Machinery Regulation: how risk assessment is changing THE NEW REGULATORY FRAMEWORK BROADENS THE SCOPE OF FACTORS TO BE CONSIDERED IN RISK ASSESSMENT, INCLUDING SOFTWARE, CONTROL SYSTEMS, TAMPERING AND LOSS OF CONNECTION pean Union (OJEU), currently constitute the specific technical standards for this type of product, and their application provides a presumption of conformity with the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive. However, in their current versions, they will not benefit fully from the presumption of conformity with the EHSRs of the new Machinery Regulation. This does not mean that the manufacturer must ‘reinvent’ the safety solutions already set out in the standard. EN 81-41 and EN 81-42 can still serve as a fundamental technical reference, including in risk assessment; however, in the absence of harmonisation with the new Machinery Regulation, the burden of demonstrating compliance with the applicable essential requirements remains with the manufacturer. This situation currently poses a real problem, particularly for small manufacturers and assemblers, who may possess the technical expertise required to construct the system but do not necessarily have an internal structure dedicated to the complex assessment and documentation activities required by the new regulatory framework. The availability of specific harmonised standards as soon as possible therefore becomes not merely a regulatory issue, but an industrial necessity. FROM RISK ASSESSMENT TO DOCUMENTATION The underlying logic remains that of EN ISO 12100 and, for lifting equipment, the established methodologies within the sector. The manufacturer must identify hazards, estimate and assess risks, determine risk reduction measures and verify that the residual risk is acceptable. Under the new Regulation, however, the assessment must be particularly detailed, including with regard to software and hardware aspects. The greater attention required by the Regulation must not be confused with the need to describe every element of the machinery analytically. The documentation must be proportionate to the risk and must make it possible to understand why the solutions adopted are sufficient to meet the applicable requirements. Where a technical standard already provides a recognised solution for a specific risk, the manufacturer should be able to document the application of that solution, rather than repeating in full the technical analysis that led to its development. A detailed analysis becomes particularly important in cases where the product deviates from the standardised solution or where no specific applicable standard exists. NEW REQUIREMENTS TO BE TAKEN INTO ACCOUNT Among the requirements that warrant particular attention are those relating to ergonomics, protection against unauthorised changes, control systems, access to machine parts and the automatic control of lifting operations. These RESS are not currently covered, or not fully covered, THE entry into force of Regulation (EU) 2023/1230 introduces some important changes to the way in which manufacturers must approach risk assessment. For the lift sector, this is not a new issue: risk assessment has long been the starting point for safe design and forms the basis of the approach taken by the EN 81 series of standards. The new Regulation makes it clearer that risk assessments must also take into account aspects that have become increasingly important in recent years, such as software, the configuration of control systems, cyber security, hardware modifications and possible remote access or interventions. This does not mean, however, that every manufacturer must start from scratch, nor that risk assessment should replace technical standards. THE TECHNICAL STANDARD REMAINS THE BEST APPROACH Where a harmonised standard applicable to the machinery exists, it constitutes the best approach for translating the Regulation’s essential safety requirements into concrete technical solutions. The standard allows the wealth of knowledge and experience developed by industry experts to be utilised and makes demonstrating conformity simpler and more consistent. This consideration is particularly important for lifting platforms. EN 81-42 and EN 81-41, whose references have been published in the Official Journal of the Euro36 NORMATIVA DI PAOLO TATTOLI* E GIUSEPPE IOTTI**
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