New PPE regulations
For over 25 years the marketing of Personal Protective Equipment has been regulated by the Directive 89/686/ CEE. Over this period various significant legislative changes have been introduced within the EU, which have made it necessary for the Directive to be reviewed in order for it to be adapted to the improvements and new focus of the New Legislative Framework. This change introduces, amongst other elements the introduction of responsibility for all of the economic agents involved in the sales process, as well as taking into consideration all types of sales including distance sales.
This document has been drawn up in order for the economic agents to be able to identify the main changes introduced by the new Regulation (EU) 2016/425.
The objective and scope of application includes PPEs for private usage that provides protection against heat (for example oven gloves).
The regulation establishes the categorization of the PPEs based solely on the risk and the following types of risks have been added:
- Harmful biological agents (we must clarify what is understood as being a harmful biological agent).
- Risk of drowning.
- Risk of cuts by hand-held chainsaws.
- Risk of bullet wounds or knife stabs.
- Risk of exposure to harmful noise.
When designing and manufacturing the PPE, and when drafting the instructions, the manufacturer must envisage not only the intended use of the PPE, but also the reasonably foreseeable use.
In addition the manufacturer must take into account the technique level when designing and marketing a PPE, and these should be submitted by the manufacturer for internal production control.
These types of EU certificates will have a limited validity of 5 years and the certificate will be reviewed upon demand by the manufacturer when:
- The PPE is modified.
- There is a change in the technique used.
- Prior to the expiration of the certificate.
OBLIGATIONS OF THE ECONOMIC OPERATORS
The Regulation provides details regarding the responsibilities of each and every one of the economic agents involved in placing the PPEs on the market and selling them.
With regards to placing the product on the market, it is important to take into consideration that this action is to be carried out by the manufacturer and the importer, and this means the first making available of the product on the Union Market.
The regulation defines a manufacturer as any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark. With regards to the documentary requirements for the PPEs, the main changes involve the technical specification and the conformity assessment.
With regards to the traceability of the equipment, the main changes that affect the manufacturer are that the manufacturer will be identified with their name, brand and contact address and the manufacturer will identify the PPE with the type, batch or series number.
The importers’ responsibilities were not established in the Directive. The importer is any natural or legal person established within the Union who places a product third country on the Union market, and they should ensure that the manufacturer has carried out the appropriate conformity assessment, that the technical documentation has been drawn up, that the product bears the CE marking, and that it is accompanied by the declaration of conformity and the informative leaflet.
The distributor is the natural or legal person other than the agents that commercialise the product in the EU that must ensure that the PPE bears the CE mark and that it is accompanied by the necessary documentation.
- Authorised representatives:
Is the natural or legal person who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks for example torequest conformity assessments, to keep the EU declaration of conformity, and technical documentation and to cooperate with national authorities.
- Notified bodies:
The requirements include Independence, impartiality and an absence of conflict of interest; they must have the technical and human means necessary in order to carry out their activity and they should participate in standardization activities in coordination with the other notified bodies.