REACH Registration Services

The Consultant has direct experience of forming and chairing Consortia for the registration of substances under REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) as well as acting as Only Representative for several major non-EU manufacturers.

The Consultant has personally developed and submitted registrations as well as leading consortia to coordinate the contributions from several reliable, technical groups to deliver cost-effective registrations. The Consultant’s background as a toxicologist with practical expertise in in-vitro and mammalian/environmental toxicology provides a relatively unique expertise to gain maximum advantage from exposure-based data waiving, read-across and category development. The Consultant led the consortia that registered a category of chemicals that is cited by ECHA as the example of best practice for category development and is currently working with OECD, US EPA and ECHA on a much larger category that will be used to illustrate the much anticipate guidance to industry of development and use of categories within regulatory processes.

The Consultant is also the co-chair of the ECETOC Task force that developed alternate guidance (TR 110 - Guidance on Assessment Factors to Derive a DNEL) to ECHA’s R8 Guidance and is expert in developing technical justifications for deviating from the default factors.

With several registrations already submitted under tier 1 and experience being gained with the compliance check and technical review processes, the Consultant is well positioned to provide a range of services, either directly or indirectly via support service groups, to registrants in tiers 2 (deadline 31 May 2013 ) and 3 (deadline 31 May 2018).

These services may include the following:

• Information and literature searching and critical review/interpretation of data;
• Production of study and endpoint summaries;
• Development of exposure based waiving and read-across justifications;
• Testing proposals;
• Justification of Assessment Factors and DNEL derivation;
• Exposure estimates;
• Preparation of IUCLID datasets and Registration Dossiers;
• Chemical Safety Assessments;
• Chemical Safety Reports;
• Advice on compliance check and technical review processes;
• Developing Exposure Scenarios;
• CLP and GHS Classification of chemicals and mixtures;
• Communication via the extended-SDS and implications for, and obligations, of downstream users.