Basic knowledge: creating a European standard, step by step

Do you have an idea or proposal for a standard? Would you like to amend an existing standard, for example to take account of developments in safety technology? You can! But how does the European standardization process actually work? This article describes the individual steps and shows you the points at which you can influence the procedure, and how.

Every standard begins with submission of an application for standardization to the respective national standards organization. In the case of Germany, this means to DIN (The article describes the procedures with reference to the example of Germany. Minor differences aside, the standards development procedure for the other CEN members is the same.), and an online form is available for the purpose.

• There is a great deal that the OSH lobby can do in advance in order to have a positive influence on the standardization project. The more thought-through and detailed the proposal, the better it will serve as a basis for discussion in the standards committee.

The application is first re­viewed by DIN. If the project can be implemented in the form of a European standard, or an international standard is the objective, DIN forwards the application to the European standards organization (CEN) or the International Standards Organization (ISO) (Dedicated standards organizations exist for the fields of electrical engineering and telecommunications; these have been disregarded here). For an application for standardization to be accepted at European level, at least five countries must declare their willingness to work on the standard (in addition to other requirements).

• Where contacts already exist to OSH experts in other European countries, they should be recruited to the effort before the project is launched, as this considerably improves the likelihood of the application being accepted. KAN can provide assistance in forging contacts.

Once the project has been adopted by the standards organization, it is assigned to the standards committee responsible for the topic. Should no suitable committee exist, a new one must be created.

The work conducted at European level is supported by national standards committees functioning as “mirror committees”. This means that the competent national committee is informed of the work, and can present its position to the working group (WG) and the technical committee (TC) at European level through the experts and delegates posted to these committees. The European working group is made up of experts who express their professional opinion freely and are responsible for the actual work on the text of the standard. The technical committee is essentially responsible for coordination and for passing resolutions. All national standards organizations post delegates to the technical committee. The delegates are bound by the agreed opinion of their respective mirror committees.

• Participation on the committees is the best way to help shape the content of a standard. Although it may entail time and expense, participation in person often pays off.

Once the document has reached a status which the experts of the working group believe can attract a consensus, the technical committee decides whether the public enquiry on the draft standard (prEN) can now be launched. The consensus principle is essential in standardization. It means that a standard should be published only in the absence of sustained opposition to its content. In exception­al cases, votes may also be taken.

• During the public enquiry stage, the text of the draft standard is freely available (in German), for inspection on the Internet at DIN4, and anyone may comment on it during a two-month period. KAN is able to provide effective support to the experts when comments are submitted on occupational safety and health aspects. The advantage of a KAN comment is that it reflects the consensus among all stakeholders in OSH in Germany, and thus carries greater weight than comments from individual stakeholders.

After the end of the public enquiry, a national comments resolution meeting is first held at which parties who have submitted objections have the opportunity to explain their comments. This is followed by an internal discussion, the results of which are forwarded by the national mirror committee to the European level. There, the experts discuss the comments received from all countries and decide by consensus or, in individual cases, by majority vote whether to accept or reject the proposed amendments to the text.

The comments that are accepted are then incorporated by the working group into the draft standard. The final draft of the new document (FprEN) is distributed again to the CEN members. No new technical comments can be submitted during this enquiry; each national standards institute can vote only to approve or disapprove the draft, or abstain. Should a sufficient majority exist for approval (At least 55% of the votes cast must be in favour, and must also represent at least 65% of the total population of all member countries having voted see CEN/CENELEC Internal Regulations Part 2 (pdf)), the standard is published as a European standard (EN).

• All standards bodies which are members of CEN are obliged to incorporate each European standard in unamended form into their national body of standards. Where national legislation conflicts with the content of the standard, reference must be made to this legislation in an “A deviation” in the annex of the standard. Reference to other national provisions may be made in a separate fore­word, notes or the annex of/to the relevant national version.

Harmonized European standards have a special status. They are produced in response to a mandate from the European Commission and support EU directives or regulations. Once the ref­erence of a harmonized standard has been published in the Official Journal of the EU, it gives rise to a presumption of conformity. This means that a manufacturer who produces a product in accordance with a harmonized standard can be presumed to be in compliance with the applicable EU legislation covered by the standard.

• Where for example serious safety concerns exist, the listing of the standard in the Official Journal of the EU can be challenged by a formal objection submitted through the governments of the Member States. In the area of occupational safety and health, KAN supports the German Federal Ministry of Labour and Social Affairs in the submission of formal objections.

Existing standards are reviewed at intervals of five years for the need for revision. Reasoned requests for revision may also be submitted in the interim. The standardization process usually lasts three years in total, not including preparatory work.

Should you have any further questions concern­ing the standards development process and your means of influencing it, or would appreciate strategic support in your work in the standards committee, please contact the KAN Secretariat. We will be happy to assist you.

Katharina von Rymon Lipinski

vonrymonlipinski@kan.de