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Orgalim Feedback to DG Growth Unit C3: Following Call on 15 December SME’S Concerns Within the Revision of the Machinery Directive

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Orgalim Feedback to DG Growth Unit C3: Following Call on 15 December SME’S Concerns Within the Revision of the Machinery Directive 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. 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 B1030 | Brussels | Belgium VAT BE 0414 341 438 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] Boulevard A Reyers 80 www.orgalim.eu 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 BluePoint Brussels [email protected] Boulevard A Reyers 80 www.orgalim.eu B1030 | Brussels | Belgium VAT BE 0414 341 438 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-
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