The so-called “trilogue negotiations” are starting in Brussels these days. The trilogue is a meeting of representatives of the legislative institutions of the EU, consisting of the Commission, Council and Parliament. The current text proposal, which has already been individually reviewed and commented on by all three institutions, is being finalised between the parties. The goal is to reach agreement on all outstanding and disputed points so that the final draft of the regulation will be in place at the end.
The new EU Machinery Regulation will replace previous EC Machinery Directive 2006/42/EC. The decisive factor here is first of all that the Directive is being replaced by a regulation, which applies directly in the EU member states and no longer needs to be converted into national law. In addition, three points are particularly noteworthy from the draft text known to date:
• Machines with high risk potential
The list of machines with high risk potential (formerly Annex IV) is being extended and provided with the possibility of influence by the EU Commission. The list can and thus will be dynamic, it being possible update the list at short notice. In addition, a notified body must be involved in future for the conformity assessment of machines in this class.
• Digitisation
As far as possible, hardcopy operating manuals and the associated carbon footprint are to become a thing of the past. However, the Commission could not fully comply with the request of some EU countries: Concerns from other member states that strictly digital instructions might not be clearly recognised and retrievable by every end customer again limited the planned digitisation initiative, mainly concerning B2C products. Digital operating instructions are permitted for B2B products. B2B customers can still insist on hardcopy form.
• Software & AI
Actually, the revision of the Machinery Directive was supposed to be all about software, so during the process it was decided without further ado to include the new European AI Regulation (previously only known as a draft) in the new Machinery Regulation. However, as the legislative process around the new AI Regulation has been considerably delayed, this project was stopped again on the advice of the Council and the Parliament and the references to the provisions of the upcoming AI Regulation were deleted. This is intended to prevent the end result from becoming various regulations that are not coordinated with each other. What has endured in all cases: the update around the aspect of software and thus in particular the handling of software, software errors and subsequent software updates.
The new Machinery Regulation is a priority for the Czech EU Presidency and is expected to be a major achievement of its term. Therefore, the ambitious goal is to successfully conclude the trilogue process in the autumn in all cases.
Conclusion
It will be exciting to see what will be left of the 200-page document and the many proposed changes. We will provide detailed insight into the innovations of the Machinery Regulation in the coming days…
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