REACH is an EU Regulation that entered into force on 1 June 2007 and passed its third registration deadline on 31 May 2018. The legislation aims to guard human health and the environment from risks associated with chemicals and, as a result, it promotes alternative methods for the hazard assessment of substances. This reduces the number of tests that must be performed on animals.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in daily life, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the Regulation has an impact on most companies across the EU. Collection of relevant information has been managed via submission of technical dossiers to the European Chemicals Agency (ECHA) over a period of years.
To comply with the regulation, businesses must identify the substances they manufacture and market in the EU, obtain a REACH registration number from ECHA if the quantity of substance is greater than 1 tonne per year, and manage the risks linked to use of those substances. It is necessary that companies registering the same substance submit their registrations jointly and appropriate risk management measures must be communicated downstream to customers.
REACH places the burden of proof on companies with duties continuing continuing after successful submission of the substance-specific technical dossier and receipt of a REACH registration number. In particular, registrants are required to submit updated information relating to company status, substance composition, classification/labelling, tonnage band and identified uses. New information concerning risks to human health and/or the environment will also trigger spontaneous update of the REACH registration dossier if those data affect risks addressed in an existing Chemical Safety Report (CSR).
The team at Arrow Regulatory Limited have assisted a substantial number of large, medium and small companies to successfully comply with the requirements of REACH since 2007. We are therefore well placed to advise on regulatory duties into the future.
Preparation and submission of technical dossiers using
Expert assessment of available data and data gap analysis
Development of integrated testing strategies with use of read-across, chemical grouping, (Q)SAR modelling and waivers whenever appropriate
Study placement and monitoring
Client-specific project management and reporting
SIEF and consortium management
DNEL/PNEC derivation, PBT/vPvB assessment, identification of Risk Management Measures
Exposure scenarios and Chemical Safety Report using Chesar and other appropriate tools
Preparation of Safety Data Sheets
Post-registration support and dossier maintenance
The unique expertise of Arrow Regulatory's consultants includes over 30 person-years working on REACH during which time we have prepared over 50 Lead Registration dossiers, including CSRs where necessary, and over 300 Member Registration dossiers. We frequently handle complex substance identity issues and put together intelligent testing strategies to minimise the use of animals and reduce costs for our clients. Team members are also experienced in Consortium and SIEF management plus associated development of cost sharing principles that are fair and transparent. We aim to provide a high level of service to all our clients, irrespective of their size.
Contact us for information on how we can help you.