Not a day goes by in my life during which I am not “confronted” with the European Union. Not only does my city of residence Barcelona boast an impressive number of inhabitants with different EU nationalities, I also notice that many of the different products I use at work, at home, and on the street come from other European countries – apart from the oranges and my favourite olive oil, perhaps. Barcelona may be an extreme example, but it is fair to say that this omnipresence of the EU is a reality in every corner of its territory. It goes to show how important and influential the union’s principles of freedom of movement (of both people and of goods) within and between the member states are.
It is this freedom of movement of goods that has made exporting products to other member states very interesting for European businesses. There are of course rules that regulate these exports, but in return for following them the market potential for any EU producer or manufacturer has multiplied! As I deal with several customers that are active in the machinery and manufacturing industry, today I would like to delve into the specific rules that govern the introduction of products onto any of the EU markets: the so-called Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery – or Machinery Directive in short. This 2006 publication replaced the 1998 version, which in turn had replaced the first Machinery Directive that came into effect in 1995.
In the words of the EU itself, the aim of the Machinery Directive is twofold:
- it “promotes the free movement of machinery within the Single Market”, and
- it “guarantees a high level of protection for EU workers and citizens”. The Directive is not only applicable in all EU countries, but also in Iceland, Liechtenstein, Norway (members of the European Economic Area), and additionally in Switzerland and Turkey.
The current text was approved in 2006 and came into effect at the very end of 2009, and applies to all machinery brought onto the market or put into service after that date. Just to be clear: the Directive also applies to manufacturers from outside the EU who want to introduce their products in one or more EU countries. The Directive does not apply to machinery manufactured within the EU but intended for markets outside of the EU (although those markets may have their own regulations).
What is the definition of machinery according to the EU Machinery directive?
What products are we talking about here? Let us throw in a definition: with some notable exceptions (automobiles, household appliances, to name but a few), the term ‘machinery’ refers to a set of components that are put together for a specific use, with at least one of those components moving, and fitted (or to be fitted) with a drive system that is powered by a form of energy other than that generated by humans or animals.
An article where we see the two objectives of the directive clearly combined is Article 5. It reads: “Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall […] provide, in particular, the necessary information, such as instructions […]”. On the one hand, it tells manufacturers what to do in order to be able to move their machinery within the EU, while on the other it provides specific instructions to safeguard its operators. It is important to understand that all these obligations are to be met at the moment the machinery is placed on the market, that is to say the moment the machinery is transferred from the manufacturer to a distributor or user.
Which information or documentation must be provided according to the EU Machinery Directive?
Now, what does the EU Machinery Directive say about this “necessary information”? First, there is an obligation to put a lot of information and warnings on the product itself: business name and address of manufacturer, designation of machinery, CE marking, designation of series or type, serial number, year of construction. Also to be included is any information concerning essential aspects of safe use, preferably in the form of clear and simple symbols or pictograms. Should there be any written or verbal information or warning on the product, this will have to be expressed in one or more of the official EU Languages – and it is the Member State in which the product is put on the market or taken into service that can determine which language(s) that should be.
Digital or print documentation?
No matter how big a machine is, it will obviously never be possible to put all relevant information about how to install, operate, and maintain it on the product itself. Therefore, all machinery must be accompanied by an instruction manual, either in physical (paper) or digital format. Even though there are no specific rules set for the format of the instruction manual, most specialists agree it is best to provide them on paper, as not all operators working with machinery will have easy access to a carrier of digital information (pc, laptop, tablet, etc.).
In recent times, however, we do see a trend towards digitalization: there is a growing number of companies that provide their machine operators with tablets or large-screen smartphones to do away with paper. While for these companies just the digital version will suffice, in general it is still common practice that both a paper version and a digital version are provided: in the “traditional” set-up, this allows the operator to print out the manual again should the paper version have been lost or have become unreadable.
According to the specifications provided in Annex I of the Directive, the instruction manual must not only cover the “intended use of the machinery”, but should also focus on “any reasonably foreseeable misuse thereof”. It then gives a long list of obligatory information that is to be included, about topics such as the installation and connection instructions, protective measures, operating methods, and many more.
Which EU languages?
As for the language of the instructions, article 1.7.4 (Annex I) gives two basic rules. First, machinery needs to be accompanied by instructions in the official EU language or languages of the country where it will be placed on the market.
What happens in countries with more than one official EU language? That depends. In Cyprus, Malta, and Ireland the sole use of English is accepted. Belgium and Finland, with three and two official EU languages respectively, accept the use of one language only in areas where only that language is spoken.
If a machine is intended for the bilingual region of Brussels, instructions will therefore have to be in both French and Dutch.
The concept of original instructions within the context of the EU Machinery Directive
The second rule is that machinery must always be accompanied by original instructions. In this context, original instructions are those that have been verified by the manufacturer or its authorized representative. If for example, instructions are written in English and then verified by the manufacturer, they are the original instructions. If the machine is then put on the market in Poland, the manufacturer has two options. The first approach is to provide the English instructions together with a Polish translation – the latter needs to have “Translation of the original instructions” written on it. In case of doubt about a particular instruction, the operators can always refer to the English original – this text will be leading.
As a second option, the manufacturer or its authorized representative in Poland may opt to verify the Polish version; by doing so, they “promote” this Polish version to “original” status, assuming all responsibilities for any discrepancies between English and Polish versions. In this scenario, only the Polish instructions have to accompany the machinery. Some translation agencies provide a service in which they not only deliver certified translations, but also explicitly assume responsibility for any damage caused by objective mistakes in their translations.
EU Machinery Directive compliance
Taking a decision on the best language strategy is complex and requires good planning. Whatever strategy a manufacturer takes, time is needed. As the instructions have to accompany the machine the moment it is placed on the market, translation will have to take place at an earlier stage. If the translation is to be verified in order to be used as “original instructions”, additional time will be needed for this verification process.
As printing your manuals can be costly, it makes sense to enquire about the necessity of providing hard copies. If your customer has decided to “go digital”, this can have cost-saving consequences for you! If a paper version is required when delivering both original and translated instructions, I would suggest to only print the version in the local language, and deliver the original instructions digitally.
Have you had any interesting experiences applying the EU Machinery Directive?
Do you sometimes face issues to meet the obligations of the EU Machinery Directive?
I would love to hear from you and have a look at the specific impact of these European rules on your business together.
Get in touch now – in any format you wish, in one of the several EU languages I speak 😊.