Standards, directives and laws in the European Union (EU)

Relationship between harmonized standards and laws in the EU.

 The European Union is increasingly merging. Machine builders will recognize this in the increasing  harmonization of laws, regulations and provisions. Not that long ago, each country published its own guidelines on the different areas of daily life and the economy, but today you’ll find more and more standardized regulations within Europe.

How are European laws, directives and standards connected?

Initially, the EU formulates general safety objectives via directives. These safety objectives need to be specified more precisely; the actual provision is made via standards.

EU directives generally deal with specific issues. The directives themselves have no direct impact on individual citizens or companies. They only come into effect through the agreements of individual countries within the EU, who incorporate these directives into their domestic law. In each EU country, a law or provision refers to the relevant EU directive and thus elevates it to the status of domestic law. Between the time a directive is adopted and the point at which it is incorporated into domestic law there is inevitably a transition period, during which time the directive awaits incorporation into domestic law in the individual  countries. However, for users this is generally unimportant because the directives themselves provide clear indication on the respective validity date. So although the titles of these documents describe them almost harmlessly as directives, in practice they have legal status within the EU.

This explains how laws and directives are connected, but doesn’t deal with the issue of the standards.

Although the standards themselves make interesting reading, on their own they have no direct legal relevance until they are published in the Official Journal of the EU or are referenced in domestic laws and provisions. These are the publications by which a standard can acquire “presumption of conformity”. Presumption of conformity means that a manufacturer can assume he has met the requirements of the corresponding directive provided he has complied with the specifications in the standard. So presumption of conformity confirms proper conduct, as it were. In a formal, legal context this is called a reversal of the burden of proof. Where the manufacturer applies a harmonized standard, if there is any doubt, misconduct will need to be proven. Where the manufacturer has not applied a harmonized standard, he will need to prove that he has acted in compliance with the directives.

If a manufacturer does not comply with a standard, it does not necessarily mean that he has acted incorrectly. Particularly in innovative industries, relevant standards either may not exist or may be inadequate. The manufacturer must then demonstrate independently that he has taken the necessary care to comply with the safety objectives of the relevant directives. Such a route is usually more complex but, in an innovative industry, it is often unavoidable.

It’s important to stress that the EU does not publish every standard in the Official Journal, so many are still not harmonized. Even if such a standard is deemed to have considerable technical relevance, it will still not have presumption of conformity. However, sometimes a standard that has not been listed in the EU Official Journal does achieve a status that’s comparable with harmonization. This is the case, for example, when a harmonized standard makes reference to the respective standard. The standard that is not listed in the EU Official Journal is then harmonized “through the back door”, as it were.