Case Studies

REACH registration and the use of QSAR to replace testing

In early 2010 CS Regulatory was approached by a client with a series of related UVCB substances that were produced, supplied and used in the presence of a carrier solvent essential to maintain the structure and substance integrity.

The substance had previously been reviewed by a consortium appointed consultant that had determined an absence of physico-chemical study endpoints and advised a test package on each substance in the range. Due to the extensive experience of CS Regulatory's staff, we very quickly determined that any of the physico-chemical tests would be technically unfeasible and/or meaningless due to the effects of the solvent.

Working with the client's process chemists, CS Regulatory was able to prepare a detailed justification for waiving physico-chemical study data along with preparing QSAR for many of the environmentally significant endpoints by assessing multiple variations of each of the UVCB structures to prepare a weight of evidence for the purposes of risk assessment.

With the IUCLID 5 registration dossiers prepared by CS Regulatory incorporating this strategy, the client successfully completed the lead registration for the 2010 deadline for all the substances including the waivers and QSAR endpoints and saved almost €1 million of testing costs.

REACH registration by read across

CS Regulatory has been working with suppliers of related metal compounds. With detailed data for the base metals available CS Regulatory designed a strategy for REACH compliance based on sound scientific principles and the pragmatic use of public domain, read across and QSAR assessment to reduce the need for animal testing and achieving significant cost reduction of regulatory compliance.

REACH compliance as Only Representative

CS Regulatory accepted the transfer of OR duties for a substance registered in the EU as an isolated intermediate. On conducting due diligence, however, it became apparent that there was a need to support non-intermediate uses, albeit at lower tonnage bands. Based on OSOR principles advocated by ECHA and expressed within the guidance, CS Regulatory accepted the role of lead registrant to undertake the necessary updates to the dossier and produce suitable chemical safety assessment to ensure the ongoing compliance for the non EU supplier and downstream users.

Downstream User compliance

CS Regulatory assisted an international supplier of armoury and projectile products with their compliance requirements. The client had dual roles as both a direct importer but also as a downstream user, and was unsure of their compliance position.

In seeking to ensure compliance with all EU regulations, CS Regulatory was employed to assess the chemical substances and products and articles from all suppliers to review the REACH status, SVHC content and CLP compliance with a view to determining our clients' registration and notification obligations.

By means of site audits and review of the various supply chains and associated documentation, CS Regulatory was able to determine the status of products and provide recommendations for ensuring compliance plus suitable documentation for use with downstream users. Assistance with relevant notification requirements was also conducted.

Biocidal product review

CS Regulatory was employed by a non-EU organisation to assess the propensity of some niche chemical products for use as potential biocides.

Utilising an approach with the member state authorities, it was possible to determine whether the required substances could possibly be evaluated as such (or had been) along with provision of budgets to allow for determination of viability of supporting such products through the biocide registration process. This allowed the client to quickly determine the implications of supporting such products within the EU.

Global registration

CS Regulatory was employed to undertake the global registration of a new (REACH non phase-in) substance. Working with its global network of regulatory consultants, CS Regulatory completed the appropriate inquiry process in the EU and due procedures in other jurisdictions and then designed a single testing package to meet the data requirements in the EU, Australia, Japan, Canada, Korea and Philippines with only minimal repetition of data for the purpose of compliance in each jurisdiction. Where most appropriate, data was acquired by testing at a suitable facility within a national regulatory jurisdiction.

CS Regulatory, in conjunction with its network of global expert partners, then successfully completed registration of the substance to each jurisdiction to allow supply to commence.