REACH is the new European Union (EU) chemicals policy that became effective throughout the EU in June 2007. REACH affects all substances manufactured or imported into the EU in quantities greater than 1 tonne per year (approx. 2,205 lbs.). Downstream Users of the chemical substances (e.g., users of base chemicals, manufacturers of consumer goods articles) need to comply with the regulations since substances that are used in articles normally intended for release as part of the article’s function are also covered under REACH. The first step that needs to be completed is the preregistration of chemicals for each specific use which begins on June 1, 2008.
Everyone who manufacturers, imports or uses chemical substances in the EU needs to start thinking about how their business is affected by REACH and what they can do to make sure the transition to the new regulations is made as simple and effective as possible. Manufacturers and importers will need to register their chemical substances with the new European Chemicals Agency and ensure they are safe for the environment and human health. Downstream Users will need to ensure that the chemicals they are using and their applications have been registered by the supply chain. Registration requires a set of hazard and exposure data requirements to be addressed in a tiered manner through the development of a technical dossier, with increasing requirements linked to increasing tonnage of manufacture, import and use. The Agency will publish a list of substances that are classified as being of very high concern (SVHC) by June 1, 2009. These chemicals will include those that are Category 1 and 2 CMRs (carcinogenic, mutagenic, and toxic to reproduction), PBT (persistent, bioaccumulative and toxic), and vPvB (very persistent, very bioaccumulative). Risk assessment and management measures will be developed by the Agency on these substances. Manufacturers, importers, and users of these substances will have an opportunity to provide additional information to the Agency to assist with this assessment.
Many of our scientists have worked in industry, with trade associations and consortia, as government regulators, or for contract research organisations, giving us unparalleled expertise with solving complex regulatory and scientific problems. Most of our REACH team has been working in the field of chemical regulation for over 20 years, and have experience with the EU NONS scheme, the U.S. HPV program, and product registrations in the EU and U.S. Combined with the varied and strong scientific and regulatory experience of our staff, this expertise gives Exponent the unique ability to offer you full and complete services to help you comply with your obligations under REACH. We have worked for a number of companies including a cleaning/maintenance products manufacturer, a global chemical company and companies in the metals and agrochemicals industries.
We offer a wide range of consulting services, and provide technical and regulatory expertise to help clients comply with REACH, including:
• Initial inventory - initial assessment of substance inventory and scope, data gap analysis, identification of responsibilities and obligations;
• Vulnerability analysis - identification of short, medium and long-term priorities and actions based on risk;
• Provision of regulatory advice and strategy;
• Acting as an Third Party Representative for EU companies or an Only Representative for non-EU companies;
• Pre-registration of substances;
• Negotiation and representation in the Substance Information Exchange Fora (SIEF);
• Document preparation - production of technical dossiers, Chemical Safety Assessments (CSA), Chemical Safety Reports (CSR) and Exposure Scenarios that include hazard evaluations, exposure assessments and robust human health and environmental risk assessments. Use of data waivers, surrogate data, computational modelling and (Q)SARs will help reduce time and costs;
• Input of information into IUCLID 5 and use of REACH-IT; and
• Establishment and management of Task Force and consortia.