I recently had a customer ask me, “What makes a Harmonized Standard?” The customer was referring to the EN Harmonized Standards and wondered if all EN publications are harmonized. As is often the case, this is actually a technical question and it depends very much on the process of standardization followed in the European Union.
Of course, there is a simple answer. A European Harmonized Standard is mandated by the European Commission. Once developed it must be adopted legislatively according to specific rules. It then allows for the presumption of conformity, that is, by using a specific harmonized standard your product is presumed to comply with the requirements of a specific directive.
However, knowing how EN standards are developed is helpful here. And the primary issue is actually the difference between standards for commerce and standards for legislated health and safety concerns.
Since EN Standards started out as a tool for creating a common market in Europe, there are many different paths a document can take in order to become a European Norm (standard). The first big push for standardization at the European regional level was started in order to remove national differences in a wide variety of publications. This involved national standards bodies putting forward various national standards for regional acceptance. And the politics of adoption were challenging.
Now, with the first wave of standardization behind them, the European standards bodies develop standards for industry, consumer, and other market-driven needs. But there is another function of standardization: Supporting legal and regulatory requirements.
This is where the harmonized (or harmonised) system has come into being. As various directives have been issued in the European sector, companies want to know how to meet the requirements of these legal mandates. Standards are the perfect tool, but there needs to be some way to verify that conforming to a particular standard can meet the obligations of a particular directive.
The EU has set up a system to provide a way for manufacturers and suppliers to insure that they are in compliance — the concept of presumption of conformity. This system is not used for all EN standards. Indeed, harmonized standards make up a small proportion of the whole body of EN publications.
Remember, a Harmonized Standard has to be linked to a directive. Indeed the request for the standard has to come from the administrative side of government, specifically to provide a way to meet the requirements of a legislative mandate. So when a Harmonized Standard is issued there must be a directive that it applies to. And the standard has got to go through an administrative vetting process to be accepted as meeting the directive’s criteria.
This is why Harmonized Lists don’t get updated right away when standards on the list get updated. The new revisions have to be reviewed by administrators on the government side to confirm continued compliance. And then they need to have the completion of the process acknowledged by publication of acceptance in the OJEU, Official Journal of the European Union.
Whew! Who knew that the use of standardization for government goals could be so complicated? Guess what! It’s actually a common situation. While legislation usually doesn’t change very often, standards are a different story. Administrators in all jurisdictions are constantly challenged with reviewing changing technical requirements and making sure that their constituents continue to be protected. And we wouldn’t really want it any other way!
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