Registration, Evaluation, Authorization of CHemicals (REACH)
REACH, Registration, Evaluation, Authorisation and Restriction of Chemical substances, is the European Union (EU) chemicals policy that became effective throughout the EU in June 2007. REACH obligations commenced on June 1, 2008. From this date, it became necessary for all new (i.e., non phase-in) substances supplied at greater than 1 tonne (approx. 2,205 lbs.) per year to be registered. The pre-registration of phase-in substances was completed on December 1, 2008. The first registration deadline for phase-in substances was December 2010 for substances of very high concern and those manufactured or imported at above 1,000 tonnes per year. The next registration deadline was May 31, 2013 for substances manufactured or imported at 100-1000 tonnes per year with a further registration deadline of May 31, 2018 for substances manufactured or imported at 1-100 tonnes per year.
Exponent offer full and complete services to help companies comply with their responsibilities under REACH. The varied and strong scientific and regulatory experience of our staff means the assistance we can provide includes but is not limited to:
- Regulatory strategy and advice – tailored to the individual requirements of the client
- Programme and project management – efficient communication and regular updates
- SIEF and consortia management – SIEF Formation Facilitator services and full SIEF/consortium management or participation
- Data evaluation and gap analysis – determination of available data held within the SIEF and in the public domain. Evaluation of their suitability (including Klimisch rating) and identification of data gaps
- Use of integrated testing strategies (ITS) – consideration of grouping and read across, exposure based and technical data waivers, expert statements and QSAR modelling
- Study placement and monitoring – independent advice on choice of laboratory
- Dossier preparation and submission – complete dossier in IUCLID 5 including preparation of robust study summaries, end point summaries, inquiry dossiers, testing proposals, classification and labelling and toxicokinetics assessment
- Chemical safety reports (CSR) – identification of uses and exposure routes including development of use descriptors, hazard assessment, DNEL/PNEC derivation, PBT/vPvB assessment, exposure assessment and development of exposure scenarios, risk characterisation and recommendations on risk management measures
- Evaluation and authorisation services – post submission support, negotiation with ECHA, socio-economic analysis
- CLP – Notification, harmonized classification dossiers
- Extended safety data sheets – incorporating exposure scenarios
- Only representative and third party representative services
How can Exponent help you meet the challenges of REACH?
With 26 offices and nearly 1,000 staff worldwide, Exponent is one of the largest scientific and regulatory consulting firms in the world. We are a leading provider of services to the chemical industry. From our offices in Europe, U.S., and China we offer a wide range of technical and regulatory expertise to help companies meet their REACH obligations. Exponent’s large REACH team comprises regulatory affairs professionals, project managers, risk assessors, socio-economic analysts, and technical specialists in all relevant scientific disciplines directly relevant to REACH. These scientists have varying backgrounds in industry, government and contract research giving us unparalleled expertise in solving complex regulatory problems.
Many of our consulting staff have been working in the field of chemical regulation for over 10 years, and have considerable experience with previous EU schemes, as well as all global chemical registration programmes. Members of Exponent’s staff have been following REACH since its inception, were involved in the consultation process that helped to shape the legislation in its final form, and contributed to the scientific and regulatory content of the official guidance documents.