Many people think that a product standard is the law that they must comply with.
We understand why you would think that, but it is not true.
A standard is just a tool used to demonstrate you that you are in conformity with the European PPE legislation.
Within this European legislation, one directive and one regulation have been devised which users and manufacturers, respectively, must comply with.
- Manufacturer’s Regulation EU 2016/425
- User’s Directive 89/656/EEG
In this section, we will more closely examine the Manufacturer’s Regulation, and you can read exactly what it does and does not contain.
- Regulation versus directive
- Intended for whom?
- What is contained in them?
- What is not contained in them?
- Related documents
Regulation or directive?
The “new” EU 2016/425 Regulation may no longer be called a directive.
Why is this so important?
A regulation must no longer be converted into national legislation. It takes immediate effect in all countries of the European Union.
A directive, on the other hand, must be converted into national legislation.
In Belgium, for example, the User’s Directive will be further elaborated in the Code on Well-being at Work (Codex). In the Netherlands, this occurs by way of the Working Conditions Act (Arbowet) and in France by way of the Labour Code (Code du Travail).
Intended for whom?
The regulation describes the requirements for bringing PPE to market.
Therefore, it is primarily the manufacturers and distributors that are addressed in this regulation.
This text is less interesting for users of PPE, since they are less concerned with which certification procedure applies to which type of PPE.
What is contained in them?
Which topics are covered by this regulation?
These are the most important topics:
PPE Categories
The regulation divides the risks into three PPE categories (I, II and III) and describes the different procedures for these 3 groups:
Category I are well-defined risks of a superficial nature, such as raingear or simple disposable gloves. The manufacturers may certify this PPE themselves.
The manufacturer draws up an attest of conformity with which he declares that the product complies with the European regulation (after the necessary testing). A type examination certificate from an independent notified body is not needed.
The product must include user's instructions.
Category III consists of clearly defined life-threatening and irreversible risks, such as respiratory protection or hearing protection
Not only is a type examination, an attest of conformity and a user's manual required for these PPE, but a system for quality monitoring whereby the manufacturer can choose between an annual partial retesting or an audit is also obligator
Category II contains all risks that are not included in either Category I or in Category II. Examples of this are cut-resistant gloves or safety helmets.
For these products, a type examination, an attest of conformity and a user's manual are required.
General Safety Requirements
This legislation also contains the so-called essential safety requirements with which the PPE must comply. On the one hand, these are general requirements that apply to all types of PPE, such as
- the requirement that the PPE itself may not cause any harmful effects,
- that it must be as comfortable as possible, and
- that it must provide the correct protection for the design (intended use).
On the other hand, general terms are used to explain how a PPE can provide protection for all risks.
Everything that must be included in a user's instruction is also described here in general terms.
What is not contained in them? – misunderstandings
The text of this European law does not describe which PPE must be tested against which standard. In order to comply with the essential safety requirements, the easiest method is to test in accordance with the harmonised standards. However, this is not obligatory.
Also not included is which result the PPE must attain for a specific application.
As a Prevention Advisor, it is not always easy to make the link between the working conditions and the appropriate PPE. It may be helpful if you know how the tests work and if you have a better understanding of the values of the classes.
To this end, we have made a complete guide which is based on the risks and the user’s legislation and which then links this to protection and to the manufacturer's legislation.
This legislative text is also not the place to find out whether or not fit testing and leak testing are required annually.
Related documents
- The harmonised European standards are an interpretation of the essential safety requirements from the text of this European legislation.
- The user's legislation, if it covers the use of PPE
- An attest of conformity
- Certificate of EU type examination
- A user's manual