ST 004-10 Lohr, 2010-03-30

Machinery Directive 2006/42/EC — 100 Days On

Rexroth Safety Experts Answer the Ten Most Frequently Asked Questions

Even 100 days after it came into effect, there are still some outstanding questions about the application of Machinery Directive 2006/42/EC. Over the past few years, Rexroth has already launched various information campaigns concerning the issue of machine safety, and several hundred designers have since attended numerous events run by the drives and control systems manufacturer. Rexroth has also set up a helpdesk at where safety specialists answer questions about the current standards sector. To launch the series, Rexroth has put together a Q&A of the ten most frequent issues surrounding Machinery Directive 2006/42/EC. Another “Industry Trends” focuses on the ten most frequent questions asked about the EN ISO 13849 standard.

1. What are the advantages of Machinery Directive 2006/42/EC?

Machinery Directive 2006/42/EC reflects the current state of technology. It contains clarifications and additions compared to the old machinery directive; thus ensuring greater legal certainty for manufacturers as it includes more accurate information on the distinction from other guidelines, the area of application and on numerous terms.

2. Which products are affected by Machinery Directive 2006/42/EC?

In comparison to the machinery directive applicable up to the end of 2009, the new version regulates a considerably larger area of application. Article 1 defines this scope: machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery. The express inclusion of partly completed machinery provides clarification on previous versions.

3. What are a manufacturer's tasks when placing machinery on the market?

According to the new machinery directive, manufacturers must ensure that their products comply with the health and safety requirements it sets out. This also means that the manufacturer must make the necessary technical documentation available and—as is the case with operating instructions—attach this to the machine. The machinery directive also stipulates that the appropriate procedures for assessing conformity are carried out for the machine and that an EC Declaration of Conformity is enclosed with the machine. The manufacturer must also affix a CE mark to the machine.

4. What needs to be taken into account for partly completed machinery?

Partly completed machinery come explicitly under the area of application of the machinery directive. For this machinery, however, only the sections in which they are specifically mentioned are applicable. For example, Article 13 describes the procedure that partly completed machinery has to be run through before it is placed on the market. Here, the manufacturer must ensure that he produces the relevant technical documentation in accordance with Annex VII, Part B, the assembly instructions in accordance with Annex VI and has also issued a Declaration of Incorporation in accordance with Annex II, Part 1, Section B. The assembly instructions and the Declaration of Incorporation—formerly the Manufacturer's Declaration—form part of the scope of delivery of the partly completed machinery. The assembly instructions must be drafted in an official EU language accepted by the customer of the partly completed machinery.

5. Does it suffice to publish the machine operating instructions on the Internet?

The machinery directive does not make any explicit specifications as to the form and medium of the operating instructions. However, the content of the operating instructions forms part of the safety measures, and users must be able to clearly link them to the machinery. In most cases, the information in the operating instructions is relevant from the time of assembly. From this time on, the manufacturer must ensure that the user is able to access the information required in line with the machinery directive. Operating instructions that are only available on the Internet do not guarantee this access, as not all users have access to the Internet at all times. In addition, providing operating instructions solely on a CD/DVD does not fulfill the requirements because it is not possible to guarantee that the devices these are played on now will still exist in 20 years time. In order to fulfill the requirements of the machinery directive, the most sensible option therefore, is to provide a traditional "paper solution" in addition to the digital media.

6. Why does a risk assessment need to be created?

Creating a risk assessment at the start of the design phase is essential for determining the applicable health and safety requirements for the machine. The manufacturer must design and build the machines in line with the results of this risk assessment. The risk assessment must not only take the intended usage of the machine into account but also every reasonable, foreseeable instance of incorrect usage. The risk assessment is an important document for the machine manufacturer in the event of potential liability claims resulting from an accident. According to the machinery directive, the risk assessment does not form part of the scope of delivery but remains with the manufacturer, unless otherwise agreed in contractual regulations.

7. At what point is a significant change made?

The decisive factor is whether new, serious hazards occur or the risk is considerably increased as a result of the change. Only a new risk assessment can indicate whether it concerns a significant change. The German Federal Ministry for Labor and Social Security (BMA) has published an interpretation paper about "Wesentliche Veränderung von Maschinen" [Significant changes to machines] that has been coordinated with the Federal States, the employers' liability insurance associations and the German Engineering Federation (VDMA).

8. Which products require a CE mark?

The machinery directive specifies the use of a CE mark for machines. This is based on the EC Declaration of Conformity. However, the machinery directive makes no provisions for partly completed machinery to use the CE mark. Theoretically, there is a danger of mixing up partly completed machinery with a "CE" mark with a complete machine. In accordance with the machinery directive, a CE mark is therefore not permitted for partly completed machinery, although the manufacturer must still always observe the relevant statutory provisions when placing partly completed machinery on the market. This means that partly completed machinery can fall under other directives that may in turn require a CE mark. Here, the manufacturer can clarify—for example, in the case of an applicable CE mark—the compliance of the partly completed machinery with the EMC or ATEX directive — but not with the machinery directive at the same time.

9. Does the manufacturer need to issue an EC Declaration of Conformity for every relevant directive?

It is not necessary to issue a single EC Declaration of Conformity for every applicable directive; rather it is sufficient to list all relevant directives for the product in one EC Declaration of Conformity. In doing so, the manufacturer must consider the requirements specified in the individual directives.

10. Where can I find more information about Machinery Directive 2006/42/EC?

In December 2009, the Machinery Directive Working Group issued guidelines on the current machinery directive under the title "Guide to application of the Machinery Directive 2006/42/EC". This interpretation is currently only available in English. An updated version of the VDMA position paper on Machinery Directive 2006/42/EC, to which Rexroth also contributed, is intended for release midway through this year. Practical support is available on the Internet in the Rexroth guidelines "10 Steps to Performance Level".

Bosch Rexroth AG is one of the world’s leading specialists in the field of drive and control technologies. Under the brand name of Rexroth the company supplies more than 500,000 customers with tailored solutions for driving, controlling and moving. Bosch Rexroth is a partner for industrial applications and factory automation, mobile applications and using renewable energies. As The Drive & Control Company, Bosch Rexroth develops, produces and sells components and systems in more than 80 countries. In 2008 Bosch Rexroth AG, part of the Bosch Group, achieved sales of around 5.9 billion Euro with 35,300 employees.

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