A Brief Note About EU Standards

On their own, standards 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. 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 ned 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 standard that's already been harmonized refers to the relevant standard. The standard that is not listed in the EU Official Journal is then essentially grandfathered into harmonization.