Since its original publication in 1989, and subsequent revisions up to 2006, it has effectively provided the highest level of machinery safety in the world, successfully supported the Internal Market as well as EU competitiveness, and continuously enabled the industry to innovate and thrive. In this context, it is important that the future legislative framework retains the balance between safety and innovation whilst offering the necessary consistency for manufacturers and users alike.
The industry fully supports the alignment with the New Legislative Framework (NLF) as it provides coherence with other Internal Market and product safety legislative acts and improves horizontal transparency. We also support the conversion of the Directive into a Regulation, which facilitates uniform application across all European Union Member States and therefore enhances the free movement of goods. Industry also appreciates the adaptation to modern technologies, by making it possible to provide machinery documentation in a digital format instead of paper.
We reiterate that these strategic objectives should also be applied to maintain coherence with the ongoing legislative proposals for the AI Act and the General Product Safety Regulation. European manufacturers in the machinery sector’s complex supply chains depend on seamless EU conformity and market access regulation for their success.
The drastic change of approach to mandatory third-party conformity assessment for all the machinery listed in Annex I would only harm the European industry without bringing any clear benefit.
The proposed requirement is:
unjustified - There is no evidence that third-party certified machines are any safer than those undergoing internal production control,
disproportionate – The European Commission’s cost estimation is largely undervalued as it does not cover the additional costs of resources, logistics, planning or the loss of lead time,
uncompetitive – the increased uncertainty, the longer time to market and additional costs will hamper innovation – disadvantaging SMEs while creating incentives for larger companies to move strategic sites to more supportive regions.
This approach would also prevent products produced in small series being made available on the market.
The fundamental principles of the NLF are essential for the good functioning of the European Standardisation System and vital to upholding and securing Europe’s competitiveness. The creation of parallel approaches to standards-setting (i.e., technical specifications) by the Commission should be avoided wherever they are intended to replace standards. Such an alternative approach would be only acceptable, when used exceptionally and under strict and clear criteria, in reference to topics for which standardisation is not appropriate. Unclear implementation would seriously harm the importance of harmonised standards and undermine the principles of standardisation.
The rules for the development of technical specifications under the proposal are not clear and we fear that the current principles used in standardisation (e.g. a consensus-based text, market relevance, a balanced representation of stakeholders and transparency, ensured by a public enquiry) will not be respected. The introduction of a less consensus-based alternative system to harmonised standards risks undermining their global importance, creating misalignments with standards developed by international standardisation organisations 1 and weakening the underlying NLF principle that requirements are defined in the legislation, while details are developed in standards.
Essential requirements (Annex III) should not be over-prescriptive or unfeasible. European manufacturers depend on the one hand on the stability of the basic NLF principles of separation of the essential requirements laid down in product legislation, and on the other on the description of their technical realisation according to the state of the art in product-specific voluntary standards. Co-legislators must also avoid introducing additional vertical requirements that risk causing unpredictability for manufacturers. Moreover, roles should also be clearly allocated and balanced between the original manufacturer, other economic operators and market surveillance authorities.
A transition period, where both legislative frameworks apply, is necessary to allow the market to adapt to the new regulation
Unrestricted “making available”3 of machinery products already manufactured under the current Machinery Directive is essential to minimise uncertainty for the supplier; the transition provisions in other pieces of legislation under the New Legislative Framework such as RED or LVD can be used as a reference.
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