Posted by admin | Posted in Records | Posted on 13-11-2009
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On 18 December 2006 the EU adopted a new regulation concerning the Registration, Evaluation, and Authorization of Chemicals ((Regulation No 1907/2006) ( "REACH"). Topics REACH chemicals imported in the EU in quantities above 1 tonne a long list of information requirements. The new regulation puts the responsibility on producers of chemicals to provide a wide variety of safety information, including toxicity, carcinogeneity, mutagenicity, environmental fate, and other information that must be "robust" and, often follow laboratory practice (GLP) standards. The EU has created new European Chemicals Agency to work in tandem with the Member States to receive and evaluate data submitted by chemical manufacturers.
Historically, the REACH regulation came as the EU's concern that there was an inequality of information between Member State governments and the producers themselves, an inequality that are not being addressed by the substance of age "dangerous" EINECS system changes in place since 1967. The new requirements to provide a long list of categories on which the chemical industry must provide information on each chemical. The process of data collection can be costly and time consuming. In addition to the cost of collecting data, the manufacturers of the products chemicals are responsible for the payment of "user fees" for the European Commission and European Chemicals Agency that can total in the hundreds of thousand.
Fortunately for many producers, the EU exempts whole categories of chemicals for REACH, including used in medical and veterinary pharmaceuticals, medical devices, cosmetics, food, and even waste. In addition, many other substances are exempt, including those temporarily in transit through the EU.
In addition, REACH encourages consortia of producers of specific chemicals to cooperate in their submissions, a process that can be more profitable for farmers who otherwise would be required to submit their scope of notification and registration of files alone. This can be crucial, because the last costing chemical companies, the costs of data collection and user fees paid to agencies, can total over one million euros. This is especially important for small and medium enterprises (SMEs) that are disproportionately affected by the costly requirements of the regulation.
It is important to understand the exemptions, as well as the appropriate way to comply with each data-reporting requirement under the REACH regulation, a task that requires both scientific and legal and regulatory framework in the background.
For more information, please contact the team of World Ibex href = "mailto: info@ibexglobal.net"> info@ibexglobal.net or visit us at www.ibexglobal.net or www.ibexglobal.co.il.
* This document is not intended to provide legal-normative but simply as an overview of the subject. For specific topics and products, consultation with an expert on regulation is desirable.
About the Author:
Tom Page teaches international and comparative environmental and public health law and regulation at the Hebrew University of Jerusalem Faculty of Law. He also serves as global regulatory affairs director for a multinational high-tech company and as a consultant to Ibex Global Environmental & Medical Technology Consulting LLC.
Article Source: ArticlesBase.com – The New Eu Reach Regulation: Major Hurdles for the Chemicals Industry
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