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Eurofins | News Flash - December 2017 | Personal Protective Equipment

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Monday, December 11, 2017

Europe

Corrigendum of Personal Protective Equipment Directive (PPE)

On 26th October, the European Commission published Corrigendum to the Commission communication in the framework of the implementation of Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE) – Official Journal of the European Union 2017/C 362/06.

Click here for further information about PPE Directive.

Personal Protective Equipment (PPE) - Regulation (EU) 2016/425

Entry into Force and Obligatoriness

The new Regulation (EU) 2016/425 on Personal Protective Equipment (PPE), came into force on 20 April 2016 and shall apply compulsorily as from 21 April 2018, the date of repeal of current Directive 89/686/EEC.


Transitional provisions

EC certificates issued under Directive 89/686/EEC (with the declaration of conformity prior to 21 April 2018) shall remain valid until 21 April 2023 unless they expire before that date.

Products covered by Directive 89/686/EEC which are in conformity with that Directive (with the declaration of conformity prior to 21 April 2018) may be placed on the market until 20 April 2019.

Field of application

The new Regulation (EU) 2016/425 on Personal Protective Equipment (PPE), came into force on 20 April 2016 and shall apply compulsorily as from 21 April 2018, the date of repeal of current Directive 89/686/EEC.

  1. “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
  2. interchangeable components for equipment referred to in point (a) which are essential for its protective function;

connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use”. 


Main News

  • Shift of category (from II to III)

In the list of PPE referred to Annex I is expected a shift from category 2 to category 3 (including hearing     protectors). In this case the manufacturer, in addiction to do the EU type-examination through engagement of a Notified Body, has to carry out a production control procedure, verified initially and regularly by a Notified Body.

  • Risk Categories

Definitions of individual categories, based on kinds of risk that the PPE has to protect, are reviewed and better defined. Category III is extended to further risks.

  • Liability

       Manufacturer’s, dealer’s, importer’s liabilities are extended and better defined.

  • Safety and health essential requirements

Beyond some marginal modifications, requirements about protection against vibrations, noise and non-ionising radiations have been reviewed.

  • PPE custom-made

With regard to PPE produced as individual units to fit to single user and classified in accordance with category III, it is possible to follow the procedure for products of category II: type exam + Internal production control.

  • Traceability

       It is introduced for manufacturers the requirement of traceability of PPE throughout the supply chain.

  • Declaration of conformity, EU Type-Examination and validity of certificates

The minimum content of the EU Declaration of Conformity is set out in Annex IX and “state that the fulfilment of the applicable essential health and safety requirements set out in Annex II”. With the declaration the manufacturer “shall assume responsibility for the compliance of the PPE” with the requirements laid down in this Regulation.

Content of EU Type-Examination issued by Notified Bodies and checking criteria of Type-Examination in case of changes made by manufacturers have been defined / revised.

It has been finally defined that the validity of EU Type Examinations, necessary for EU declaration of conformity, is 5 years.

  • Penalties

       As provided for in the article 45, Member States will issue specific proportionate penalties.

 

Conformity Procedures

 

Please find below the diagram about conformity procedures, as laid down in new Regulation.