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©iStockphoto Chemicals in the Environment and their Health Implications The European Union takes action Environment Chemicals contribute in a multitude of ways to modern-day living. Although many serve our general well-being, some chemicals are toxic and can harm our health. In recent years a worrying increase in certain health problems has been partially explained by the use of such chemicals. The European Union (EU) has been a front runner in the design of legislation that offers greater protection to its citizens. And in keeping with the WSSD 20201 commitment, the EU has laws in place to protect human health from harmful chemicals. Several of these prohibit or limit the use of hazardous chemicals and encourage a swift phase-out of the most harmful ones. 1 International global awareness of the potential harm to human health and the environment caused by exposure to chemicals led the international community at the 2002 World Summit on Sustainable Development (WSSD) to take on board a global commitment that by 2020 chemicals are used and produced in ways that lead to the minimisation of significant adverse effects on human health and the environment. Biocides Biocidal products contain or generate active substances and are used against harmful organisms such as pests and bacteria. They can be found in household products such as disinfectants, rodenticides, repellents, and insecticides. Others are used in industrial and agricultural applications to protect natural or manufactured products from damage. Due to their intrinsic properties and uses, biocidal products may pose health risks. The EU is establishing a regulatory framework aimed at significantly increasing the safety of biocidal products used and sold in the EU. It provides for the phase out of biocides that are carcinogenic, mutagenic, and toxic to reproduction, disrupt the endocrine system or which are dangerous to the environment. Products containing identified substances of high concern will be subject to comparative assessment so that the products with the highest risk will be eliminated and only safe products will remain on the market. The new legislation will enter into force in 2013. Pesticides Pesticides are used to control harmful organisms such as weeds and insects. However, their use may endanger health and the environment. Many studies have examined the effects of pesticide exposure and links have been found with cancer, problems with fertility and reproduction, respiratory diseases, disruption of the hormone (endocrine) system, immune system, and nervous system. The EU pesticides legislation (Directive 2009/128/EC) bans the use of certain dangerous chemicals in these products. Pesticides that are known to cause cancer, damage DNA, are toxic to the reproductive system or harm the hormone system must be phased out. Products containing certain hazardous substances are to be replaced if safer alternatives are shown to exist. The law also requires countries to produce National Action Plans for the sustainable use of pesticides in agriculture as well as reduced pesticide dependency more generally, including in public parks, gardens and recreation grounds. Endocrine disruptors Endocrine disruptors are chemicals that interfere with the hormone (endocrine) system causing adverse health effects. A wide range of substances, both natural and man-made, are thought to cause endocrine disruption, including pharmaceuticals, pesticides and industrial organic chemicals. Although endocrine disruptors are most widely associated with reductions in human fertility, they may also affect the development of the nervous and immune systems; and some studies point to a link with cancer, diabetes, endometriosis and other diseases. There is evidence that the incidence of endocrine-related disorders in humans has increased in recent years. Multiple causes underlie this trend, but evidence is mounting that chemical exposure is involved. The European Community Strategy on endocrine disruptors adopted in 1999 outlined the actions necessary to address the potential health and environmental impacts of endocrine disruption. Provisions on endocrine disruptors have also been included in key legislation.2 In January 2012 the European Commission released a major study, “State of the Art Assessment of Endocrine Disruptors” (http://ec.europa.eu/environment/ endocrine/index_en.htm). The study which provides a thorough scientific review was commissioned to inform the EU’s work on the development of criteria to identify and regulate hormone disruptors under EU law. The study will also facilitate the review and possible revision of the European Community’s Strategy on Endocrine Disruptors. Heavy Metals - Cadmium, Lead and Mercury The term heavy metal generally refers to metallic elements that have a relatively high density and are toxic at low concentrations. Cadmium in the environment comes from the burning of fossil fuels such as coal or oil, and incineration of municipal waste. Cadmium may also be emitted into the air as a result of metal production or from the production of nickel-cadmium batteries. Cadmium is extremely toxic even in small amounts. It is expelled slowly from the body and so can accumulate over time causing intestinal damage, digestive problems as well as kidney and bone disease. Lead is a malleable and ductile metal and is therefore used widely in construction and manufacturing. Lead accumulates in soils and sediments through deposition from air sources, direct discharge of waste to water bodies, mining and erosion. Lead enters the body by ingestion or inhalation. The majority of lead inhaled goes directly into the bloodstream and can affect the nervous system. Mercury comes from natural sources (such as volcanoes) and also from human activity. Fossil fuel burning, mining, smelting, the use of mercury in certain products and solid waste combustion have boosted levels in the atmosphere. From here it is deposited onto land and into water bodies causing contamination. Humans can be exposed to mercury in their diet, especially if they eat a lot 2 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH 1907/2006 ) (Article 57) and Regulation (1107/2009) concerning the placing of Plant Protection Products on the Market. of seafood. High doses of mercury can be fatal for humans, but even relatively low doses can seriously affect the nervous system and have been linked with harmful effects on the cardiovascular, immune and reproductive systems. The EU has made considerable progress in addressing mercury since the launch of the EU Mercury Strategy in 2005. The Strategy was revised in 2010. Developments include: restrictions on the sale of measuring devices containing mercury, a ban on exports of metallic mercury from the EU and new rules on its obligatory safe storage. The EU’s Industrial Emissions Directive adopted in 2010 will further reduce mercury emissions from industrial processes. The EU strongly supports the international process (under UNEP)3 to develop a global legally binding instrument on mercury. Cadmium, lead and mercury are controlled under the Restriction of Hazardous Substances Directive (2002/95/EC). Strict limit values are set for these metals in specified types of electrical and electronic equipment. The End-of-Life Vehicles (2000/53/EC) Directive also restricts their use. In addition, cadmium in jewellery products and plastics has been banned under the REACH Regulation (EC 1907/2006), while under the Water Framework Directive (2000/60/EC), cadmium and mercury are listed as priority hazardous substances and lead as a priority substance. Persistent Organic Pollutants Persistent Organic Pollutants (POPs) are chemical substances that remain intact in the environment for long periods, are transported across boundaries, accumulate in the fatty tissue of living organisms including humans and are found at higher concentrations in the food chain. Because of their toxic characteristics, POPs pose adverse effects to human health and the environment. POPs are associated with cancer, neurological damage, birth defects, sterility, and immune system defects. The Stockholm Convention is the main global legally binding instrument protecting us from POPs. The EU is strongly committed to the effective implementation of the Stockholm Convention and has actively encouraged the listing of additional chemicals under the Convention. Moreover the EU’s POPs Regulation (EC No 850/2004) supports and reinforces the provisions and to a certain extent goes beyond the Convention. The Regulation contains provisions regarding production, placing on the market and use of chemicals, management of stockpiles and wastes, and measures to reduce unintentional releases of POPs. Combination effects of chemicals – Chemical Mixtures We are exposed daily to various concentrations of chemicals from a range of sources. Some studies suggest that different chemicals in combination can have damaging effects on our health even when they are below the “safe-level” for individual chemicals. In the EU the regulation and risk assessment of chemicals is usually based on a single substance approach. This means that the evaluation is conducted chemical by chemical. However, there are concerns that this may not provide sufficient protection from the risks posed by simultaneous exposure to multiple chemicals and that another approach is required. During the Swedish Presidency of the EU in 2009, the environment ministers asked the European Commission to analyse whether and how existing legislation addresses this problem and to propose appropriate modifications and guidelines. The Commission will publish its report on this issue during 2012. Pharmaceuticals in the Environment Pharmaceutical residues have become an important source of environmental contamination. Many pharmaceutical chemicals are designed to be non-degradable and thus present a risk when they enter, persist and disseminate in the environment. The European Commission recognises that the pollution of the environment by pharmaceutical residues is both an emerging environmental problem and public health concern and is committed to addressing this matter. Nanomaterials are chemical substances or materials that are manufactured and used at an extremely small scale. Numerous products containing nanomaterials are already in use, and the market is expected to flourish over the coming years. Nanomaterials have the potential to improve the quality of life and to contribute to industrial competitiveness. However, the new materials may also raise health and safety concerns. These risks, and to what extent they can be tackled by existing risk assessment measures in the EU, have been the subject of several scientific opinions issued by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks. The Committee’s general view is that, there is still scientific uncertainty about the safety of nanomaterials and therefore safety assessment must be done on a case-by-case basis. 3 United Nations Environment Programme. ©iStockphoto Nanomaterials Key Horizontal Policies and Important Tools The EU has also developed a number of important policies and tools that protect human health and the environment. REACH and CLP in particular strive to ensure that Europe’s citizens are better informed about and protected against hazardous chemicals. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. This regulation (EC 1907/2006) is a key part of the EU’s endeavour to make the use of chemicals safer. REACH attempts to address long-term exposures and its implications for human health and the environment. The regulation creates a single regulatory system dealing with industrial chemicals, and seeks to close the knowledge gap by placing the responsibility on industry to provide safety information on their substances and to manage the risks from chemicals. REACH’s philosophy is that no chemical substance in whatever form should be placed on the market without adequate documentation. Each producer and importer of chemicals in volumes of one tonne or more per year must register them with the European Chemicals Agency (ECHA) and submit information on their properties, uses and safe ways of handling them. REACH also calls for the progressive substitution of the most dangerous chemicals by suitable alternatives. The first registration deadline closed on 30 November 2010. Approximately 5000 substances were registered with ECHA. This marks a major step towards the safe management of chemicals. The classification, labelling and packaging of chemicals is important in ensuring that people handling and using chemicals are aware of the dangers. The United Nations developed an internationally agreed system, known as the Global Harmonised System of Classification and Labelling of Chemicals (UNGHS). The EU Regulation on Classification, Labelling and Packaging of chemicals (CLP) (EC No 1272/2008) aligns the existing EU classification system to the UNGHS. All companies manufacturing or importing hazardous substances were required to appropriately classify, label and package them in accordance with CLP by 1 December 2010 and to duly notify the European Chemicals Agency (ECHA). More than 100,000 substances were notified. The data allow ECHA to establish a classification and labelling inventory providing workers and consumers with the information necessary to select safer substances and to limit risk Assessing Human Exposure Human Biomonitoring (HBM) is the gathering and analysing of samples of human tissues or body fluids to identify the presence and levels of chemicals in the human body. These chemicals are taken in directly or indirectly from the environment. This form of monitoring is an important tool for assessing human exposure to environmental substances. The EU Research Programme is funding a project to develop a framework for Human Biomonitoring at EU level called COPHES. The partner project, DEMOCOPHES, is testing the feasibility of a coherent approach to Human Biomonitoring in Europe, by looking at biomarkers for mercury, cadmium, phthalates and environmental tobacco smoke in human hair and urine. The project will collect samples and data from 120 motherchild pairs in each participating country. More information: http://ec.europa.eu/environment/chemicals/ © European Union, 2012 ©iStockphoto Reproduction is authorised provided the source is acknowledged.