American Journal of Law & Medicine

Regional harmonization of occupational health rules: the European example.

This study of the occupational health law of the European Union looks first at the jurisdiction of the Union and the history and scope of its legislation in this area.

The main body of the Article examines the level of protection that is afforded to the workforce under European Union law. The Article first considers the way in which assessment of risk is handled and then passes on to measures that are provided for both preventing and protecting against health risks. It notes the greater role given to protection. The Article also mentions the ancillary measures that are destined to make both prevention and protection effective. Finally, it looks at the Union's detailed provisions for worker involvement in occupational health matters and the more meager ones on employment rights and compensation.

The Article ends with a discussion of the problems faced by the Union in enforcing its rules and an assessment of the strengths and weaknesses of the European Union's occupational health law. It is suggested that, overall, it deserves a positive judgment.


We live in a very competitive world, and one of the potential victims of this aggressive free-for-all is occupational health and safety.(1) This is a particular problem in regional blocs where different national rules are more likely to distort trade. In order to prevent the erosion of its competitive position, a state must either emulate its trading partners or insist that all respect certain rules. Thus, the United States insisted on a side agreement on labor standards to complement the North American Free Trade Agreement (NAFTA).(2) Annex 1.9 of this agreement lists occupational health and safety as one of the principles that the Parties are committed to promote, albeit each in its own way. The European Union (EU)(3) has gone even further and set out a harmonized set of rules for the twelve member states in this area. It has done this with the express intention of reducing national differences that "may result in different levels of safety and health protection and allow competition at the expense of safety and health."(4)

There are two reasons for this more radical approach in Europe. First, economic integration in the EU is much greater than in the NAFTA and hence the potential for distortion of trade is higher. Second, the ideal of a community that ensures a minimum level of social protection throughout its member states has been one of the principles of European regional integration from the inception of the EEC in 1957(5) up to the present EU.(6) The improvement of occupational health and safety is an essential part of this social dimension.(7)

The harmonization of occupational health and safety rules in the EU is unique among regional blocs. Particularly as concerns health, where the issues are more complex and the differences between the member states more profound, this represents a considerable achievement. For this reason alone, it deserves analysis. In addition, as the NAFTA takes hold and perhaps expands, it may also need to envisage a harmonization of the partners' occupational health and safety rules. In this case, the European example may serve as a useful model.

This Article concentrates on occupational health. It looks at the scope of the EU's legislation, the level of protection that it affords the workforce and the approach it takes towards enforcement of the rules. The Article concludes with a brief overall assessment.



With the exception of basic standards for the protection of workers against ionizing radiation, which are regulated under the EAEC,(8) the EU regulates occupational health through the EC.(9) At first this was done by way of the Community's general harmonizing authority under Article 100. Then, in 1987, the SEA introduced the present Article 118a, which gives the EC explicit authority to harmonize occupational health rules in the member states.

The EC shares its jurisdiction over occupational health with the member states.(10) In fact, its own role is quite limited as it may only set out minimum requirements.(11) However, deriving inspiration from the first paragraph of Article 118a(1),(12) the 1989 Framework Directive goes further. It is entitled "measures to encourage improvements" in occupational health and, in its preamble, it emphasizes this commitment to raising standards in the member states.(13) Its daughter directives reflect this wider scope.

The TEU does not modify the provisions of the three Community treaties on occupational health, nonetheless it introduces uncertainty regarding the EU's future role. First, as it does not have exclusive jurisdiction over occupational health, the EC must henceforth respect the subsidiarity principle that the TEU makes an explicit part of the EC Treaty. This means that it can enact occupational health measures "only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member states...."(14) Second, the Social Agreement appended to the EC Treaty(15) seems to restrict the Community's role to supporting and complementing the activities of the member states.(16) It also provides for Community-level collective agreements to take the place of EU legislation.(17)


The EU's substantive legislation on occupational health comprises mainly a number of individual directives grouped around two framework directives, Council Directive 80/1107 (the 1980 Directive)(18) and Council Directive 89/391 (the 1989 Directive). There are also independent directives dealing with ionizing radiation,(19) vinyl chloride monomer (VCM)(20) and medical treatment aboard vessels,(21) as well as a series of Council Resolutions setting out general goals(22) and a Commission Recommendation on occupational diseases.(23)

The EU also has legislation setting up various bodies in the area of occupational health. Theses bodies do not materially affect the substance of EU law, however the European Agency for Safety and Health at Work(24) could make it easier for workers and their representatives to obtain information on occupational health issues.

In addition to this specific legislation, there are enactments in other areas that are relevant to occupational health. These concern such matters as environmental pollution by asbestos,(25) dangerous substances and preparations,(26) genetically modified microorganisms (GMOs),(27) noise levels of construction equipment(28) and technical harmonization.(29)

The 1980 Directive is now largely redundant and the Commission has proposed repealing it and replacing its daughter directives with directives derived from the 1989 Directive.(30) The 1980 Directive constitutes a rather vague framework for action by member states to protect workers against occupational health risks. Its shortcomings are mitigated somewhat by the daughter directives, but these are restricted to dealing with lead, asbestos, machinery noise, and a ban on a small number of agents and activities.(31) The 1980 Directive does not apply at all to ionizing radiation, sea transport or air transport.(32)


The 1989 Directive marks an important turning point. It establishes a set of general principles that directly regulate major aspects of occupational health.(33) Its daughter directives apply the general principles to specific situations, such as particular hazards and types of work.(34) In addition, three daughter directives establish general rules for the workplace, the use of work equipment and the use of personal protective equipment.(35) All this represents a reasonably comprehensive regulatory system. However, the 1989 Directive still leaves remedies and their enforcement almost exclusively in the hands of the member states. At most, it requires member states to enact "the legal provisions necessary for the implementation" of the 1989 Directive and "to ensure adequate controls and supervision."(36) The independent directive on ionizing radiation is somewhat more specific, as it requires member states to "establish a system or systems of inspection to supervise the examinations and monitoring specified in the ionizing radiation directive and to initiate surveillance and intervention measures wherever necesary."(37) In addition, pregnant and breast feeding women must be able "to pursue their claims by judicial process ... or by recourse to other competent authorities."(38) Nevertheless, as in all cases, the enforcement procedures are determined and administered by the member states.

The new rules in the 1989 Directive also expand the coverage of hazards. For example, biological agents, some carcinogens, back injury, display screens and stress become subject to EU rules.(39) There are also special rules for pregnant and nursing women, night workers, miners, fishermen, prospectors, sailors and construction workers.(40) Moreover, the 1989 Directive applies to all work activities and thus complements the existing directives on VCM, ionizing radiation, lead, asbestos and machinery noise.(41) However, important gaps persist. For example, carcinogens that do not come within the definition given in Directive 90/394,(42) musculoskeletal hazards other than back injuries, and physical agents not including ionizing radiation, machinery noise, and display screens remain unaddressed. Furthermore, the coverage of chemical hazards remains restricted to lead, asbestos and VCM, although the use of certain other chemicals is prohibited or restricted.(43) The EU's occupational health program is, however, a continuing one. Thus, a Commission proposal on physical agents will expand coverage to vibration and non-ionizing radiation,(44) another will establish general rules to protect workers against chemical hazards at work,(45) and special rules are to be enacted for young people.(46)

Another important change is that the provisions of the 1989 Directive and its daughter directives are mandatory except for some provisions on workers' rights. Thus, member states may restrict the information provisions to larger undertakings and opt out of worker participation altogether.(47) Otherwise, all provisions must be enacted into national law. Moreover, because of their precise and unconditional nature, most of these provisions are susceptible of direct effect, which means that individauls can rely on them in national courts even in the absence of national implementation.(48) However, this will not permit employees to take action against their employers for failure to comply with their obligations under EU law. In the case of EU directives, direct effect does not extend to the enforcement of rights against private individuals.(49)

A final point is that member states do not enjoy much discretion in their implementation of the EU rules under the 1989 Directive. The general phrases in the 1980 Directive are replaced by principles that are enunciated as specific obligations on employers and, to a much lesser extent, employees. However, neither the 1989 Directive nor the EC Treaty require uniformity. Thus, member states may enact more stringent requirements.(50) Furthermore, member states are still permitted to use their own discretion in specific instances.

One area where discretion is permitted is health surveillance. Clinical and/or biological examinations are normally mandatory where the risk to health is high, but it is largely up to the member states (or the responsible doctor) to determine how these examinations should be conducted.(51) Discretionary conduct may, however, be subject to minimum requirements. In the case of asbestos, for example, a chest examination is required,(52) and when a worker's hearing is checked, there must be an octoscopy combined with an audiometric test.(53) In addition, the new proposal on chemical agents requires that atomic absorption spectroscopy be used for establishing the blood-lead level.(54)

The member states may also use discretion in choosing their methods of measurement, albeit subject to some basic EU rules. Thus, a continuous method must be used for measuring VCM in enclosed polymerization plants,(55) while the biological monitoring of workers exposed to lead must include a measurement of the blood-lead level.(56) Furthermore, a measuring method may be suggested without foreclosing the possibility of using another method that yields equivalent results.(57)



1. Hazard v. Risk

Let us first deal with terminology. There is a difference between a hazard, which is the presence of a harmful chemical, biological or physical agent, and a risk, which is the danger that a hazard poses for the health of workers that are exposed to it. The level of danger depends upon the nature of the hazard and the degree and duration of the exposure.

2. Overall Approach

The first step in risk assessment should be the detection and identification of the hazard(s). In the EU directives on back injury, display screen equipment and GMOs and in the proposal on chemical agents, the employer is required to determine whether there is a hazard present that might pose an occupational health risk.(58) However, this is not the general approach in the EU. Both the 1980 Directive, as revised in 1988, and its 1989 successor are expressed exclusively in terms of risk.(59) Furthermore, the bulk of the individual directives deal with known hazards, and all they require is an assessment of risk based on the level of exposure to the agent in question. Fortunately, the level of exposure at which workers are said to be at risk is often predetermined, in which case the assessment process is straightforward.(60) In contrast, where exposure levels are not predetermined it is up to the assessor to decide if the nature, degree and duration of the exposure presents a risk to workers' health.(61)

3. Methods of Assessing Risk

Monitoring the ambient exposure levels is the method used for assessing risk with respect to VCM, asbestos, machinery noise and certain other physical agents.(62) Both ambient and biological monitoring are used for lead and ionizing radiation.(63) The method of assessment for some other hazards is sui generis but should be carried out in accordance with the relevant criteria.(64) No particular method is expressly required for assessing risk from carcinogens and biological agents or for pregnant and breast-feeding workers.

Feedback from the workforce can also help in the assessment of risk. Thus, the individual directives on lead, asbestos and noise provide for worker involvement in the process.(65) The 1989 Directive makes this a general requirement.(66) There is no provision for workers to gather information independently at the workplace unless this is implicit in the provision that workers' representatives must be given the means to meet their occupational health responsibilities.(67)

4. Pre-testing to Reduce Risk

EU law does not require as a general rule that agents be pre-tested before their use in the workplace. However, there are a number of rules applying to chemicals that clearly entail such an obligation. In the first place, dangerous chemicals and dangerous preparations, which consist of a mixture of two or more chemicals,(68) cannot be placed on the market in a member state unless they are labeled in a way which identifies, in generic fashion, the hazards that they constitute for human health.(69) Standard phrases which indicate special risks emanating from these hazards (R phases) and the safety measures to be taken must be used.(70) However, it is unlikely that such sparse information will provide much help in protecting the health of the workforce. Moreover, such labeling is only effective as long as it is conveyed to the worker who handles the potentially dangerous mixtures, and this is not expressly required under the pertinent directives.

More significant is the requirement that the manufacturer or importer of a new dangerous chemical or preparation must provide a technical dossier to the national authorities in the member state where the product is produced or into which it is imported. This requirement must be fulfilled at least forty-five days before the product is placed on the market,(71) otherwise, it cannot be commercialized.(72) This report must contain enough information to permit an appreciation of the risks associated with use of the chemical or preparation as well as details of the tests conducted to determine the risks. National authorities may ask for more information or require further testing where they consider it necessary.(73) In addition, industrial users of such chemicals and preparations must be provided with specific information on the risks involved and the appropriate protections for the workforce.(74) This is to be done before the product is delivered. The problem is that EU law does not yet require that workers receive any of this information. Member states must convey the technical information in the report to the Commission, which then informs the other member states.(75) However, industrial users are not obliged to pass on any information to their workers. This will change if the Commission's proposal on chemical agents is enacted because it provides that all risk evaluations required by EU law must be reflected in the mandatory safety and health documents to which the workforce will have access.(76) Workers may also be able to obtain this information through the new European Agency for Safety and Health at Work.(77)

5. Recognizing the Potential for Multiple Hazards

Multiple hazards are a problem area in occupational health because there is only limited knowledge about the way agents react together. Thus, it is not surprising that EU law contains only rudimentary attempts to deal with the issue. As a general rule, employers need only take account of workers that are "exposed to particular risks."(78) However, there is a broader provision in the directive on display screen equipment, which calls for employers to account for the combined effects of the hazards present.(79) Additionally, the directive on the organization of working time could be viewed as an attempt to eliminate overworking as a factor in the exacerbation of other occupational health risks.(80) All of these procedures signal an awareness in EU law that existing conditions with respect to a worker may combine with a workplace hazard to produce a greater risk than normal.

The approach is slightly different in the directives on ionizing radiation and asbestos. There, the hazard that presents the greatest danger is used to assess risk. Thus, if there is combination of external and internal exposure to ionizing radiation, the external exposure calculations are used whenever a substantial part of the body has been externally exposed.(81) If there is exposure to a mixture of radionuclides, the minimum level of exposure to any radionuclide that might conceivably be present is used.(82) With asbestos, higher limit values are allowed for chrysotile, except where it is mixed in any amount with other asbestos fibers.(83)

Finally, there is the biological agents directive, which provides that risks are to be assessed "on the basis of the danger presented by all hazardous biological agents present."(84) However, this directive is problematic because it assumes that their adverse effects can be calculated by simple addition.

6. Conditions of the Risk Assessment

The 1989 Directive makes risk assessment mandatory for employers and imposes upon them the obligation to possess proof of compliance with this requirement.(85) There are, however, certain conditions that must be fulfilled if a risk assessment is to be effective and fully benefit the workforce. However, the Directive does not assure that all conditions will be met, although in some instances the deficiency is reconciled through individual directives.

The first condition is that the assessment be completed prior to work commencing. However, the 1989 Directive does not make this a requirement, and most individual directives are equally permissive.(86) Prior assessments are only mandatory for heavy loads and GMOs.(87) In addition, prior assessments have been proposed for ionizing radiation and chemical agents.(88) Second, the assessment must be up-to-date. The Directive requires employers to "be alert to the need to adjust ... to take account of changing circumstances,"(89) but this is imprecise. Fortunately, most individual directives deal with this point.(90) Some stipulate new assessments where there is reason to believe that circumstances have changed(91) while others require regular renewals or frequent monitoring.(92) Only the proposal on chemical agents specifically calls for the assessment to be kept up-to-date. …

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