module B Certificate Article 10
CE Module B Certificate(CST ULTRA)
Article 10
CE Module B Certificate (CST PRO)
Article 10
UKCA Module B Certificate Article 10
CE Module D Certificate Article 11B
UKCA Module D Certificate Article 11B
CE Declaration of Conformity
Article 12
CE Declaration of Conformity(CST PRO & CST ULTRA)
Article 12
UKCA Declaration of Conformity
Article 12