Orgalim feedback to DG Growth unit C3: following call on 15 December SME’s concerns within the revision of the Machinery Directive
Ms Bonvissuto asked Orgalim representatives to provide answers to the in depth questions on the following topics:
➢ Digital instructions ➢ Substantial modification ➢ How to deal with AI
A. Digital instructions
1. Whether the paper instructions should be available by request or as a default,
Orgalim is against providing instructions on paper as an obligatory requirement. If the complete instructions are supplied in a digital format providing a summary on paper should be down to the manufacturer’s choice.
A paper might not always be the best solution for providing the most-up-to-date safety related information. A product screen, plastic sheets or marking directly on the product can in some situations be a more appropriate solution for delivering safety relevant information. The manufacturer can also provide the instructions as a download if the necessary information is supplied with the machinery.
If the product is a consumer product then the need for an instruction manual is required through the GPSD (Article 2 (b)). Through these provisions the requirements are to provide the paper format on the request of the consumer.
See (slide 47) https://orgalim.eu/position-papers/internal-market-orgalim-comments-proposals- revision-machinery-directive-200642ec
2. What can be written into the legislation on how the manufacturer should ensure that the print version is available to those that request it in the shortest delay possible,
The requirements of B2B and B2C customers can be met by involving economic operators in the supply chain, consumers will have direct access to the paper instruction manual without having to contact the manufacturer again.
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This can be arranged contractually once the manufacturer has provided the instructions digitally the distributor can easily deliver printed instructions upon the customer’s request. Furthermore, the employer is obliged to make a safety risk assessment before purchasing the machine. This is also better for the global supply chain, and for ecological reasons.
The decision to provide a print version copy free of charge is a commercial matter.
2.b How to implement the “on request” transition.
This will be covered through the alignment to the NLF (model provisions of the Decision 768/2008).
Machinery purchased through distributors
In the vast majority of cases, consumers procure machinery from distributors. This case is covered by the distributor's obligations. According to the model provision in Article R5 (2), the distributor must ensure that machinery is supplied with instructions. The dealer checks with the client in which forms the instruction handbook is available and which form the client prefers. If the consumer wishes to receive the instruction handbook in paper form, the dealer can meet this request directly.
Agreements between distributors and manufacturers are necessary to enable business activities. It is possible for these two economic operators to conclude agreements to ensure that public service obligations are met and that the interests of consumers with regard to paper-based instruction handbooks are effectively taken into account. These agreements also cover arrangements for bearing the costs of making the paper-based instruction handbook available. Dealers are likely to have a vital interest that manufacturers bear these costs in full.
Furthermore, the distributor is obliged under Article R4 (7) to take corrective measures if the product does not comply with the regulations. Even if this provision does not contain any direct rules on the bearing of costs, there is no dispute at all as to who should bear the costs of remedying the defects.
Machinery purchased directly
In cases where machinery is purchased directly from the manufacturer by consumers, consumers can request a paper instruction handbook directly from the manufacturer.
Safety components and partly completed machinery
These products are integrated into final products, therefore the instructions or assembly instructions cannot be addressed to the user. This information is addressed to the person who builds a machine or retrofits an existing machine with one. These are persons with obligations of a manufacturer or persons with very similar obligations.
In these cases, information from the instructions or from the assembly instructions must be available to customers before the product is purchased, e.g. for the conformity assessment
Orgalim is registered under the European Union Transparency Register – ID number: 20210641335-88
Orgalim +32 2 206 68 83
BluePoint Brussels [email protected]
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B1030 | Brussels | Belgium VAT BE 0414 341 438
procedure of a machinery into which a party completed machinery or a safety component is installed.
If a safety component is retrofitted, the instructions must be available at the time of the design of the conversion or retrofitting of the used machine, not at the time of delivery of the safety component.
(The answer is based on negotiations with the Danish authorities)
3. How to describe the digital format or carrier in the legislation
The legislation should simply refer to “a widely readable digital format that accompanies the machinery or can be obtained remotely” this will ensure technological neutrality. Digital formats will vary depending on the specific use context. Examples of possible digital formats could be provided in the guidelines and can be developed in standardisation. Examples of the digital formats we envisage are a data carrier, cd or a link to a website that is specific to the machinery in question.
See (slide 47) https://orgalim.eu/position-papers/internal-market-orgalim-comments-proposals- revision-machinery-directive-200642ec
4. How to ensure that the information provided is the right version
The conditions for the download and the time-period available for the download should be specified in the Regulation. Regarding the time period availability, the regulations for the storage of the technical file according to Annex VII shall be applied.
See (slide 47) https://orgalim.eu/position-papers/internal-market-orgalim-comments-proposals- revision-machinery-directive-200642ec
5. Comments to the list of safety information (in slide 51)
Orgalim is against providing instructions on paper as an obligatory requirement. If the complete instructions are supplied in a digital format providing a summary on paper should be down to the manufacturer’s choice. Finally, the EN ISO 20607 standards provides the state of the art on providing safety instructions and which confirms that it is not possible to extract the safety instructions from the rest of the user manual.
B. Substantial modifications
The Commission would like Orgalim to comment on:
➢ The conditions that should be imposed on these requirements ➢ How the modifications should be controlled legally.
Orgalim is registered under the European Union Transparency Register – ID number: 20210641335-88
Orgalim +32 2 206 68 83
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Orgalim cannot provide further feedback on these questions at this time.
C. How to deal with AI
Orgalim considers that the current legislation for products integrating AI is fit for purpose only small amendments to the Machinery Directive’s Annex I requirements section 1.2 may be necessary.
The answers below are based on the Orgalim position on AI of 10 September 2020
1. Possible definition of AI
The Orgalim proposal for a definition of AI, was provided in our previous position papers1 :
“AI refers to computer systems based on algorithms designed by humans that, given a complex task, operate by processing the structured or unstructured data collected in their environment according to a set of instructions, determining the best step(s) to take to perform the given task, via software or hardware actuators. AI computer systems can also adapt their actions by analysing how the environment is affected by their previous actions.”
This definition is similar to the definition given by the Commission’s High-Level Experts Group on AI2, as it insists on the human origin of any AI and highlights the fact that a machine can only perform an action assigned from the outset by a human - whether a designer, computer specialist or manufacturer. This ‘narrow AI’ has been deployed effectively and safely in manufacturing for several decades.
2. What is high risk AI
It is important for policymakers to differentiate between the varying degrees of risk linked to use of AI technologies in their different applications. There must be a clear, well-defined distinction between low-risk and high-risk AI applications. Clear criteria should be established for identifying critical areas in a way that is legally certain. In Orgalim’s view, the quality of any future regulation will depend on the ability to identify a common, transparent and easily applicable understanding of ‘high-risk’. High-risk situations should be defined in cooperation with industry, based on risk-benefit considerations and adjusted when necessary. Clear definition of criteria for perceived high-risk
1 See https://www.orgalim.eu/position-papers/orgalim-comments-upcoming-impact-assessment-machinery- directive (p.2) See https://orgalim.eu/position-papers/digital-transformation-orgalim-manifesto-european-agenda- industrial-ai (p. 3) See https://orgalim.eu/position-papers/digital-transformation-orgalim-input-european-commission- consultation-artificial (p3) 2 See the “Ethics Guidelines for Trustworthy AI” of 8 April 2019 of the High Level Expert group on AI: “Artificial intelligence (AI) Orgalim is registered under the European Union Transparency Register – ID number: 20210641335-88
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applications and the degree of autonomy is crucial, in order to avoid over-regulation of completely harmless automation. For example, in mechanical engineering, we believe AI applications are generally safe and uncritical, according to their risk assessment.
When something has been identified as a high-risk application (which we believe will be a minority of industrial AI applications) a targeted approach to risk-management could be the right one. Taking this into account, it can for instance be concluded that most industrial AI application use cases have entirely different ethical implications compared to consumer-oriented AI solutions for end-consumers. It is crucial that the framework for identifying high-risk use cases is predictable and proportionate in order to create a stable environment for investments.
3. Reflections on whether AI decisions cause safety problems
Orgalim stands for an enabling and innovation-friendly AI framework in Europe with our built-in democratic values. We recognise that AI applications might bring new challenges, including for the industrial sectors represented by Orgalim. It is important for policymakers to differentiate between the varying degrees of risk linked to use of AI technologies in their different applications. An indiscriminate understanding of AI-technologies risks hampering innovation and creating uncertainty and should be avoided.
As of today, the only possible fundamental and universal consideration about AI-systems is that there are no philosophical, technological or legal grounds to consider them anything else but artifacts generated by human intellect. Embedded AI-based applications are considered products both by the EU (1) product safety legislation (before the placing on the market) and in the (2) Product Liability Directive (PLD - after the placing on the market). While the first set of rules imposes essential safety requirements for products to be certified and thus distributed into the market, the latter aims at compensating victims for the harm suffered from the use of defective goods. The first body of norms relating to product safety legislation is essential and plays an important role in ensuring the safety of users and consumers within the European market. We could build on this ex ante detailed regulation and technical standardisation by potentially looking at the development of specifically tailored and appropriate norms for emerging technologies, where necessary.
When it comes to machine safety, we do not see a need for action by the EU-legislator. State of the art testing technology, standards and validation methods must be further developed, but at the legislative level – such as the EU Machinery Directive – where the safety requirements are formulated in a technology-neutral manner and also apply to machines with AI elements. Therefore, factories with AI are just as safe as those without AI, as all safety requirements must be fulfilled in the same way.
Orgalim is registered under the European Union Transparency Register – ID number: 20210641335-88
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Despite the fact that there are several views on the PLD3, Orgalim supports the Commission’s assessment which stipulates that the current PLD is ”coherent with the EU legislation protecting consumers, relevant and future-proof” and “fit for purpose”4. In addition, as regards the Product Liability Directive of 1985, Orgalim has assessed that, thanks to its technology-neutral specifications, its provisions remain valid even in the digitalised domain. Therefore, its scope should not be extended to services or stand-alone software, the concept of “joint liability” should not be introduced, of “defect” should remain interpreted on a case-by-case basis by the Courts, and of “damage” should be limited to material damage. More generally on liability, Orgalim fully supports paragraph 29.7 of the High-Level Experts Group on AI’s Policy and Investment Recommendations urging “policy-makers to refrain from establishing legal personality for AI systems or robots”. Moreover, there is also no need to adjust the national liability regimes; they provide a legal framework within which AI problems can be solved.
4. Further reflection would be helpful on whether the regulation should apply to the whole machine or only to the logic unit.
The first concern for Orgalim is that the Machinery Directive should remain technology neutral. It already covers products with embedded AI that have been produced by our industry for many years. Therefore, we believe that the majority of industrial AI applications should not be considered high risk.
When considering the question of logic units it must be acknowledged that the logic unit itself does not cause any harm, the risk depends on the machine and must be taken into account in the risk assessment. Therefore, it is not possible to consider a logic unit without considering the machine and it follows that legislation covering that logic unit will be extended to the whole machinery. The situation can be compared to the requirements for CE marking safety components.
See full Orgalim position on AI here
3 https://ec.europa.eu/info/sites/info/files/report-safety-liability-artificial-intelligence-feb2020_en_1.pdf 4 See European Commission (2018). Report from The Commission to the European Parliament, the Council and the European Economic and Social Committee on the Application of the Council Directive on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products (85/374/EEC). Brussels, European Commission., 34 and 70. Orgalim is registered under the European Union Transparency Register – ID number: 20210641335-88
Orgalim +32 2 206 68 83
BluePoint Brussels [email protected]
Boulevard A Reyers 80 www.orgalim.eu
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