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.
We offer a wide range of consulting services, and provide technical and regulatory expertise to help clients comply with REACH, including:
- Comprehensive management of the REACH process – including vulnerability analysis, identification of short, medium and long-term priorities and actions based on risk
- Provision of regulatory advice and strategy – prioritization of actions to enable a company to meet their REACH obligations efficiently and cost effectively
- Initial review — assessment of a company’s substance inventory, evaluation of existing data , identification of responsibilities and obligations and confirmation of additional information/data that will be required
- Devise intelligent testing strategies to help reduce time and costs – based on a tiered approach using data waivers, surrogate data, computational modeling and (Q)SARs
- Acting as an Only Representative for non-EU companies and taking on the legal responsibility this entails
- Negotiation and representation in the Substance Information Exchange Fora (SIEF) and acting as a Third Party Representative for companies during these discussions
- Document preparation — production of technical dossiers including input of information into IULCID 5 and use of REACH IT, 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
- Establishment and management of Task Force and consortia.