How are European standards developed?

Generally speaking, anyone can file a proposal for a standard to be developed if they explain why it is needed. Such proposals are submitted via the national standards body in the country in question (the DIN in Germany’s case), which forwards them to the European Committee for Standardization (CEN) (or CENELEC).

If a sufficient number of CEN members give their consent and are willing to be involved in the development work and if the financing is secured, CEN assigns the project to a Technical Committee (TC), which in turn forwards the mandate to one of its Working Groups (WGs). At the national level, mirror committees follow the standard’s progress. The CEN members appoint delegates to the TC to act as a bridge between the European and national standardization levels and to represent the national opinion. The experts whom the CEN members appoint to the WGs primarily express their opinion as specialists.

The WG draws up the actual text of the standard (working draft). The TC informs the national mirror committee about how work is progressing. It is also the TC that decides whether the draft is sufficiently advanced to be passed via the national standards bodies to the public enquiry stage as a draft European standard (prEN) or whether the WG has to make amendments first.

During the public enquiry stage, all stakeholders can send in comments on the draft standard. In Germany, they send them to DIN. The mirror committee responsible at DIN combines all of the comments in one common German comment and forwards it to the TC. All national comments are discussed by the WG and incorporated into the draft standard in accordance with the WG’s conclusions. The resulting final draft is submitted to the national standards bodies for voting. Once it has been accepted, the standard is published and must be adopted as a national standard by all CEN members. According to the official schedule, standards should be completed within three years.

Harmonized standards listed in the EU Official Journal give rise to a presumption of conformity.

How can OSH stakeholders influence the European standardization procedure?

Firstly, they can file a proposal for a standard themselves if this is deemed necessary for OHS purposes. This approach enables them to formulate their objectives for the standard at an early stage, thus setting the tone for the content of the future standard. But there are also other ways of exerting influence during the preparation of a standard.

The most important and most effective way is to be actively involved in a standardization committee – be it at the national or the CEN level. During the public enquiry stage, comments can be submitted via DIN. In Germany, the Commission for Occupational Health and Safety and Standardization (KAN) can provide support, if desired, for stakeholders seeking to draw up comments concerning OSH. If a key stakeholder in the standardization process, for example the OSH sphere, rejects a draft standard, DIN is not allowed to vote in favour of it at the CEN level (“Block vote by an interested party”). It is also possible to convince DIN to vote “No but...“. By so doing, DIN offers CEN a way to have the standard accepted by Germany as well if certain conditions are met.

It is also helpful to discuss the draft standard with European OSH experts via the internet platform set up by EUROSHNET, the European OSH network, before submitting a national comment.

Once standards have been completed and adopted at the national level, they are reviewed every five years. It is also possible to submit a proposal for revision at an earlier date. Again, KAN can support parties interested in doing so.

In the case of harmonized standards, there is a special way of exerting influence once they have been published if they do not comply with the European level of protection. In such cases, the individual Member States can submit a “formal objection” to the European Commission to prevent the standard from giving rise to a presumption of conformity – either completely or in part.

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How are international standards developed?

Generally speaking, anyone can file a proposal for a standard to be developed if they explain why it is needed. Such proposals are known as new work item proposals. They are submitted via the national standards body in the country in question (the DIN in Germany’s case), which forwards them to the International Organization for Standardization (ISO) (or the IEC).

If a sufficient number of ISO members give their consent and are willing to be involved in the development work and if the financing is secured, ISO assigns the project to a Technical Committee (TC), which in turn forwards the mandate to one of its Working Groups (WGs). At the national level, mirror committees follow the standard’s progress. The ISO members appoint delegates to the TC to act as a bridge between the international and national standardization levels and to represent the national opinion. The experts whom the ISO members appoint to the WGs primarily express their opinion as specialists.

The WG draws up a committee draft (CD), which the national standards bodies have to comment on within three months. If a consensus is reached, each ISO member passes the draft international standard (DIS) to the national public enquiry stage. The stakeholders then have five months to present their comments to their national standards body. The comments are incorporated into the DIS and the WG prepares a final draft international standard (FDIS). The FDIS is then presented to the ISO/IEC members for voting. Votes must be cast within two months.

There is no obligation to adopt international standards as European or national standards. However, where international standards are adopted as European standards, modifications can be made. The Dresden and Vienna Agreements are intended to encourage unaltered adoption of international standards as European standards. According to the official schedule, international standards should be completed within three years.

How can OSH stakeholders influence the international standardization procedure?

Whether a new work item proposal is actually accepted depends completely on the ISO members entitled to vote. It is therefore particularly important to secure the support of other countries in advance. The OSH position can be incorporated into standardization work by means of active observation of standardization work, cooperation with European OSH experts (for example via EUROSHNET), comments during the enquiry stage and active involvement in the national mirror committee or the ISO committees.

In order for technical matters to be considered in a standard, the comment should be submitted at the CD stage, as far as possible, and not at the DIS stage, when the standard is usually already at an advanced stage. When voting on whether to approve a draft standard, the national standards body (influenced by the interests of various stakeholder groups, for example the OSH sphere) can vote “No but…”. Whilst constituting a rejection, this vote also points to a solution which would change the negative vote into a positive one.

Standards are reviewed every five years, allowing new positions to be put forward. But OSH stakeholders can also submit a proposal for revision at an earlier date if they explain why such revision is required.

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