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New CE Regulations

Hearing protection regulations in 2018

The world is rapidly changing, as are living standards. To be on top and the first in business, companies and entrepreneurs have to be up-to-date with the latest news in their industry. The year 2018 is a year when the new PPE Regulation (EU) 2016/425 should be applied. The prior Personal Protective Equipment regulation was more or less unchanged since 1989, and now a new regulation brings with it new standards for, among other elements of PPE, hearing protection.

What is hearing protection?

Hearing protection is a set of measures to protect the hearing from external influences and to reduce the risk of hearing loss. People should protect their hearing if the sound or the noise level at the workspace exceeds 85 dBA. There are special devices to measure the noise level, but there are also tips for workers to self-estimate if the hearing protection is needed.

The worker requires hearing protection if:

  • He has to raise his voice to speak to a person one meter away
  • The ears ‘ring’ after noise exposure
  • After leaving the noise area, the sounds are dull, flat or muffled

Figure 1 shows examples of sounds both in and out of the workplace to give a sense of perspective on the noise levels.

It is important to know that real protection from hearing loss is achieved only with the use of protective equipment for 100% of the time spent in a noisy environment.

Types of devices

There is no better hearing protection than simply removing noise from the equation. In certain situations, however, this is not possible. There is no single ‘best’ protector for all individuals and all situations; however, there is a rule: to be effective, it must fit properly. Besides this, the hearing protection device has to have sufficient noise reduction, and be comfortable and be compatible with other personal protective equipment.

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Hearing protection devices can be divided into the main four types: foam plugs, moulded plugs, canal caps and earmuffs. Each type has pros and cons, depends on the situation and individual the correct one should be chosen.

Foam plugs

Relatively comfortable protectors, blocking the most noise. The plugs should be compressed and put into the ear canal, where they expand to plug it. From a glance, the foam plugs usage is very simple: Roll – Pull – Hold. Nevertheless, the roll-step is correctly done by almost everyone, while pull and hold steps are done correctly by only half of users. The proper fit is when the body of the ear plug is within the canal, and not visible from the front view of a person. Remember, only the proper fit and correct usage makes the foam plugs effective. That’s why training on use and insertion is recommended.

Moulded plugs

Moulded plugs are protectors positioned as one-size-fits-most, but are still available in different sizes. Be aware that sometimes a different size of moulded plug may be needed for each ear. By trial and error of various sizes the person should choose the comfortable ones. The moulded plugs are washable, re-usable and suitable for dirty and dusty environments as there is no need to roll them, meaning no risk of introducing dirt to ear canal.

Canal caps

Canal caps are protectors based on foam or moulded plugs that are attached to a flexible plastic or metal band. Canal caps are is one of the most convenient type of protectors. When it’s quiet the worker can leave the band hanging around the neck. When the hazardous noise starts again they can be quickly inserted.

Earmuffs

Protectors that seal against the head and directly over outer ear. There is a variety of models and sizes, some of them even have electronic components to help users communicate or to block impulsive noises. One of the potential drawbacks of earmuffs is that workers wearing glasses wouldn’t get good protection, as the temples of the glasses break the seal. Also, for some people earmuffs can be uncomfortable in hot environments.

Besides these four types of hearing protectors, dual protection can be used. Dual protection is a combination of ear plugs and earmuffs and is recommended for exposures of eight hours above 100 -150 dBA. Dual protection can be applied for roof bolter, underground auxiliary fans, and continuous mining.

Manufacturers of hearing protection devices are always on the move and trying to develop new protectors that are hybrids of the traditional types. Still, the best hearing protector is the one that is comfortable and convenient to a certain individual.

The legislation

Personal Protective Equipment Regulation (EU) 2016/425

Health is one of the most important components of a blissful life. Happily, the new legislation is focused on improving the safety of Personal Protective Equipment (PPE) on the market to protect workers from harmful influences. PPE Regulation is a legislative act that must be applied in all EEA countries, which includes the 28 current members of the EU, as well as Iceland, Liechtenstein and Norway. The list of EU countries in 2018 is as follows:

Austria – Belgium – Bulgaria – Croatia – Cyprus – Czechia – Denmark – Estonia – Finland – France – Germany – Greece – Hungary – Ireland – Italy – Latvia – Lithuania – Luxembourg – Malta – Netherlands – Poland – Portugal – Romania – Slovakia – Slovenia – Spain – Sweden – United Kingdom

The new Personal Protective Equipment Regulation (EU) 2016/425 was issued in April 2016, and following a two-year transition period, it should be applied starting from the 21 April 2018. From now on the EU-Type Certificate (prior: EC-Type Certificate) should be issued to new PPER, but the Member States will allow marketing the products covered by the old PPE Directive 89/686/EEC until 21 April 2019. EC-Type Examination certificates issued under PPED 89/686/EEC, before 21 April 2019, remain valid until 21 April 2023, unless they expire before that date.

Check-list for manufacturers to prepare for changing legislation:

  • Ensuring that reclassified products meet the new classification
  • Identifying and addressing products that are tested to withdrawn standards
  • Working with the certification agent and/or Notified Body leading up to the (EU) 2016/425 PPE Regulation effective date

The key change that directly relates to hearing protection devices is that hearing protection is now categorised as harmful noise, meaning the risk level is moving from category II to III. With this it becomes complex PPE, which includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health. This means that hearing protection is now subject to the strictest conformity assessment procedures and requires EU-Type Examination (prior: ECType Examination). Besides this, the EU type-examination certificates gained five-years validity. However, the custom made PPE (which in most cases applies to earplugs as they are measured to fit the ear) fall under category III, but they still can use conformity assessment for category II products (Article 19, PPE Regulation 2016/425).

EU-Type examination

Notified Bodies play a big role in EU-Type Examination. A Notified Body is an independent organisation that has a right (by means of accreditation), given by an EU country, to carry out tasks related to conformity assessment procedures. The Notified Body is chosen by the manufacturer. The up-to-date list of bodies notified by EU countries can be found on the EU’s NANDO website. In EU-Type Examination a Notified Body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of the Regulation.

Each Notified Body has its identification number. The CE marking shall be followed by the identification number of the Notified Body involved in the procedure. The identification number of the Notified Body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

Obligations of economic operators

An economic operator can be defined as the manufacturer, the authorised representative, the importer, and the distributor of the product. Previously the PPE Directive focused on manufacturers placing products on the market, but the new Regulation will also hold importers, distributors, or anyone involved in the supply chain accountable. All parties involved in introducing PPE to the market are obliged to take appropriate measures to ensure that all products meet standard requirements and are in compliance with the new Regulation.

Manufacturer means any natural or legal person who designs or manufactures PPE, and markets it under his name or trademark. The obligations of the manufacturer are:

  • Provide an EU Declaration of Conformity or a link to where the complete document can be obtained
  • Implement internal production control to ensure compliance to the Regulation
  • Provide detailed technical documentation for the products
  • Take into account the planned and the reasonably predictable use of the PPE.
  • Include detailed, clear, understandable, intelligible, and legible instruction and information in a language which can be easily understood by consumers and other end-users.

An authorised representative means any natural or legal person established within the European Union who has received the written mandate from a manufacturer to act on his behalf in relation to specific tasks. The obligations of ensuring that the product was designed and manufactured in accordance with the applicable health and safety requirements, as well as the obligation to draw up the technical documentation cannot be a part of the authorised representative’s mandate. The mandate shall allow the authorised representative to do at least the following:

  • Keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the PPE has been placed on the market
  • Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPE
  • Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative’s mandate

The obligations of the importers and distributors are:

  • Before placing PPE on the market, must ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer
  • Making sure that the manufacturer has completed all the technical documentation
  • For 10 years after the PPE has been placed on the market, must keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request

However, there are cases when the importer/distributer is considered as manufacturer:

  • When importer/distributer places PPE on the market under his name or trademark
  • When importer/distributer modifies PPE already placed on the market in such a way that compliance with the Regulation 2016/425 may be affected

CE marking procedure

CE marking – is a marking by which the manufacturer ensures that the product (PPE) is in conformity with the applicable requirements. The CE marking should be affixed by manufacturer before the product placed on the market. The role of importer – to ensure that the PPE bears the CE marking, when the distributer should verify that the product bears the CE marking.

The CE marking cannot be affixed on hearing protection devices without conformity assessment procedure lead by the Notified Body, drawing up Technical Files (including User Instruction Manual), and drafting the EU Declaration of Conformity. Only when all those steps are completed the CE marking can be affixed and the product can be placed on the market.

The CE marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE.

Harmonised standards

Harmonised standard – is a document that sets out specifically agreed, consistent requirements for an item. Standards are voluntary which means that there is no automatic legal obligation to apply them. However, laws and regulations may refer to Standards and even make compliance with them compulsory.

Conclusion

The Personal Protective Equipment (PPE) Regulation 2016/425 is issued to ensure all PPE, including hearing protection devices, meets common standards of quality and performance. One of the main reasons to strict the regulation is the problem of hearing loss. In today’s workforce, approximately 30 million people are exposed to hazardous noise; thousands of workers suffer from preventable hearing loss. Of course it is related not only to hearing protection devices, but to high workplace levels. However, proper manufactured, tested and certified Hearing Protection Devices together with safety trainings are able to reduce the risks of hearing loss.

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