Since 1995 all new machinery in scope of the Machinery Directive has to be designed and constructed to meet common minimum European requirements for safety. The outward signs of compliance are CE marking on the equipment and a document (Declaration of Conformity) issued by the Responsible Person (normally the manufacturer) declaring the product's conformity. To achieve compliance the Responsible Person must undertake a conformity assessment process to meet the Directive's obligations. This includes meeting all relevant essential health and safety requirements (EHSRs) for the product, producing comprehensive user instructions, and showing how compliance has been achieved in the technical file. For certain higher risk products the conformity assessment process will normally require the use of an independent Notified Body.
These requirements have been implemented in the UK by the Supply of Machinery (Safety) Regulations 2008, as amended by the Supply of Machinery (Safety) (Amendment) Regulations 2011. In addition to machinery these requirements also apply to interchangeable equipment, safety components placed independently on the market, lifting accessories, chains, ropes and webbing, removable transmission devices and partly completed machinery. These regulations are enforced by the HSE in Great Britain for most industrial and professional products or local trading standards services for consumer products.
Manufacturers of new machinery (and other products in scope) to be placed onto the European-wide market of the European Economic Area (EEA) must design, construct and supply safe products that comply with the Machinery Directive 2006/42/EC. In particular, they must be designed and built to meet the relevant essential health and safety requirements listed in Annex 1 of this Directive. This requirement applies to the manufacturers of machinery, even where it is for their own use. It also applies to those who modify existing machinery to such an extent it must be considered a new machine, and to those who bring existing non-CE marked machinery onto the EEA market, or into service, for the first time.
Importers, distributors and suppliers should ensure that only safe and compliant machinery (CE marked and accompanied by a Declaration of Conformity and instructions in the language of the end user) is placed onto the EEA market. A printable leaflet Supplying new machinery outlines machinery supplier's duties.
Users of new machinery should ensure that they only selected and put into service new machinery which is safe and complaint, keeping it safe and compliant in use. A printable leaflet Buying new machinery outlines what machinery purchasers should do.
The Machinery Directive is one of a number of "New Approach" Directives concerned with the implementation of a common European market for free trade between EU member states. The principal effect is to remove barriers to trade by requiring common standards for the health and safety of new products. It is intended to be applied equally and consistently throughout the EU and the other trade partners of the EEA, to facilitate a free open common market for products within scope (most new machinery and some other related equipment).
The current Machinery Directive (2006/42/EC) came into full effect from 29 December 2009 and is implemented in the UK by the Supply of Machinery (Safety) Regulations 2008. This Directive updated and replaced the earlier Machinery Directive 98/37/EC, which in turn replaced the first Machinery Directive 89/392/EEC. This was originally implemented in the UK by the Supply of Machinery (Safety) Regulations 1992, later amended in 1994 and 2005, but these were repealed and replaced in full at the end of 2009 by the current regulations. Where possible the UK regulations implement the European Directive by copying the text unaltered, in particular the Annexes, such as Annex 1 detailing the essential health and safety requirements (EHSRs) for machinery and other products in scope.
The Supply of Machinery (Safety) Regulations are made under the European Communities Act 1972. This means they are not a regulations made under the HSW Act (referred to as "relevant statutory provisions"). However, in the case of products for use at work, the investigation and enforcement powers of the HSW Act such as Prohibition and Improvement Notices, initiating legal proceedings, are called up by schedule 5 of the Supply of Machinery (Safety) Regulations. This means HSE deals with any non-compliance in a similar way to other health and safety matters. This includes the right of recipients of enforcement Notices to appeal to an Employment Tribunal within 21 days of the Notice being served. Most offences under the Supply of Machinery (Safety) Regulations are triable either way, giving the options of trial either in a Magistrates Court (maximum financial penalty of £5000 per offence) or the Crown court (where the financial penalty can be unlimited, and imprisonment for a term not exceeding two years can also be imposed). Different provisions for enforcement by Trading Standards Authorities, who enforce the Machinery (Safety) Regulations for consumer goods, are made under the 1987 Consumer Protection Act.
The basic requirements of the Machinery Directive (compliance with EHSRs, compiling a technical file, CE marking, Declaration of Conformity, provision of user instructions) have not changed since it was first implemented throughout the EU in the 1990s. Also unchanged are the fundamental principles for the health and safety of machinery by design and construction. The wording and order of the EHSRs have evolved a little, mostly to clarify what was meant, and to add some new requirements as the Directive's scope expanded (eg the inclusion of safety components placed independently on the market).
A further amendment to the Directive (2009/127/EC) was published in 2009. This relates principally to environmental protection aspects of machinery for applying pesticides (so should not affect the majority of products within scope of the Machinery Directive). All EU member states must apply these new provisions from 15 December 2011.
New amending regulations, the Supply of Machinery (Safety) (Amendment) Regulations 2011) will implement this change from 15 December 2011. It is not expected that this small change will profoundly affect product manufacturers of machinery for applying pesticides as many of these aspects should have already been considered and designed for by the current manufacturers of these products. However, manufacturers of machinery for applying pesticides will need to re-visit their conformity assessment process, checking it takes the new EHSRs fully into account, and ensure that technical files and other documentation is updated accordingly.
In common with most other New Approach product Directives, the Machinery Directive requires products in scope (including almost all new machinery) by design and construction to:
In order to meet the requirements of any Directive it helps to understand the key definitions, particularly what is 'machinery', and which machinery is in scope, as well as which machinery is not in scope.
The manufacturer, or the manufacturer's authorised (in writing) representative in Europe (in the UK they are known as the Responsible Person), carry the full responsibility for the safety and conformity of the product. This duty must be met before the product is placed on the market or put into service. If the manufacturer, or the manufacturer's authorised representative, is UK based they must meet these requirements as implemented by the Supply of Machinery (Safety) Regulations 2008 (as amended).
Intermediate suppliers do not have responsibilities under the Supply of Machinery (Safety) Regulations 2008, unless they are also the Responsible Person (eg import non CE marked machinery from outside the EEA). However, they will have general responsibilities to ensure the item is safe under section 6 of the HSW Act.
Users who make machinery for their own use also have the full manufactures' responsibilities for CE marking and compliance with the Supply of Machinery (Safety) Regulations. This must be done before they put the machine into service for the first time. Users who directly import non-CE marked machinery from outside the EEA also have to meet the Supply of Machinery (Safety) Regulations as if they were the manufacturer.
Under the Machinery Directive (and other European provisions), member states have a responsibility to undertake market surveillance of products placed on the market. The designated market surveillance authority, such as the HSE, are required to be adequately organised and empowered to perform these functions.
There is a legal presumption (Article 7 of the Directive) that CE marked machinery accompanied by a Declaration of Conformity complies with the Directive. Although such products placed on the market are entitled to free movement their compliance with the Directive can be checked by the market surveillance authority. Where provisions are found not to be satisfied appropriate enforcement of the provisions of the Directive will be made. Where the health and safety of persons (and where appropriate that of domestic animals or property) is liable to be compromised, member states must take all appropriate measures, for example by prohibiting the placing on the market, withdrawal of the product from the market, or restricting its free trade (Article 11).
Accordingly the Supply of Machinery (Safety) Regulations make provision for market surveillance, including enforcement in the UK and have appointed HSE to cover most industrial products in Great Britain (in Northern Ireland this duty is given to HSE NI).