CE Marking - Machinery Directive 2006/42/EC.
This proposal for a Regulation takes into account the result of the evaluation of the machinery Directive 2006/42/EC.
Following the recommendations highlighted during the evaluation the proposal covers:
Clarity on the scope, exclusions and some definitions, including a new definition on "substantial modification" when the machine suffers a substantial modification, without the manufacturers agreement once is placed on the market.
New risks originating from digitalised machinery. In particular those originated from a direct human-robot collaboration, connected machinery, software updates that affects the behaviour of the machinery after its placing on the market, as well as the ability of manufacturers to conduct a full risk assessment on machine learning applications before the product is placed on the market. As far as the autonomous machines, the Regulation explicitly considers the possibility of no driver, and sets up requirements.
Clarifications on a number of requirements on "traditional machinery" related to installation of lifting appliances, slow speed lifts, seating, protection against hazardous substances, overhead power lines and vibration from portable handheld and hand guided machinery
Criteria to define high risk machinery and the possibility to adapt the current list of high-risk machinery to the state of the art as well as a mandatory third-party conformity assessment for this type of machinery.
Digitalisation of the machinery instructions and the manufacturers declaration of conformity with the possibility to request paper instructions at the time of buying the machinery product.
Alignment to Decision 768/2008/EC to bring together all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of machinery products
Detailed explanation of the specific provisions of the proposal
Scope and definitions
The scope of the proposed Regulation remains the same but is clarified by adding the subject matter in Article 1, adapting the wording of the scope and adding a new indent in the definition of machinery that includes assembly missing only the upload of a software intended for its specific application to prevent manufacturers classifying them as partially completed machinery. Furthermore, the definition of safety component has been also clarified to include non-physical components such as software.
There is a new definition of substantial modification to ensure that machinery, placed on the market and/or put into service, that suffers substantial modifications is in conformity with the essential health and safety requirements in Annex III.
Additionally, the general definitions of the NLF Decision 768/2008/EC have been inserted.
The Regulation clarifies also the application of other specific Union harmonisation legislation when the risks to be addressed in the machinery are not contemplated in Annex III.
The exemption of the means of transport on road is extended beyond the Union type approval legislation to increase the legal certainty. The reason is to prevent that vehicles not covered by that legislation are covered by default by the machinery legislation, as this legislation is not meant to regulate risks other than those stemming from the machinery function (such as sawing, excavating, etc.), and not the risks exclusively related to its transport function of persons or goods. Furthermore, as for the exemption on the list of electrical and electronic products regulated by the Low Voltage Directive as some of those products are progressively incorporating Wi-Fi functions, e.g. washing machines, and are therefore covered by Directive 2014/53/EU of the European Parliament and of the Council 11 as radio equipment, those products should also be excluded from the scope of this Regulation.
The proposal sets up classification rules for high-risk machinery empowering the Commission to adopt delegated acts to adapt the list of high-risk machinery in Annex I. This list is obsolete and needs to be adapted to the technical progress and new type of machinery presenting high risks such as machinery with AI ensuring safety functions.
Obligations of economic operators
The proposal incorporates obligations for manufacturers, importers and distributors to be aligned with the NLF Decision 768/2008/EC. This will clarify the respective obligations, which are proportionate to the economic operators’ responsibilities. Furthermore, when a machinery is substantially modified according to the definition, the one that modifies the machinery becomes manufacturer and must comply with the relevant obligations. As the complexity of the machinery supply chain is increasing, there is a general obligation of cooperation of third parties involved in the machinery supply chain, other than the economic operators.
Presumption of conformity of machinery
The presumption of conformity of machinery when manufacturers apply the relevant harmonised standards or parts thereof published in the Official Journal of the European Union remains. However, in order to ensure the presumption of conformity when there are not harmonised standards the Commission will be empowered to adopt technical specifications. This will be a fall-back option to be used only in cases the standardisation bodies are not able to provide standards or provide standards that do not respond to the Commission standardisation request and the essential health and safety requirements of Annex III.
The proposal keeps the manufacturer internal check option for machinery that is not classified as high risk. However, for high-risk machinery, considering that Annex I will be adapted to the technological progress when needed and the NLF alignment, only third party certification will be accepted, even when manufacturers apply the relevant harmonised standards.
The proposal updates the corresponding modules in line with the NLF Decision 768/2008/EC.
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and for the confidence of all interested parties in the New Approach system. Therefore, in line with the NLF Decision, the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.
Union market surveillance, control of machinery entering the union market and union safeguard procedure
The proposal integrates the NLF Decision 768/2008/EC provisions. This will reinforce the market surveillance and will clarify the safeguard close procedure. Commission decisions on measures taken by Member States on products placed on the EU market will be required only if other Member States disagree with such a measure, which will simplify Commission’s work.
Essential health and safety requirements (EHSRs) traditional machinery:
The proposed Regulation adapts or adds following EHSRs to address specific machinery risks:
1.1.2. Principles of safety integration has been adapted to allow the machinery users to test the safety functions of the machinery.
1.6.1 on maintenance has been adapted to facilitate a timely and safe rescue when operators are trapped in the machine
Digital documentation: EHSRs 1.7.4 on instructions and Annex V on the manufacturer’s declaration of conformity allow that manufacturers provide digital instructions and the declaration of conformity. Nevertheless, a paper format is mandatory upon request.
EHSR 1.7.4 on instructions has been further adapted to request information on emissions of hazardous substances from the machinery and EHSRs 220.127.116.11 and 18.104.22.168 on vibrations from portable handheld and hand-guided machinery to adapt the instructions on vibrations in order to reduce the exposure occupational injury.
EHSR 2.2 on portable hand-held and/or hand-guided machinery is adapted to capture or reduce emissions of hazardous substances.
Section 3 on offset risks due to the mobility of machinery has been adapted to address the risks on autonomous machines and remote supervisory stations.
EHSR 3.2.2 seating for mobile machinery has been adapted to reinforce the drivers’ safety.
EHSR 3.5.4 on risks of contact with live overhead power lines has been added to avoid the accidents when machinery makes contact with overhead lines.
EHSR 6.2 on control devices has been adapted allowing when possible on slow-speed lifts control devices other than hold-to-run to allow innovation.
Installation of lifting appliances: in view of facilitating market surveillance activities the manufacturer’s declaration of conformity will add the address where the machine is permanently installed only for lifting machinery installed in a building or a structure.
Essential health and safety requirements machinery with new digital technologies:
The risk assessment that manufacturers must carry out before the machinery is placed on the market/ put into service will need to include also the risks appearing after the machinery is placed on the market due to its evolving and autonomous behaviour.
Cybersecurity with an impact on safety
In view of addressing, the risks stemming from malicious third party actions and that have an impact on the machinery safety the proposal adds a new EHSR 1.1.9 and clarifies EHSR 1.2.1 on safety and reliability of control systems.
Machines are becoming more powerful, autonomous and some look almost like humans, which requires adapting the EHSRs related to the contact between the human and the machinery i.e. EHSRs 1.1.6 on ergonomics and 1.3.7 on risks related to moving parts and psychological stress.
Machinery with evolving capacity
Although AI system risks will be regulated by the Union legislation on AI, the proposal must ensure that the entire machinery is safe, considering the interactions between the machinery components including the AI systems. In this respect following EHSRs have been adapted: general principles, 1.1.6 on ergonomics, 1.2.1 on safety and reliability of control systems and 1.3.7 on risks related to moving parts and psychological stress.
Traceability of machinery safety
The safety of machinery increasingly relies on the software behaviour once the machinery has been placed on the market. In view of supporting the conformity assessment process and the market surveillance, a few new requirements have been added in EHSR 1.2.1 on safety and reliability of control systems and in the information required in the technical file in Annex IV.
The proposal empowers the Commission to adopt, where appropriate, implementing acts to ensure the uniform application of this Regulation. Those implementing acts will be adopted in accordance with the provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers.
The proposal empowers the Commission to adopt delegated acts in order to adapt the list of high risk machinery in Annex I to take into account the progress of technical knowledge or new scientific evidence and the indicative list of safety components in Annex II.
Evaluation and review
The Commission will monitor the implementation, the application and the compliance to these new provisions with a view to assessing their effectiveness. The regulation requests a regular Commission’s evaluation and review and the submission of a public report in this respect to the European Parliament and to the Council.
The proposed Regulation will become applicable 30 months after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the safeguard clause procedure needs to be applied shortly after the entry into force of this Regulation to simplify the mechanism. Transitional provisions are foreseen for products manufactured and the certificates issued by notified bodies under Directive 2006/42/EC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements. Directive 2006/42/EC will be repealed and replaced by the proposed Regulation.