A glance at the new Machinery Regulation: what do you need to know?

The die has finally been cast: European manufacturers will soon have to comply with the new Machinery Regulation. This is set to be published by the European Official Journal in July 2023, entering into force 20 days later. Due to the overall transitional period of 42 months, machinery can still be supplied under both the Machinery Directive (2006/42/EC) and the new Machinery Regulation until early 2027.

The Machinery Regulation lays down safety and health requirements for machinery manufactured and sold within the European Union. In doing so, it aims to maximise the protection of workers and consumers, and promote the free movement of machinery within the European market.

The rules and regulations are designed for machinery manufacturers. With a CE mark, they indicate that their machines comply with the Regulation. In addition, the guidelines also apply to the user in specific situations: 

• The user has constructed their own machine – which falls within the scope of the Machinery Regulation – and is making it available on the market.
• Without the intervention of an importer, dealer or distributor, the user is purchasing a machine or related product outside the European Union.
• The user is making substantial modifications to the machine, rendering it non-compliant with the CE marking given by the original manufacturer.

The new Machinery Regulation clarifies some complex issues. Consider, for example, 'incomplete machinery' and 'substantial modifications'.

Furthermore, the European Commission wishes to align regulation with technological advances, which have been accelerating for several years now. The Machinery Regulation therefore leaves more room for emerging technologies such as artificial intelligence (AI), and new applications of digitalisation systems and cyber security. 

You can consult the publication in the European Official Journal here.

With the new Machinery Regulation, Parliament aims to further harmonise standards within the European market. After all, a regulation imposes rules that apply to all member states, while a directive merely sets a common goal. Each member state can then individually decide how to achieve that goal.

The new Machinery Regulation involves a number of changes. Here is a list of the main changes:

• A machine's operating instructions only need to be available digitally. Consumers can, however, obtain a free paper instruction manual on request for up to six months after their purchase. In addition, a manufacturer may mention the link to the declaration of conformity in the instructions rather than including the declaration in full.
• Annex I replaces Annex IV because the list is outdated and cannot be adapted quickly enough to changes in the market. In the new Annex I, the Commission has therefore decided to specify the risk level of machinery. The annex therefore consists of Part A and Part B, depending on the level of risk.
• Some paragraphs were amended. Therefore, according to section 1.1.2 of the essential requirements (Annex III), the user must now be able to test the safety functions. This can be carried out primarily during the design and construction phase, but also with test procedures if necessary.
• The definition of 'machine or related product' was expanded and now includes cobots – machines without programming or application.

The Machinery Regulation introduces some new concepts and requirements:

• The controversial topic of 'substantial change' was included in the definition list.
  This criterion includes situations not foreseen by the manufacturer that may affect conformity with the relevant essential requirements.
• 'Importer' and 'distributor' are now among the market players, in addition to the previously-defined 'manufacturer' and 'authorised representative'.
• The Commission has the option to add to or remove products from the categories of 'dangerous machinery' and 'safety components'.
• New requirements relating to cybersecurity and artificial intelligence have been added.
• The new Machinery Regulation also applies to additive equipment. This includes, for example, 3D printers.