More and more machines, sites or electrical equipment make use of self-learning algorithms to increase the usability for customers and users. In relation to product safety this represents a novelty: the behaviour of products does no longer necessarily possess a certain functional range when being placed on the market. Due to self-learning software components this functional range can face modifications or upgrades.
To face these challenges the EU Commission has submitted a legislative proposal for a concept dealing with Artificial Intelligence (AI) on a European scale. This proposal promotes the use of AI and intends to take all risks into account that might emerge together with AI systems. At the end of this legislative initiative there shall be a regulation with harmonized specifications. These rules are supposed to regulate the development, placing on the market as well as the application of such AI systems in the EU.
“On Artificial Intelligence, trust is a must, not a nice to have. With these landmark rules, the EU is spearheading the development of new global norms to make sure AI can be trusted “, states Margrethe Vestager, Executive Vice-President for a Europe fit for the Digital Age.
Link and effective dates
- Here you can find a link to the proposal of the new AI regulation.
- The suggested contents within the proposals are neither already valid nor can be granted that the Commission will implement them
- The proposal suggests that the new regulation must be applicable 30 months after its official publication (This date is referring to the acceptance of the final draft, not to this draft which can still face numerous modifications).
- The new AI regulation shall be a supplement to the new Machinery Regulation. Therefore, both drafts have the same date of issue.
Contents of the draft (selection):
Background: Control requirements for artificial intelligence
In recent years AI systems have undergone a rapid technical development. The EU Commission has made a call for action to launch a harmonized European regulation to counter the challenges caused by AI systems. This involves a common European framework that considers positive aspects as well as possible risks of such systems. The targets are to protect both fundamental rights as well as users to establish a legal basis for the rapidly developing field of AI.
The new regulation is following a risk-based approach: “That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate “. This means that life threatening AI systems are forbidden, systems with high risks allowed under strict obligations only. The proposal foresees a classification of risks with four levels; on the basis of use cases they cover the heaviness of potentially emerging risks:
- Unacceptable risk
- Limited risk
- Minimal risk
According to that AI systems with an unacceptable risk are forbidden as they are a safety hazard for users. If there is a high-risk AI system, strict obligation must be fulfilled before it can be launched on the market. In the case of a limited risk the AI regulation merely mentions potential dangers, for minimal risks an unlimited application shall be granted.
Interaction with the new Machinery Regulation
Both drafts state that the new regulations will complement each other. The AI regulation primarily covers safety hazards to emerge from AI systems that steer a machine. In addition to that, the Machinery Regulation shall secure the integration of the AI system into the overall machine, in order not to endanger the safety of machinery as a whole.
Furthermore, the European Commission underlines that manufacturers must conduct only one declaration of conformity for both regulations.
Artificial Intelligence and standardization
Harmonized standards will obtain a key role in meeting the requirements of the AI regulation. An approach will be the provision of technical solutions for users.
An initial attempt to integrate the limits of mechanical learning into machinery is the recently published ISO/TR 22100-5:2021-01 „Safety of machinery - Relationship with ISO 12100 - Part 5: Implications of artificial intelligence machine learning “.
Certainly, further standards and technical specifications will follow once the European Organizations of standardizations are put in charge of the development of such special AI standards.
Until August interested individuals may place their comment on the elaborated drafts of regulations for AI systems and Machinery. Afterwards the European Parliament and the EU member states have to accept the final drafts. Once this has occurred the new regulations are valid right away within the entire European Union. Yet, this legislative process usually takes approximately two years.
- The usage of AI systems has increased; hence the legislator has recognized a need for action towards a regulation of AI usage
- The proposals for an AI regulation and the Machinery regulation have been published at the same time. This indicates that the EU Commission seeks to interlock future legal provisions (directives and regulations)
- Manufacturers that already use or plan to use AI systems should deal with the upcoming AI requirements at an early stage. With that approach later adjustments of systems can be avoided and reduced.
Posted on: 13.07.2021