The Machinery Directive 2006/42/EC is a key piece of EU legislation that follows the ‘New approach‘ principles. For this reason, it represents a valued pillar to ensure that safety requirements for machinery products are met before they can enter the European market.
On April 21, 2021, the European Commission (EC) has published a Proposal for a Regulation to update the EU machinery legislation framework, in order to adapt it to ever changing technologies, as well as to enhance its effectiveness.
The main purpose of the EC Proposal is to address the following issues:
● New technologies: the Directive was written 15 years ago and no longer sufficiently covers new risks from emerging technologies. The proposed Regulation takes into consideration technologies, such as autonomous machines, software to update machinery behaviour and human-robot collaboration. Concerns around manufacturers‘ ability to conduct a complete risk assessment on machine learning applications are also addressed;
● Legal uncertainty: the Directive reportedly lacks clarity of definitions (definition of machinery) and scope (or exclusions thereof), and contains some safety gaps in traditional technologies (e.g. substantial modifications are not properly addressed). Overall, the Directive has been evaluated as not clear or safe enough, and at the same time its prescriptiveness hinders innovation. The proposed Regulation focuses on ensuring a coherent interpretation of scope and definitions and to enhance safety also for traditional technologies;
● High risk machinery: the Proposal for a Regulation is reassessing the conformity procedures by also updating the respective list contained in Annex I, due to insufficient provisions in the current Directive;
● Heavy costs and administrative burdens: manufacturers were found to have high monetary costs due to the requirement to have printed paper-based IFUs for ex., which has also raised environmental concerns. The Regulation’s Proposal seeks to switch to electronic documentation, while also considering the possible obstacles to this transition, .e.g. lack of internet access for certain end users;
● Inconsistencies with other pieces of Union product safety legislation: The Regulation will address this by ensuring coherence and aligning the Regulation to the Decision 768/2008 outlining the New Legislative Framework (NLF) in Europe;
● Divergencies in interpretation due to transposition: as a Directive, the MD 2006/42/EC was implemented in 27 national legislations, which resulted in not harmonized interpretations. To avoid this, the instrument chosen is the Regulation, which will apply directly without the need of national transposition.
In conclusion, the Commission has decided to adopt a Proposal to boost competitiveness by minimizing burden for manufacturers. At the same time, it aims to improve safety with additional and revised requirements, by taking into consideration technology development. Furthermore, the new Regulation – once adopted by EU decision-making bodies – is expected to simplify the regulatory environment, while maintaining the spirit of the ‘New Approach‘.
21 June 2021
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References and further readings:
● Commission Staff Working Document (2021). Impact Assessment Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products. Retrieved on 21 May 2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021SC0082&from=EN
● Commission Staff Working Document (2021). Executive Summary Of The Impact Assessment Report Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products. Retrieved on 21 May 2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021SC0083&from=EN
● Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, retrieved on 21 May 2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008D0768&from=EN
● European Commission (2021). Proposal for a Regulation of the European Parliament and of the Council on machinery products. Retrieved on 21 May 2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52021PC0202&from=EN