In 2009, EU Machinery Directive 2006/42/EC became mandatory for manufacturing companies selling or distributing products in the European Union. While it’s by no means new, Directive 2006/42/EC is a powerful piece of legislation that requires special attention from manufacturers looking to expand into the European market.
A directive, as differentiated from a regulation, is a legislative act that defines a goal that all member states of the EU must achieve. But, each member state must decide how. Meanwhile, a regulation is “self-executing” and does not require measures of implementation. A regulation is completely binding to member states and they have to apply it exactly the way it’s written. With a directive like Machinery Directive 2006/42/EC, member states have the ability to interpret with some amount of leeway, as long as the end result as it is outlined in the text of the directive is the same.
Inside EU Machinery Directive 2006/42/EC
Directive 2006/42/EC is a modification of several older directives published by the European Commission. Back in the 1990s, the European Commission first drafted Directive 89/392/EEC, which applied to manufacturers operating in the EU. These were replaced by updates 91/368/EEC, 93/44/EEC, 93/68/EEC and 98/79/EC.
Directive 2006/42/EC and associated European regulations address both manufacturers of machine and safety components, machinery distributors and users. Directive 2006/42/EC lays down the foundation and regulatory basis for the harmonization of Essential Health and Safety Requirements (EHSR) in the field of machinery at Community level. It addresses a number of problems with the original directive, such as overlap with other regulations.
The “2006” part of the 2006/42/EC directive was the year of the regulation’s authoring, but it was accepted and published in all EU languages in January 2008. Because of all the advanced warning, no transition period took place in 2009, as manufacturers had more than three years to adjust and meet requirements.
Since its implementation, manufacturers must be completely compliant with Machinery Directive 2006/42/EC in order to distribute or sell within the EU. Additionally, full compliance with the directive is required in order for a product to carry the CE Mark.
The CE Mark and Why It’s Important
EU directives are important for manufacturing companies because they affect the ability of a product to carry a CE Mark. The letters “CE” appear on many products sold in the European Economic Area (EEA). When products carry a CE mark, they have met the EU’s standards for health, safety, and environmental protection. CE marks also signify that a company’s product has been made following the same rules as everyone else in the marketplace, encouraging fair business practices and competition.
When a business has a CE mark on a product, it indicates that the product is compliant with all EU directives that apply to it, and can thus be traded in the EEA without restriction. This is a huge advantage for product acceptance in this region.
Who Does the Directive Apply To?
How do you know if your product is affected by these changes? According to the wording of the directive, machines with the following specifications are affected:
- An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application
- An assembly referred to in the first indent (above), missing only the components to connect it on site or to sources of energy and motion
- An assembly referred to in the first and second indents (above), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure
- Assemblies of machinery referred to in the first, second and third indents (above) or partly completed machinery (also a defined term, see below) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
- An assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort
According to Article II, there is another, even broader scope of machines and machine components that must meet 2006/42/EC standards. These include:
- Interchangeable equipment defined as a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool
- Safety component defined as a component which:
- Fulfills a safety function
- Is independently placed on the market
- Endangers the safety of persons if it fails or malfunctions
- Is necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function
- An indicative list of safety components is set out in Annex V , which may be updated in accordance with Article 8(1)(a)
- Lifting Accessory defined as a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories
- Chains, Ropes and Webbing means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories
- Removable Mechanical Transmission Device means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product
Translation Requirements
Machinery Directive 2006/42/EC outlines some requirements for translation in section 1.7.4.1 – 1.7.1.3. Annex I Section 1.7.4. Specifically, the directive requires that any definitive or original instructions must be included with a product alongside the full translation of those same instructions into the appropriate European community language.
Alternatively, if a machine has been imported by an EU user and the instructions are not translated into the language of the EU state they are importing to, this EU user has the option to translate the instructions on behalf of the manufacturer. The EU user is responsible for the validity of the translations.
This particular requirement regarding translated instructions can be a huge hurdle for large companies operating in the EU without a translation partner with experience in the EU market and industry expertise. Because the translations of the instructions are linked to the liability of the manufacturer or importer of a machine, accurate and high quality translations in official European languages are crucial for risk management and overall acceptance in the marketplace.
Full compliance with Machinery Directive 2006/42/EC is essential for success in the EU. Working within complicated regulations can be difficult and confusing at times, but full understanding and partering with the right experts can get you far in the global market.
