Chemicals Regulatory Advice and REACH services
We are familiar with the challenges that manufacturers of chemicals have faced and continue to face as a consequence of the legislation that has emerged from Brussels during recent years with the objective of standardising the basis on which chemicals and related products are placed on the market in Europe.
We have followed the progress of the Biocidal Products Directive and the Plant Protection Products Directive and the impact this legislation has had upon industry. Members of our team have spoken at a number of conferences on various aspects of the legislation, the need to protect confidential data disclosed in the review process and also in relation to the problems associated with both preserving and leveraging value by sharing such information with customers and other affected parties.We act for global clients in various sectors, including chemicals and automotive, providing advice and support to in-house legal and regulatory teams on REACH strategy and compliance issues.
Our experience with the REACH Regulation (EC 1907/2006) and similar legislation, together with our ability to draw upon the expertise of our commercial, intellectual property, competition and environmental teams, allows us to offer guidance to companies and consortia on the complex issues associated with data sharing and product registrations required to comply with REACH.
We are a REACHReady approved service provider and a member of the Chemical Industries Association. Our REACH services include advice and support with respect to the legal issues associated with the following:
• interpreting the legislation and understanding its impact for individual businesses
• advising all actors in the supply chain, including manufacturers, importers, formulators, downstream users and producers of articles
• membership of substance information exchange forums (SIEF)
• data sharing agreements and letters of access
• protection of intellectual property and trade secrets
• assessment of ownership and admissibility of data for dossier inclusion, in particular the analysis of potential third party rights
• review and drafting of consortia agreements and pre-consortia agreements
• consortia formation and management, including management of the issues surrounding new joiners and early leavers
• competition law/anti-trust implications of dealing with competitors and the potential abuse of a dominant position
• attending SIEF and consortia meetings to provide guidance and avoid competition law infringements
• review and drafting of Third Party Representative and Only Representative agreements
• data compensation and the resolution of associated disputes
• working with regulatory consultants to provide a seamless comprehensive service through registration and beyond
• representation before European institutions such as the Commission, the European Chemicals Agency (ECHA) and national competent authorities
• challenging decisions and the proposed course of action of regulatory bodies and enforcement authorities (HSE and DEFRA)
• reviewing and drafting REACH clauses for commercial contracts
• advising producers and importers of articles regarding registration of substances with intended release and the notification/information requirements concerning candidate list and Annex XIV substances - substances of very high concern (SVHC) - in the articles and
• using REACH as a business opportunity with respect to the leveraging of value from data required for registration purposes.
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