The European Parliament has approved the adoption of the new Machinery Regulation on April 18th, 2023 and published it in the Official Journal of the European Union on June 29th, 2023.
The new EU Regulation 2023/1230 improves consistency, eliminates transposition issues, and increases legal certainty in all member states. It considers digital technologies like AI, IoT, and robotics and their safety/liability challenges.
The new Machinery Regulation defines the substantial modification of machinery and outlines its legal consequences. Machinery safety requires a conformity assessment procedure if substantial modifications are made or if modifications are carried out that affect the machine’s compliance with statutory provisions for CE marking. The catalogue of machines subject to inspection has been expanded. Manufacturers cannot assess conformity alone for inspected machines. Software providing safety function is included in the safety component definition (Article 6). Manufacturers can provide digital instructions but must provide a paper format upon request. The presumption of conformity is applied in cases of conformity with technical specifications or parts thereof (Article 17).
The new Machinery Regulation addresses updates or developments of software installed in machinery or related products during the risk assessment. These risks must include those that may arise during the product’s lifecycle due to an intended evolution of its behavior to operate with varying levels of autonomy.
However, machines or related products that incorporate software programmed solely to execute specific automated functions, without the ability to learn or evolve, are exempted from these provisions.
In cases where safety software is marketed separately, it must conform to the Machinery Regulation and bear the CE marking. Additionally, it must be accompanied by an EU declaration of conformity and instructions for use, where appropriate.
For the first time, the Machinery Regulation applies to an immaterial product.
Safety component means a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfill a safety function and which is independently placed on the market, the failure or malfunction of which endangers the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function.
Instructions and sales literature
The instructions may now be provided in a digital format. Such instructions and information shall clearly describe the product model to which they correspond.
When the instructions for use are provided in a digital format, the manufacturer shall:
- Mark on the machinery or related product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions.
- Present them in a format that makes it possible for the user to print and download the instructions for use and save them on an electronic device so that he or she can access them at all times, particularly during a breakdown of the machinery or related product. This requirement also applies when the machinery or related product’s software embeds the instructions for use.
- Make them accessible online during the expected lifetime of the machinery or related product and for at least 10 years after the placing on the market of the machinery or related product.
Sales literature describing the machinery or related product shall not contradict the instructions for use regarding health and safety aspects.
Artificial Intelligence and machinery safety risk
Manufacturers must consider the learning phase of machines that incorporate self-learning systems and implement safety circuits to limit their behavior within the risk assessment. This prevents them from exceeding the limits.
The new Machinery Regulation includes essential safety and health requirements for mobile machines, such as driverless mobile machines (AGI), prevalent in hospitals and warehouses.
As all machines connect to data networks susceptible to malicious attacks, the Machinery Regulation requires safety circuits that prevent hazardous machine behavior from malicious attacks. It also introduces a safety and health requirement to protect computer systems from corruption.
Collaborative robots (cobots) require new safety solutions to ensure people’s safety in collaborative applications, including psychological stress. As a result, the Machinery Regulation modifies the safety and health requirement for risks arising from moving parts.
EU Declaration of Conformity
The new Machinery Regulation replaces the CE Declaration of Conformity with an EU Declaration of Conformity, in accordance with the updated legislative framework. If a product is subject to multiple EU acts, the manufacturer must prepare a single EU Declaration of Conformity that covers all of them.
Machinery or related products presenting a higher risk factor
The list of high-risk products previously found in Annex IV of Directive 2006/42/EC has now become Annex I in the new Machinery Regulation, with the inclusion of safety components featuring self-learning capabilities and machinery incorporating self-learning systems.
The six categories of products requiring the involvement of a notified body for conformity assessment through an internal manufacturing control procedure are:
- Detachable mechanical transmission devices, including their guards.
- Guards for detachable mechanical transmission devices.
- Vehicle lifts.
- Portable explosive-powered tools for fastening or other impact machines.
- Safety components with totally or partially self-learning behavior using automatic learning approaches that guarantee safety functions.
- Machines with self-learning systems using automatic approaches guaranteeing safety functions, and they have not independently entered the market.
One example is the inclusion of systems that ensure safety functions and have self-evolving behavior in Annex I due to their characteristics, such as data dependency, autonomy, opacity, and connectivity, which can significantly increase the likelihood and severity of harm and affect the machinery or related product’s safety.
Safety software marketed separately needs to comply.
However, if the machinery embeds a system where the safety component has already undergone third-party conformity assessment when independently placed on the market, the machinery should not require re-certification by a third party based only on the system’s embedding.
Manufacturers must meet the new requirements by the deadline, but they have time to prepare. Although there were expectations of a transition period, the key date regulation is expected to remain unchanged. The regulation’s publication in the Official Journal of the EU, anticipated for July 2023, will determine the exact compliance date. The new regulation will be enforced 42 months after its entry into force, typically 20 days after publication, as agreed by negotiators. Thus, compliance with the new requirements is mandatory from January 2027. Companies must start dealing with the new requirements before the effective date since they must prepare the declaration of conformity, technical documentation, and more in accordance with the new regulation from that date.
EC type-examination certificates and approval decisions issued in accordance with Article 12 of Directive 2006/42/EC shall remain valid until they expire.
AI, IoT, and robotics can pose risks to legally protected interests, despite their many opportunities. As their applications expand, the probability of such risks occurring will also increase. For small and medium-sized enterprises (SMEs) in the machinery sector, legal certainty is particularly crucial, as they often have limited resources to interpret legal texts.
Greater clarity and harmonization of safety requirements resulting from legal certainty will benefit SMEs that rely on harmonized standards to ensure compliance. The International Organization for Standardization provides feedback and coordination for the standardization of emerging technologies to enhance competitiveness within the EU and globally.
The new regulation will come into force after 42 months (from January 14th 2027)