David Collier, business development manager, Pilz Automation, clears up some of the confusion and misguidance over the Machinery Directive, 2006/42/EC.
Many industrial pundits, including relatively new suppliers of safety components, talk of the ‘new’ Machinery Directive, with some even stating that it came into force earlier this year.
However, the current Machinery Directive, 2006/42/EC, has been in place since the end of 2009 and compliance with its essential health and safety requirements (EHSRs) has been mandatory for a manufacturer placing a machine on the European community market since then.
The Machinery Directive is the instrument that all EU member states have adopted to establish the safety requisites that machinery must possess in order to be introduced into the community market. Its objectives are to ensure the free movement of goods in all the member states, and to ensure identical safety requirements for machinery in every country.
The EU Commission issues this directive, which is transposed into UK national law by the government as the Supply of Machinery (Safety) Regulations, and is enforced by the HSE. As such compliance with the Directive’s requirements is mandatory.
Authorised bodies (such as the CENELEC and CEN) issue standards which are harmonised to the directive and offer recommendations or best practice, and as such are not mandatory.
A manufacturer is the person responsible for designing and manufacturing a product with a view to placing it on the community market on his own behalf. This includes those who significantly modify existing machines, link machines to form a new machine production line, or import machines from outside the European economic area for use within Europe.
The manufacturer has an obligation to ensure that the machine is designed, manufactured and conformity assessed to the essential requirements of all the applicable directives (including the Machinery Directive, and possibly others such as LVD, EMC, ATEX, PED). A CE mark must be placed upon the machine to symbolise the conformity of the product with the applicable directives, and that appropriate conformity assessment procedures have been completed. A signed Declaration of Conformity must be produced, declaring the applicable directives and the means by which presumption of conformity has been met.
One way of demonstrating compliance is through the use of standards which have been harmonised to the directive. These emanate at international level from either the International Standards Organisation (ISO) or the International Electrotechnical Commission (IEC), and later are adopted into Europe as Euronorms (EN), and at national level as British Standards (BS) in the case of the UK. Euronorms can be harmonised to relevant European directives, and eventually they can be withdrawn.
The confusion promoted by less well informed pundits about what happened at the end of last year has nothing to do with the Machinery Directive being ‘new’ - what actually happened was that EN 954-1, the standard for safety related controls on machinery, was withdrawn from the list of standards on the Official Journal which provides presumption of conformity to the Machinery Directive. There are now two alternatives to EN 954-1, these being EN ISO 13849 or EN 62061, both giving wider scope than EN 954-1 to cover more modern technologies than were available when EN 954-1 was first written, including devices such as software configurable controllers using Safety Related Application Software (SRASW).
An important point to note is that the use of standards is not mandatory - they are best practice documents. What is mandatory is compliance with the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive. Users can use whatever means they like to achieve compliance, although it can be very costly and difficult. The use of standards such as EN ISO 13849 or EN 62061 provide perhaps the most convenient way when it comes to safety related controls because they are harmonised to the directive and are viewed as best practice.
We should not forget that there is an ‘end user’ directive relevant to machines - the Amended User of Work Equipment Directive 2009/104/EEC. It stipulates that the employer shall take the necessary measures to ensure that work equipment made available to workers is suitable for the work, without impairment to their safety or health. This directive was adopted into UK Law on 5th Dec 1998 as the current Provision and User of Work Equipment Regulation (PUWER) 1998. A user who is about to buy a machine should look for the CE mark and Declaration of Conformity, and before placing it into use, conduct and document a PUWER assessment.
Key factors to comply with include protection from dangerous machinery parts, conditions of work equipment, training of workers, written safety instructions, and requirements on control and electrical systems. Of relevance to this last part is regulation 18 ‘Control systems’, for which the HSE issued a guidance note which basically states that EN ISO 13849-1 (no longer EN 954-1) provides guidance on control systems ‘so as to achieve high levels of performance related to safety’. This applies to new and existing machines when carrying out a PUWER assessment.
Manufacturers and users of machines should carefully consider from whom they purchase safety products (such as safety controllers) and services (such as training), basing their choice partly on the level of the supplier’s competence to correctly educate/inform on matters of compliance, as well as the ability to select the optimum solution, assist in such activities such as design/programming/configuration, and to provide good technical support.
David Collier is business development manager at Pilz Automation Technology, and delivers training on EN ISO 13849-1, EN 62061 and Pilz’s safety software PAScal.
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