EU CHEMICALS

RNCOS (2007) EU Chemical Industry Analysis Report, RNCOS Market Research Solutions. 

Current EU Chemical Control Legislation for New and Existing Chemicals... 

On 13 February 2001 the European Commission adopted the much-discussed White Paper Strategy for a Future Chemicals Policy (a. 10). The current EU chemical control measures were considered to result in too great a disparity between new and existing substances, with the high cost of new substance notification stifling innovation. Furthermore, although existing substances account for >99% by volume of chemicals in commerce, they were considered to be relatively poorly assessed and controlled in comparison with new substances. 

The main objective of the new EU Chemical Strategy is to ensure a high level of protection for human health and... 

It is important to evaluate existing studies with regard to their adequacy and completeness, especially where test standards vary. Guidance on evaluating data for use under the EU chemical schemes is given in the... 

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... 

This presentation discusses current EU chemical legislation and examines the shortcomings of some of the regulations in place with respect to dangerous chemicals. The Commission White Paper is discussed, and in particular, the REACH system which involves the registration, evaluation and authorisation of chemicals used in food-contact applications. The impact of the REACH system on food-contact plastic manufacturers is examined, with respect to suppliers of monomers and additives, plastic manufacturers, converters and packagers. 

More directly and in the shorter term there will be consequences for employment. As a capital-intensive industry, the chlor-alkali sector itself does not employ large numbers of people. However, the indirect employment consequences of closure are much greater. Industry estimates may be seen as being too well informed and therefore unreliable, and instead it might take governmental estimates. The European Commission (DG-III, nowDG-Enterprise) has estimated that there would be a loss of 10 000 jobs in the EU chemical industry by the year 2010 - ignoring secondary effects [6]. The... 

Commission s consultation on a new EU chemical policy (REACH), 1 July 2003 See the PRIO tool provided by KEMI at http //www.kemi.se/templates/... 

Existing substanees and new substances are still being treated differently by applicable regulations even 25 years after introduction of the EU chemicals legislation. 

The SubChem project was developed in the context of discovered deficits in regulating, assessing and dealing with chemicals in Germany and Europe. The project work coincided with review of the EU chemicals pohcy with the result that the initial scientific results of SubChem were also able to contribute to the political process surrounding the chemicals White Paper and the REACH ordinance. 

This is also accounted for in the planned EU chemicals regulation. Substances that are very persistent and very bioaccumulative can be introduced subject to authorisation, even when there are no scientifically based indications of (eco)toxicological effects. 

Several Commission DGs as well as the Joint Research Center and the European Chemicals Bureau are actors involved in the EU chemical legislation, see Figure 2.5. 

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 data to be used in the hazard assessment of chemical substances, 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). 

It should be noted that this alternative approach in some aspects is comparable to the more simple T25 approach more recently proposed within the EU chemical s regulation (see Section... 

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. 

This book also covers the connection between the new EU Chemicals Policy (REACH) and Chemical Leasing. Within REACH, cooperation, networking and communication based on documentation, evaluation and minimisation of hazards is indispensable. The new business model can serve as a basis for this intensified dialogue and cooperation. 

All these new service-oriented chemical business models require a close co-operation between the provider and the user of the chemical. Therefore, the potential of these business models has also to be seen in connection with the new EU Chemicals Policy (REACH), which will require a new relationship between provider and user and the conventional paradigm supplier here - customer there" will hardly be crowned with commercial success."... 

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