04 Oct 2021

Joint Industry Statement on Priorities for the Machinery Products Regulation

The Machinery Directive is ostensibly the single most important piece of legislation for the European manufacturing industry. 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 predictability for manufacturers and users alike.

To this end the co-signatories:

  • Welcome the alignment with the New Legislative Framework (NLF) and coherence with other legislation

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 remind 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.

  • Reject the introduction of mandatory 3rd party conformity assessment

The drastic change of approach to mandatory 3rd 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,
  • disproportionateThe 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 to be made available on the market.

  • Warn against undermining the consensus-based standardisation approach

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 European 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. The opposite 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 with the 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[2] that requirements are defined in the legislation, while details are developed in standards.

  • Stress the importance of respecting the NLF principle of technology-neutral legislation

Essential requirements (Annex III) should not be over-prescriptive or unfeasible. European manufacturers depend on the stability of the basic NLF principles of separation of the essential requirements laid down in product legislation, on the one hand, and the description of their technical realisation according to the state of the art in product-specific voluntary standards on the other. 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.

  • Request a clear transition period

A transitional 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 suppliers, the transition provisions in other pieces of legislation under the New Legislative Framework such as RED or LVD can be used as a reference.


[1] It is unclear whether the Vienna Agreement is applicable to technical specifications written in accordance with Regulation (EC) No 1025/2012

[2]See CENELEC legal platform opinion https://www.sercobe.es/wp-content/uploads/2021/09/BT_N_12672_Technical-Specifications-as-alternative-to-hENs.pdf

[3] Article 3 (11) of the proposal ”making available on the market” means any supply of a machinery product for distribution or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge;

Back to Product compliance & standardisation
View the complete Policy Paper
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DIGITALEUROPE's response to the Standardisation Strategy
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