The purpose of the new regulation is as follows: "This Regulation lays down requirements for the design and manufacture of PPE intended for placing on the market with a view to ensuring the protection of the health and safety of users as well as to establish rules relating to the free circulation of PPE ".
The new regulation defines PPE as:
- equipment designed and manufactured to be worn or held by a person to protect against one or more health or safety risks.
- An interchangeable component for equipment referred to above and which is essential to the protection function of said equipment.
The introduction of a new regulation has several objectives. The main objective is to adapt the old (89/686) directive, which has become obsolete.This one dated in fact from 1989.
1 / Breaking away the differences in the application of the current Directive
Experience in previous legislation has highlighted some inconsistencies.Member states now have no room for transposition into national law.
2 / A clearer presentation of the categories of PPE
- Category 1: minor risks. These are gloves that provide protection for low levels of risk (eg gardening gloves) Manufacturers can self-certify these PPE.
- Category 2: Intermediate risks. This is PPE that does not fall into category 1 or category 3.
- Category 3: irreversible or fatal risks. These PPE must be tested and certified by an approved organization. The quality system of the company is audited by an independent body. All PPE manufactured by PIERCAN belong to this category the most restrictive.
3 / Clarify the responsibility of the market players.
Economic operators in the supply chain now have traceability obligations and an active role to play in ensuring that only compliant products circulate.
• THE MANUFACTURER
Any natural or legal person who manufactures PPE, or has it designed or manufactured under his own name or trademark. He is responsible for the design, manufacture and completion of the product conformity assessment.Its responsibilities remain the same regardless of whether it is established in the EU or outside the EU. He ensures the traceability of the PPE. It draws up and makes available the EU declaration of conformity with the product on paper or on a website. It retains this document for 10 years from the time of marketing.
Any natural or legal person established in the European Union who puts PPE from a third country on the Union market. Established within the EU, he puts PPE from a third country on the Union market. It ensures that the manufacturer has complied with its product conformity assessment obligations. He ensures the traceability of the PPE, indicates his name and his address on the product or on the packaging or on the accompanying documents and carries out tests on the PPE already put on the market.
Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes PPE available on the market. It ensures that the manufacturer has complied with its obligations to assess the conformity of the product in accordance with the regulations in force at the time of placing the product on the market. It ensures the traceability of the PPE and ensures that the product carries the required markings. If the product is distributed over the distributor's brand, it must perform the product conformity assessment. He becomes a manufacturer of PPE and must therefore assume the obligations incumbent on him.
2 key dates in the application of the new regulation:
• 21 April 2018
Repeal of Directive 89/686 EC. Implementation of the regulation 2016/425.During a transitional period of one year, 2 types of PPE will coexist:
- PPE compliant with Directive 89/686 EC
- PPE compliant with the 2016/425 regulation
• April 21, 2019
All PPE manufacturers must comply with the 2016/425 By-law. EPI distributors placed on the market before 21 April 2019 may continue to be made available on the market until the end of their validity or until 21 April 2023.
• EU TYPE EXAMINATION CERTIFICATE
This document replaces the EC Type Examination Certificate. This is a document issued by a European Notified Body on the basis of an analysis of the technical documentation provided by the manufacturer, a prototype of the PPE, the carrying out of necessary tests and examinations. This document is valid for a maximum of 5 years.
• THE EU DECLARATION OF CONFORMITY
This document replaces the EC declaration of conformity. It is now supplied with each PPE: either when the product is placed on the market or accessible on a website.