Essential (health and safety) requirements
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All New Approach product safety Directives impose essential requirements that products covered by the Directive must meet. In most cases they are health and safety requirements although in some Directives (eg for combustion engine emissions) they are environmental or (for electro-magnetic compatibility) not directly related to health and safety. Before the product may be placed on the market, or brought into use, for the first time designers and manufacturers must meet, to the state of the art, all essential requirements relevant to the particular product. In most cases these requirements set broad objectives for securing:
- the health and safety of the users of products,
- others who may be affected, such as consumers of materials processed on certain types of machinery (eg food, cosmetics and pharmaceuticals)
and in some cases the safety of domestic animals and the environment.
What are essential requirements?
These are broad objectives for health and safety specified in each product safety Directive stating how the designer and manufacturer should construct applicable products for safety and compliance. They are also known as Essential Health and Safety Requirements (EHSRs) in the Machinery Directive, and as Safety Objectives in the Low Voltage Directive. They can be found in an Annex to each product safety Directive and are copied across into the schedules of the UK regulations implementing that Directive. They set a common minimum European level for the safety and health of the products covered.
Must essential requirements be met?
Yes, where a corresponding hazard exists for the product, the objectives of all relevant essential requirements must be met, in so far as the product is used under the conditions foreseen by the manufacturer (or the manufacturer's authorised representative), who must also take account of foreseeable abnormal situations.
While each essential requirement is mandatory, taking account of the state of the art, it may not be possible to meet the objectives set by them. In these cases the product must, as far as possible, be designed and constructed with the purpose of approaching their objectives. Although the precise means by which an objective is met is left to the product designer / manufacturer, over time the possibilities and standards for meeting those objectives may change as the state of the art for health and safety increases.
The notion of the "State of the Art" is not defined, however it includes both a technical and economic aspect. It is a dynamic concept reflecting what can be done at reasonable cost using generally available technology at the time. But it is not an excuse for the lowest common achievable safety level, nor necessarily what all manufacturers of a particular product currently do for safety.
The state of the art can change over time as new technologies appear and new methods of safety evolve, such that what was previously the state of the art may some years later no longer be so. Further discussion of this concept may be found at paragraph 161 of the European Commission Guide to the Machinery Directive.
Designers and manufacturers must meet the common minimum standards of all the relevant essential requirements when placing their products on the market. Designers and manufacturers can choose to go beyond these minimums. However, market surveillance authorities cannot require those placing products on the market, or bringing them into use for the first time, to go beyond these common minimum health and safety requirements.
What matters do safety Directives' essential requirements cover?
- Physical safety, including health effects, of a product in all its various aspects (eg selection of materials used, means of control, safeguards, emissions from the product, etc)
- the principles of safety by design taking account of foreseeable use and misuse
- and information for end users (eg markings, warnings, especially of risks that remain, and comprehensive instructions).
In the main essential requirements set objectives to be reached rather specifying the precise method of compliance leaving this to harmonised standards to develop. This allows designers and manufacturers to choose the most appropriate ways to meet those objectives for their particular product
As an example, EHSR 1.3.7. of the Machinery Directive 2006/42/EC says:
"1.3.7. Risks related to moving parts
The moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with guards or protective devices.
All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, the necessary specific protective devices and tools must, when appropriate, be provided to enable the equipment to be safely unblocked.
The instructions and, where possible, a sign on the machinery shall identify these specific protective devices and how they are to be used."
and EHSR 18.104.22.168. of the Machinery Directive 2006/42/EC says:
"22.214.171.124. Fixed guards
Fixed guards must be fixed by systems that can be opened or removed only with tools.
Their fixing systems must remain attached to the guards or to the machinery when the guards are removed.
Where possible, guards must be incapable of remaining in place without their fixings."
While neither EHSR specifies the precise means of meeting the safety objective, leaving room for innovative solutions, the second one describes for example the objective that "fixings on fixed guards" should meet to achieve the aims of both of these EHSRs.
To give a further example, Safety Objective 2 of Annex 1 of the Low Voltage Directive 2006/95/EC says:
"2. Protection against hazards arising from the electrical equipment
Measures of a technical nature should be prescribed in accordance with point 1, in order to ensure:
- that persons and domestic animals are adequately protected against the danger of physical injury or other harm which might be caused by direct or indirect contact;
- that temperatures, arcs or radiation which would cause a danger, are not produced;
- that persons, domestic animals and property are adequately protected against non-electrical dangers caused by the electrical equipment which are revealed by experience;
- that the insulation must be suitable for foreseeable conditions."
One of the aims here is to protect not just people but also domestic animals and property from harm, from both foreseeable electrical, and non-electrical dangers.
How can essential requirements be met?
In addition to general and industry knowledge and guidance about how any particular risk covered by an essential requirement should be managed, there are formal standards covering all kinds of products.
Most standards are just informative and have no legal status, however transposed harmonised standards prepared under a mandate given to CEN (European Committee for Standardization) or CENELEC (European Committee for Electrotechnical Standardization) can if properly applied give a presumption of conformity with part, one or more essential requirements of a Directive.
Standards, may help with good product design. But under the European New Approach product safety regime the use of any standard by designers to meet mandatory essential requirement is completely voluntary. There is no requirement to use any standards to meet the essential requirements of product safety Directives. However, the existence of a relevant standard may effectively define the "state of the art" at the time it was originally prepared and so designers in seeking to meet essential requirements should take note of any relevant transposed harmonised standards as this sets the level of risk reduction that must at least be achieved. And in many cases standards can help designers meet essential requirements.
In what way should essential requirements be met?
Many Directives indicate the order of preference in which risks must be managed, following the long standing principles of:
- firstly, risk avoidance, by design
- secondly, protection against risks that cannot be eliminated
- thirdly, warning of any residual risks that remain
Where a hazard can be avoided by design that method should be employed in first preference when meeting any applicable essential requirements. But in many cases hazards persist, perhaps because they are a fundamental part of the product (eg the blade of a circular saw), and so physical methods of protection must be employed to meet the objectives of the essential requirement. However, it is not always possible to protect against all risks (eg part of the blade of a circular saw necessarily remains unguarded) and manufacturers will have to warn users of any residual risks. The job of the product designer is to consider all relevant essential requirements and seek the best methods of meeting their objectives, to the state of the art, taking account of the fundamental hierarchy of safety outlined above.
Do essential requirements cover all product risks?
Some "total" product safety Directives have a comprehensive list of essential requirements dealing with all aspects of health and safety (eg the EHSRs for machinery), whereas others only cover a restricted range of hazards (eg, the essential requirements of the EMC Directive only deal with issues of electromagnetic compatibility).
Essential requirements from more than one Directive may apply to a particular product. For example, most machinery is electrically powered so both the Machinery and EMC Directives will apply, and the designer and manufacturer must take account of and simultaneously meet the requirements of both Directives' essential requirements. For "total Directives" that cover all risks only one can be applied to any product. However, this situation is covered, for example medical devices which are also machines. Although medical machinery is excluded from the scope of the Machinery Directive, the EHSRs of the Machinery Directive are "called up" by the Medical Devices Directive, in so far as those EHSRs are relevant to that medical device. Similarly the essential requirements of the Low Voltage Directive are brought into the Machinery Directive in EHSR 1.5.1, thus allowing any Standard developed for the Low Voltage Directive to be used in the design of machinery.