Click on the headings to go to a linked page showing guidance
The term 'article' is given to items that are defined by their physical shape and are function according to this shape and not their chemical composition. There are some fine dividing lines and this guide helps define article and chemical and also describes what need to be considered if manufacturing or importing articles. (update Nov 2011)
If registering a substance at over 10 t, a chemical safety report is needed. Although tools are available to help extract data from the IUCLID dossier (CSR tool and Chesar), the CSR is perhaps the most technically challenging and important documents required under REACH. The CSR for hazardous substances will dictate the content of the extended-SDS. Many CSRs produced for the 2010 deadline have been rushed or poorly understood by registrants and may need updating. (update Feb 2012)
There is a need to update dossiers already submitted if any new data is generated, if significant changes to the chemical safety report, or if there are errors. (update Jan 2012)
To make registrations for REACH or for other regulatory submissions, IUCLID is needed. At first glance, it appears difficult to use and although downloading (free) can be traumatic to those not proficient with IT, once installed and basic functions understood (right and left clicks), it is a good piece of software.
(update Jan 12)
Most registrants will be working with others to prepare a dossier and the majority of these will be taking a passive role, only paying for access and preparing a shortened dossier in IUCLID to cover their personal registrations. However, it is important to check that the cost of the letter access is fair and that the information in any joint CSR or that the substance identity is applicable to you.
(Checked Jan 2012)
If new data are required to evaluate substance properties, it is important to plan the tests carefully and select the correct methods to maximise the data for the minimum costs. If animal test data is considered necessary, planning to avoid in-vivo studies or to at least minimise the number of animals used is essential. Through careful planning, costs can be reduced. (update Dec 2011)
If supplying a 'phase-in' substance, it is still possible to make a late pre-registration if it is less than a year before the due date for the registration at tonnage of supply. This facility will obviously close in May 2017.
A phase-in substance is one that is on EINECS with EC number starting '2' or is a no-longer polymer, starting '5'. There are some other exceptional circumstances open to those manufacturing, but not placing on the EU market, before June 2007. (update Oct 11)
If it is not possible to make a late pre-reigstration (for example, non-phase in substance or if past the period allowed for pre-registration) it is necessary to make a formal Inquiry to ECHA before starting any registration activity. This is needed even if you know you have a new unique substance or if you know other registrants and have already come to an arrangement for data share etc.
(update Nov 11)
The requirements to provide an SDS have not changed as a result of REACH or CLP (except where materials are now classified, but were not previously considered hazardous), but the SDS format is now more rigid and there is an expectation to include a lot more data. The skills needed to prepare an SDS are now significant and writing an SDS needs a good level of knowledge in chemistry, toxicology and environmental sciences (as well as the old issues of first aid, transport, occupational hygiene etc).
(Checked Jan 2012)
Working with competitors is a commercially challenging process, but experience has shown that industry sectors that work together for the common good will have a less troublesome experience with REACH than those who try to gain commercial advantage or attempt to profit at the expense of others. Advice can be provided on SIEF and Consortia.
Training and support are offered, including a peer review service and limited authoring services - Denehurst cannot handle bulk SDS writing, but can recommend other service providers
Registration for REACH does not mean that every test outlined in Annexes VII - X need be performed and it is possible to request waivers from testing in the dossier. These waivers may be based on studies not being appropriate (for example, flash point test on high melting point solid) or may be due to exposure waivers (long-term soil degradation on something readily biodegradable) or my be due to simply not being justified (new animal testing on an endpoint that is not applicable).
These following links may have been broken during the move of the web-site to a new server and are slowly being checked as we get time. Please contact Denehurst about these topics if any problems
REACH uncovered - what is REACH all about and why is it not as bad as we feared ?
Life in a SIEF - What next
Joint registrations- the role of a passive member of a SIEF in joint registrations
Short checklist for those approaching a joint submission deadline
What is fair in sharing costs - cost sharing will end in tears for some
Choosing an Only Representative - an important decision
Confidentiality issues with Only Reps may need you to consider a 'trustee'
The Spirit of REACH
Compare pre-REACH with REACH
Support for SIEF
SIEF and Consortia management
Only Representative
Please contact info@denehurst.co.uk for further details or if these links are not working during the migration from the old web-site.
Denehurst Chemical Safety Ltd
These guides have been developed for use in training events
While the migration of the web-site continues, some of the links may have been broken. We have been rather busy and not been able to work on these as much as we would have liked.