You have one year to go until the final REACH registration deadline (of May 31st 2018) for your “phase-in” substances (these are the substances that were pre-registered before May 31st 2017). By the 2018 date, all non-exempt substances manufactured in, or imported into, the EU in quantities of 1 – 100 tonnes per year must be registered with ECHA or disappear from the market. So, if your company has any outstanding REACH registration obligations, now is definitely the time to act. If your existing substance was not pre-registered by May 31st this year, you will no longer be able to manufacture or import that substance prior to registration (and this will have to proceed via the more time-consuming ECHA Inquiry Dossier process). At ECHA’s recent Stakeholders’ Day in Helsinki, Geert Dancet (the Executive Director) said that this year is “crucial” for anyone pre-registering within the REACH Annex VII and VIII tonnage bands, as it is “the only way to get immediate access” to data held by other (potential) registrants. For companies approaching REACH for the first time, it can be surprising how time- and resource-consuming (and potentially expensive) it is to put together a satisfactory registration dossier. This is particularly true for SMEs. While there is a wealth of guidance and support materials available through ECHA, national competent authorities and sector-specific trade associations, the whole REACH registration process can still be daunting if you do not have the expertise in-house. And in certain cases – such as chemicals being registered under Annex VIII (10 – 100 tonnes/year) that are classified as hazardous to human health and/or the environment – there are many additional tasks required (e.g. a detailed worker exposure and risk assessment), for which an experienced service provider with a proven REACH track record is the ideal support. Bibra is well placed to help you fulfil your REACH registration needs. We’ve worked on 100s of successful REACH lead registrations for the previous (2010 and 2013) deadlines, and are currently working with companies and Consortia on over 100 substances (including precious metals, petrochemical additives, SVHCs, fragrances, UVCBs, intermediates) ahead of the 2018 deadline. Our extensive experience in searching for, collecting and reviewing REACH-relevant data, developing Integrated Testing Strategies and Data Gap Analyses, and in the preparation of dossiers (e.g. developing Robust Study Summaries) in IUCLID 6 format, is highly regarded by our clients – the optional offering of our IUCLID 6 webhosting service is also utilised by several of our current REACH patrons. If required, we also have experience of the preparation of member (co-registration) dossiers in IUCLID (or directly via REACH-IT). Bibra scientists specialise in the use of read-across (including the preparation of robust justification reports sympathetic to ECHA’s 2017 Read Across Assessment Framework; RAAF) and (Quantitative) Structure-Activity Relationships ((Q)SAR), in predicting the likely toxicokinetics/ADME of substances (e.g. based on physical-chemical characteristics), deriving D(M)NELs and PNECs, proposing classification and labelling according to the EU CLP regulation, and in the compilation of Chemical Safety Assessments (CSAs, as documented in the CSR). Navigating your way through the complex and resource-intensive process of REACH registration can be a daunting task. We can help relieve the anxiety of coping with REACH registration, and beyond, by providing you with sensible and expert advice as to your various options at each crucial stage. We have a long and proven history of working closely with clients in ways that best suit them, openly discussing problems and the costs associated with the particular task in which we are involved. We will not forget that this is your dossier, and you call the shots.
If we can be of assistance to you, or you would like more information, please contact us +44 (0)20 8619 0770 | www.bibra-information.co.uk