With the final REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) deadline looming at the end of May this year, the race is on to complete testing and prepare dossiers in time.
This last deadline affects chemicals manufactured or imported in the EU from 1-100 tonnes per annum. As this Phase 3 deadline is relevant to low production volume substances it means many more SME’s are involved in the regulatory process compared with the previous phases in 2010 and 2013. Many of these organisations may not have had previous experience of registering substances with ECHA (European Chemicals Agency) and many may need assistance from expert regulatory consultants and experienced CRO’s.
With only a few months to go ECHA have stated that the number of substances registered to date is far less than they had expected. It was estimated there would be around 25,000 substances registered by the end of May and at the current pace of registrations it is looking to fall short of this number.
If you haven’t yet embarked on your REACH journey, there could be trouble ahead! Don’t be caught out, there is much work to be done – including assessing the requirements, laboratory testing, dossier completion and submission. CRO’s such as ourselves have seen a significant increase in the level of REACH work, especially in the last year. With many new requests still appearing and pressure to try to achieve results before the deadline of 31 May. Unfortunately, the length of time taken to complete just the laboratory testing phase is being underestimated, given the volume of work being placed with CRO’s and the finite capacity of the industry.
Identifying appropriate partners to work with to assist in navigating the complex regulatory system is key for those with little or no experience of REACH. Swift assessment of costs and timescales will allow you to decide on the viable options for the business to move forward with.
To assist with the REACH process, the ECHA website provides lots of useful information to help you understand more about the REACH process and your potential obligations: https://echa.europa.eu/reach-2018.
It is not clear at this stage what will happen if all this work is not completed by the deadline, but many hope that as long as they have tests placed with labs or partially completed packages, they may be given longer to complete the full package of work required and make their final submissions.
As a well-respected, GLP Compliant Ecotoxicology Laboratory Chemex offers high quality laboratory services to a range of industries worldwide. Our services cover a broad spectrum and include both Freshwater Ecotoxicology (required for REACH) and Marine Ecotoxicology (suitable for OSPAR/OCNS registrations) testing against a range of species. A wide selection of Environmental Fate studies are also on offer. In addition, many Physico-Chemical properties can be determined, as required for REACH registrations. We also have a range of instrumentation in-house, available to provide GLP compliant analytical support for studies.
Chemex works to internationally recognised guidelines including OECD, OPPTS, PARCOM, ISO and JMAFF with studies performed in support of new chemical registrations, REACH, data gap filling and other non-regulatory purposes.
Chemex has been an associate member of EOSCA (European Oilfield Speciality Chemicals Association) for many years, we therefore have considerable experience in dealing with chemicals for the Oilfield sector. Should you require any assistance with the testing of substances in this area for OSPAR/OCNS purposes, please contact us for further information on costs and timescales.
We have built our reputation by providing a competitively priced, reliable service and believe that we offer a personal approach that can be lost with larger organisations. At Chemex, we know that good communication is key and our staff are encouraged to work closely with clients at every stage of a project to ensure we are meeting their requirements. Our Study Directors are available to assist with technical queries regarding studies at any stage and we believe that a high level of client contact is crucial.
Having gained a wealth of experience over the years, our team are able to assist with your REACH testing requirements. We can help you to achieve your goals in a timely manner and partner you through your regulatory journey.
For further details on Chemex capabilities and how we can help you to move forward with your testing plans, please visit our website www.chemex.co.uk or contact us on firstname.lastname@example.org for a competitive quotation.
Visitors to our site near Cambridge, UK are always welcome, please call to arrange a meeting today on +44 (0)1954-252519.