EU CHEMICAL RISK

Judging from previous EU chemical risk management decision-making, the choice of control instrument, scope and detail of regulatory action proposed by a Member State depends on its national regulatory approach and administrative structure [31, 32]. This affects inclusion of different actors in decision-making... 

For ecosystems, the collection of threshold values for NO(A)EL for several species is used to determine a predicted no-effect concentration (PNEC) for each environmental compartment. Environmental monitoring often observes effects that different environmental concentrations have on various ecosystem sub-groups. Laboratory multi-species test systems are available, but are limited in number and rarely appear in EU chemical risk assessments (see [125]). 

EU chemical risk assessment and management decision-making processes appear to be separated into five or more Techmcal Committees and Working Groups attended by different regulators and overseen by at least three Directorate-Generals of the European Commission. 

In a book on EU chemical risk management, Calow identified four approaches to risk management suspicion, hazard, technical, and risk-benefit [256]. These are categorised according to the amount of scientific evidence and the amount of caution involved in decisionmaking (Figure 2.8) ... 

A product lifecycle ranges from resource extraction through manufacture to use and final waste disposal or processing. Under the current EU chemical risk assessment procedure, lifecycle thinking considers the risks at each stage of a substance s lifecycle, with the possible summation of multiple sources of exposures to a single substance [144], LCA that quantitatively evaluate the overall environmental and health impacts of processes, services or products can complement risk assessment as a useful decision-support tool for chemical risk management [183, 188, 536]. 

A decision by the European Parliament to put restrictions on the use of six phthalate plasticisers ignores scientific risk assessments and threatens the basis for Reach, the impending European legislation on chemical strategy. The Strasbourg parliament has voted to ban DEHP, DBP and BBP in children s toys and childcare items. DINP, DIDP and DNOP will be banned from use if the toys or items can be put in the mouth by children. An EU scientific risk assessment said children were not at risk from DINP in toys. A similar study in the US by the Consumer Product Safety Commission reached the same conclusion. European Commission... 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

Chemical risk assessments are carried out by many national and international bodies, including major actors such as the World Health Organization (WHO) - particularly the International Programme on Chemical Safety (IPCS), the OECD, the Unites States, and the European Union (EU). The efforts undertaken by these major acting bodies in terms of chemical risk assessments are reflected in this book. 

The two most important aims of REACH are to improve the protection of human health and the environment from the risks of chemicals while enhancing the innovative capability and competitiveness of the EU chemicals industry. 

In the new EU chemicals regulation REACH, which entered into force on 1 June 2007, detailed guidance documents on different REACH elements, including risk characterization and the use of assessment factors, are currently in preparation (spring 2007). These documents will probably be available on the EU DG Environment REACH Web site (EU 2006) when published. 

The US-EPA has in its 1996 Proposed Guidelines for Carcinogen Risk Assessment (US-EPA 1996) adopted the dose descriptor LEDio (the 95% lower confidence limit on a dose associated with a 10% extra tumor risk) whereas in its 2005 Guidelines for Carcinogen Risk Assessment (US-EPA 2005), no defined incidence has been recommended (see Section 6.3.2). Within the EU chemical s regulation, the dose descriptor T25 has been proposed (see Section 6.3.3). In the newly proposed MOE approach, the JECFA and the EFSA have recommended the dose descriptor BMDLio (see Section 6.4). 

Within the EU chemical s regulation, a more simple approach based on the dose descriptor T25 has been proposed as a basis for quantitative risk characterization of non-threshold carcinogens. 

Although REACH involved a revision of most EU chemical control legislation, one existing directive that was not incorporated into REACH is the Solvent Emissions Directive [26]. The aim of this Directive is to prevent or reduce the effects of volatile organic compounds (VOCs) on the environment (mainly via the atmosphere) and reduce the potential human health risks from solvent-based activities. Most of the provisions of the directive relate to emission and inventory control, but one part of the directive has potentially negative consequences in terms of Green Chemistry. 

The REACH system was initiated to improve the protection of human health and the environment from the risk that can be posed by chemicals, to enhance the competitiveness of the EU chemicals industry (a key sector for European economy), to promote alternative methods for the assessment of hazards of substances, and to ensure the free circulation of substances on the international market of the European Union. The regulation was formally enforced on 1 June 2007. However, according to the REACH schedule, the registration procedures started from 1 June 2008 [1, 2]. 

REACH came about as a result of the growing awareness that the former legislative framework governing chemical substances in the EU, which consisted of a patchwork of many different directives and regulations that had developed over the years, contained several serious flaws that risked jeopardising human health and the environment and hampering the competitiveness of the EU chemical industry. 

Renn O, Benighaus C. 2006. Framing the perception of cumulative stressors, especially chemical risks. Report on approaches to the characterization of knowledge of risks, uncertainties and ambiguity and their use and quality assurance in the IP domain. EU FP6 Project NOMIRACLE, Deliverable 4.3.2. Stuttgart (DE) Dialogik. 

The relevance of REACH goes beyond the transformation of EU chemicals safety management. Internally, REACH S institutional design and procedural sequences may well become a model for EU risk regulation generally (Pesendorfer 2006). 

At least as important is the role of REACH in international risk regulation. The Commission makes no secret of its aspirations to promote the REACH approach to chemical safety beyond EU borders. Countries such as Switzerland, Norway, Japan, Canada, Korea, New Zealand and China have apparently expressed a keen interest to learn from REACH. 36 And even in countries where governments have declared no such intention, such as the USA,37 REACH is being used as a yardstick against which to assess domestic chemical risk regulation (Hogue 2007). 

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