REACH Sameness Testing & Read-Across Services
Concept Life Sciences can assist you with a tailormade program to support your dossier submissions under the REACH testing programs. Our state-of-the art UKAS accredited testing laboratories and skilled analytical scientists enable fast, efficient and accurate data. We can provide REACH testing services to ensure you meet the submissions in time for the 2018 deadline
Whilst many testing laboratories are only able to supply simple results of a REACH test; Concept Life Sciences’ strengths in data assessment enable us to offer additional support and advice to further explain results and non-compliances. Our experience of different materials testing and development of new methodologies means we can ensure appropriate test methods are used at all times.
What is REACH?
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.
How Can We Support Your REACH Registration?
We have one of the broadest ranges of analytical capabilities in Europe and extensive experience in supporting the REACH registration process in 2010 and 2013. Concept Life Sciences offers REACH substance sameness and identification testing, and REACH read-across services, to ensure your successful dossier submissions and registrations to ECHA for the 2018 deadline . Our laboratories are equipped with state-of-the-art analytical instrumentation to enable fast, efficient and accurate data generation with attention to detail, efficiency and safety. This enables us to develop specific programs of testing to support the specific registration requirements of our global chemical customers. Read more about our services below:
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 REACH and CLP regulations. We use 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 co-registrants 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 / quantification.
REACH read-across – mechanistic studies to efficiently address toxicological data gaps
A key challenge for REACH registrants 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.
We have experience of designing and running studies that provide robust read across data in a cost-effective way. Conceptually, our 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.
For more information on our REACH testing services, please email us: email@example.com