Scope:

Evaluation of the Machinery Directive 2006/42/EC 

Evaluation Findings:

The overall conclusion is that the directive is generally relevant, effective, efficient, coherent and has EU added value. Some drawbacks have been identified in relation with its effectiveness and coherence due to shortcomings in monitoring and enforcement of the directive as well as the need for better legal clarity in its provisions and relationship with other legislation that the directive interplays with, such as the Low Voltage Directive. It has also shown that some administrative requirements challenge its efficiency. The evaluation also showed that the directive, underpinned by the New Approach principles, is sufficiently flexible to allow technological developments in a digital era. However, further innovation in digitisation may test the directive's effectiveness in the future.

Which objective(s) does the Commission pursue?

The revision of the Machinery Directive takes into account the need for greater legal clarity, simplification and adaptation to technical progress. More specifically, the problems the initiative aims to tackle are:

• a lack of coherence with the wider EU framework and enforcement difficulties – the fact that the directive is not aligned with the ‘new legislative framework’ (see Decision No 768/2008/EC) generates administrative burden and additional costs for economic operators, market surveillance authorities and EU institutions (e.g. the procedure for handling safeguard clauses, the form and content of documentation, etc.);

• a lack of legal clarity in the scope and definitions – experience from implementing the directive indicates a lack of legal clarity in some of its provisions. In particular, the definition of ‘partly completed machinery’ gives rise to legal uncertainty and additional costs for operators and national authorities. Also, certain categories of products that are explicitly excluded from the scope are not defined in such a way as to ensure clear delimitation vis-à-vis other applicable legislation, e.g. the Low Voltage Directive

• administrative burden and additional costs for operators due to requirements for paper documentation – the directive is not clear as to whether the documentation accompanying products can be in digital formats; and

• challenges posed by technical progress in digitalisation, e.g. artificial intelligence and Internet of Things

Estimated savings and benefits

The alignment to the new legislative framework means a better functioning of the directive and its enforcement, but also a burden simplification for manufacturers dealing with several product safety acts applying to their products (e.g. machinery to which both the machinery directive and the radio equipment directive apply). It streamlines the process of safeguard procedures, by involving manufacturers and Member States before the Commission is notified and triggers a Commission decision only in cases where there is disagreement between Member States. Another simplification aspect is the complementarity between the AI and machinery legal proposals, where the AI regulation delegates the conformity assessment to the machinery, so that the risk assessment for the whole machinery with AI systems is done only through the future regulation on machinery products. Finally, the change from a directive to a regulation, will avoid Member States transpositions and will ensure coherence in the interpretation of the legal act and in its implementation.

According to the impact assessment, the costs savings estimated for the preferred option reflected in the Commission Proposal are as follows:

⮚ Allowing digital instructions generates considerable economic benefits (printing and paper cost savings, etc.) that greatly outweigh the costs generated (purchasing, setting up and maintaining a server, etc.). It is estimated that up to EUR 16.6 billion (EUR 201 000 per company) printing costs will be saved with digital instructions and declaration of conformity.

⮚ EUR 15 million yearly costs savings are estimated in social costs for sick leave and fewer occupational injuries thanks to reduced vibration peaks in handheld machines.

⮚ Clarifications where there had previously been a lack of legal clarity or differences in interpretation between Member States would lead to cost savings between EUR 5 000 and 10 000 per instance.

⮚ Conversion to a regulation would bring cost savings in terms of clarification procedures of EUR 100 to EUR 500 per instance.

⮚ The costs savings estimated from the alignment to the new legislative framework are not quantifiable.