Regulation (EU) 2023/1230 on machinery ‒ a legal regime for machinery in Europe
At last it’s here. Long-awaited Regulation (EU) 2023/1230 on machinery (the “Machinery Regulation”) was published in the EU Official Journal on 29 June 2023. Private industry and public authorities alike will now have a new set of rules on the safety requirements for machinery, which will replace Directive 2006/42/EC on machinery (the “Machinery Directive”) that has been in force for 17 years. Even though the Machinery Regulation does not constitute a paradigm shift for industry, it nevertheless introduces numerous changes that will be relevant in practice and with which economic operators will have to deal in order to ensure product compliance.
I. Old wine in new bottles?
In keeping with the current European regulatory trend in product safety law, this central piece of legislation for machinery and equipment will in future be directly applicable as a European regulation. Although during the legislative process calling the regulation the “Machinery Products Regulation” remained an option to the very end, ultimately the less cumbersome name “Machinery Regulation” was adopted. On the other hand, for no apparent reason, European legislators decided to turn the numbering of the numerous annexes, with which users of the Machinery Directive were familiar, upside down. For example, the essential health and safety requirements are no longer to be found in Annex I, but are now in Annex III. This is unfortunate because it makes it more difficult to compare old and new law and, for no good reason, hinders the seamless application of the new provisions in practice.
The material scope of application of the new Machinery Regulation, on the other hand, corresponds largely to that of the Machinery Directive. It covers not only machinery and partly completed machinery, but also interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable drive shafts. However, the definition of safety component has been expanded to include software and other digital components that stand alone and perform safety functions. The non-exhaustive list of safety components can now be found in Annex II of the Machinery Regulation, instead of in Annex V of the Machinery Directive as before.
II. Adaptation of European machinery law to the New Legislative Framework (NLF)
The new regulation is based on a package of legislation known as the New Legislative Framework. As a result, machinery law has now been brought up to date in terms of its methodology and terminology with the latest European regulatory techniques in relation to product compliance. On the one hand, this adaptation means that importers and distributors will now be covered by machinery law and will also have to satisfy obligations with regard to machinery that are already familiar from the New Legislative Framework. It is worth mentioning here in particular that the obligation to notify the authorities where product risks are identified can now affect manufacturers, importers and traders alike. On the other hand, the time period over which the Machinery Directive will apply has been extended.
III. Codification of material changes
Since time immemorial the question of how machinery may be modified after it has been placed on the market or put into service without it thereby becoming new machinery and therefore having to undergo, among other things, a new conformity assessment procedure has been discussed. The Machinery Directive was silent when it came to distinguishing between new and used machinery, which is why authorities and market operators had in practice to seek guidance from interpretation aids (e.g. the European Commission’s “Blue Guide” and the Federal Ministry of Labour’s “Interpretation Paper”). The principles laid down in the interpretation aids are now codified in the Machinery Regulation. A “substantial modification” is now defined as any modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer. This modification must create a new hazard or increase an existing risk so that new safeguard procedures are required. Any person who substantially modifies machinery expressly becomes a manufacturer and is subject to the associated obligations listed in Article 10 of the Machinery Regulation. Partly completed machinery, on the other hand, is not covered by the requirements for substantial modification as it is only intended to be integrated into machinery.
IV. Extension of essential health and safety requirements
The essential health and safety requirements in Annex III of the Machinery Regulation have been revised and extended. Particularly noteworthy are the new health and safety requirements on cyber security and artificial intelligence. In future, manufacturers will have to take sufficient safety measure precautions to adequately protect machinery against accidental or intentional attacks by third parties. The safety requirements for artificial intelligence were inserted into the existing legal structure without mentioning the term “artificial intelligence”. Manufacturers are required to take the “learning phase” of AI into account in their risk assessment and to define the limits of learning in advance and protect them with safeguard procedures. Unfortunately, European legislators did not succeed in their original plan of dovetailing the new European AI Regulation with the Machinery Regulation. As a result, there is a risk of inconsistencies arising in future between the two regulations. These may have to be eliminated by adapting the Machinery Regulation at short notice.
V. Half-hearted digitalisation
Digitalisation has also found its way into the Machinery Regulation, but not nearly to the extent that is currently being discussed in connection with the digital product passport (DPP). Legislators remain half-hearted, especially when it comes to the requirements for instructions. While manufactures will in future always be able to provide declarations of conformity and declarations of incorporation in digital form, this only applies to a very limited extent to extensive instructions. These currently have to include different language versions and require a considerable amount of paper. In the case of B2B sales of machinery, digital instructions will generally be permitted. However, paper versions will have to be made available within one month of purchase if requested by the end customer. This means that where machinery is sold through a distributor, a manufacturer can, long after a product has been placed on the market, be confronted at short notice with requests for instructions in paper form. If a manufacturer is able to foresee that machinery will be used by private users, it must, on the other hand, continue to ensure for an unforeseeable period of time that the machinery is accompanied by at least the safety information in paper form. In view of the widespread use of smartphones by European consumers nowadays, it is difficult to understand the logic behind this provision or the necessity for it.
The new Machinery Regulation comes into force on 19 July 2023 and will be mandatory after a transition period of three and a half years. By such time, machinery may, in addition, already be subject to the new requirements of the European AI Regulation. Economic operators should keep an eye on further developments and familiarise themselves with the numerous changes. This applies in particular to the extended health and safety requirements and the new catalogues of obligations for manufacturers, authorised representatives, importers and distributors. For companies, it is a matter of adapting their product compliance management to the new legal regime in good time.