Standards and certifications

PPE regulation

All companies in the PPE industry, including both manufacturers and distributors, are required to comply with the 2016/425 Personal Protective Equipment (PPE) regulation.

Classification of categories Obligations and responsibilities

In 2016, some changes were made to the PPE Regulation compared to the older regulations.

The main changes were:

PPE protecting against mortal danger including chainsaw trousers, jackets, gloves and boots changed from category II to category III.
For each product, an EU Declaration of Conformity should be supplied.
The validity of new EU certificates is limited to five years.
The manufacturer’s address should be on the label.

Classification of categories

The following table shows the 2016 classification of categories.

PPE category	Description	Example
Category I	PPE « of simple design » (protection against superficial mechanical injury or atmospheric conditions that are not exceptional)	Sleeves ; Waterproof jacket
Category II	« intermediate » PPE – neither simple nor complex design (includes risks other than those listed in categories I and III)	Shock-absorbing helmet ; EN 388 – mechanical resistance of gloves
Category III	« complex » PPE (PPE protecting against mortal danger or dangers that may seriously and irreversibly harm the health of the user)	Chainsaw protective trousers ; Chainsaw protective jacket ; Chainsaw protective gloves and boots; EN ISO 11393

Why was this PPE Regulation (EU) 2016/425 introduced?

The introduction of this PPE regulation helps to assure that the products always respect the requirements of the standard, and that they have been tested more than once at the initial submission for CE approval.

Obligations and responsibilities

How does this affect the obligations and responsibilities of all parties concerned ?

The manufacturer

Obligations of certification: In the 2016/425 regulation, PPE protecting against mortal danger is category III PPE. The major evolution is in certification.

Cat.II PPE has to be certified by a Notified Body for EU Type Examination.
Cat.III PPE has the same obligation as cat.II PPE, but must also organise quality assurance procedures. This can be on the product (Module C2) or on the production (Module D).
We have chosen the Module D procedure.

Documentary and administrative obligations

Access to the EU Declaration of Conformity:
For all PPE, the EU Declaration of Conformity must be accessible. We have created a portal , where everyone has access to our products’ Declarations of Conformity. The link is also mentioned on the User Manual and on the label in each garment.
Set-up traceability of the PPE:
The manufacturer must guarantee traceability of every product. The combination of our style number and production number allows us to trace back every separate style to the production.
Follow-up of quality:
The Regulation imposes the manufacturer to have a follow-up system for the quality of the productions. Our follow-up system already allows us to trace back

the date of production
the production plant
the production line
the production batch number of the raw materials used (fabrics, blocking material, …). It is linked to our delivery systems and our quality control systems.

The quality control plan has been transmitted to a Notified Body, according to the transmission of EU certificates from category II to category III. This quality control plan will be audited every year. (Module D).

The distributor

The transition from category II to category III does not impose extra obligations for the distributor.

As long as the product is conform the legislation at the moment of purchase, there is no major reason to forbid the availability of the product. The distributor has, however, the obligation to verify if the PPE has the CE marking (EU), if the PPE is accompanied by user instructions and information in a correct linguistic version that is understandable for the users.

The importer

The obligations for the importers are very similar to the obligations of the manufacturers, but they must also add their company name and address on the PPE, and assure that the appropriate procedures for evaluation of the conformity have been realised by the manufacturer.

The economic operators

The economic operators (manufacturer - importer - distributor) have the obligation to have a traceability system and to keep the information during 10 years from the date that they have supplied the PPE to another or that they have been supplied the PPE.

From each operator that has supplied them a PPE
From each operator whom they have supplied a PPE with

The employer

For the employer, the transition from category II to category III, and from the Directive to the Regulation, does not impose extra obligations.

His obligation is to assure the supply of PPE adapted to the risk, and the risk analysis, to his employees.

The employee

For the employee, the transition from category II to category III, and from the Directive to the Regulation, does not impose extra obligations. He must wear the PPE supplied by his employer, and he must take care of the state of the PPE, and inform himself via the user manual and the caring instructions, supplied with each PPE.