The purpose of REACH is to fill the gaps in our knowledge of the properties and uses of substances, in order to reduce their impact on human health and the environment. To make this process as efficient and cost effective as possible, REACH provides for the formation of Substance Information Exchange Fora or SIEF, to enable potential registrants to share existing knowledge, and collectively identify any gaps that exist.
H2 Compliance provides the tools and resources to take account the service of SIEF communication. After analysing customers’ needs and registration strategy, the company offers bespoke or full programme services, including specific analysis, management of responses and administrative support.
While the service is adjusted to customers’ needs, it uses common tools and conducts similar steps in order to establish consistent processes. Regular progress reports and overviews of the status of SIEF members are published in the chosen communication tool. Surveys and responses are managed, for example, on substance sameness and lead registrant, and individual emails are answered. The communication platform is set up and maintained, as are the distribution lists.
The formation of SIEFs and, in some cases, consortia has been driven by the need to share data for the purpose of REACH registration. Taking this process through to a successful conclusion clearly relies on technical and regulatory knowledge but it also calls for specific programme management, legal contract and financial expertise.
H2 Compliance offers a fully flexible SIEF/consortium management programme incorporating all the key elements required to support organizations undertaking the registration process. The programme can be adopted in its entirety or viewed as discrete services that can be selected individually or in combination as client needs dictate. The service is underpinned by the technical, regulatory, managerial and legal expertise of the company’s consultants and partners.
If you would like to talk to a member of H2 Compliance about your requirements please call us today on +353 1 2989136 (for Cork office +353 21 4868120, or New York office +1 518 5123553) or email us at firstname.lastname@example.org.
Alternatively you can use our enquiry form here and a member of our team will be in touch ASAP.
H2 Compliance recognizes the fact that the registration process involves several distinct areas of activity. Its SIEF/consortium management framework has therefore been structured to provide support accordingly.
- High level administrative support: SIEF/ consortium management, consortium agreements, Letter Of Access, establishing formal consortium structure, coordinating financial activities, SIEF Facilitation, Third Party and Lead Registrant roles, establishing substance identity and sameness, coordinating data compensation process and arranging annual audits
- Data gathering and review: Gathering, validating and valuing existing data, gap analysis, searching and retrieving data from alternative sources, QSARs and read-across
- Acquisition of missing data: Devising test strategies, costs and schedules, preparing proposals for new testing, test coordination, validation of new data, study summaries and robust study summaries
- Generation of the registration dossier and associated documents: Downstream user information, Exposure Scenarios, identification of Risk Management Measures, Classification and Labelling, Hazard Assessments (including PBT and vPvB), derivation of DNELs and PNECs, performance of CSAs and assembly of CSRs, preparation of SDS, dossier preparation and submission
- Post-registration monitoring: Management of regulatory status, late registrants, dossier updates
The pre-registration process is now complete, manufacturers and importers are requested to enter the Substance Information Exchange Forum (SIEF) to share relevant and available data among all potential REACH registrants of the same phase-in substance.
This Forum aims to allow you to:
- React to requests from other participants
- Provide other participants with ‘proof of cost’ and give access to existing studies upon request
- Request missing information from other SIEF participants
- Agree on cost-sharing mechanisms
- Receive financial compensation for data shared
- Collectively identify a need for further studies
- Make arrangements to perform any studies identified
- Agree on classification and labelling