Changes related to Regulation (EU) 2016/425 on Personal Protective Equipment


    Since the new approach Directives, when the European Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (PPE) was published, only the harmonized standards have been renewed, but not the root document for the CE certification of PPEs.

    After years of work of experts from all the European countries in this field, the Regulation (EU) 2016/425 was published in the Official Journal on 31st March 2016.

    The aim of this post is to give a general vision of this new Regulation (EU) 2016/425 regarding the European Directive, but not to go into depth on it.

    When will the new Regulation be applicable?

    Although the new Regulation was published on 31st March 2016, there will be a long transitional period until the complete repeal of the Directive. The application will gradually start to affect the Notified Bodies and in 2018 we will be able to issue new certificates according to Regulation (EU) 2016/425.

    figure 1

    What are the concept changes?

    We find three main changes of concept in the Regulation.

    The first change in the terms of the Regulation is that the CE Type Certificate becomes EU Type Certificate. This is just a formal change, since the marking remains the same, but this change of language will help users to understand that the CE mark is a real mark, with all the implications, and not a “made in Europe” or other concepts not very clear for common users.

    The second change in this general concept is the renewal of the certificates. Until now, there was only a Recommendation for Use of the Horizontal Committee inviting the Notified Bodies to include an expiration date on the certificates. The reality is that most of the Notified Bodies have not applied this recommendation for use and the applicant was requesting the renewal of the certificate in case of change of the standard, and not always.

    Now, the certificates will be issued with an expiration date of maximum 5 years. The applicant can ask for the renewal between 1 year and 6 months before the expiration date of the certificate. For those cases of certificates issued by Applus+ IDIADA; we will contact you to remind you of the expiration date and the need of doing this renewal.

    Personal Protective Equipment

    If there is no change in the state of the art or the PPE and if we verify that there is no change in the harmonized standard, we will proceed with a simplified, quicker and cheaper, renewal of the certificate.

    The last concept change is on the Essential Health and Safety Requirements (EHSR), where in point 1.3.4, we find the protective clothing with removable protectors must be assessed as a combination during the conformity assessment procedures.


    The new Regulation will introduce a higher control of all PPEs, from a simple glove to the most complicated firefighter suit. The technical documentation presented by the manufacturer will be more detailed and the Notified Bodies will have more resources to control the PPE and its changes.

    The manufacturer will be obliged to renew the EU certificate at the Notified Body every 5 years. The obligation of certificating variants or actualizing in case of change on the harmonized standard is still on force, so the EU certificates will mean a high control of the market by means of these revisions.


    By Laura Alcober





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