The European Commission has published a ‘guidance document’ to clarify the transition from the PPE Directory 89/686/EEC to the PPE Regulation 2016/425.
CE-marking of Personal Protective Equipment (PPE)
Protective clothing and gloves belong to the group of personal protective equipment, or PPE. PPE have to be placed on the European market according to the regulations laid down in the EU Regulation 2016/425 .
This Regulation determines the fundamental safety requirements with which products have to comply and the procedures that have to be completed before placing a PPE on the internal market.
In this way, EU Regulation 2016/425 facilitates the free movement of PPE in the internal market with due respect of the minimal requirements regarding the consumer's safety and security (the so-called fundamental requirements). The actual technical elaboration of the fundamental requirements is based on harmonized European standards, which confer an irrefutable presumption of conformity with the legislation.
As a visible indication of conformity with the fundamental requirements, the producer is obliged to affix the CE-mark on his equipment.
The EU Regulation 2016/425 appeals to notified bodies for a number of tasks. This is especially the case for the CE-type examination of PPE belonging to categories II and III and for the monitoring of PPE of category III. PPE of category don't require any formal intervention by a notified body, although it may act as consultant or laboratory.
If you want to place a PPE on the market as a manufacturer or as an importer, you have to prove that the PPE in question is in conformity with the fundamental requirements.
To this end, you always have to draw up a technical file including all elements producing this proof. You have to keep this technical file until 10 years after the production of the PPE has stopped and submit it on demand of the supervising authority.
PPE are divided into 3 categories according to the gravity of the risk against which they protect.
The category determines the procedure you have to complete before placing a PPE on the market.
- Category I - PPE protecting against minor risks: In this instance, it suffices to draw up a technical file. The manufacturer may then affix the CE-mark as a sign of conformity, without intervention of a third party.
- Category II - PPE protecting against moderate risks: As always, you have to draw up a technical file. In addition, a CE type examination has to be carried out by a notified body. The notification number of the notified body has to be mentioned in the information to the user. Only when the notified body has issued a type examination certificate, you are allowed to affix the CE-mark.
- Category III - PPE protecting against mortal injuries or irreversible harm: As always, you have to draw up a technical file, and a CE type examination has to be carried out by a notified body.
In addition, a notified body has to carry out an annual quality monitoring. You may choose between two possibilities: either, the notified body takes samples from your production, which are then submitted to tests, or the notified body audits your quality system.
Only when you are in possession of a CE type examination certificate and a positive report of the monitoring, you may affix the CE-mark. This mark has to mention the notification number of the notified body performing the monitoring.
Declaration of conformity
The EC type examination certificate holder also produces a 'declaration of conformity' – a document including details of the company, information on the product, a list of the European Directives and the standards the product complies with, and a legally-binding signature on behalf of the organisation. The certificate holder has the responsibility to ensure that all supplied products are consistent with the type-approved model and continue to meet all the essential requirements of the PPE EU Regulation 2016/425.