In the PPE (Personal Protective Equipment, subject of Directive 89/686) sector, like in many other sectors, (harmonised) standards are an important element in the conformity assessment in Europe. Standards are developed to translate the essential health and safety requirements from the legislation into practical technical requirements used by manufacturers, notified bodies, market surveillance authorities, users and other stakeholders to check conformity of products.

As in other sectors, PPE (harmonised) standards are being revised constantly. In practice we see that with as good as with every revision additional requirements on products are introduced. Comparing the first versions of EN standards, most of them published in the early 90ies, with those of today show a clear increase in number and complexity of tests, leading to increased costs for testing and certification.

Standards should set requirements for the protection of the health and safety of the wearer of the PPE in real life conditions, translating those to testing in laboratory conditions. Test methods must be validated and robust, meaning that the same result must be obtained at any time in any laboratory following the test procedure. Only those requirements that contribute to the health and safety of the wearer of the PPE for the given risk should be a mandatory part of (harmonised) standards.

Inflation in testing and certification costs is, especially for SMEs, a high economic burden and may also be hindering development and innovation of products. For the EU PPE manufacturers in general, the high certification costs, compared to other parts of the world, make it difficult to compete outside the EU. The competitive position of the EU companies is at stake. The introduction of ISO standards is said to be a solution to this issue. However, while in Europe the ISO standards are introduced as EN harmonised standard, this is not always the case in important parts of the world where separate different national standards are kept. While in theory global standards are positive for the globalisation of the market, in practice in the PPE sector this is not so much the case, even on the contrary.

We also need to draw the attention to the market surveillance activities in the PPE field. Unfortunately these are fairly limited (varies between the Member States) for PPE. In practice we see regularly products on the market that are non-compliant with the legislation and/or applicable standards. Suppliers providing those products have a clear economic advantage over those that are fully compliant. By making standards more and more complex, this economic advantage is growing, while at the same time the efforts from market surveillance authorities are not growing (or even decreasing giving the budget cuts in all Member States).

In the CEN and CENELEC PPE standardisation groups, test laboratories and notified bodies are often well represented. Manufacturers are not always as well represented and users are as good as absent. This is reinforced in the ISO and IEC standardisation groups as expenses to participate are a lot higher, if only by travel expenses to attend meetings. The lack of balance in the groups means that standard development is not always viewed from what should be the core : the wearer of the product, his/her protection, his/her health and safety.

Based on the above, ESF proposes to develop a methodology covering the above mentioned concerns. This methodology should, on its own, be subject, as for a standard, to a consultation of and a final vote by the national members of CEN/CENELEC.
With this methodology, a check of the existing (and new work on) standards followed by a deleting of unnecessary testing and optional requirements can start.

We don’t want to jeopardise the health and safety of the users of our products, on the contrary.

Some examples (examples from a couple of types of PPE are needed, preferably one form each type of PPE : fall protection, footwear, gloves, clothing, head protection, respiratory protection, hearing protection, eye protection) :

Heat and flame protective clothing for industrial use :

• First version of standard : EN 531:1995, Amendment in 1998, replaced by EN ISO 11612:2008, replaced by EN ISO 11612:2015
  Evolution in the requirements :
  • From 1 test method for flame spread (after 5 cleaning cycles) to 2 test methods (only one needs to be applied) for flame spread (both on ‘as received’ and after maximum number of cleaning cycles instead of 5 + specific mentioning need to test on all hardware and accessories)
  • Test on heat resistance was introduced with EN ISO 11612:2008
  • Convective heat test : from on ‘as received’ to after pre-treatment
  • Radiant heat test : from on ‘as received’ to after pre-treatment
  • Molten aluminium test : from on ‘as received’ to after pre-treatment
  • Molten iron test : from on ‘as received’ to after pre-treatment
  • Contact heat test was introduced with EN ISO 11612:2008
  • Tests on mechanical properties were introduced with EN ISO 11612:2008
  • Design requirements have been clarified over the different versions
• The above changes make the testing about 3,5 times more expensive. The changes also lead to more complex technical files, user instructions, labelling etc.

Respiratory protective devices.

In this field, European standardisation had already started before the publication of the PPE Directive in 1989. Since about 10 years, ISO is developing standards for respiratory protective devices starting from a scientific concept driven by physiologic requirements. The purpose of ISO is to have their standards also adopted as EN ISO and thus as harmonised European Standards. Even if the intentions are good, the impact on the market (not only suppliers, but also users, authorities and any other stakeholder) can be revolutionary as the current approach for products and the selection of them is completely different. Not only several new test methods will be introduced, new marking and codification of the devices is being developed. The introduction of work rate might complicate the development of ‘multi-purpose systems’, for which there is certainly a demand from the market. At this stage it is not yet clear what the impact on cost for testing and certification will be exactly, nor what the impact will be for all stakeholders to train all involved in the new rationale. It is also not clear yet if and when other parts of the world will adopt the ISO standards.

The following steps will be taken :

• The result of the petition will be communicated to the relevant authorities (EU Commission, EU Parliament, national authorities) and stakeholders (CEN, CENELEC, ISO, IEC, Coordination of Notified Bodies, national standardisation bodies, ...).
• Meetings between ESF, authorities and CEN/CENELEC and stakeholders to discuss solutions in practice will be organised.
• Based on the above, a press conference will be planned at the occasion of the A+A exhibition (27-30/10/2015 in Düsseldorf, Germany).
• Based on the outcome of the discussions, concrete proposals will be prepared and defended