- June 25, 2008
- Scientific Technologies, Inc.
- Feature
Summary
European safety legislation is significant and far reaching. At first glance, it can seem like just more red tape which compounds the problems of operating in a highly competitive world. The truth, however, is far from this. The legislation is based on experience and common sense and represents a consistent message for industry — it must be safe! The rational behind the framework of measures is to ensure the safety of individual workers whoever or wherever they may be.
So what do you and the rest of industry do now?
What are the specific steps required for conformity with the law?
In order to formulate your course to conformity you must have an understanding of the basic structure of the legislation and its accompanying standards.
First of all, what is the law and which regulations are applicable? There are two European Directives which are general in nature and are of direct relevance to the safety of most types of industrial machinery and equipment. These are: The Machinery Directive and The Use of Work Equipment by Workers at Work Directive.
These two Directives are directly related. The Essential Health & Safety Requirements (EHSRs) from the Machinery Directive can be used to confirm the safety of equipment in the Use of Work Equipment Directive.
This section deals with aspects of both of these directives and it is strongly recommended that anyone concerned with the design, supply, purchase or use of industrial equipment within the EC and EFTA countries familiarize themselves with their requirements. It is an inescapable fact that suppliers and users of machinery will simply not be allowed to operate in the EC unless they conform with these directives. Having the knowledge to "get it right" is very important.
There are several other European Directives, either in place or being prepared, with relevance to industrial safety. Most of them are fairly specialized in their application and are therefore not discussed here. However it is important to note that, where relevant, their requirements must be met. Examples are—The Low Voltage Directive, The EMC Directive, and The Prevention of explosion due to hazardous atmospheres Directive.
The Machinery Directive
89/392/EEC as amended by 91/368/EEC and 93/44/EEC
This Directive covers the supply of new machinery and other equipment including safety components. In most cases it is an offense to supply machinery unless it complies with the Directive. This means that it must satisfy the essential safety requirements contained in Annex I of the Directive, a correct conformity assessment must be carried out and a "Declaration of Conformity" must be given.
The Directive came into full force for machinery on January 1, 1995 and for Safety Components on January 1, 1997. It is the responsibility of the manufacturer, importer or end supplier of the equipment to ensure that equipment supplied is in conformity with the Directive.
Essential Health & Safety Requirements
(referred to as EHSRs)
The Directive gives a list of EHSRs to which machinery must comply where relevant. The purpose of this list is to ensure that the machinery is safe and is designed and constructed so that it can be used, adjusted and maintained throughout all phases of its life without putting persons at risk. It gives a hierarchy of measures for eliminating the risk:
(1) Inherently Safe Design—Where possible the design itself will prevent any hazards from arising. Where this is not possible
(2) Additional Protection Devices—e.g., Interlocked guards, light curtains, sensing mats etc. should be used. Any residual risk which cannot be dealt with by the above methods must be contained by
(3) Personal Protective Equipment and/or Training. The machine supplier must specify what is appropriate.
Suitable materials should be used for construction and operation. Adequate lighting and
handling facilities should be provided. Controls and control systems must be safe and reliable. Machines must not be capable of starting up unexpectedly and should have one or more emergency stop devices. Consideration must be given to complex installations where processes upstream or downstream can effect the safety of a machine. Failure of a power supply or control circuit must not lead to a dangerous situation. Machines must be stable and capable of withstanding foreseeable stresses. They must have no exposed edges or surfaces likely to cause injury.
Guards or protection devices must be used to protect risks such as moving parts. These must be of robust construction and not be easy to bypass. Fixed guards must be held in place by fixings which can only be undone with tools. Movable guards should be interlocked. Adjustable guards should be readily adjustable without the use of tools.
Electrical and other energy supply hazards must be prevented. There must be no risk of
injury from temperature, explosion, noise, vibration, dust , gasses or radiation. There must be proper provision for maintenance and servicing. Sufficient indication and warning devices must be provided. Machinery shall be provided with instructions for safe installation, use, adjustment etc.
Conformity Assessment
The designer or other responsible body must be able to show evidence in the form of a technical file that proves conformity with the EHSRs. This file should include all relevant information such as test results, drawings, and specifications, as shown in the following section.
Where equipment is designed to specified harmonized European standards it simplifies the task of showing conformity. These standards are not legally compulsory, however, their use is strongly recommended as proving conformity by alternative methods can be an extremely complex issue. The structure of these standards which are produced by CEN (the European Committee For Standardization) and CENELEC (the European Committee For Electrotechnical Standardization) to support the Machinery Directive are explained later in this guide. Together CEN and CENELEC form the Joint Institute For Standardization In Europe.
A thorough documented risk assessment must be conducted to ensure that all hazards at the machine are dealt with.
Technical File
The person responsible for a Declaration of Conformity must ensure that the following documentation will be available on his premises for inspection purposes.
A
A technical file comprising:
• Overall drawings of the equipment together with control circuit drawings
• Full detailed drawings, calculation notes etc. required to check the conformity of the machinery with the EHSRs.
• A list of:
1. The EHSRs relevant to the equipment.
2. Harmonized European Standards used.
3. Other standards used.
4. Other technical specifications used in design.
• A description of methods adopted to eliminate hazards presented by the machinery
• If desired, any technical report or certificate obtained from an approved body (test house) or laboratory.
• If conformity is declared with a Harmonized European Standard, any technical report giving test results for it.
• A copy of instructions for the machinery.
B For series manufacture, details of internal measures (quality systems etc.) to ensure that all machinery produced remains in conformity.
The manufacturer must carry out necessary research or tests on components, fittings or the completed machinery to determine whether by its design and construction it is capable of being erected and put into service safely.
The technical file need not exist as a permanent single file but it must be possible to assemble it to make it available in a reasonable time. It must be available for ten years following production of the last unit. Failure to make it available in response to a substantiated request by an enforcement authority may constitute grounds for doubting the conformity.
The technical file does not need to include detailed plans or any other specific information as regards sub-assemblies used for the manufacture of the machinery unless they are essential to verify conformity with the EHSRs.
Conformity Assessment for Annex IV Machine
Certain types of equipment are subject to special measures. This equipment is listed in Annex IV of the Directive and includes dangerous machines such as some presses and injection molding machines. Annex IV also includes certain safety components such as light curtains and two hand control units.
For Annex IV machines not in conformity with Harmonized European Standards there are three procedures to choose from:
1. Send the technical file to an approved body who will acknowledge receipt of the file and keep it.
NOTE: With this option there is no assessment of the file. It may be used as reference at a later date in the event of a problem or a claim of non compliance.
2. Send the technical file to an approved body who will verify that the Harmonized Standards have been correctly applied and will issue a certificate of adequacy for the file.
3. Submit an example of the machinery to an approved body (test house) for EC type examination. If it passes, the machine will be given a EC type examination certificate.
For Annex IV machines not in conformity with a standard or where no relevant Harmonized European Standard exists an example of the machinery must be submitted to an approved body (test house) for EC type examination.
EC Type Examination
For an EC type examination the approved body will require a technical file and access to the machine to be examined. They will check that the machine is manufactured in accordance with its technical file and that it satisfies the EHSRs applicable to it. If the examination is successful an EC type examination certificate will be issued. A body which refuses to issue a certificate must inform the other approved bodies.
Declaration of Conformity Procedure
The responsible person must draw up an EC Declaration of Conformity and affix the CE
mark to all machines supplied. The machines should also be supplied with the Declaration of Conformity.
NOTE: Safety components should have a Declaration of Conformity but not a CE mark in respect to the Machinery Directive (although they may be CE marked with respect to the EMC or Low Voltage Directives).
The CE mark represents self certification but it is an offense to affix the CE mark unless the machine satisfies the EHSRs and it is, in fact, safe. It is also an offense to affix a mark to machinery which may be confused with the CE mark.
NOTE: The affixing of the CE mark also indicates compliance with any other European directives to which the machinery may be subject.
Declaration of Conformity
The certificate forming the Declaration of Conformity must include details of the manufacturer and responsible person, details (make, serial no. etc.) of the machine, details of the approved body if appropriate, details of any standards used and the details of the person empowered to sign the declaration certificate. It must state conformity with the EHSRs or with the example of the machinery that underwent EC type examination.
EC Declaration of Incorporation
Where the equipment is supplied for assembly with other items to form a complete machine at a later date, the responsible person may issue a Declaration of Incorporation with it (instead of a declaration of conformity). The CE mark should NOT be affixed. The declaration should state that the equipment must not be put into service until the machine into which it has been incorporated has be declared in conformity. This option is not available for equipment which can function independently or which modifies the function of a machine.
The Use of Work Equipment by Workers at Work Directive 89/65/EEC. While the Machinery Directive is aimed at suppliers, this Directive is aimed at users of machinery. It covers all in
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