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The Yellow Book - Engineering Safety Management
Safety Legislation
Use this page for information on safety legislation and links to related web sites.

Parts of Section 3 of Hazards Forum, Safety-related systems, Guidance for engineers, March 1995, Section 3 have been reproduced with the permission of the Hazards Forum. They are distinguished by paragraph numbers included between brackets.

Information has also been adapted from the UK section of the European Agency for Safety and Health at Work.

The section is structured as follows.

Introduction
Criminal Liabilities
 
Civil liabilities: contract law
Civil Liabilities: Neglicence and Product Liability
Legislation & International Standards
Protective Measures and Defences
 
The International Dimension
European Safety Legislation Links

 

Introduction Top

[3.3] Legislation in this area [of legal liabilities] is developing, and is likely to continue to do so for some time. In parallel, real cases are coming to the courts. These will both clarify interpretation of some aspects of law, and, probably, identify weaknesses in its formulation. These cases should be monitored, since their outcome may affect responsibilities of both employees and employers, in both civil and criminal law.

[3.4] There are important differences between criminal and civil liability. Either or both might apply in a particular circumstance. [...]

Criminal Liabilities Top

[3.5] UK criminal law relating to product safety includes two groups: that dealing with safety at work, based largely on the Health and Safety at Work etc. Act 1974 (HSWA); and that dealing with consumer safety, based largely on Part 11 of the Consumer Protection Act 1987 (CPA).

Health and Safety at Work etc. Act 1974 (HSWA) Top

Health and safety legislation in the UK is made under the power of various Acts of Parliament. The Health and Safety at Work etc Act 1974 (HSWA) is the main Act which allows the Health and Safety Commission to bring in new legislationas appropriate.

Most Statutory Instruments (S.I.'s) relevant to health and safety are made under the Health and Safety at Work etc. Act 1974 though others are issued under other Acts of Parliament. Statutory Instruments can:

  • amplify existing legislation;
  • introduce new aspects;
  • repeal existing legislation; and
  • modify existing legislation

The following Statutory Instruments can be obtained on-line from the HM Stationery Office:

[3.6] The Act places a duty on employers to ensure, so far as is reasonably practicable, the health, safety and welfare of their employees (Section 2 of HSWA). It also requires employers, employees, and the self-employed to ensure, so far as is reasonably practicable, the health and safety of other persons who may be affected by their undertakings (Section 3). It places a similar duty on manufacturers, designers and suppliers of articles for use at work in respect of the people who use those articles (Section 6).

[3.7] Failure to comply with duties described in the HSWA is a criminal offence and penalties can range from fines to imprisonment. It is the duty of the Health and Safety Commission to make appropriate arrangements for the general purposes of the Act, while the Health and Safety Executive (HSE) enforces the legislation. The Act empowers the Secretary of State for Employment to make health and safety regulations, which are normally proposed by the Commission.
Railways and Transport Safety Act 2003 Top

The Railways and Transport Safety Act 2003 is an Act to make provision about railways, including tramways; to make provision about transport safety; and for connected purposes.

Guidance and the application of standards Top

[3.8] The Commission can also issue, with the consent of the Secretary of State, Approved Codes of Practice (ACOPS) which give practical guidance on how to comply with the Act or Regulations. ACOPs are, along with all relevant standards, admissible in evidence in any prosecution brought under the HSWA. A defendant who had not complied with an ACOP would have to prove compliance with the provisions of the HSWA in some other way.

[3.9] The HSE also produces booklets, leaflets and guidance notes which contain detailed technical specifications, quantitative guidance, and reference to standards. This guidance has no legal status as such, although it is widely recognised as setting desirable standards and may be relevant evidence in any prosecution brought under the HSWA.

[3.10] The application of standards is different in product sectors covered by European Union "New Approach" Directives, which, while ostensibly related to the removal of technical barriers to trade, may have a strong health and safety element. In general, products complying with a harmonised European standard from CEN/CENELEC/ETSI are deemed to meet the requirements of the relevant Directive(s), and thus any national legislation. If products do not comply with the standard then they must meet the requirements of the Directive(s) in some other way. Several of the current New Approach Directives relate to safety in the workplace and several more are under discussion. None deals with software as a separate issue. (See also paragraphs 3.30 - 3.36).

Duties on the designer, manufacturer, supplier or importer of safety-related systems Top

[3.11] If plant incorporating a safety-related system is designed for use or operation at work, Section 6 of the HSWA will apply. The designer, etc. will have to ensure, so far as is reasonably practicable, that the hardware and software designed and constructed for safe operation of the system. This includes undertaking all necessary research, testing and examination. It may not be necessary to repeat tests and examinations carried out by other persons in the supply chain, provided that it can be demonstrated that the system is appropriate for the purpose for which it is being supplied. All information necessary for the safe operation of the system must be provided.

Duties on the writers and suppliers of software Top

[3.12] Whether software is supplied as part of a system or provided as a separate package, Section 3 of the HSWA will apply, and there is a responsibility to ensure that use of the software will not expose any people to health and safety risks. As in Section 6, suppliers must carry out or arrange for any necessary testing of what they supply, to the extent that is reasonably practicable, and must provide their customers with any necessary information so that their use of it can be safe.

Duties on the end user Top

[3.13] Under Section 2 of the HSWA, employers must provide, so far as is reasonably practicable, safe plant and safe systems of work for their employees, as well as adequate training and information. In respect of PESs this will require reasonable tests and checks on in-house programming, and information and training for system operators.

Consumer Protection Act 1987 (CPA) Top

[3.14] This act is intended to enact the European Directive on Product Liability, 1985. Section 10 of Part 11 of the Act makes it a criminal offence to supply any consumer goods which do not comply with the "general safety requirement".

[3.15] Non-compliance with the general safety requirement occurs when a person supplies, offers to supply or possesses for supply, consumer goods which are not reasonably safe having regard to all the circumstances. The circumstances which will be taken into account in determining whether goods are reasonably safe or not include:

  • how the goods are marketed, their packaging and presentation, what marks are on the product, and what warnings or instructions are given
  • whether any standards have been published which might apply to the goods in question
  • whether there were any means by which the goods might reasonably have been made safer, taking into account the cost of so doing and the extent of the additional safety provided.

[3.16] The published standards referred to in 3.15 above are "any standards of safety published by any person The courts may therefore take into account, in determining whether the general safety requirement has been met, not only standards produced by ISO or BSI, or harmonised European standards, but those produced by organisations in particular industries, such as trade associations, and other bodies, such as RTCA/EUROCAE. The importance placed by a court on any given standard will depend to some extent upon the importance credited to the issuing organisation.

[3.17] It is however a defence under section 10 of the Act for the supplier to show that the feature of the goods leading to the charge is directly due to compliance with requirements imposed by law or by European Union obligations, or that the feature of the goods in fact complies with the relevant safety regulations or with standards of safety approved by the UK government under such safety regulations.

[3.18] Section 10 of the Act does not apply to goods intended for export or to second-hand goods. Nor does it apply to retailers if they had no reasonable grounds for believing that the goods failed to comply with the general safety requirement.

[3.19] "Consumer goods" are defined for the purpose of Section 10 as "any goods which are ordinarily intended for private use or consumption " but excluding a number of products, such as motor vehicles and aircraft, food, water, gas, drugs, and tobacco.

Civil liabilities: contract law Top

[3.20] In addition to any terms expressly stated in particular contracts, there are, under the Sale of Goods Act (1979), two implied terms to a sale which may be of relevance. The first (Section 14(2)) is that the goods supplied are of merchantable quality. Such goods are defined as goods which are "as fit for the purpose or purposes for which goods of that kind are commonly bought as is reasonable to expect having regard to any description applied to them, the price (if relevant) and all the other relevant circumstances." The second (Section 14(3)) is that of fitness-for-purpose, and applies where a purchaser has either expressly or by implication told the vendor any particular purpose for which the goods are being bought. In this case, the implied condition is that the goods are reasonably fit for that purpose, even if the purpose is not one for which such goods are commonly supplied. This requirement does not apply where the circumstances show that the purchaser does not rely on the skill and judgement of the seller, or when it would be unreasonable to do so.

[3.21] In non-consumer cases only, (i.e. cases where the buyer is in business or where the buyer holds himself out as being in business), sellers may attempt to contract out of these provisions of the Sale of Goods Act, but any such attempt is subject to the test of reasonableness as set out in the Unfair Contract Terms Act 1977.

[3.22] There is a degree of overlap between the two implied conditions set out in 3.20 above, but the important point is that both the concepts of quality and fitness-forpurpose are present in a contract of sale. In the case of software, whether embedded in a product, or used to control a system, a material failure of the software to function correctly would probably mean that it was not fit for its purpose, and the supplier of the software would accordingly be liable for breach of contract. Other contracts such as hire and supply of services may contain similar provisions: in these cases the Supply of Goods (implied Terms) Act 1973 and the Supply of Goods and Services Act 1982 are relevant.

[3.23] The responsibility of a professional engineer to an employer or client is to exercise reasonable care and skill in accordance with the normal contemporary standards of their profession. This is an implied term contained in contracts for the supply of services. If, despite the exercise of such care and skill, the outcome is unsuccessful, the engineer will not normally be in breach of a contractual duty. An exception to this will be where there is a term (express or, in suitable circumstances, implied) in the contract between the designer and client that the design will achieve a certain purpose. A material failure in this case will amount to a breach of contract.

[3.24] There are instances where the engineer will be under contract to design and supply. Here the duty is that of supplying goods which are of suitable quality and fit for their purpose, as in 3.20 above.

Civil Liabilities: Negligence and Product Liability Top

[3.25] If a "person" (which, in law, includes a corporate body such as a company) is injured, or their property or goods are damaged or destroyed as a result of another's negligence, they can recover damages in a civil action for that negligence. The extent to which pure economic loss arising from such negligence can be recovered is at present uncertain.

[3.26] To prove negligence, plaintiffs have to prove that they were owed a duty of care, that there was a breach of that duty, and that the loss or damage was a direct result of the negligence. Quite often, these are not easy to prove, and in consequence many injured persons have received less than full compensation. For example, although the law of negligence has developed considerably over the past twenty-five years, generally in favour of those making claims, if engineers can show that they exercised the standard of skill normal to their profession and acceptable at that time to their peers, it is unlikely that they would be found negligent.

[3.27] A significant change came about with the Consumer Protection Act, 1987 which introduced a new product liability law. Part 1 of the Act provides that people injured or suffering loss to their private-use belongings as a result of the failure of a product to provide the safety that people generally are entitled to expect are to be compensated as of right by the producer of the product without having to prove negligence. However, there is no provision in the Act for compensation for any consequential economic loss suffered as a result of the injury or damage.

[3.28] Embedded software produced by the manufacturer of a product will attract liability just as much as the hardware. Software produced by another party which is embedded in the product or is used for the design of a product may be a more complex matter. Depending on all the facts of the situation, including the extent to which it was reasonable for the manufacturer of the product to depend on the software's correctness, the software producer may be liable.

[3.29] The General Product Safety Regulations 1994 implement the provisions of EC Directive 921591/EEC. They require that products placed on the market are safe; that customers are provided with information relevant to the risks involved in the use of product; and that suppliers keep themselves informed of factors which might affect the safety of items they supply. There are also requirements for distributors.

Legislation & International Standards Top

[3.30] The law in individual states is for the most part based on national legislation. Nevertheless some European and even international standards may acquire legal status through the essential requirements contained within European Union (EU) "New Approach" Directives and harmonised European standards.

[3.31] Individual Member States transpose EU Directives into national legislation. In the UK this is achieved by Statutory Instruments (i.e. Regulations) under specific Acts of Parliament.

[3.32] Regulations may require the use of appropriate standards if these exist. Under the "New Approach" Directives such standards are identified as fulfilling the essential requirements of a Directive, though their use is not mandatory.

[3.33] It has been agreed that where harmonised European standards exist, they will be adopted as national standards by the standardisation bodies of all Member States.

[3.34] Where CEN/CENELEC (and ETSI, for telecommunications standards) have produced harmonised European standards in line with essential requirements, these can be used to demonstrate compliance with a particular Directive. It may be possible to demonstrate compliance without recourse to harmonised European standards, but this is likely to be more difficult.

[3.35] Some ISO/IEC standards are adopted by CEN/CENELEC as harmonised European standards.

[3.36] There are very good reasons (including particularly the need to demonstrate that appropriate actions have been taken) for conforming to standards and regulations and for following guidelines wherever possible, notwithstanding the fact that compliance with standards is in principle "voluntary".

Protective Measures and Defences Top
Insurance Top

[3.37] Insurance can give limited protection against some civil claims: specific advice should be sought from brokers specialising in this field.

Best practice and compliance with standards Top

[3.38] A defendant may claim that (for instance) best practice was followed and the relevant standards applied. An injured party may argue that "Strict liability" applies and that it is not necessary to demonstrate negligence on the part of the defendant, and that the defendant's "best practice" argument is irrelevant. However although it may not be an absolute defence, the "best practice" argument may be used in mitigation. Note that strict liability does not supplant actions for negligence.

[3.39] Mere compliance with standards is unlikely to be regarded as evidence that sufficient cqire has been taken or that best practice was followed. It will be necessary to demonstrate that the standards complied with are relevant and appropriate to the system and the circumstances in which it was to operate.

[3.40] Where "best practide" arguments are used a well-prepared safety case (see paragraphs 1.43 - 1.48) may be valuable.

[3.41] There is an ethical debate alongside the legal debate. Individual professional engineers may find themselves in conflict with their employing organisations over the ethics of a "best practice" defence. The argument of the injured party, who is concerned solely with having suffered because of a dangerous system, is very reasonable.

Development risks Top

[3.42] One of the defences against liability under Part 1 of the Consumer Protection Act, 1987 is the so-called "development risks defence" or "state of the art defence". This states that the manufacturer may not be liable if "the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products while they were under his control". It will be far from easy to succeed in this defence.

[3.43] This defence would appear to be quite generous depending as it does upon what engineers "might be expected" to do. It appears however that in introducing this defence the UK government has been over-generous, as the wording of the European Directive provides a defence only where "the state of scientific and technical knowledge at the time when [the producer] put the product into circulation was not such as to enable the existence of the defect to be discovered". This wording is far more stringent, and proceedings are being taken against the UK government for its divergence from the Directive. Engineers must be wary of the more generous wording of the United Kingdom Directive. When designing products for the European market, they must allow for this greater stringency.

Warning Top

[3.44] In determining whether the safety of a product is such as persons generally are entitled to expect, "all the circumstances shall be taken into account". Among the circumstances included in the Consumer Protection Act, 1987, are "the manner in which, and purposes for which, the product has been marketed .... and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product" and "what might reasonably be expected to be done with or in relation to the product".

[3.45] Warnings and instructions as to the uses to which software should or should not be put will therefore be useful, but will not provide a complete defence if there is in fact a programming fault in the software which causes damage. However, if the software supplier can prove that warnings and instructions were disregarded, then the partial defence of contributory negligence will be available under the Act, thus reducing the amount of damages awarded.

[3.46] In addition, the proper use of warnings and, perhaps, instructions that the customer should test the software if it is to be used in certain situations, may also help where the software producer, and the producer's customer (e.g. the supplier of a complete system) are jointly and severally liable to the injured party. In that situation the court will apportion liability between the software producer and the producer of the system in such manner as is "just and equitable" under the Civil Liability (Contribution) Act 1978. Putting some responsibility on the system supplier may be helpful to the software producer in such a case.

[3.47] Software suppliers should aim to organise their activities so that they are able to define the level of responsibility which they are prepared to accept for a given software product. If possible they should also carefully define the purposes for which the software should or should not be used.

[3.48] However, a warning that it should not be used for certain purposes might lead to problems. Such a warning could not possibly cover all possible applications, and the omission of one potentially hazardous application could, by inference, be taken to mean that the product was suitable for that application. A more general warning, on the lines of "this product should not be used for control function where malfunction could prove hazardous" might provide a defence, but any such limitation would have to be reasonable otherwise it could be seen as attempting to shift the burden of responsibility from producer to user to an unjustifiable extent. An injured party may claim that such general warnings are irrelevant and should not be taken into consideration, where the product is in fact used in potentially hazardous circumstances.

The International Dimension Top

[3.49] In the European Union, plaintiffs in a civil case may be able to bring their claim where any agreement states a claim will be brought in the state where the defendant is domiciled, where the defendants' branch or agency is domiciled, or "where the harmful event occurs". This latter may be either where the original act giving rise to the damage occurred (the place of manufacture of the defective product) or where the actual damage occurred (the place of injury). Companies could therefore find that they become involved in litigation in other EU countries as well as the UK.

[3.50] A plaintiff may indulge in "forum shopping", where, of the several jurisdictions available to him, a plaintiff may decide to go for the one with the best perceived chance either of winning or of getting the highest possible damages. The possibility of forum shopping is restricted by treaties in the case of defendants who are domiciled in certain European countries.

[3.51] Factors affecting forum shopping include:

  • levels of damages customarily awarded in the various countries
  • the extent to which member states are likely to permit the recovering of purely economic loss
  • how long it takes to bring cases to court
  • costs
  • availability of witnesses
  • (in cases of product liability) the extent to which different countries have derogated from the Directive with respect either to imposing a maximum level of damages, or to the "development risks" defence.

[3.52] Although these factors are of relevance to the plaintiff when choosing jurisdictions, nonetheless English courts may not regard them as crucial in their determination of which court is the appropriate forum for the case.

[3.53] Since January 1994 the European Economic Area (which includes all EU countries and all EFTA countries, except Switzerland) has been in force and some European Community measures apply throughout the Economic Area.

[3.54] In the United States of America, on the other hand, the rules are totally different. A company with manufacturing, marketing and distribution operations in the USA will be subject to the stringent US laws of warranty, tort and strict liability, and the very heavy levels of damages often awarded by American juries with all the concomitant problems of obtaining insurance cover. The position of a company which exports products to the USA through a wholly-owned subsidiary which, however, has no assets, or of a UK company whose components are used in US-manufactured products is different again and, indeed, differs from state to state.

European Safety Legislation Links Top

Health and Safety at Work
The European Agency for Health and Safety at Work (part of the European Commission) has prepared a number of directives to protect the health and safety of workers at work. The reference texts of the main safety directives and other safety-related directives can be obtained from their web site.

Internet links: - The European Agency for Health and Safety at Work
- Main Safety Directives
- Safety-Related Directives

 

Consumer Safety
The European Commission has prepared a number of directives to protect consumers. The reference texts of the directives can be obtained from the EU.

Internet links: - The EU
- Consumer Safety Directives

 

Transport Safety
The reference texts of the european directives in the field of inland transport, air transport and maritime transport can obtained from the EU.

Internet links: - The EU
- Inland Transport Safety Directives
- Air Transport Safety Directives
- Maritime Transport Safety Directives

 

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