REACH is a European Regulation concerning the safe use of chemicals, with the aim to improve the protection of human health and the environment through a system of Registration, Evaluation, Authorisation and Restriction of Chemicals. This legislation for REACH registrations is hugely important if you’re a manufacturer or importer of chemical substances in the European Union (primarily in quantities of ≥1 tonne/year). REACH requires that industry has certain knowledge regarding the properties of its substances and that it manages and communicates potential risks appropriately.

Chemical manufacturers/importers are required to prepare a registration dossier in order to assess whether their substance may cause adverse effects to human health and/or the environment, either based on test results or alternative (scientifically justified) information. The REACH Standard Information Requirements (SIRs) are those data which are required as a minimum to meet the registration obligations. These vary with the (manufacture/import) annual tonnage level of the chemical, but generally involve a series of physicochemical, toxicological and ecotoxicological endpoints as well as information on the substance identity.

Characterisation of the substance in question is an important initial step in the Registration process, to understand exactly what chemical is being produced/imported. This may lead to the formation of a substance information exchange forum (SIEF) amongst legal entities (such as manufacturers, importers, and data holders) who are dealing with the same substance, with the aim of sharing information and costs as well as limiting vertebrate animal testing where possible (which is a key principle of the regulation).

Literature searches and company data gathering exercises are essential tools in the identification of REACH-relevant data on a particular substance. These can be used to negate the need for conducting new tests, to demonstrate where data-gaps exist in the available information, and where new testing and/or alternative approaches (e.g. (Q)SAR) might be needed.

Many aspects of a registration (e.g. data capture and management) are handled by a specifically designed software application (IUCLID) which is maintained by the European Chemicals Agency (ECHA). The key features of a REACH registration include the following: completion of (Robust) Study Summaries ([R]SSs) and associated Endpoint Summaries for the relevant sections as outlined by the SIRs (these might involve substance-specific data or information on a surrogate species – read-across); information on classification and labelling (according to the EU CLP criteria); PBT assessment; and calculation of DNELs/PNECs for characterisation of the human health/environmental dose response. The conduct of a chemical safety assessment (CSA) is often required with the inclusion of a chemical safety report (CSR) (at >10 tonnes/year), demonstrating the safe use of the substance. ECHA recommends the use of its Chesar software to carry out the CSA (e.g. the exposure and risk assessment) and to generate sections 9 and 10 of the CSR. Submission of IUCLID dossiers to ECHA is accomplished via the web-based software REACH-IT.

The bibra team are adept in handling all aspects of a REACH enquiry, from initial literature searches, data-gap analysis and IUCLID populating right through to CSA/CSR preparation and dossier submission. We are well placed to assist with your REACH registrations and IUCLID preparations (and responding to ECHA evaluations), so get in touch and we can discuss your requirements.

 

 

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