CE mark

Harmonized standards

The EU directives impose general requirements for safety and health. The more technical specifications are given in the harmonized standards. By following the harmonized standards, you are sure to meet the essential health and safety requirements of the directives.

Harmonized standards describe in detail how the overall requirements of the directive can be met. They apply in all EU countries and replace any national standards. The difference between European standards and harmonized European standards is that the harmonized standards have been commissioned by the EUROPEAN Commission. The European harmonized standards relate directly to the directives and help to ensure the free movement of products. By complying with the standards, manufacturers are sure that they meet the corresponding essential health and safety requirements of the directives.

When the EU adopts a directive and it is subsequently made national legislation, everyone who markets products/services in Europe shall be able to document that they meet the requirements of the directive.

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Harmonized standards

Must standards be complied with?

In some cases, yes!

Directives are legislation and must, of course, be followed. Standards are recommendations and, as a general rule, using a standard is voluntary. However, there are some exceptions where you must comply with a standard.

  • Where laws or directives prescribe that certain standards shall be followed;
  • Where a business advertises that a product or service meets the requirements of a given standard;
  • Where it is stated in a contract or in a marking or labelling scheme that a product or service must comply with one or more standards.

If you do not use the harmonized standards, you must document your solution yourself. However, if you use the standards that are made for a particular directive, referring to the standards in your documentation will suffice.

Directives containing requirements for CE marking:

Harmonized standards and related directives

Directives based on the "new approach" principles without requirements for CE marking:

Harmonized standards and related directives

Other directives/regulations with associated standards:

Harmonized standards and related directives

97/67/EF
Postal services

765/2008 (EF) - 1221/2009 (EF)
The new legislative framework and the eco-management audit scheme (EMAS) 

2009/128/EF
Inspection of pesticide application equipment