As of 21 April 2019, the new P.P.E. (Personal Protective Equipement) Regulation was fully implemented. The previous one was more than 20 years old and needed to be adapted to the current technologies, production processes and working conditions.
It is a legal requirement for any company in the PPE industry- including both manufacturers and distributors - to comply with this regulation.
The most important changes from 21st April 2019
- The categorisation of certain categories or products has changed:« Protective Clothing for Users of Hand-held Chainsaws » changes from category II to category III (see overview below).
- The declaration of conformity EU should be supplied for each product (or internet link)
- The validity/expiration of new EU certificates is limited to 5 years.
- The manufacturer’s address should be on the label.
Classification of categories
|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|
The new PPE Regulation (EU) 2016/425 has entered into force on 21t April 2018.
Since 20 April 2019, manufacturers can no longer supply (place on the market) according to the old PPE Directive 89/686/CEE.
Advantages of the new PPE Regulation (EU) 2016/425
The new legislation stimulates the increase of the safety level of the available PPE, in order to guarantee that all PPE that is commercialised on the European market is in conformity with the PPE Regulation (EU) 2016/425, and by consequence, with the relevant standards in force.
For category III products, it will also help 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. In addition, all products that are introduced on the market will be approved to the latest versions of the standards.
At SIP Protection, we have welcomed those modifications that are introduced in the new PPE Regulation (EU) 2016/425 and that will even more improve the user’s safety.
How does this affect the obligations and responsibilities of all parties concerned ?
Obligations of certification: Category II PPE has become category III
The major evolution here is in the 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 an internet portal, where everyone has access to our DoC’s.
The address is mentioned on the User Manual and on the label in each garment. It is also accessible via this link.
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 allows us already 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, …) 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 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.
This means that it is important for the distributor to know where he is in the supply chain:
- If he buys directly from the manufacturer, it is obvious that the PPE are put on the market at the moment that he purchases the goods.
- If the PPE were purchased before 21 April 2019, and if they comply with the 89/686/CEE, then they can be sold until 21 April 2023.
- If the PPE were purchased after the 21 April 2019, they must comply with the PPE Regulation (EU) 2016/425.
- If he buys via another distributor, he will have to ask his supplier for information on the date of putting the PPE on the market.
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 (manufacturer - importer - distributor)
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
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.
For the employer, 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.
Questions and Answers
Q. How does all the above affect my current SIP Protection products?
A. The only tangible elements of the products concerned by the changes are the instructions and the markings on the products.
The product must mention brand, and address, in order to assure traceability. The actual production process and the QA process of SIP Protection will not change. We already performed quality controls on the products that we manufacture, according to the category III requirements, regardless whether they were category II.
Q. What is the relation with the Standard EN 381 and class 3?
A. The EN 381 standard «Protective Clothing for Users of Hand-held Chainsaws» does not change. Class 3 in this Standard corresponds to the speed of the chain of a chainsaw, but that is a different discussion.
The EN 381 standard, and the concerned products, change from category II to category III, with all consequences as written in the above article.
Attention : a new standard, EN ISO 11393 is actually being introduced, and will replace the EN 381 standard. The EN 381 EU certificates will remain valid until their expiry date. This EN ISO 11393 standard and its changes will be commented on in another topic.
Q. What is the difference between a Directive and a Regulation?
A. Directives establish certain results required to achieve, but each single member state can decide itself how to transpose into national laws.
Regulations are legally binding for each member state, and come into force on a precise date in all member states.
The earlier in the supply chain a non-conforming product is stopped, the easier and the more efficient. Working with a reliable and professional partner for the supply of PPE is even more important in the future than it is already now.