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Environmental & Health Laws, Europe
Environmental & Health Laws, Europe MI Szynkowska and A Pawlaczyk, Lodz University of Technology, Lodz, Poland Ó 2014 Elsevier Inc. All rights reserved.
Introduction More than 50 years ago, under growing public awareness of threats to the environment, governments began to manifest their concern and introduced regulations to combat pollution of inland waters, ocean, and air, and to safeguard certain cities or areas. Parallel, special administrative organs, ministries, or environmental agencies were established to more effectively manage environmental and health legislations. The crucial moment in the forming phase of the European environmental policy was 1972, when the United Nations General Assembly convoked a world conference on the human environment in Stockholm. As a result, the Declaration on the Human Environment and the ‘Action Plan’ containing 109 Recommendations were adopted. In 1982, the World Charter for Nature was elaborated by the General Assembly, when the United Nations reaffirmed and developed the general principles of the Stockholm Declaration. In 1992, in Rio, the second global meeting covered by the United Nations took place, known as the United Nations Conference on Environment and Development (UNCED). As an outcome of this meeting, two documents were established: the Declaration on Environment (whose main concept is sustainable development, integrating development and environmental protection), and an action program called Agenda 21 (which indicates the specific action to be taken to achieve more sustainable types of development). In 2002, in Johannesburg, another important conference was held. As a consequence, the participating governments accepted the Declaration on Sustainable Development. These conferences and other conventions and legal agreements resulted in establishing key principles of environmental and health law by giving meaning to the not yet formalized legal instruments, being fundamental to create the most important European environmental and health legal systems. Environmental law is recognized as a wide category of laws, which includes laws that specifically address environmental issues, and more general laws, having a direct impact on environmental issues. According to the modern definition of the environment in the context of sustainable development, this term covers all the physical and social factors of the surroundings of human beings, including land, water, atmosphere, climate, sound, odor, taste, energy, waste management, coastal and marine pollution, the biological factors of animals and plants, cultural values, historical sites, and monuments and aesthetics. As a consequence, environmental law can be generally defined as the body of law that encompasses all the elements to control human impacts on the Earth and public health. According to UNCED, environmental priorities can be classified into two categories. One of them is related to the protection and conservation of various environmental media, such as protection of the atmosphere, halting of deforestation, protection of land resources, conservation of biological diversity, protection of freshwater resources, and protection of oceans and seas and marine living resources. The second category identified includes the priorities related to the
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regulation of particular activities or products and by-products of human technological and industrial innovation considered particularly environmentally harmful; the following priorities can be distinguished: biotechnology, toxic chemicals and their trade, agricultural practices, hazardous wastes and their trade, radioactive wastes, solid wastes, and sewage-related issues. Collaterally to environmental law, health law was developing. Health law is defined as a set of rules regulating the promotion and protection of health, health services, the equitable distribution of available resources, and the legal position of all parties concerned (namely, patients, health care providers, health care institutions, and financing) and monitoring bodies. As a discipline, health law concerns both social human rights such as the right to health care and individual human rights. Health law is nowadays used especially as an instrument of monitoring and surveillance of population health status, communicable disease control, health protection, prevention of ill health, improvement of health and quality of life, promotion of positive health, and prolonging of life expectancy.
European Legislation The progress in developing the international acts is a direct response to particular incidents (e.g., the Chernobyl accident) or the availability of new scientific evidence that action is required to prevent environmental damage. All categories of environmental or health issues require international regulations, which are extremely complex, comprising thousands of rules that aim to protect the Earth’s living and nonliving elements and its ecological processes. The view of the European Union as an independent regulatory organization covers the idea of the European Community (EC) as a regulatory state, in a way to create the regulations that can be adopted all across different environmental and health policies and all across various sectors of economy, which includes the application of horizontal legislation. The main purpose of the European legislation is to develop standards at a European level and to regulate related environmental matters among countries within Europe, which makes it possible to better carry out, within a single institutional framework, the tasks related to environmental and health issues, in accordance with the principle of subsidiarity and the principle of sustainable development (which says that any activity shall be taken as to the rational and sustainable use of natural resources in order to guarantee that present generation social and economic needs and needs for healthy environment will be satisfied without jeopardizing the rights of future generations to satisfy their own needs). For example, the European Economic Community (EEC) is a pioneer of crucial environmental standards such as Directive 67/548 (connected with the Classification, Packaging and Labeling of Dangerous Preparations) or Directive 70/157 (related to the Permissible Sound Level and the Exhaust System of Motor Vehicles); and following the adoption of the REACH Regulation (Registration, Evaluation, Authorisation,
Encyclopedia of Toxicology, Volume 2
http://dx.doi.org/10.1016/B978-0-12-386454-3.00582-0
Environmental & Health Laws, Europe
and Restriction of Chemicals) the EEC has the most advanced regulation on chemicals in the world, which generates information for facilitating the implementation of the environmental and health regulations related to chemicals’ safety.
Basic Principles of the Environmental Law In 1973, the declaration on the Programme of Action of the European Communities on the Environment was adopted. The participating member countries initiated the first common environmental policy frame of the EEC. Because the EEC was not able to establish a legal basis for common environmental protection actions, the Commission was responsible for the development of the first Communication on Action of the European Communities on the Environment (EAP). The EAP was accepted by the Council and held 1973–76. The first EAP was a guideline rather than a formal legal act, but it was a crucial document for the following community’s environmental policy actions. In the first EAP, four basic principles for the community environmental policy were elaborated. The principle of prevention (1) says that the prevention is a more effective way of environmental protection management than ex post facto cure of pollution and that all measures and activities should be taken prior to the occurrence of adverse effects. The polluter pays principle (2) assumes that the polluter should compensate the costs associated with the elimination of the danger of the environment pollution, bear the cost of pollution and pay for the damage caused to the environment, and restore the environment to the condition before the damage as close as possible. According to the subsidiary approach (3), municipalities should undertake on their territories all measures and activities of environmental protection and improvement that are not under the exclusive competence of state authorities. The last rule says that member states are given the power to enact more stringent national measures than those provided by the community (4).
Environmental Regulations Addressing Protection and Conservation of Various Environmental Media In 2010, the text containing the basic law and encompassing the Consolidated Versions of the Treaty on European Union and the Treaty on the functioning of the European Union (2010/C 83/ 01) was adopted. This document includes the annexes and protocols, as a consequence of the amendments introduced by the Treaty of Lisbon (signed in 2007 in Lisbon), the declarations annexed to the Final Act of the Intergovernmental Conference (which accepted the Treaty of Lisbon), and the Charter of Fundamental Rights of the European Union (proclaimed in Strasbourg in 2007). This and other decisions, texts and numerous directives are responsible for the regulation of environmental law on the territory of Europe. Some selected European legislation acts adopted and addressing the protection and conservation of various environmental media are described here. In 2004, Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage was established. This act regulates a framework for environmental liability according to the rule called polluter pays, in a concept of preventing and remedying environmental damage.
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In terms of the pure air strategy, in 2005, the Communication (COM (2005) 446) was released. The elaborated strategy assumed improvement of the environmental legislation and integration air quality issues into linked policies. In 2008, Directive 2008/50/EC on ambient air quality and cleaner air for Europe was established. This directive describes the system of air quality evaluation concerning sulfur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter (PM10 and PM2.5), lead, benzene, carbon monoxide, ozone, promoting the reduction of the level of air pollutants to the levels minimizing the toxic effects on human health and environment. The daughter directives include, e.g., Directive, 1999/30/EC (setting the limit values for SO2, NO2, NOx, PM, and lead); Directive, 2000/69/EC (setting the limit values for benzene and CO2); Directive, 2002/3/EC (setting the objectives and thresholds for concentrations of O3); Directive, 2004/107/EC (setting the target values for concentrations of As, Cd, Ni, and benzo(a)pyrene); Integrated Pollution Prevention and Control Directive (IPPC) 96/61/EC (enforcing the need to control the pollutant releases from certain industrial activities to air, water, and land); Large Combustion Plant Directive 2001/80/EC (regulates emissions of SO2, NOx, and dust from large combustion plants in order to reduce acidification by establishing emission limit values); Solvent Emissions Directive 1999/13/EC (limits of emissions of VOCs in the environment); Petrol Vapour Recovery Directive (control of emissions from motor vehicles); Paints Directive 2004/42/EC (controls of emissions of VOCs in certain paints); Sulphur Control of Liquid Fuels Directive 1999/32/EC (to reduce emissions of SO2 from combustion of heavy fuel oil and gas oil by limiting sulfur content in these oils); and Waste Incineration Device (WID) 2000/76/EC (regulates the standards for incineration of waste). The climate change issue is regulated by many legislative acts. On the basis of an analysis of the effects of climate change, among other documents, three Commission Communications were released. Communication on EU policies and measures to reduce greenhouse gas emissions toward a European Climate Change Programme (COM (2000) 88), from 2000, intends to help all stakeholders participate in preparatory work on policies and measures to reduce greenhouse gases. In 2005, a communication entitled “Winning the Battle against Global Climate Change” (COM (2005) 35) was published. It assumes the enhancement of international cooperation and the elaboration of new measures in coordination with other European policies. In 2007, a communication entitled “Limiting Global Climate Change to 2 degrees Celsius – The Way Ahead for 2020 and Beyond” (COM (2007) 2) was established. Water protection and management issues are mainly regulated by Directive 2000/60/EC from 2000, establishing a framework for EC action in the field of water policy. Its main goal is to ensure good ecological and chemical status for all EC waters by 2015 (including inland surface waters, groundwater, transitional waters, and coastal waters). In 2008, Directive 2008/56/EC, introducing a framework for EC action in the field of marine environmental policy, was adopted. The Marine Strategy Framework Directive defines the general principles for the protection, conservation, and restoration of the marine environment to achieve good ecological status of the marine ecosystems, including the Baltic Sea, the northeast Atlantic, the Mediterranean, and the Black Sea.
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Regarding soil regulations, the “Thematic Strategy for Soil Protection” communication was published by the Commission (COM (2006) 231) along with a proposal setting out a legislative framework for the protection of soil and sustainable use of soil and amending Council Directive 2004/35/EC, both in 2006. The objective of the directive is to create the background for measures to identify problems, prevent soil degradation, and remediate polluted or degraded soil. In 1992, Council Directive 92/43/EEC on the conservation of natural habitats and wild fauna and flora (known as the Habitats Directive) was elaborated, aiming to maintain biodiversity by conserving natural habitats and wild fauna and flora in the territory of the Member States. In the framework of the Habitats Directive, the so-called NATURA 2000 network (the biggest ecological network in the world) of special conservation areas and protected areas was established. Additionally, in 2009, Directive 2009/147/EC on the conservation of wild birds was elaborated to reverse declining wild bird species by forming a system prohibiting practices such as killing or capturing birds, etc. The conservation and exploitation of marine resources are regulated by Council Regulation (EC) No 2371/ 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy, adopted in 2002. This regulation is a fundament of the Common Fisheries Policy (CFP), entering the basic rules of the sustainable exploitation of living aquatic resources (including the fish stocks and marine ecosystems, access to waters and resources and the fleet). Lately, European attention has been focused on directives concerning the biofuels market and the market of genetically modified products. EU strategy of using biofuels is regulated by two acts: Directive 2003/30/EC on the promotion of the use of biofuels or other renewable fuels for transport (from 2003) and the Commission Communication from 2006 entitled “An EU Strategy for Biofuels.” According to the first document, the framework created by the EU promotes an increasing share of biofuels in order to decrease the greenhouse gas emissions (the plan of action assumes that biofuels will have constituted more than 20% of European petrol and diesel consumption by 2020). The second act is intended to promote the use and production of biofuels in the EU and in the developing countries on a large scale. The EU strategy of using genetically modified products is controlled by Regulation 1829/2003/EC, from 2003, on genetically modified food and feed, which supplements Regulation 1830/2003/EC concerning the traceability and labeling of genetically modified organisms, or GMOs (defines the rules of placing on a market GMOs and foodstuffs containing them), and Directive 2009/41/EC, from 2009, on the contained use of genetically modified microorganisms, or GMMs (aiming to protect from the contained use of GMMs possessing the negative consequences).
Environmental Regulations Addressing Particular Activities or Products The waste issue is controlled by general Directive 2008/98/EC on waste and repealing certain earlier directives; this is a legal framework dedicated to the whole waste cycle and treatment
of waste from production to disposal. Its main goal is to protect the human health and environment from the negative effects caused by waste generation and waste management. The landfill strategy is regulated by Council Directive 1999/ 31/EC on the landfill of waste, which assumes the most effective reduction of the possibility of the harmful impact on the environment, mainly on the surface water, groundwater, soil, air, and human health. The waste incineration strategy was described in Directive 2000/76/EC on the incineration of waste, from 2000, in which EU introduced the measures and technical requirements on waste incineration plants and waste coincineration plants to limit the risk of pollution and danger to human health. Moreover, the following documents were elaborated; e.g., in 2005, Commission Communication entitled “Taking Sustainable Use of Resources Forward: A Thematic Strategy on the Prevention and Recycling of Waste,” COM (2005) 666 (guidelines for the limitation of the pressure of the waste production and management on the environment and for the promotion of the effective recycling); Green paper from the European Commission on the management of biowaste in the European Union, COM (2008) 811 (strategy of the management of biowaste, which includes biodegradable garden or park waste, food or kitchen waste from households, restaurants, caterers or retail premises, and waste from food processing plants). The waste issues are also regulated by documents relating to the different groups of waste, naming: l
hazardous waste, includes documents such as: B Council Decision 93/98/EEC and Council Decision 97/ 640/EC, a set of rules of controlling transboundary movements of hazardous wastes and their disposal B Commission Decision 2000/532/EC containing a list of waste and hazardous waste l waste from specific activities, such as: B Directive 2010/75/EU on industrial emissions B Management of waste from extractive industries, Directive 2006/21/EC B Communication on removal and disposal of disused offshore oil and gas installations, COM(98) 49 B Council Directive 86/278/EEC on the use of sewage sludge in agriculture B Directive 2000/59/EC for ship-generated waste and cargo residues B Directives on the titanium dioxide waste: disposal (Council Directive 78/176/EEC), surveillance and monitoring (Council Directive 82/883/EEC), and reduction of pollution caused by waste from the titanium dioxide industry (Council Directive 92/112/ EEC) l radioactive waste and substances, including acts such as: B Communication on the present situation and prospects for radioactive waste management in the European Union, COM(98) 799 B Council Directive 2011/70/Euratom establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste l waste from consumer goods, such as: B Disposal of polychlorinated biphenyls and polychlorinated terphenyls, Directive 96/59/EC
Environmental & Health Laws, Europe B Disposal of spent batteries and accumulators, Directive 2006/66/EC and repealing Directive 91/157/EEC B The reusing, recycling and recovering of motor vehicles, Directive 2005/64/EC B Waste electrical and electronic equipment, Directive 2002/96/EC and Directive 2002/95/EC
Common Policies Connected with Public Health The European health strategy involves all programs, policies, and initiatives that aim to attain a higher level of health protection. One of the fundamental programs proposed by EC is presented in the Proposal for the Regulation of the European Parliament and of the Council on establishing the Health for Growth Programme, the third multiannual programme of EU action in the field of health for the period 2014–20, COM (2011) 709, from 2011. The main purpose of this strategy is to improve citizens’ health and the sustainability of health care systems. European health policies are also realized by the following programs and initiatives: Communication on the health strategy of the European Community, COM (2000) 285, from 2000 (contains general and integrated health strategy and public health framework); Communication on the precautionary principle (which says that in the case of any rational doubt that a certain activity may cause harmful environmental effects, all the measures for protection of the environment shall be undertaken, before scientific evidence becomes available); COM (2000) 1, from 2000 (it applies the precautionary principle to elaborate guidelines on the increasing level of environmental protection through preventative actions taken in the face of risk); Communication on Action against Cancer: European Partnership, COM (2009) 291, from 2009 (actions against cancer covering the period 2009–13); Decision No 1350/2007/EC establishing a second programme of Community action in the field of health (2008–13), from 2007 (draws the outcomes of the first programme of Community action in the field of public health in the years 2003–08); European environment and health strategy, COM (2003) 338, from 2003 (the aim of this initiative is to establish a framework that helps to understand the complex relations between the environment and health). Health law in Europe also deals with different fields of health security and monitoring, and this issue is regulated by, e.g., Council Recommendation 2009/1019/EU on seasonal influenza vaccination, from 2009; Communication on cooperation in the European Union on preparedness and response to biological and chemical agent attacks (Health security), COM (2003) 320, from 2003, or Decision No 2119/98/EC, setting up a network for the epidemiological surveillance and control of communicable diseases in the Community, from 1998. The HIV/AIDS question is discussed in Communication Combating HIV/AIDS in the European Union and neighboring countries, 2009–13, COM (2009) 569, from 2009. The recommendations about blood, blood components, and human tissues are contained in regulations such as Directive 2002/98/EC, setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components, from 2003 and amending Directive 2001/83/EC; Council Recommendation
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on the suitability of blood and plasma donors and the screening of donated blood in the European Community, from 1998; Directive 2004/23/EC, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells, from 2004; or Directive 2010/53/EU, on standards of quality and safety of human organs intended for transplantation, from 2010. The EU also ensures the protection of citizens against the dangers related to certain medical treatments and rare diseases. The recommendations are found in the following documents: Council Recommendation 2009/C 151/02, on an action in the field of rare diseases, from 2009; Council Directive 97/43/Euratom, on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom, from 1997 or Council Directive 89/618/Euratom on informing the general public about health protection measures to be applied and about steps to be taken in the event of a radiological emergency, from 1989. European health law also comprises issues such as exposure to environmental tobacco smoke (Proposal for a Council Recommendation on smokefree environments, COM (2009) 328, from 2009); ban on smoking in public places (Resolution, from 1998); European strategy to reduce alcohol-related harm (Communication COM (2006) 625); healthy diet for a healthy life (Commission Recommendation, 2010/250/EU); Alzheimer’s and other dementias (Communication COM (2009) 380); or combating stress and depression-related problems (Council conclusions, from 2001).
See also: Risk Assessment, Human Health; Environmental Exposure Assessment; Environmental Risk Assessment, Cosmetic and Consumer Products; Environmental Risk Assessment, Pesticides and Biocides; EU Risk Assessment Committees; European Food Safety Authority (EFSA); The European Medicines Agency (EMA); REACH; Occupational Exposure Limits; Acute Health Exposure Guidelines; Toxicology and Global Public Health; Law and Toxicology; Environmental Toxicology.
Further Reading Division of Policy Development and Law Environmental Law Branch United Nations Environment Programme, 2005. Register of International Treaties and Other Agreements in the Field of the Environment. United Nations Environment Programme, Nairobi. UNEP/Env.Law/2005/3. Douma, W.Th., 1996. The precautionary principle. Úlfljótur 49, 417–430. Fu, C., 2008. The evolution and transformation of European environmental policy and law. Asia Eur. J. 6, 245–259. Legemaate, J., 2002. Integrating health law and health policy: a European perspective. Health Pol. 60, 101–110. Louka, E., 2004. Conflicting Integration. The Environmental Law of the European Union. Hart Publishing, Oxford, UK. Regional Environmental Center, 2008. Handbook on the Implementation of EC Environmental Legislation. Umweltbundesamt GmbH. Sands, P., Peel, J., 2012. Principles of International Environmental Law, third ed. Cambridge University Press, Cambridge, UK. Shelton, D., Kiss, A., 2005. Judicial Handbook on Environmental Law. United Nations Environment Programme. The Ministry of Environment and Physical Planning, 2005. The Law on the Environment. Ministry of Environment & Physical Planning, Skopje, Macedonia.
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Training Manual on International Environmental Law, 2007. United Nations Environment Programme UNEP.
Relevant Websites http://ec.europa.eu/environment – European Commission: Environment. http://europa.eu/legislation_summaries/environment – Europa: Summaries of EU Legislation - Environment.
http://www.landmarkchambers.co.uk/cel/notes-and-articles – Landmark Chambers: Centre for Environment Law. http://www.practiceandpolicyofenvironmentallaw.com/forms/chapter1.pdf – Introduction to Environmental Practice Policy: An introduction to environmental law in practice. http://www.wipo.int/wipolex/en – World Intellectual Property Organization - one-stop search facility for national laws and treaties.
Introduction More than 50 years ago, under growing public awareness of threats to the environment, governments began to manifest their concern and introduced regulations to combat pollution of inland waters, ocean, and air, and to safeguard certain cities or areas. Parallel, special administrative organs, ministries, or environmental agencies were established to more effectively manage environmental and health legislations. The crucial moment in the forming phase of the European environmental policy was 1972, when the United Nations General Assembly convoked a world conference on the human environment in Stockholm. As a result, the Declaration on the Human Environment and the ‘Action Plan’ containing 109 Recommendations were adopted. In 1982, the World Charter for Nature was elaborated by the General Assembly, when the United Nations reaffirmed and developed the general principles of the Stockholm Declaration. In 1992, in Rio, the second global meeting covered by the United Nations took place, known as the United Nations Conference on Environment and Development (UNCED). As an outcome of this meeting, two documents were established: the Declaration on Environment (whose main concept is sustainable development, integrating development and environmental protection), and an action program called Agenda 21 (which indicates the specific action to be taken to achieve more sustainable types of development). In 2002, in Johannesburg, another important conference was held. As a consequence, the participating governments accepted the Declaration on Sustainable Development. These conferences and other conventions and legal agreements resulted in establishing key principles of environmental and health law by giving meaning to the not yet formalized legal instruments, being fundamental to create the most important European environmental and health legal systems. Environmental law is recognized as a wide category of laws, which includes laws that specifically address environmental issues, and more general laws, having a direct impact on environmental issues. According to the modern definition of the environment in the context of sustainable development, this term covers all the physical and social factors of the surroundings of human beings, including land, water, atmosphere, climate, sound, odor, taste, energy, waste management, coastal and marine pollution, the biological factors of animals and plants, cultural values, historical sites, and monuments and aesthetics. As a consequence, environmental law can be generally defined as the body of law that encompasses all the elements to control human impacts on the Earth and public health. According to UNCED, environmental priorities can be classified into two categories. One of them is related to the protection and conservation of various environmental media, such as protection of the atmosphere, halting of deforestation, protection of land resources, conservation of biological diversity, protection of freshwater resources, and protection of oceans and seas and marine living resources. The second category identified includes the priorities related to the
348
regulation of particular activities or products and by-products of human technological and industrial innovation considered particularly environmentally harmful; the following priorities can be distinguished: biotechnology, toxic chemicals and their trade, agricultural practices, hazardous wastes and their trade, radioactive wastes, solid wastes, and sewage-related issues. Collaterally to environmental law, health law was developing. Health law is defined as a set of rules regulating the promotion and protection of health, health services, the equitable distribution of available resources, and the legal position of all parties concerned (namely, patients, health care providers, health care institutions, and financing) and monitoring bodies. As a discipline, health law concerns both social human rights such as the right to health care and individual human rights. Health law is nowadays used especially as an instrument of monitoring and surveillance of population health status, communicable disease control, health protection, prevention of ill health, improvement of health and quality of life, promotion of positive health, and prolonging of life expectancy.
European Legislation The progress in developing the international acts is a direct response to particular incidents (e.g., the Chernobyl accident) or the availability of new scientific evidence that action is required to prevent environmental damage. All categories of environmental or health issues require international regulations, which are extremely complex, comprising thousands of rules that aim to protect the Earth’s living and nonliving elements and its ecological processes. The view of the European Union as an independent regulatory organization covers the idea of the European Community (EC) as a regulatory state, in a way to create the regulations that can be adopted all across different environmental and health policies and all across various sectors of economy, which includes the application of horizontal legislation. The main purpose of the European legislation is to develop standards at a European level and to regulate related environmental matters among countries within Europe, which makes it possible to better carry out, within a single institutional framework, the tasks related to environmental and health issues, in accordance with the principle of subsidiarity and the principle of sustainable development (which says that any activity shall be taken as to the rational and sustainable use of natural resources in order to guarantee that present generation social and economic needs and needs for healthy environment will be satisfied without jeopardizing the rights of future generations to satisfy their own needs). For example, the European Economic Community (EEC) is a pioneer of crucial environmental standards such as Directive 67/548 (connected with the Classification, Packaging and Labeling of Dangerous Preparations) or Directive 70/157 (related to the Permissible Sound Level and the Exhaust System of Motor Vehicles); and following the adoption of the REACH Regulation (Registration, Evaluation, Authorisation,
Encyclopedia of Toxicology, Volume 2
http://dx.doi.org/10.1016/B978-0-12-386454-3.00582-0
Environmental & Health Laws, Europe
and Restriction of Chemicals) the EEC has the most advanced regulation on chemicals in the world, which generates information for facilitating the implementation of the environmental and health regulations related to chemicals’ safety.
Basic Principles of the Environmental Law In 1973, the declaration on the Programme of Action of the European Communities on the Environment was adopted. The participating member countries initiated the first common environmental policy frame of the EEC. Because the EEC was not able to establish a legal basis for common environmental protection actions, the Commission was responsible for the development of the first Communication on Action of the European Communities on the Environment (EAP). The EAP was accepted by the Council and held 1973–76. The first EAP was a guideline rather than a formal legal act, but it was a crucial document for the following community’s environmental policy actions. In the first EAP, four basic principles for the community environmental policy were elaborated. The principle of prevention (1) says that the prevention is a more effective way of environmental protection management than ex post facto cure of pollution and that all measures and activities should be taken prior to the occurrence of adverse effects. The polluter pays principle (2) assumes that the polluter should compensate the costs associated with the elimination of the danger of the environment pollution, bear the cost of pollution and pay for the damage caused to the environment, and restore the environment to the condition before the damage as close as possible. According to the subsidiary approach (3), municipalities should undertake on their territories all measures and activities of environmental protection and improvement that are not under the exclusive competence of state authorities. The last rule says that member states are given the power to enact more stringent national measures than those provided by the community (4).
Environmental Regulations Addressing Protection and Conservation of Various Environmental Media In 2010, the text containing the basic law and encompassing the Consolidated Versions of the Treaty on European Union and the Treaty on the functioning of the European Union (2010/C 83/ 01) was adopted. This document includes the annexes and protocols, as a consequence of the amendments introduced by the Treaty of Lisbon (signed in 2007 in Lisbon), the declarations annexed to the Final Act of the Intergovernmental Conference (which accepted the Treaty of Lisbon), and the Charter of Fundamental Rights of the European Union (proclaimed in Strasbourg in 2007). This and other decisions, texts and numerous directives are responsible for the regulation of environmental law on the territory of Europe. Some selected European legislation acts adopted and addressing the protection and conservation of various environmental media are described here. In 2004, Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage was established. This act regulates a framework for environmental liability according to the rule called polluter pays, in a concept of preventing and remedying environmental damage.
349
In terms of the pure air strategy, in 2005, the Communication (COM (2005) 446) was released. The elaborated strategy assumed improvement of the environmental legislation and integration air quality issues into linked policies. In 2008, Directive 2008/50/EC on ambient air quality and cleaner air for Europe was established. This directive describes the system of air quality evaluation concerning sulfur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter (PM10 and PM2.5), lead, benzene, carbon monoxide, ozone, promoting the reduction of the level of air pollutants to the levels minimizing the toxic effects on human health and environment. The daughter directives include, e.g., Directive, 1999/30/EC (setting the limit values for SO2, NO2, NOx, PM, and lead); Directive, 2000/69/EC (setting the limit values for benzene and CO2); Directive, 2002/3/EC (setting the objectives and thresholds for concentrations of O3); Directive, 2004/107/EC (setting the target values for concentrations of As, Cd, Ni, and benzo(a)pyrene); Integrated Pollution Prevention and Control Directive (IPPC) 96/61/EC (enforcing the need to control the pollutant releases from certain industrial activities to air, water, and land); Large Combustion Plant Directive 2001/80/EC (regulates emissions of SO2, NOx, and dust from large combustion plants in order to reduce acidification by establishing emission limit values); Solvent Emissions Directive 1999/13/EC (limits of emissions of VOCs in the environment); Petrol Vapour Recovery Directive (control of emissions from motor vehicles); Paints Directive 2004/42/EC (controls of emissions of VOCs in certain paints); Sulphur Control of Liquid Fuels Directive 1999/32/EC (to reduce emissions of SO2 from combustion of heavy fuel oil and gas oil by limiting sulfur content in these oils); and Waste Incineration Device (WID) 2000/76/EC (regulates the standards for incineration of waste). The climate change issue is regulated by many legislative acts. On the basis of an analysis of the effects of climate change, among other documents, three Commission Communications were released. Communication on EU policies and measures to reduce greenhouse gas emissions toward a European Climate Change Programme (COM (2000) 88), from 2000, intends to help all stakeholders participate in preparatory work on policies and measures to reduce greenhouse gases. In 2005, a communication entitled “Winning the Battle against Global Climate Change” (COM (2005) 35) was published. It assumes the enhancement of international cooperation and the elaboration of new measures in coordination with other European policies. In 2007, a communication entitled “Limiting Global Climate Change to 2 degrees Celsius – The Way Ahead for 2020 and Beyond” (COM (2007) 2) was established. Water protection and management issues are mainly regulated by Directive 2000/60/EC from 2000, establishing a framework for EC action in the field of water policy. Its main goal is to ensure good ecological and chemical status for all EC waters by 2015 (including inland surface waters, groundwater, transitional waters, and coastal waters). In 2008, Directive 2008/56/EC, introducing a framework for EC action in the field of marine environmental policy, was adopted. The Marine Strategy Framework Directive defines the general principles for the protection, conservation, and restoration of the marine environment to achieve good ecological status of the marine ecosystems, including the Baltic Sea, the northeast Atlantic, the Mediterranean, and the Black Sea.
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Regarding soil regulations, the “Thematic Strategy for Soil Protection” communication was published by the Commission (COM (2006) 231) along with a proposal setting out a legislative framework for the protection of soil and sustainable use of soil and amending Council Directive 2004/35/EC, both in 2006. The objective of the directive is to create the background for measures to identify problems, prevent soil degradation, and remediate polluted or degraded soil. In 1992, Council Directive 92/43/EEC on the conservation of natural habitats and wild fauna and flora (known as the Habitats Directive) was elaborated, aiming to maintain biodiversity by conserving natural habitats and wild fauna and flora in the territory of the Member States. In the framework of the Habitats Directive, the so-called NATURA 2000 network (the biggest ecological network in the world) of special conservation areas and protected areas was established. Additionally, in 2009, Directive 2009/147/EC on the conservation of wild birds was elaborated to reverse declining wild bird species by forming a system prohibiting practices such as killing or capturing birds, etc. The conservation and exploitation of marine resources are regulated by Council Regulation (EC) No 2371/ 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy, adopted in 2002. This regulation is a fundament of the Common Fisheries Policy (CFP), entering the basic rules of the sustainable exploitation of living aquatic resources (including the fish stocks and marine ecosystems, access to waters and resources and the fleet). Lately, European attention has been focused on directives concerning the biofuels market and the market of genetically modified products. EU strategy of using biofuels is regulated by two acts: Directive 2003/30/EC on the promotion of the use of biofuels or other renewable fuels for transport (from 2003) and the Commission Communication from 2006 entitled “An EU Strategy for Biofuels.” According to the first document, the framework created by the EU promotes an increasing share of biofuels in order to decrease the greenhouse gas emissions (the plan of action assumes that biofuels will have constituted more than 20% of European petrol and diesel consumption by 2020). The second act is intended to promote the use and production of biofuels in the EU and in the developing countries on a large scale. The EU strategy of using genetically modified products is controlled by Regulation 1829/2003/EC, from 2003, on genetically modified food and feed, which supplements Regulation 1830/2003/EC concerning the traceability and labeling of genetically modified organisms, or GMOs (defines the rules of placing on a market GMOs and foodstuffs containing them), and Directive 2009/41/EC, from 2009, on the contained use of genetically modified microorganisms, or GMMs (aiming to protect from the contained use of GMMs possessing the negative consequences).
Environmental Regulations Addressing Particular Activities or Products The waste issue is controlled by general Directive 2008/98/EC on waste and repealing certain earlier directives; this is a legal framework dedicated to the whole waste cycle and treatment
of waste from production to disposal. Its main goal is to protect the human health and environment from the negative effects caused by waste generation and waste management. The landfill strategy is regulated by Council Directive 1999/ 31/EC on the landfill of waste, which assumes the most effective reduction of the possibility of the harmful impact on the environment, mainly on the surface water, groundwater, soil, air, and human health. The waste incineration strategy was described in Directive 2000/76/EC on the incineration of waste, from 2000, in which EU introduced the measures and technical requirements on waste incineration plants and waste coincineration plants to limit the risk of pollution and danger to human health. Moreover, the following documents were elaborated; e.g., in 2005, Commission Communication entitled “Taking Sustainable Use of Resources Forward: A Thematic Strategy on the Prevention and Recycling of Waste,” COM (2005) 666 (guidelines for the limitation of the pressure of the waste production and management on the environment and for the promotion of the effective recycling); Green paper from the European Commission on the management of biowaste in the European Union, COM (2008) 811 (strategy of the management of biowaste, which includes biodegradable garden or park waste, food or kitchen waste from households, restaurants, caterers or retail premises, and waste from food processing plants). The waste issues are also regulated by documents relating to the different groups of waste, naming: l
hazardous waste, includes documents such as: B Council Decision 93/98/EEC and Council Decision 97/ 640/EC, a set of rules of controlling transboundary movements of hazardous wastes and their disposal B Commission Decision 2000/532/EC containing a list of waste and hazardous waste l waste from specific activities, such as: B Directive 2010/75/EU on industrial emissions B Management of waste from extractive industries, Directive 2006/21/EC B Communication on removal and disposal of disused offshore oil and gas installations, COM(98) 49 B Council Directive 86/278/EEC on the use of sewage sludge in agriculture B Directive 2000/59/EC for ship-generated waste and cargo residues B Directives on the titanium dioxide waste: disposal (Council Directive 78/176/EEC), surveillance and monitoring (Council Directive 82/883/EEC), and reduction of pollution caused by waste from the titanium dioxide industry (Council Directive 92/112/ EEC) l radioactive waste and substances, including acts such as: B Communication on the present situation and prospects for radioactive waste management in the European Union, COM(98) 799 B Council Directive 2011/70/Euratom establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste l waste from consumer goods, such as: B Disposal of polychlorinated biphenyls and polychlorinated terphenyls, Directive 96/59/EC
Environmental & Health Laws, Europe B Disposal of spent batteries and accumulators, Directive 2006/66/EC and repealing Directive 91/157/EEC B The reusing, recycling and recovering of motor vehicles, Directive 2005/64/EC B Waste electrical and electronic equipment, Directive 2002/96/EC and Directive 2002/95/EC
Common Policies Connected with Public Health The European health strategy involves all programs, policies, and initiatives that aim to attain a higher level of health protection. One of the fundamental programs proposed by EC is presented in the Proposal for the Regulation of the European Parliament and of the Council on establishing the Health for Growth Programme, the third multiannual programme of EU action in the field of health for the period 2014–20, COM (2011) 709, from 2011. The main purpose of this strategy is to improve citizens’ health and the sustainability of health care systems. European health policies are also realized by the following programs and initiatives: Communication on the health strategy of the European Community, COM (2000) 285, from 2000 (contains general and integrated health strategy and public health framework); Communication on the precautionary principle (which says that in the case of any rational doubt that a certain activity may cause harmful environmental effects, all the measures for protection of the environment shall be undertaken, before scientific evidence becomes available); COM (2000) 1, from 2000 (it applies the precautionary principle to elaborate guidelines on the increasing level of environmental protection through preventative actions taken in the face of risk); Communication on Action against Cancer: European Partnership, COM (2009) 291, from 2009 (actions against cancer covering the period 2009–13); Decision No 1350/2007/EC establishing a second programme of Community action in the field of health (2008–13), from 2007 (draws the outcomes of the first programme of Community action in the field of public health in the years 2003–08); European environment and health strategy, COM (2003) 338, from 2003 (the aim of this initiative is to establish a framework that helps to understand the complex relations between the environment and health). Health law in Europe also deals with different fields of health security and monitoring, and this issue is regulated by, e.g., Council Recommendation 2009/1019/EU on seasonal influenza vaccination, from 2009; Communication on cooperation in the European Union on preparedness and response to biological and chemical agent attacks (Health security), COM (2003) 320, from 2003, or Decision No 2119/98/EC, setting up a network for the epidemiological surveillance and control of communicable diseases in the Community, from 1998. The HIV/AIDS question is discussed in Communication Combating HIV/AIDS in the European Union and neighboring countries, 2009–13, COM (2009) 569, from 2009. The recommendations about blood, blood components, and human tissues are contained in regulations such as Directive 2002/98/EC, setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components, from 2003 and amending Directive 2001/83/EC; Council Recommendation
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on the suitability of blood and plasma donors and the screening of donated blood in the European Community, from 1998; Directive 2004/23/EC, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells, from 2004; or Directive 2010/53/EU, on standards of quality and safety of human organs intended for transplantation, from 2010. The EU also ensures the protection of citizens against the dangers related to certain medical treatments and rare diseases. The recommendations are found in the following documents: Council Recommendation 2009/C 151/02, on an action in the field of rare diseases, from 2009; Council Directive 97/43/Euratom, on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom, from 1997 or Council Directive 89/618/Euratom on informing the general public about health protection measures to be applied and about steps to be taken in the event of a radiological emergency, from 1989. European health law also comprises issues such as exposure to environmental tobacco smoke (Proposal for a Council Recommendation on smokefree environments, COM (2009) 328, from 2009); ban on smoking in public places (Resolution, from 1998); European strategy to reduce alcohol-related harm (Communication COM (2006) 625); healthy diet for a healthy life (Commission Recommendation, 2010/250/EU); Alzheimer’s and other dementias (Communication COM (2009) 380); or combating stress and depression-related problems (Council conclusions, from 2001).
See also: Risk Assessment, Human Health; Environmental Exposure Assessment; Environmental Risk Assessment, Cosmetic and Consumer Products; Environmental Risk Assessment, Pesticides and Biocides; EU Risk Assessment Committees; European Food Safety Authority (EFSA); The European Medicines Agency (EMA); REACH; Occupational Exposure Limits; Acute Health Exposure Guidelines; Toxicology and Global Public Health; Law and Toxicology; Environmental Toxicology.
Further Reading Division of Policy Development and Law Environmental Law Branch United Nations Environment Programme, 2005. Register of International Treaties and Other Agreements in the Field of the Environment. United Nations Environment Programme, Nairobi. UNEP/Env.Law/2005/3. Douma, W.Th., 1996. The precautionary principle. Úlfljótur 49, 417–430. Fu, C., 2008. The evolution and transformation of European environmental policy and law. Asia Eur. J. 6, 245–259. Legemaate, J., 2002. Integrating health law and health policy: a European perspective. Health Pol. 60, 101–110. Louka, E., 2004. Conflicting Integration. The Environmental Law of the European Union. Hart Publishing, Oxford, UK. Regional Environmental Center, 2008. Handbook on the Implementation of EC Environmental Legislation. Umweltbundesamt GmbH. Sands, P., Peel, J., 2012. Principles of International Environmental Law, third ed. Cambridge University Press, Cambridge, UK. Shelton, D., Kiss, A., 2005. Judicial Handbook on Environmental Law. United Nations Environment Programme. The Ministry of Environment and Physical Planning, 2005. The Law on the Environment. Ministry of Environment & Physical Planning, Skopje, Macedonia.
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Training Manual on International Environmental Law, 2007. United Nations Environment Programme UNEP.
Relevant Websites http://ec.europa.eu/environment – European Commission: Environment. http://europa.eu/legislation_summaries/environment – Europa: Summaries of EU Legislation - Environment.
http://www.landmarkchambers.co.uk/cel/notes-and-articles – Landmark Chambers: Centre for Environment Law. http://www.practiceandpolicyofenvironmentallaw.com/forms/chapter1.pdf – Introduction to Environmental Practice Policy: An introduction to environmental law in practice. http://www.wipo.int/wipolex/en – World Intellectual Property Organization - one-stop search facility for national laws and treaties.