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The current proposal of EU Machinery Regulation is meant to drive innovation and digitalization following the path set out by the AI draft Regulation.
On April 21, 2021, along with the proposal for a Regulation on Artificial Intelligence (AI) and as part of the broader “Artificial Intelligence Package,” the European Commission issued the proposal for a Regulation on machinery products that will replace the Machinery Directive (Directive 2006/42/EC) currently in force.
In this article, we focus on the new obligations on manufacturers, distributors, and importers against the background of the digital transition.
Current market framework, Machinery Directive and digitalization
The machinery sector is a crucial part of the engineering industry and one of the driving industrial pillars of the EU economy. According to the recent report released by the Technopolis Group for the Commission, machinery and equipment manufacturing production was the main business activity of 80,000 enterprises across the EU in 2018. The sector employed 3 million people in the same year. The total annual turnover of the sector amounts to approximately EUR 700 billion. In 2018, the EU Member States with the highest value-added generated by the sector were Germany (EUR 108 billion) and Italy (EUR 37.2 billion), followed by France and the Netherlands.
In this context, the Directive 2006/42/EC defines a harmonized regulatory framework for placing machinery products on the single market, ensuring free movement within the EU and a high level of protection for users and exposed people. The Directive applies to various products, from construction machinery and lawnmowers to 3D printers and robots. In addition to machines stricto sensu, the scope of application covers other related products, such as safety components and partly completed machinery products. The aim is to ensure a sustainable recovery from the COVID-19 crisis, fostering innovation but safeguarding the competitiveness of European manufacturers and designers on a global level playing field.
Despite several technological and market changes, in 2018, the European Commission assessed that the Directive is still relevant towards achieving its goals and consistent with other relevant national, European, and international legislation. However, at the same time, the Commission highlighted some critical issues in terms of effectiveness in facing the challenges posed by emerging digital technologies, such as AI and IoT (Internet of Things), and efficiency concerning costs to be incurred for compliance with the requirements set out by the Directive. In this scenario, the Commission pointed out the need to:
- deal with new risks related to emerging digital technologies;
- ensure a consistent interpretation of the scope of definitions and improve traditional technologies safety;
- re-assess high-risk machines and corresponding compliance procedures;
- reduce paperwork related to documentation;
- assure consistency with other EU acts on product safety; and
- prevent possible differences in interpretation resulting from transposition in each Member State.
For instance, a potential new risk associated with technological progress is the updating/modification of hardware or software components of a machine after this has been placed on the market or put into service, which could cause the latter to behave in a way not initially foreseen by the manufacturer, requiring a new conformity assessment to be performed and a new CE marking to be affixed.
As part of the following 2020 report on implications of AI, IoT and robotics, the European Commission also concluded that these technologies pose new challenges in terms of product safety and liability such as connectivity, autonomy, data dependency, opacity, products and systems complexity, software updates and a more complex security and supply chain management.
New Regulation on machinery products: entry into force, applicability, and transitional period
The Machinery Directive will be superseded by adopting a new EU regulation on machinery products, which – by its general scope and direct applicability – will ensure greater legal certainty and a high level of harmonization of health and safety requirements in the design, construction, and trade of machinery products throughout the EU.
In addition, the proposal has been issued along with the proposal for a Regulation on AI, considering all changes resulting from the digital transition and the impact of new technologies on European product safety legislation. Consistently, both the Regulation on machinery products (the Machinery Regulation) and the Regulation on AI will apply to machinery products.
It should be noted that the principle of technological neutrality, which already permeated the text of the current Machinery Directive, remains crucial: the Machinery Regulation does not lay down specific technical solutions to be adopted to comply with safety requirements, which will be a matter for manufacturers.
According to the proposal, the Machinery Regulation will enter into force on the 20th day following its publication but will become applicable 30 months after its entry into force. The Machinery Directive will be repealed on the same date. A transitional period is also provided during which it will still be possible to place on the market machinery complying with the Directive and not yet with the Regulation, particularly within 42 months from the date of entry into force.
Following the draft Machinery Regulation (April 2021), the European Parliament proposed several amendments at its first reading. Among them, as we will see, the proposals include extending the deadline for the application of the Machinery Regulation and the repeal of the Directive from 30 to 48 months after the entry into force and extending the transitional period from 42 to 60 months.
Major novelties in the proposal of Machinery Regulation compared to the Directive
The Machinery Regulation explicitly references modifications to products already placed on the market or put into service. It will apply not only to new machinery products, as provided for in the Machinery Directive, but also to products that have undergone “substantial modifications” such as to entail changes in the original performances, purpose, use or type of the products, so the product is considered as new, also concerning the different or higher risks invoked. The user who makes such changes will have to fulfil the same obligations under the legislation as manufacturers.
A new conformity assessment will only be required relating to those parts of the product that have been substantially modified unless the modification affects the entire product. The subject involved will not be necessary to repeat tests and prepare new documentation regarding aspects not affected by the changes. Safety updates, repair and maintenance works do not constitute substantial modifications.
Two new economic operators: importer and distributor
The Machinery Regulation introduces two new figures: the importer and the distributor.
The “importer” is the person who places a product from a third country on the European market for the first time. It is the importer’s responsibility to ensure that the manufacturer has fulfilled all obligations in terms of product conformity with the provisions of the Machinery Regulation. In line with this, the manufacturer is obliged to indicate its contact details on the product.
The “distributor” is the person, other than the manufacturer and the importer, who makes a product available on the market. The distributor is responsible for verifying, before making a product available on the market, that the machine bears the CE marking, that it is accompanied by the necessary documentation, instructions, and information, and that the manufacturer and the importer have indicated on the product/packaging the identification elements of the product and their contact details. This responsibility is less onerous if compared to manufacturers’ and importers’ o ligations. Like the importer, the distributor must also ensure that the conformity of the product is not compromised during storage and transport.
Security components: software is included
The Machinery Regulation also adds digital components, including software, to the definition of “safety component.” As a result, software that fulfils safety functions and is placed on the market independently will have to be accompanied by an EU declaration of conformity and, where applicable, instructions and information necessary for its use and bear the CE marking.
EU Declaration of Conformity
The “EU Declaration of Conformity” replaces the “EC Declaration of Conformity” referred to in the Directive. If more than one EU act applies to a single product requiring it, a single EU declaration of conformity must be drawn up.
Towards digital documentation to the overall objective of simplification
For practical purposes and to reduce environmental impact, the manufacturer will need to be able to make the necessary documentation available digitally (EU declaration of conformity, instructions and information), without prejudice to the obligation to provide a hard copy if required. In this respect, one of the latest proposed amendments refers to the requirement that the documentation and information are downloadable and savable throughout the entire life-cycle of the machine product.
In some instances, competent national authorities could reasonably request to make the source code or programmed logic included in the technical documentation available to verify the product’s compliance with the health and safety requirements in Annex III. However, some amendments propose the deletion of such provision.
High-risk machinery products: will it be necessary to go through the notified body?
With reference to conformity assessment for machines listed in Annex I (high-risk products) and those added in line with technological developments, the Machinery Regulation excludes the possibility for the manufacturer to apply the internal production procedure. Therefore, examination by a notified body will always be necessary, even if the manufacturer applies harmonized relevant standards and whatever procedure is followed. On the contrary, some amendments have been proposed to maintain the possibility upon manufacturers to also apply the internal production control procedure (module A) in Annex VI for “potentially” high-risk machinery products. As we will discuss in more detail in the second part of this article, the amendments include a proposal to replace, throughout the entire text, the reference to machine products presenting “high risks” by “potentially high risks.”
Further amendments: scope of application, information asymmetry and sanctions minimum amount
Other amendments were also proposed to clarify the scope of application, with particular regard to the exclusion from the Machinery Regulation of:
- motor vehicles – except for machinery mounted on them – which have as their only objective the approved transport of goods, persons or domestic animals
- household appliances intended for domestic use which are not electrically operated furniture, except for their mechanical safety devices
Non-type-approved, off-road and (also but not exclusively intended for) competition vehicles, e-bikes, e-scooters, similar means of transport, and specific equipment for use in fairgrounds or amusement parks should be included.
It was also proposed to add and clarify certain definitions, including “partly completed machinery,” based on the need to distinguish better definitions relating to partly completed machinery from those relating to other categories of machine products, also about the requirements and obligations of economic operators, including conformity assessment procedures.
Further proposed amendments aim to reduce the information asymmetry between machine products manufacturers and end-users by requiring the manufacturer to consider the safety impact on consumers and, upon request, to provide information on significant details that may affect the safe operation when a machine product is installed on a vehicle. The manufacturer should also provide users with information on security updates and identify cyber risks in a timely and reliable manner.
Lastly, the amendments suggest that, in the event of a severe breach of the Machinery Regulation, a minimum amount of sanctions (to be determined by the EU Member States) of at least 3% of the worldwide turnover achieved by the economic operator in the previous fiscal year should be introduced.
Even though the European institutions are currently discussing the proposal of Machinery Regulation, it is driving towards an effective and timely overcoming of the significant limits of the Directive, which is essentially structured in the adaptation of the previous regulatory framework to the new technological and market context, but also the simplification and digitalization of administrative requirements.
As for the next steps, the analysis of the proposed amendments will take place in the European Parliament’s Committee on the Internal Market and Consumer Protection. We will follow and analyze the evolution of the draft until the final version is published.
On a similar topic, you may find interesting the article “Is the draft EU Artificial Intelligence Regulation on the right track?“.