Mirey Bonfil / 3M – Advanced Application Engineer
The Personal Protective Equipment Directive 89/868/EEC, which has been in force since most of us entered to the occupational health & safety sector, was replaced by the Personal Protective Equipment Regulation 2016/425 on April 21, 2018. Why would such a change be needed and what kind of reflections will have on our lives?
Firstly, it is necessary to understand the difference between directive and regulation. A regulation is related to actions which are directly put into practice for all the affiliate member states when it is published and are applicable to all the member states. The directive should be implemented by the member state. It identifies specific objectives, requirements and concrete outcomes that must be reached for each member state. It determines a process for implementation by the member states. In order to fulfill these objectives, the national authorities shall establish or adapt their legislation until the date specified in each directive.
The Regulation on Personal Protective Equipment in Turkish legislation was updated considering the European Parliament and Council Regulation 2016/425 on the official newsletter dated May 1, 2019, and it was declared that the Personal Protective Equipment Regulation (89/686/EEC) published on the Official Newsletter dated 29/11/2006 and numbered 26361 was abolished.
Why was this process necessary? The PPE Directive 89/686/ EEC was adopted on December 21, 1989, that is exactly 30 years ago, and became fully effective in July 1995. In this case, it was decided to make such a change in order to improve market surveillance, increase the consistency of quality and product conformity assessments and so improve the security of both products and users, adapt to the developing technology/ era and harmonize with existing business practices.
What are the major differences in this change?
- Instead of product-associated classification, the risk-associated classification change was made.
- Classification change for specific product categories: For example, hearing protection classified as “harmful noise” (risk) has been switched from Category II to Category III.
- It has become mandatory to submit an EC Declaration of Conformity (or a link to be obtained) with each PPE.
- For 10 years after the introduction of the PPE, it keeps a copy of the EU declaration of conformity and technical documents available upon the request of the market surveillance authorities.
- 5-year validity/expiry date restriction has been introduced for new certificates.
- Additional requirements for Distributors/Importers have been set.
- It has been required to have a postal address on the product or packaging or document supplied with the PPE.
As it can be understood here, one of the major changes is the change of the category of hearing protection equipment. With this change, although there are two elements that will change legally, the most important issue is how to choose appropriate hearing protection equipment. To put these two issues frankly, with the transition from Category II to Category III, 1- The requirement of annual production plant audits has been introduced; 2- The requirement of insertion of the Notified Body number to the CE marking on the product (CEXXXX) has emerged.
In case of daily use, we recommend viewing the standard EN 458:2016 “Recommendation-Guideline for Selection, Use, Protection and Care of Hearing Protectors”, which was published in its updated version in March 2016. This standard a standard which has also been adopted by Turkey and as TS EN 458 guiding in several different fields from how to calculate the appropriate and sufficient damping values, importance of compatibility with other PPE to correct wearing of hearing protectors. With this standard, it is also emphasized that the hearing protectors should be fit, that is, the suitability to your ear structure and/or ear canal or the correct fitting/wearing is also important. Therefore, we also encounter with the importance of fit testing, which is mandatorily conducted for all employees working in noisy environment as per the regulations in United Kingdom and United States, must be carried with selected hearing protection equipment for the employees before they enter into a noisy environment and they must start working with appropriate and adequate hearing protectors and they must keep the report of test outcome until the next fit testing.
With the new regulation, the safety of the users and the products has increased and the revision of the standards such as EN 458 has become more important by using the technology and choosing the right product in the right place.