New Machinery Directive - Will you still comply?

The New Machinery Directive came into force at the end of 2009. Unlike previous versions, there was no transitional period for compliance.

The Machinery Directive has been through several incarnations since it was first implemented in the UK by the Supply of Machinery (Safety) Regulations 1992 and the Supply of Machinery (Safety) (Amendment) Regulations 1994. In 2001, improvements designed to simplify and clarify the existing Directive were published as proposals for a third amendment, and the new Directive was published in 2006. This version will become enforceable on 29 December 2009, and unlike previous amendments, there is no transitional period for compliance.

There are radical changes to some parts of the Directive. Affected parties will have to act quickly to address additions to the Declaration and alterations to the essential health and safety requirements (EHSRs), including where they affect control systems, if they are to comply with the new regulations.

To help organisations of all sizes work out how they will be effected, there are useful definitions set out under the Directive. For example, a comprehensive definition of a machine describes an assembly of linked parts or components at least one of which moves, with the appropriate actuator, control and power circuits, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material. And a control system is one that “responds to input signals from the machine, or from the operator, and generates output signals, which make the machine operate in a desired manner”. So if, for example, an operator presses a start button, the control system may respond by closing a contactor and energising a motor.

A further definition is that of a safety-related control system, which is described as one that “contributes to reducing any risk to an acceptable level or if it is required to function correctly to maintain or achieve safety”.

Incidentally, machinery moved by directly-applied manual effort is excluded from the terms of the Directive. The term “machinery” also covers an assembly of machines, which are controlled so that they function as an integral whole – such as a production line.

Expanded scope
It all seems fairly straightforward, but the Scope of the Directive shows otherwise. The Scope includes terms such as safety components, lifting accessories and chains, ropes and webbing. New inclusions further expand the scope to include devices for construction site hoists, and for lifting people with reduced mobility.

Obviously, the physical care and protection of employees and customers should be the first consideration when business owners install and operate machinery. But, as far as the business implications are concerned, the rules and regulations imposed by the Directive are various and sometimes quite stringent.

All of the European directives are brought into UK law by the issue of Regulations, which means that if you don’t comply you are committing a criminal offence punishable by fines – and, possibly, imprisonment.

In fact, the European Commission has underlined the importance of the new directive by instructing that penalties for non-compliance should be “effective and dissuasive”. And in the UK that means a £20,000 fine and/or three months’ imprisonment for a summary conviction, and a £20,000 fine and/or an even more dissuasive two years’ imprisonment for conviction on indictment.

Compliance clearly needs vigorous attention but, in short, it involves four key requirements:

• demonstrating compliance with the essential health and safety requirements;
• carrying out the appropriate conformity assessment procedure;
• drawing up and issue the Declaration of Conformity or Incorporation; and
• applying the CE Mark.

Bear in mind that the Directive doesn’t concentrate simply on one item at a time – processes and systems are also involved. If you are creating a complex assembly, such as a production line, by interlinking a series of existing machines, you are effectively creating something new – so the whole assembly must comply with the Directive. Similarly, altering the function or performance of a machine or complex assembly is also essentially creating a new machine, which must comply. If, for example, you are started a project to build an assembly towards the end of 2009, you may now need to ensure that the project is using the new Directive as you will not be able to produce a final declaration under the old Directive. Similarly, if your products have been series manufactured, having been CE Marked at the start of the series production, the Declarations will no longer be valid, so whole product ranges will need to be recertified to the new Directive before they can go on sale this year.

Alterations to the EHSRs are too numerous to detail here, but they affect issues such as ergonomics, operating positions, seating, lighting, manual controls, starting machinery, stability of machinery, protection devices, machinery instructions, plus machinery for foodstuffs and for cosmetic and pharmaceutical products.

The need to conform
There are also key changes to the Declaration of Conformity. The person who is authorised to compile the Technical File must be established in the European Community. Where appropriate, there must be a statement confirming Declaration of Conformity with other applicable directives. And there is no longer a separate declaration for safety components, and the declaration must be typewritten or handwritten in capital letters.

There are also significant additions and changes to the EHSRs that will affect machine design, including requirements for guarding and control systems. Some of the safety devices that fall under the scope of the Directive include, as already mentioned, control devices for calling lifting appliances and antifall devices for hoists, plus monitoring devices for loading and movement control in lifting machinery – as well as solenoid valves controlling dangerous movements of machinery.

Control systems, says the Directive, must be designed and constructed in a way that will prevent a hazardous situation arising. Manual controls must be clearly visible and identifiable, and the use of pictograms is recommended. And an operator must, from each control position, be able to ensure that no one is in the danger zone – even if that means that the machinery can be controlled only from positions in one or more predetermined zones or locations.

Starting is covered too. The Directive states that it must be possible to start machinery only by the voluntary action of a manual control provided for that purpose. The restarting of a machine or a change in operating conditions may however be effected by the voluntary action of a device other than the manual control provided for that purpose, unless this would lead to a dangerous situation.

There are obviously many more issues contained within the new Machinery Directive, and it is vital that business organisations move in good time to make sure that they comply. But it is worth underlining here that in terms of control integrity, there are other European Standards in force that are also relevant.

EN 954-1 Safety of Machinery – Safety Related Parts of Control Systems, the standard that previously applied to all safety-related parts of control systems, will be replaced by two standards that co-exist. The original standard will remain valid until November 2011 to provide a period of transition to the new version. People that design and install electronic safety systems can choose between the requirements of either EN ISO 13849-1 or EN/IEC 62061, and still fully comply with the European Machinery Directive.

In general terms, EN ISO 13849-1 takes a four-stage approach to the design of safety-related control systems:

1. Perform a risk assessment (EN ISO 14121).
2. For the identified risks, allocate the safety measure (Performance Level or PL).
3. Devise a system architecture that is suitable for the PL.
4. Validate the design to check that it meets the requirements of the initial risk assessment.

The New Machinery Directive

The new Machinery Directive is a necessary move forward with the increasing movement of businesses and their plant within the European Community, and with the growing importance placed on the health, safety and well-being of the people that work with or near the machinery. But it still places a demanding requirement on a vast range of businesses.

The decision that needs to be made in every quarter is whether there is sufficient manpower, let alone expertise, inhouse to carry out the necessary risk assessments and make changes – or whether it is necessary to outsource the task. Either way, companies need to make sure that they are completely upto-date, properly informed and ultimately compliant.