[PDF] Commission Regulation Ec No 340 2008 Of 16 April 2008 On The Fees And Charges Payable To The European Chemicals Agency Pursuant To Regulation Ec No 1907 2006 Of The European Parliament And Of The Council On The Registration Evaluation Authorisation eBook
Commission Regulation Ec No 340 2008 Of 16 April 2008 On The Fees And Charges Payable To The European Chemicals Agency Pursuant To Regulation Ec No 1907 2006 Of The European Parliament And Of The Council On The Registration Evaluation Authorisation Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Commission Regulation Ec No 340 2008 Of 16 April 2008 On The Fees And Charges Payable To The European Chemicals Agency Pursuant To Regulation Ec No 1907 2006 Of The European Parliament And Of The Council On The Registration Evaluation Authorisation book. This book definitely worth reading, it is an incredibly well-written.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union Regulation of 18 December 2006. Under this regulation all importers or manufactures of substances are obliged to register the substances. Without data, no market. It is a regulation which impacts all chemcal substances around the world. For the different tasks the European Chemical Agebncy (ECHA) is charging a fee. The attached regulation describes the fees for the tasks and the different company sizes.
This book discusses the law and practice of the European Union's new chemical regulatory programmes known under the acronym ''REACH'. REACH is intended to ensure the safe management of risks associated with chemical substances throughout the supply chain. Its scope is very broad; subject to limited exceptions, REACH applies to all bulk chemicals used in industrial processes and to chemicals present in products such as cleaning products, paints, clothing, furniture, and electrical appliances. The newly established European Chemicals Agency (ECHA), the Commission, and member state authorities are in charge of administering the various parts of the REACH Regulation, creating a complex patchwork of government powers, procedures, and oversight. The volume is written by experienced REACH practitioners. It addresses both the key legal regulatory issues associated with REACH and the key management and practical challenges. In addition to analysing the scope, the processes, and the obligations of the industry under REACH, the book covers the strategy and management of REACH compliance from the perspective of the regulated entities. The focus is on the strategic and practical decisions facing companies subject to REACH's various regimes. Significant attention is paid to REACH consortia, which are a key instrument in compliance management, and to the competition law issues arising in connection with REACH consortia. It also covers legal remedies, enforcement, intellectual property rights, and civil liability for damages arising from chemical substances as well as how companies can shape their REACH compliance programme to reduce their liability exposure.
The only book to not only discuss the technicalities of the European REACH chemicals registration process, but also to directly address the resulting business risks and business solutions. In this text for practitioners, the author pulls together the key knowledge needed to successfully run a business under REACH, distilling thousands of pages of official documentation, and incorporating experiences from different-sized enterprises in a global context. Starting with the basics of the REACH framework, she explains the entire process on how to register with the European ECHA office with a particular emphasis on small and medium-sized businesses. Along the way, she describes key milestones and presents sample documents from real case studies. The final part of the book addresses strategies to ensure a reach-compliant operation, including recommendations for in-house processes as well as communicating with suppliers and downstream users. As a result, managers in the pharmaceuticals and chemicals industries will learn how to operate their companies in full compliance with REACH standards.
This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union Regulation of 18 December 2006. Under this regulation all importers or manufactures of substances are obliged to register the substances. Without data, no market. It is a regulation which impacts all chemcal substances around the world. This ebook contents the consolidated version of the legislation.
Enabling power: European Communities Act 1972, s. 2 (2) & Health and Safety at Work etc. Act 1974, ss. 15 (1) (2) (3) (c) (4) (b) (6) (b) (8) (9), 82 (3) (a), sch. 3, paras. 1 (1) (b) (c) (4) (5), 2 (1), 3 (2), 15 (1), 16. Issued: 20.03.2009. Made: 16.03.2009. Laid: 16.03.2009. Coming into force: 06.04.2009. Effect: S.I. 1996/825, 1998/494, 2001/880, 2002/2676, 2677, 2776; 2004/3386; 2006/2739; 2008/960, 2108, 2852 amended & S.I. 2002/1689; 2005/2571; 2008/2337 revoked, in accord. with Sch. 6 & 7. Territorial extent & classification: E/W/S. General. EC note: These Regulations consolidate, revoke and re-enact with amendments the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002. These Regulations, as respects Great Britain: (a) provide for the enforcement of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, (the CLP Regulation), in addition to the enforcement of these Regulations; (b) implement parts of Directive 2006/121/EC of the European Parliament and the Council of 18 December 2006 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency; (c) implement Council Directive 1992/32/EEC amending for the 7th time Council Directive 67/548/EEC , in so far as its provisions relate to the classification, packaging and labelling of dangerous substances (the substances Directive); and (d) implement Council Directive 1999/45/EC) on the classification, packaging and labelling of dangerous preparations (the preparations Directive). 3. These Regulations also implement the Directives referred to below which adapt to technical progress and modify the substances Directive and the preparations Directive. These Directives are: (a) Commission Directive 91/410/EEC, 14th adaptation to technical progress of the substances Directive; (b) Commission Directive 93/21/EEC, 18th adaptation to technical progress of the substances Directive; (c) Commission Directive 2000/32/EC, 26th adaptation to technical progress of the substances Directive; (d) Commission Directive 2001/59/EC, 28th adaptation to technical progress of the substances Directive; (e) Commission Directive 2004/73/EC, 29th adaptation to technical progress of the substances Directive; (f) Commission Directive 2001/60/EC, 1st adaptation to technical progress of the preparations Directive; and (g) Commission Directive 2006/8/EC amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to the preparations Directive.
PFAS (per and polyfluoroalkylsubstances) are known to be extremely difficult to degrade in the environment and to be bioaccumulative and toxic. Exposure to PFAS is suspected to increase the risk of adverse health effects, such as impacts on the thyroid gland, the liver, fat metabolism and the immune system. This study estimates the socioeconomic costs that may result from impacts on human health and the environment from the use of PFAS. Better awareness of the costs and problems associated with PFAS exposure will assist decision-makers and the general public to make more efficient and timely risk management decisions. Findings indicate that the costs are substantial, with annual health-related costs estimated to 2.8 – 4.6 billion EUR for the Nordic countries and 52 – 84 billion EUR for all EEA countries. Overall non-health costs are estimated at 46 million – 11 billion EUR for the Nordic countries.Upon request the excel spreadsheets used for the monetarisation and valuation in this report can also be provided along with a guidance on how to use the estimation of costs for value transfer. Please contact any of the consultants or members of the steering group from the Swedish Chemicals Agency or the Danish Environmental Protection Agency if you are interested in receiving these excel spreadsheets.