Machinery can be described as "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".
The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy, and theMachinery Directive 2006/42/EC provides the regulatory basis for the harmonisation of the essential health and safety requirements for machinery at European Union level.
Essentially performing a dual function, the Directive not only promotes the free movement of machinery within the Single Market, but also guarantees a high level of protection to EU workers and citizens. Being a "New Legal Framework" Directive, it promotes harmonisation through a combination of mandatory health and safety requirements and voluntary harmonised standards. Such directives apply only to products which are intended to be placed (or put into service) on the EU market for the first time.
The Machinery Directive 2006/42/EC was published on 9th June 2006 and it is applicable from 29th December 2009, replacing the Machinery Directive 98/37/EC.
Guide to application of Directive 2006/42/EC - 1st Edition - December 2009
This 1st Edition of the Guide to application of the Machinery Directive 2006/42/EC includes comments on the Preamble, on the legal provisions set out in the Articles, on the essential health and safety requirements set out in Annex I and on the requirements for Declarations set out in Annex II. The 2nd Edition of the Guide, planned for the spring of 2010, will be completed with comments on Annexes III to XI of the Machinery Directive. It is intended to publish regular updates of the Guide in order to introduce answers to questions agreed by the Machinery Committee and the Machinery Working Group.
New EU Machinery Directive Announced
February 19 2009
Conformity Assessment Procedures
Essential Health and Safety Requirements
On December 29 2009 the new EU Machinery Directive (2006/42/EC) will take effect in Europe, replacing EU Directive 98/37/EC. The directive is a crucial instrument in regulating the free circulation of machinery within the European Union and the European Free Trade Association countries Iceland, Liechtenstein, Norway - as well as Turkey and Switzerland on the basis of special agreements. However, its importance is widely underestimated by machinery manufacturers in the rest of the world. Machinery that does not meet the requirements of the directive cannot be sold in the aforementioned countries, and violations can lead to expensive delays in placing the machinery on the market or enforced recalls. The new directive constitutes part of the so-called 'new approach' towards the technical harmonization of laws and regulations in order to create a uniform and harmonized European market.
The existing directive was introduced with the aim of reducing the number of accidents relating to machines by setting stricter safety standards (ie, by requiring special safety features when designing specific machines). All machinery which is moved within the European Union is subject to the directive's requirements and the same will apply under the new directive.
Under the existing directive, machinery is defined as:
"An assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material."
This definition has been broadened.
According to Article 2 of Directive 2006/42/EC, a 'machine' is now any product listed in Article 1(1)(a) to (f), including:
- interchangeable equipment;
- safety components;
- lifting accessories;
- ropes and webbings;
- removeable mechanic transmission devices; and
- partly completed machinery.
In addition, Article 2 offers another, far more comprehensive explanation of the term 'machine', the details of which can be found in the Official Journal. This expanded definition means that many more products must comply with the safety requirements.
Manufacturers or authorized representatives, defined as "any natural or legal person established in the community" (eg, affiliates or subsidiaries) that produce or distribute products listed in Articles 1(1)(a) to (f) must:
- draw up a declaration of conformity;
- affix and comply with the requirements of CE mark labels;
- provide the necessary instructions, such as an operating manual;
- prepare additional technical documents according to the directive; and
- comply with the "basic requirements for the protection of safety and health for the construction and assembly of machinery" as stated in Annex 1 of the new directive.
- safety components delivered as replacement parts;
- equipment for use in playgrounds and amusement parks;
- weapons, including firearms;
- the following means of transport:
- specific agricultural and forestry tractors;
- specific motor vehicles and their trailers;
- vehicles exclusively intended for competition; and
- vehicles intended for air, water and rail transport;
- seagoing vessels and mobile offshore units and machinery installed on board such vessels or units;
- machinery designed and constructed for military or police purposes;
- machinery designed and constructed for research purposes for temporary use in laboratories;
- mine winding gear;
- machinery intended to move performers during artistic performances;
- household appliances intended for domestic purposes;
- audio and video equipment;
- ordinary office machinery;
- high and low voltage switch gear and control gear;
- IT equipment;
- electric engines; and
Conformity Assessment Procedures
As under the existing directive, the conformity of most machines will continue to be certified by the manufacturer. The simplest way to demonstrate compliance with thedirective is to comply with harmonized European standards covering all the relevant requirements.
In most cases the manufacturer or its authorized representative must determine the essential health and safety requirements applicable to the machinery in question and carry out a risk assessment. The "General Principles" section in Annex I of the directiveprovides some excellent guidance on this area.
The list of categories of machine subject to particular conformity assessment procedures is set out in Annex IV. For these Annex IV products, when harmonized standards are unavailable or do not cover all essential safety requirements or when a manufacturer considers them inappropriate for the product in question, the opinion of an independent third party – a 'notified body' – must be sought. This body's opinion can take the form of either an EC type-examination or an approval of the manufacturer's full quality assurance system. Notified bodies are entitled to carry out the necessary audits and inspections and issue the aforementioned approvals.
The notified bodies are appointed by the member states after having proven that they have the necessary expertise. Although a notified body has various responsibilities under the directive, the manufacturer (or authorized representative) always remains responsible for the compliance of its product.
The new machinery directive requires the member states to monitor the performance of the notified bodies and to withdraw or suspend the notification status of a body if it fails to carry out its duties properly.
The manufacturer or its authorized representative must prepare a technical construction file before drawing up the EC declaration of conformity. Although it is not necessary for all documentation to be made permanently available in material form (eg, in hard copy or electronic form), it must be provided when asked for by the notified body.
The new directive sets out even more explicitly the duties of the member states to organize their market surveillance. These obligations include cooperation between the market surveillance authorities of the member states, but also mandate respect for confidentiality and transparency.
Directive 2006/42/EC enables the European Commission to adopt a decision after consulting the Machinery Committee. It provides the authority to prohibit or restrict the placing on the market of a category of machines presenting risk by virtue of technical characteristics.
Before placing new machinery on the market, the manufacturer must notify the respective market surveillance authorities. These authorities must inform the manufacturers if they suspect that the product does not comply with the directive.
Where machinery introduced to the market before December 29 2009 must continue to comply with Directive 98/37/EC, it cannot be assumed that the product also complies with the new directive. This is due to some modifications to the essential health and safety requirements set out in Annex I of the new directive. Manufacturers must now review their products and adapt them as necessary in order to meet the new directive's requirements. As this also relates to EC type-examination certificates issued under the present directive, these certificates must be updated to refer to 2006/42/EC. At present, the notified bodies carrying out a corresponding review of these certificates and preparing an update of the situation. From December 29 2009, new products can be put into circulation with reference to Directive 2006/42/EC only .
Manufacturers that have introduced products to the market according to one of the procedures set out in Article 8 (2)(c) of the existing directive (ie, Receipt of Technical File or Certificate of Adequacy to Harmonized Standards) must now apply one of the procedures set out in Articles 12(3) and (4) of the new directive since these procedures will become defunct.
However, for products manufactured in accordance with harmonized standards that cover all the relevant health and safety requirements, the manufacturer will now be able to self-certify the conformity of the product according to the procedure set out in Article 12(3)(a) ofDirective 2006/42/EC.
Essential Health and Safety Requirements
Both machinery directives contain a listing of health and safety-related requirements which machinery must meet. The intention of this listing is to ensure that the machinery is safe and is designed and constructed in a way that it can be operated, adjusted and maintained throughout its lifecycle, including during scrapping and dismantling, without putting people, domestic animals or property at risk. A manufacturer must also take into account any reasonably foreseeable misuse of its machinery.
The Principles of Safety Integration in Annex I of the directive provide a detailed overview of the considerations incumbent upon a manufacturer when designing and constructingmachinery. It specifies that a manufacturer's priority is to eliminate or reduce risks as far as possible through inherently safe machinery design and construction. If this cannot be achieved, the manufacturer must take the necessary protective measures in relation to risk that cannot be eliminated. The manufacturer must inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether particular training is required and specify need for personal protective equipment.
Although Annex I declares the health and safety requirements to be mandatory, it contains a loophole. It recognizes that it may not be possible for all machinery to meet all of its objectives taking into account the state of the relevant art. For these cases it declares that the machinery must be designed and constructed in order to comply with the health and safety objectives as far as possible. This provision is hidden away in the annex of thedirective and it remains to be seen whether manufacturers will use it as a provision of last resort in order to continue to keep their products on the market.
For further information on this topic please contact Mark Schönmetzler at Smith & Partners by telephone (+49 7031 439 9600) or by fax (+49 7031 439 9602) or by email (firstname.lastname@example.org).
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