21 June 2022

Everything about the Machinery Directive 2006/42, machine safety and CE marking (for machines) in the Netherlands

Category: International law, Regulatory Compliance

What you need to know about the Machinery Directive

Europe is well known for its large manufacturing industry. Machine production accounts for a substantial part of this. This includes both the production of relatively (small) machines used by consumers and large industrial machines, or groups of machines, for companies. The European Union issued its first machinery directive in 1989. This established common rules and enabled the possibility of free trade of European machines in the European internal market.

Dutch regulation on machine safety, CE marking and product liability

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC creates a uniform level of protection for the prevention of accidents involving machinery, and partly completed machinery, when placed on the market within the European Economic Area. The machinery directives have each been transposed into national law  in the Netherlands (Warenwetbesluit machines and Warenwetregeling machines) and contain a large number of regulations on machine safety, CE marking and distribution of liability.

This paper discusses and presents some practical questions concerning the Machinery Directive and its national implementation in the Netherlands.

When is a machine, an unfinished machine or an assembly of machines involved?

The Machinery Directive 2006/42/EC applies to various types of products, including machinery. The definition of machine is not straightforward. Even the legislator responsible for the Machinery Directive needed 184 words to define the principles underlying a machine. At the same time, the directive describes a number of exclusions, such as those for certain safety components and for certain electrical and electronic equipment covered by the Low Voltage Directive, including certain household appliances and IT equipment.

The determination of what a machine is under the Machinery Directive is of decisive importance in order to be able to determine whether CE marking is required, whether technical documentation must be prepared and whether special safety regulations must be observed.

Furthermore, an assembly of machines may have to be separated from a machine installation. This is a practical distinction, as it is not always clear whether it is an assembly of machines and has therefore become the subject of independent discussion, or whether it concerns a separate machine (or machines).
Also checkout: enforcement of CE-marking rules in the Netherlands

Which regulations on machine safety must be observed?

The Machinery Directive contains a large number of essential health and safety requirements for the design and construction of machinery. In short, according to Article 5 of the Machinery Directive, it must be ensured that the machine complies with the aforementioned essential health and safety requirements.

The Machinery Directive refers to a corresponding appendix on the essential health and safety requirements. However, this appendix comprises many pages and is formulated and designed in an extremely confusing manner.

In addition, manufacturers can choose to manufacture a machine according to a corresponding harmonised standard. Although there is no obligation to comply with such a standard, this gives a presumption of conformity with the essential health and safety requirements covered by the harmonised standard.

In practice, the question of whether or not machinery meets the health and safety requirements is often the basis of litigation in this field.

Function of the CE marking

With the CE marking (CE stands for ‘Conformité Européenne’), the manufacturer, marketer or authorised representative of the EU declares, in accordance with EU Regulation 765/2008, “that the product complies with the applicable requirements laid down in the Community harmonisation legislation concerning its affixing”.

This expresses that the manufacturer, marketer or EU authorised representative knows the special requirements for the product he or she sells and that the product complies with them.

Who is permitted to award the CE marking?

Every product that falls under an EU directive requires a CE declaration of conformity.

If it is clear that a product is covered by an EU directive, and therefore requires a CE marking, a question arises as to whether the manufacturer can independently decide to affix this CE marking or whether he or she must first contact a notified body for this purpose.

As a rule, you as the manufacturer take responsibility for affixing the CE marking. It is a key indicator of a product’s conformity with the applicable EU legal provisions.

In some directives, legislation requires the involvement of an independent and designated testing and certification institute (“notified body”).

Notified bodies can issue an examination and an approval of the quality assessment system, thus allowing the manufacturer to place a certain type of machine, or even different types of machines from a certain production system, on the market with the CE marking.

Technical documentation and EC declaration of conformity

Before machinery can be placed on the market, the manufacturer must have a technical file and must have drawn up the EC declaration of conformity. The declaration of conformity is a written confirmation from the manufacturer that a product meets the requirements of all CE directives.

Several questions in relation to this often arise. One such question is, “Who is the manufacturer, the person placing the product on the market or the EU authorised representative and therefore responsible for product safety?”. Another question that often arises is whether the technical file and the EC declaration of conformity meet the legal requirements.

Who is manufacturer? Who is liable for the product?

It is not always easy to determine who is the manufacturer of a product in terms of the CE directives.

For example, who is referred to as the manufacturer of an assembly of machines when several parties supply a part of a production line? Even if there is no production line, but several separate products are used to build a group of machines, it is not always easy to determine who is considered the manufacturer.

This also raises the question of the liability of the machine manufacturer after the machine(s) have been used by another party for an assembly of machines. What is the solution to this issue of liability?

Procedures: liability for damages, compliance and enforcement procedures

Many proceedings connected with the Machinery Directive are civil liability proceedings or administrative enforcement proceedings. Correct and tailor-made support requires comprehensive knowledge of civil liability law and the EU regulations on public administrative regulations. It also requires a good general technical understanding and a broad network of technicians and experts.

Blenheim’s multidisciplinary team, consisting of both Dutch and German lawyers, is at your disposal at all times to answer any questions you might have on this subject area. We solve legal conflicts efficiently and quickly, avoiding costly and time-consuming legal disputes.