European Union existing chemicals

In the European Union, coal-derived complex chemical substances, ie, those contained in the European Inventory of Existing Commercial Chemical Substances, have been classified for carcinogenicity in the twenty-first adaptation to technical progress of the European Commission (EC) Dangerous Substances Directive 1994 67/548/EEC (57). The EC Regulation 793/93 requires data sets to be submitted by producers or importers to the... 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

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... 

Selling existing adhesives to the general public, containing anyone of 43 newly classed dangerous chemicals, could be illegal, if the European Union s Council of Ministers... 

While participating in the European Union programme on risk assessment of existing chemicals, Euro Chlor (representing all major European chlorine producers), recognised the need to carry out a detailed risk evaluation on chemicals linked to the production of chlorine. In view of concerns about specific risks of organohalogen compounds to the marine environment as a sink for all watercourses, Euro Chlor focused on this environmental compartment, with emphasis on the North Sea. This sea area has been extensively studied and is controlled by the Oslo and Paris Convention for the Prevention of Marine Pollution (OSPARCOM). For a series of chemicals on lists of concern adopted by the North Sea Conference (1990), risk assessments are being carried out to demonstrate their variable environmental profiles. 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

Some sectors of industry are already developing practical programmes on substitution. At the same time, expertise exists within the European Union to helpsmall and medium companies implement safer products and processes. Some governments, such as in Sweden and Denmark, already provide technical and other support to companies to help them identify safer substitutes to harmful chemicals. 

FIGURE 3.7 An example of a European Union risk assessment report on existing chemicals. 

The types of harm that chemicals have the capacity to cause (in other words their hazards) are qualitatively different and not commensurate with each other. At one extreme are effects that require reasonably high concentrations of the substance, are immediate and localized (for example flammability, explosivity, corrosiveness and acute toxicity). The causal relationship between a particular chemical exposure and such effects is usually obvious, or at least easy to demonstrate. Those affected generally include those who deal directly with the chemical and it is often possible to handle and store the chemical in such a way that harm is avoided. The existing European Union (EU) regulatory system, dating from the 1967 dangerous substances directive (Council Directive 67/548/EEC) was clearly set up with... 

SimpleBox was created as a research tool in environmental risk assessment. Simple-Box (Brandes et al. 1996) is implemented in the regulatory European Union System for the Evaluation of Substances (EUSES) models (Vermeire et al. 1997) that are used for risk assessment of new and existing chemicals. Dedicated SimpleBox 1.0 applications have been used for integrating environmental quality criteria for air, water, and soil in The Netherlands. Spreadsheet versions of SimpleBox 2.0 are used for multi-media chemical fate modeling by scientists at universities and research institutes in various countries. SimpleBox models exposure concentrations in the environmental media. In addition to exposure concentrations, SimpleBox provides output at the level of toxic pressure on ecosystems by calculating potentially affected fractions (PAF) on the basis of species sensitivity distribution (SSD) calculus (see Chapter 4). 

Currently there is relatively little guidance for the use of QSARs to predict the toxicity and fate (especially in the environment) of chemicals. Some guidance is provided within the European Union (EU) where a comprehensive technical guidance document (TGD) was produced to support the Directive on New Substances and the Regulation on Existing Substances (European Economic Community, 1996). This document includes a substantial chapter providing guidance on the use of QSARs in environmental risk assessments. 

Until the adoption of the new chemical legislation, REACH, within the European Union in June 2007 there was no requirement of identification, assessment and evaluation of all other chemicals used in products. REACH will in a step-wise transition period be fully enforced by 2018. One important improvement with the new legislation is that the importers and producers now will be responsible to collect data and evaluate toxicological and ecotoxicological effects of the chemical content of their products before putting them on the market. Another important improvement is that both existing and new chemicals will be evaluated. 

Hansen BG, van Haelst AG, van Leeuwen K, and van der Zandt P (1999) Priority setting for existing chemicals European Union risk ranking method. Environmental Toxicology and Chemistry 18 772-779. 

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