March 24, 2017
There have already been two registration deadlines for substances manufactured in or imported into the EU, firstly for quantities >1000 tpa as of 1 December 2010, and secondly for quantities >100 tpa as of 1 June 2013. There is, nonetheless, a considerable lack of preparedness for the next deadline of May 2018 dealing with low-volume substances (i.e. substances manufactured or imported at >1tpa). This category of substances represents a large portion of the different chemical types currently used in the European Union and, as such, represents a significant challenge for both manufacturers and Contract Research Organisations (CROs).
This lack of preparation makes it likely that there will be a large body of work involving substance characterisation, testing for physical chemical properties, environmental fate testing, ecotoxicology assessments and dossier preparation that will need to be completed in a short period of time.
Substance characterisation for simple single component substances can take between one to three months, and complex substances or mixtures can take substantially longer. The required physicalchemical properties can take between two to six months depending upon substance properties, while the corresponding ecotoxicological and environmental fate studies can take up to two months.
In total it can take almost a year to complete the testing package. Furthermore, the International Uniform Chemical Information Database (IUCLID) substance registration dossier has to be prepared and submitted on time. This means that the 2018 deadline is not as far away as it may seem, and starting the REACH testing for your substances is already becoming urgent, especially in view of the likely loading on CROs and test laboratories. This urgency is all the more pressing in the case of complex substances which present analytical and testing challenges alike.
Smithers Viscient has extensive experience with the testing of a wide variety of substance types including the so-called difficult substances, e.g. substances with very poor water solubility, and has a good understanding of the regulatory requirements under REACH. Smithers can prepare a testing plan based upon the already known intrinsic properties of the substance, prescribing only the required tests and in some instances preparing waivers if applicable. This approach ensures that the most cost-effective approach is taken to fulfil the client’s REACH testing requirements. Smithers Viscient has fully equipped laboratories both in the UK and USA housing the latest analytical equipment and applying the most commonly used techniques including LC-MS/MS, GC-MS, FT-IR and UV.
Smithers Viscient is proud to offer toxicology testing services, including general toxicology, neurotoxicology studies,toxicokinetics, and dietary exposure, as well as subchronic and chronic toxicity studies. Our developmental and reproductive toxicology (DART) offerings include ExtendedOne Generation Reproductive Toxicity Studies (EOGRTS; OECD TG 443).
Our employees are highly qualified and experienced individuals with a focus on helping existing and potential clients with their testing requirements and ensuring the timely delivery of results.
Smithers Viscient also offers regulatory advice including preparation of IUCLID summaries and registration dossiers for either joint or individual submissions.
The REACH May 2018 deadline may be over a year away but the real deadline for getting the required test packages started is much sooner. Smithers Viscient is well equipped to help our clients meet therequirements of REACH- the time to prepare