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 is December 2010 for substances of very high concern and those manufactured or imported at above 1000 tonnes per year. Subsequent registration deadlines follow in 2013 and 2018. Formation of Substance Information Exchange Fora (SIEFs) for potential registrants and data holders of phase-in substances will facilitate sharing of available data for registration purposes in order to minimize the amount of new testing that needs to be done to achieve compliance.
How Does REACH Affect You?
Everyone who manufacturers, imports, or uses chemical substances in the EU at levels of above 1 tonne per year is affected by REACH. This not only includes industrial chemicals, but also includes substances such as food packaging materials, cosmetic ingredients, and pesticide and biocide actives that have other industrial uses. It is therefore of utmost importance to make sure the transition to the new regulation is made as simple and effective as possible. Manufacturers and importers will need to register all of their chemical substances supplied at greater than 1 tonne per year with the new European CHemicals Agency (ECHA) and ensure they are safe for the environment and human health. Downstream Users (e.g., users of base chemicals, manufacturers of consumer goods articles), need to ensure that the chemicals they are using and their applications have been registered.
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. Fundamental to this new legislation are provisions avoiding unnecessary animal testing in animals and for data sharing among registrants. REACH also requires the preparation of a Chemical Safety Report (CSR) – essentially a risk assessment and risk management report that describes the chemical and its hazards, uses, and exposure potential, and recommends methods for reducing risk and exposure.
Other key elements of the progression of REACH are the evaluation of certain registration dossiers and higher level testing proposals, substance evaluation and authorization of substances of very high concern (SVHCs), and restriction of high risk chemicals where the risks cannot be adequately controlled, as well as required community-wide regulation.
Exponent’s REACH team offers the following to clients:
- Experience—A company-wide REACH team with an in depth understanding of the REACH Regulation and the latest developments to the guidance material. Our consultants have been working with REACH since its inception and have been involved in writing a number of the REACH guidance documents
- Technical Expertise—Specialists in all areas relevant to REACH including toxicologists, ecotoxicologists, and regulatory affairs professionals, capable of producing all necessary regulatory documentation including IUCLID 5 dossiers and Chemical Safety Reports
- Capacity—Significant in house resources available to handle all aspects of the REACH regulatory process, including dedicated project managers to oversee a company’s entire REACH program
- Geographic Presence—A major US consultancy with a dedicated European REACH office capable of handling Only Representative Registrations for non-EU manufacturers and to ensure effective communication with the European Chemicals Agency
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.
Exponent has provided REACH support to a range of companies across a number of industries. Companies range from SMEs working in one industry to global companies across a number of industries. The varied and strong scientific and regulatory experience of our staff, gives Exponent the ability to offer full and complete services to help companies comply with their responsibilities under REACH. The assistance we can provide includes but is not limited to:
- Regulatory strategy and advice
- Programme and project management
- SIEF and consortia management – SIEF Formation Facilitator services and full SIEF/consortium management or participation
- Data evaluation and gap analysis – determination of availability of data held by a company and in the public domain and evaluation of their suitability (Klimisch rating), review of data within the SIEF, literature searches and identification of data gaps
- Use of Intelligent Testing Strategies (ITS) – identification of data gaps, consideration of grouping and read across, exposure and technical data waivers, expert statements and QSAR modelling
- Study placement and monitoring
- Extended Safety Data Sheets
Dossier preparation and submission – complete dossier in IUCLID 5 including robust and end point study summaries, enquiry dossiers, testing proposals, classification and labelling and toxicokinetics assessment
- Chemical safety assessments/reports – identification of uses and exposure routes, 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, applications for authorisation and socio‐economic analysis
- Only Representative and Third Party Representative services