Concept Life Sciences, the group created from the merger of Scientific Analysis Laboratories, Agenda1, Peakdale Molecular, CXR Biosciences and REC, has launched two REACH testing services.
The first testing service is Substance Sameness and Identification Testing for the 2018 REACH Registration deadline.
Substance identity (ID) is essential for joint REACH registrations and is delivered at Concept Life Sciences, in compliance with the REACH and CLP regulations, using one of the widest ranges of spectroscopic and chromatographic equipment available in Europe to determine chemical structure, composition, purity and identification of impurities.
ICP, XRPD, XRF and other physical techniques are also employed for the identification of inorganics.
REACH sameness for coregistrants needing to demonstrate that their substance is the same as the lead registrant is achieved chromatographically using the Substance Identification Profile (SIP) to determine purity, composition, and named impurity identification and quantification.
The second REACH testing service offered is the REACH read-across. This addresses a key challenge for REACH registrants which is to find the best way to fulfil the REACH toxicological information requirements, without using excessive experimentation with all its attendant costs.
One solution specifically permitted by ECHA is to use read-across: using the available data from one substance to inform the risk assessment of another.
Concept Life Sciences has experience of designing and running studies that provide robust read-across data in a cost-effective way.
Its approach involves using short-term mechanistic studies to characterise all of the, structurally related, substances in a category for key attributes such as absorption and metabolism, and grouping substances based on this, so only a small subset of chemicals in a category require full toxicological characterisation.
If required, this approach can be further extended to include, for example, toxicogenomic screening, to explain any observed toxicological effects.
Darryl Chapman, VP of Sales & Marketing, Analytical Services, commented: “We are very pleased to be able to launch both of these REACH testing services in time for the 2018 deadline. Concept Life Science’s analytic experience and laboratory capabilities place us in an excellent position to offer high-quality REACH testing services to our clients.”
REACH is the European Community Regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances.
REACH testing is a critical part of European legislation to ensure that products entering the marketplace are safe for consumer use. REACH requires manufacturers and importers to gather information on the properties of their chemical substances, which enables the safe handling and registration of chemical information in a central database managed by the European Chemicals Agency (ECHA).
Chemical property data, generated to meet REACH testing requirements, is a mandatory part of the REACH Registration process.
The Concept Life Sciences Group recently announced a multimillion pound investment drive, comprising a comprehensive expansion and rebranding programme, to give its international client base a world class integrated service.
Michael Fort, Concept’s Executive Chairman, explained: “During 2017 we plan to expand our laboratory operations by around 30% and our scientific staff by a similar number. By the end of the year we expect to employ approaching 200 staff qualified to higher degree and PhD level bringing our total compliment to almost 700 heads. This is a reflection of both the actual growth experienced during 2016 and on early indications for 2017.”