New Implemented Personal Protective Equipment Regulation (PPE Regulation) EU 2016/425 Implementation Dates On March 9, 2016 the Personal Protective Equipment (PPE) Regulation EU 2016/425 was approved and published in the Official Journal of the European Union. During a two year transition period this Regulation will replace the Personal Protective Equipment Directive 89/686/EEC. This Directive will be repealed with effect from April 21, 2018 and the newly implemented Personal Protective Equipment Regulation EU 2016/425 will enter into force on May 21, 2018.
The basic scope of the regulation, 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, remains the same, but contains the following inclusions:
- Interchangeable components which are essential for the protective function of the PPE.
- Connexion systems for PPE 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.
The Technical Documentation has been re-specified in the new Regulation, for the means used by the manufacturer to ensure the conformity of the PPE with the applicable essential health and safety requirements.
Technical Documentation must be compiled covering all relevant documentation, including a description of the PPE, the intended use, an assessment of the risks, a list of the essential health and safety requirements , the design specifications, levels of class of protection, materials used, the (harmonised) standards used, the design calculations, the test results, the proof of internal production control system, the manufacturer’s instructions, the relevant information for the user , a copy of the EU Declaration of Conformity and appropriate Certificates.
Evident differences between the repealed PPE Directive and newly implemented PPE Regulation is that clothing intended for private use with reflective or fluorescent elements included for reasons of design or decoration does not fall under the PPE Regulation and is, therefore, not covered by this Regulation.
For products intended for private use to protect against atmospheric conditions (heat or cold conditions) that are not of an extreme nature or to protect against damp and water, for example umbrellas and dishwashing gloves, fall outside the scope of this Regulation as well.
Products, such as oven gloves and similar products do fall within the scope of this Regulation.
Further, changes have been made with regard to the categories of the PPE in the Regulation. For example, products such as prevention products for drowning, damage caused by chainsaws, high pressure jets, and prevention of damage by bullets, knives and excessive noise are upgraded in more stringent categories. This means that they will require a constant surveillance.
The new Regulation contains clear legal requirements for importers, distributers and the supply chain. This means the economic operators have a clear obligation based on the Regulation.
Furthermore, in order to provide market surveillance authorities easy access to the EU Declaration of Conformity, the new Regulation states that the manufacturer should ensure that PPE is accompanied either by a copy of the EU Declaration of Conformity or by the internet address at which the EU Declaration of Conformity can be accessed.
The EU type Declaration (before named the EC Type Certificate) is now valid for a period of 5 years. Further, it is now the responsibility of the manufacturer to request the Notified Body to verify the EU type Declaration in case the product is modified, the intended use of the product was changed, there are changes to the (harmonised) standard(s) or the Declaration will expire.
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