REACH is based on the principle of one substance, one registration. For this reason, when a manufacturer and/ or importer pre-registers a substance it becomes a participant in a SIEF (Substance Information Exchange Forum). The SIEF includes all companies that pre-registered one and the same substance. The SIEF facilitates data sharing between Pre-Registrants, and ultimately, where possible, the joint submission of the technical dossier. The aim is to avoid unnecessary testing, or repetition of tests on vertebrate animals and to ease the financial burden on registrants. REACH does not however provide for clear rules on how the information should be exchanged between the SIEF participants.
Many industry organisations (including ITIA) therefore voluntarily formed consortia to assist their members register their substances in accordance with REACH legislation. No Consortium-formation guidelines are provided by the European Commission but industry is expected to ensure that any Consortium is compatible with EU competition law.
ITIA has been researching and developing the legal framework for a REACH Consortium that will generate the required dossiers and also has done much of the technical groundwork to prepare for REACH. After an exercise to identify W data-gaps, a research programme has been developed by ITIA to generate the data that, together with existing data, is necessary to conduct the risk assessments on the selected W substances covered by the Tungsten Consortium.
Entitlement to obtain a copy of the REACH-registration dossiers, (ie to refer to and to use them, as well as all the supporting data and/or studies) will be on the basis of a separate licence for each substance. If a member company requests more than one licence, all such licences will be granted in the form of one Licence Agreement.
The four-year budget (2007-2010) for the Consortium is US$4,800,000. Individual contributions towards that budget are based on the funding formula of the Consortium Agreement, with a minimum of US$10,000 per annum, and will depend on the number of companies that join the Consortium: the more members, the lower will be each company’s contribution.
Contact the ITIA Secretariat for a copy of the full Consortium Agreement.
REACH is a complex, long-term business obligation and it is the responsibility of individual companies to assess what REACH means to them in the impact of their business. The Secretariat will, however, help as much as possible with enquiries directly related to the Consortium.
Please address any questions about REACH and the Tungsten Consortium to the ITIA Secretariat at info@itia.info.