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Abstract: REACH, the new EU Regulation on chemicals, implies a significant restructuring and enlargement in the field of chemicals regulation, and thus also of enforcement. The importance of the Forum for enforcement included in REACH for a good implementation of REACH was early recognised. In 2006 the Nordic Chemicals Group and the Netherlands granted funds to start a joint EU project on enforcement of REACH. The aim of the project was to: - Identify present enforcement and new needs due to REACH - Investigate the state of preparation of the Member States and start preparing for the operative work of the Forum - Elaborate work division, co-operation and information exchange - Prepare a draft proposal for Rules of Procedure for the Forum - Develop a compendium of useful enforcement methods The project has resulted in several independent reports that are included in this final report. A presentation of the results has been given by the project at the 1st meeting of the Forum 11 December 2007
The European Chemicals Agency's Enforcement Forum for Exchange of Information on Enforcement (ECHA Forum) has finalised its ninth REACH-EN-FORCE (REF-9) project, where the compliance with REACH authorisation obligations was assessed. This was an EU-wide enforcement project including EEA countries carried out during 2021 in 28 countries. National enforcement authorities completed 690 inspections on substances suspected to be covered by a substance entry from Annex XIV to the REACH Regulation in 516 companies. 43 different substance entries listed in Annex XIV were addressed as part of these inspections. In this project report, 502 substance inspections in 404 companies are presented and analysed. In these inspections, inspectors could confirm that the inspected substance is a substance listed in Annex XIV and is placed on the market or is used at the time the inspection was conducted. 31 different Annex XIV substances were actually addressed in these 502 substance inspections with chromium trioxide and strontium chromate the two most frequently inspected substances.
The European Chemicals Agency's Enforcement Forum for Exchange of Information on Enforcement (Forum) has finalised its eighth REACH-EN-FORCE (REF) project, where the compliance of certain CLP, REACH and BPR duties related to substances, mixtures and articles sold online were assessed. This was an EU-wide enforcement project carried out during 2020 in 29 countries of the EEA and Switzerland (BPR duties only). When inspecting the offers of products sold online, inspectors could evaluate their compliance with: the CLP Regulation in regard to: o i) whether the online advertisement of a hazardous mixture provides information to the customer about the type of hazard as indicated on the label; or o ii) for hazardous substances, whether the customer is informed about the hazard class and/or the applicable hazard category; the REACH obligation for the most updated version of the safety data sheet (SDS) to be supplied/available with the hazardous substance or mixture for industrial/professional uses in an official language of the receiving Member State or upon request; specific entries of REACH Annex XVII: products or articles containing restricted substances such as cadmium and nickel in jewellery, phthalates in childcare products and toys and CMRs7 (the full list of restrictions assessed in this project can be found in Table 3b); and BPR duties, which were assessed by checking the online advertisement of the biocidal product (BP) and whether it was the sale of an authorised BP or made available under transitional measures. This report outlines the project, conclusions and recommendations for companies, the Enforcement Forum, national authorities, the European Commission and the public. The project targeted all potential companies (web shops and marketplaces) selling or mediating online hazardous substances, mixtures, biocidal products or articles subject to REACH, CLP and/or BPR requirements (private sellers excluded). Member States/inspectors decided which regulations to investigate under this project, depending on their own national enforcement strategy and the division of authorities' responsibilities. The inspected companies were situated within the enforcement authority's own country, within the EU or outside the EU.
The Nordic chemicals agencies have jointly controlled the Nordic market of give-away products. These products were controlled against the requirements of several EU-legislations (REACH Regulation, Toy Safety Directive, RoHS Directive, POPs Regulation and the Battery Directive). The results show that economic operators lack knowledge of the applicable requirements, as well as lacking understanding of the extent of their obligations. They are missing appropriate systems to comply with the rules. Nevertheless, the Nordic chemicals agencies have observed an interest from business organisations to be better at understanding and complying with the applicable rules. This joint enforcement project has also contributed to creating closer collaboration between the Nordic chemicals agencies resulting in sharing more information and ensuring better resource efficiency.
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.
EU law and governance have faced a new development – the proliferation of EU enforcement authorities, which have grown in number over the last 15 years. These entities, either acting alone or together with national enforcement authorities, have been investigating and sanctioning private actors on their compliance with EU law. Law Enforcement by EU Authorities investigates whether the system of control (in terms of both judicial and political accountability) has evolved to support the new system of law enforcement in the EU.
Wide-reaching and subject to few exceptions, the EU's new chemical regulatory programmes known as REACH impose obligations on all chemical companies, including manufacturers, importers, distributors, and product suppliers. This book addresses the key regulatory issues, management, and practical challenges associated with the REACH regulations.
This perceptive book provides an exploratory, explanatory and normative account of the EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its regulator, the European Chemicals Agency (ECHA). Ê W
This book is an essential guide and support to understanding of the science and policy, procedure and practice that underpins the REACH risk assessments required for the use and placing on the market of chemicals in the European Union. A clear understanding of information provision and how this affects the assessment of chemical safety is fundamentally important to the success of policy on chemicals and ultimately to the sustainability of the chemicals industry. Within the book, the scientific processes that underpin the policy are explained in a practical way. Importantly, it includes coverage of techniques to help solve the problems of using potentially risky and hazardous chemicals through the use of less hazardous alternatives and ‘green chemistry’, and also the analysis of the risks of the use of the most hazardous substances against the social and economic benefits of use. Chemical Risk Assessment: A Manual for REACH covers the following main themes: i) Assessment of chemical risk; ii) Risk management; iii) Hazard reduction, substitution and green chemistry; iv) Risk versus benefit – socio-economic analysis. The book acts as a practical guide and overview to chemicals risk assessment and risk management (in the EU context), as well as a support text for planning for the challenges of the future, which will see ever-increasing pressure to withdraw hazardous substances from the EU (and global) market, balanced against opportunities for innovation in the development of less hazardous chemicals.