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PPE: New 2016/425 regulation

Posted in Normalization on 2019-05-14 by Dr Jean-Claude Cannot
In March 2016, the new 2016/425 regulation on Personal and Protective Equipment was voted by the European Parliament. This document repeals Council Directive 89/686/EEC.

NEW 2016/425 REGULATION : WHY IS THERE A NEW DOCUMENT FOR PPE?


Almost thirty years after its publication, it was necessary to review this legislation on Personal and Protective Equipment (PPE) for mainly organisational and political reasons:

  • The European Community (EC) became the European Union (EU);
  • New rules were established in order to harmonise the different European laws and facilitate their use;
  • The collaboration of member States with regard to control of the market has progressed;
  • The market requires more and more information about products.

Furthermore, the experience gained over these thirty years had enabled organisational and technical improvements to be highlighted that it was important to implement.

The PPE Directive is now unanimously recognised as one of the successes of the new European approach launched in 1992. This text has enabled an improvement in the protection of individuals in their workplace, and the standardisation of this pro-tection across all member States, thus allowing very significant progress to be made in numerous countries. A single market was created and the free circulation of PPE throughout Europe enabled companies in the sector to develop. Many products offering mediocre protection were able to be removed with the obligation to comply with essential health and safety requirements. It is for these varied reasons that the new regulation should not call into question the general philosophy of the directive, and in particular the heart of the text, appendix 2: the essential health and safety requirements are almost identical in both texts. Furthermore, the PPE classification certification rules have not changed (see 1).

 

PPE 2016/425 REGULATION : THE BIG CHANGES

 

  • Use of the highest level European legislative text, i.e. the regulation, in order to ensure that application is thorough and identical throughout all member States.
  • Use of new European certification tools, modules (see 2).
  • Clarification of the situation regarding certain PPE (kitchen gloves are category II PPE, whereas PPE to prevent against chainsaw cuts is category III. etc.).
  • Clear definition of economic operators (see insert).
  • Clarification on the use of harmonised standards.
  • New rules for appointing regulatory bodies (certification activity accreditation requirement).
  • Harmonisation of market control by the member States.
  • Definition of a five-year period of validity maximum for EU-type certificates.
  • Unification of the declarations of conformity and traceability of PPE on the market.

 

PPE CERTIFICATION RULES & TEXT CORRESPONDENCE

 

CONTACT US

 

CHANGES FROM A PRACTICAL POINT OF VIEW

 

From a point of view of the certification of protective gloves, footwear, and clothing, the main changes to be taken into account between directive 89/686 and regulation 2016/425 for manufacturers are:

 

  • Inclusion of the manufacturer’s address on the product’s marking;
  • The possibility of making EU declarations of conformity available on a website. The link must be clearly indicated in the instructions and each EU declaration of conformity must cover a specific product batch;
  • Inclusion of a batch/series number on the product (related to the EU declaration of conformity);
  • For PPE subjected to pre-ageing: inclusion of the month and year of manufacture and/or the month and year of expiry;
  • Performance of a risk analysis by the manufacturer, proof to be provided upon application for certification;
  • A five-year validity period for EU-type examination certificates;
  • The change of protective equipment to prevent against chainsaw cuts to category III;
  • That an importer or distributor who places PPE on the market under their own name or brand be considered a manufacturer.

In addition to these changes, it is clearly necessary to review product instructions (reference to the regulation, possible expiry date, website for the EU declaration of conformity, etc.).

 

THE NEW CERTIFICATION

 

For new products, the requirements of regulation 2016/425 on the certification of PPE are applicable to products placed on the market after 21 April 2018. Certificates based on the directive may also be issued until 20 April 2019 (not recommended!). After this date, only the regulation will be applicable. For products certified under the directive and already on the market, it will be necessary to transfer their certification under the regulation. Tens of thousands of items of PPE are concerned, therefore the workload for manufacturers and regulatory bodies is considerable. In order to limit the scope of the re-certification work, the Commission has envisaged two scenarios.
 

 

The simplified directive/regulation transition procedure

 

Certain products certified under the directive may benefit from a simplified certification procedure under the regulation. This is the case of products for which:

 

  • There are no changes from a conception, design, and manufacture point of view;
  • There are no changes to the harmonized standards applicable;
  • There are no changes to essential health and safety requirements (change of category, for example);
  • The initial technical file and test reports are recent;
  • There are no changes to the regulatory body.

In this event, the manufacturer files their transfer requests with the regulatory body, which will convert their EC certificate without carrying out any new tests.

 

The procedure enabling the directive certificate to be extended

 

In accordance with the document issued by the European Commission in December 2017, some products certified under the directive may continue to be marketed until 20 April 2023 with their initial certificate if:

 

  • There are no changes from a conception, design, and manufacture point of view;
  • There are no changes to the harmonized standards applicable;
  • There are no changes to essential health and safety requirements (change of category, for example);
  • The manufacturer implements all six adaptations imposed by the new regulation:
  • The manufacturer’s postal address must be present on the PPE;
  • Traceability between the PPE and the declaration of conformity must be guaranteed (for example, by a batch number or manufacture date);
  • The new declaration of conformity model must be used;
  • The declaration of conformity must be easily accessible to all (Internet or paper);
  • The instructions must comply with the requirements of the regulation;
  • If the PPE is likely to degrade over time, an expiry date must be provided.

 

In the event of testing at the request of the authorities, the manufacturer must demonstrate that it complies with these points. Figure 3 enables all cases to be summarised. 
The manufacturer must, therefore, issue EU declarations of conformity under regulation 2016/425/EU based on an EC certificate under directive 89/686/EC.

 

 NEW SUMMARY OF ALL REGULATION CASES

“Own-brand” certificates

 

For “own-brand” certificates, we used to issue extensions to the directive in minor variants. Under regulation 2016/425, it is the original manufacturer who will introduce the certification request for the secondary manufacturer, from their technical documentation and subject to an agreement between the two parties. CTC will then issue certificates on behalf of the secondary manufacturer. The initial technical documentation will be sent to the regulatory body with the changes related to the secondary manufacturer: example of marking and instructions. The elements will be retained by the regulatory body, which may send them to the competent authorities upon specific request.

 

 

NEW 2016/425/EU REGULATION / IN CONCLUSION

 

The current situation is critical. Numerous manufacturers have waited for the new regulation in order to launch new products, and requests to transfer from the directive to the regulation are very high in number. Consequently, all regulatory bodies have extremely busy certification schedules, and the jurisprudence has not yet been established. The European Commission is still developing its position. We would also note that the interpretations from one member State to another may sometimes differ.

 

CTC was one of the first PPE regulatory bodies for the directive, and it has awarded more than 30,000 certificates in accordance with this framework. This experience is well known and, since 30 November 2017, CTC has also been notified under regulation 2016/425 for module B (EU-type examination) and module C2 (conformity with type based on the internal control of manufacturing and supervised controls of the product at random intervals). Our Certification division is fully mobilised to provide its services and support to PPE manufacturers of protective gloves, footwear, and clothing.

 

CONTACT US

 

ECONOMIC OPERATORS


MANUFACTURER


Any natural or legal person who manufactures PPE, or who has PPE designed or manufactured, and who markets it under their own name or brand.


REPRESENTATIVE


Any natural or legal person established in the European Union who has received a written mandate from the manufacturer to act on their behalf in order to carry out specific tasks.


IMPORTER


Any natural or legal person established in the European Union who places PPE from a third country on the Union market.


DISTRIBUTOR


Any natural or legal person involved in the supply chain, other than the manufacturer or importer, who makes PPE available on the market.


An importer or distributor is considered to be a manufacturer when:

  • They places PPE on the market under their own name or trademark;
  • They change PPE already on the market and this change affects compliance with the regulation.

 

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