1. Is following a standard a legal obligation?

There is no legislation that requires a PPE to comply with a European (or any other) standard.

The only obligation is to comply with European legislation, which in this context is EU 2016/425.

Following a standard is the easiest way to have a product certified, but it is not an obligation.

2. Harmonised European standard – what does that mean?

EU 2016/425 is the legislation that you must comply with if you want to sell PPE.

This legal text is intended as a robust basic framework. When it comes to risks and the protection to be provided, the legislation remains very vague, at most a few sentences per risk.

For a more workable interpretation, the European Commission instructed CEN to write standards for a specific risk or group of risks.

When CEN has finished a standard, it is published – you can then buy it from the national standardisation body. For Belgium this is NBN, in the Netherlands NEN, in France AFNOR, …

After that, the EC examines whether the standard provides a sufficient interpretation of EU 2016/425. If that is the case, the standard receives the status “harmonised”. This status gives presumption of conformity: by complying with the requirements of this standard, you may claim that you comply with the requirements of the legislation.

Approximately twice a year the EC publishes the new list of harmonised standards. Non‑harmonised standards do not give you any guarantee of full conformity with EU 2016/425.

Here you will find the current harmonised standards grouped by product type. Harmonised standards

3. What exactly is a standard?

Standards can be divided in 2 major groups:

• Test standards:
  describe how a test must be carried out (equipment, duration, temperature, …). They contain no minimum or maximum requirements. In the English word “standard”, this standardisation of a test procedure is reflected best. In languages where the noun is derived from “norm” you might be surprised to find no requirements.
• Specification standards:
  mainly contain requirements, both regarding design, material properties, instructions for use, labelling, …

The advantage for authors of standards is that in a specification standard they can easily refer to a test standard without having to include it in full. The disadvantage for the user/reader is that if you want to understand everything, you have to go through quite a number of texts before you see the complete picture.

4. What happens when a new standard appears?

European standards are evaluated every five years. They are:

• confirmed for five years, or
• revised if they no longer correspond to the state of the art.

When a new standard is ready, the following steps are taken:

• publication by CEN
• assessment by the EC
• publication in the OJEU → harmonised
• withdrawal of the previous harmonised version

Only then does the new harmonised standard replace the old version.

For every new certification, this new harmonised standard is then followed.

All existing products, certified according to an older standard, may continue to be sold. There is no obligation whatsoever to have all products re‑certified according to the new standard.

Since the legislation includes that a certificate can only be valid for five years, all products will eventually be certified according to the newer versions.