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Until technology (and in some cases, attitudes) change, animal testing still has a place in chemical safety assessment. Denehurst aims to minimise animal testing requirements where possible, through the use of predictive modelling, read-across assessments and other methods encouraged by ECHA guidance. Support can be provided as part of an intelligent testing strategy.
Denehust does not commission animal testing and free advice and support is given to help justify avoidance of animal work.
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.
Chemical Safety Reports
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 original deadlines were rushed or poorly understood by registrants and may need updating.
Chesar allows easy generation of well-formatted professional looking reports, but can give incorrect answers; software is a very useful tool, but the science behind the assumptions and calculations must be understood to use the tools correctly
Candles are considered to be chemical mixtures and are therefore subject to CLP and REACH, with correct labelliing required. Labelling needs to be on packaging, or if supplied with no packaging, and necessary warnings can be communicated by other suitable methods (eg ties or 'instructions for use')
The Community Rolling Action Plan is known as CoRAP and if your substance is included on the list of substances for review, then it is important to quickly ensure the dossier is fully up to date and has been independently reviewed. It is also important to engage with the National Competent Authority responsible for this review.
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.
ECHA are performing many reviews on old dossiers and with very few exception, the questions raised are valid; ideally, if old dossiers are now considered to be failing to meet current expecations (especially in substance identity) spontaneous updates are recommended.
Exposure scenarios are needed when a substance is registered and a CSR has been prepared. These need to be added to the SDS to form the 'extended-SDS'. Obviously, if an SDS is not needed (non-hazardous), then an Exposure Scenarios is not needed.
The issue of Exposure Scenarios for mixtures is more complex, but all relevant information in the CSR of a substance needs to be communicated downstream in any mixture SDS. There is a choice between simply using the substance ES, creating an ES for the mixture based on the hazardous components 'contributing' to the mixture hazards or to incorporate the findings of the substance ES into the body of the mixture SDS.
Under Article 26 of REACH, it is necessary to check that no other animal test data exists or if testing is in progress before starting new laboratory work. The Inquiry process will allow ECHA to confirm the substance identity and check in their records whether new testing is needed or whether data on the substance or (in theory) on similar materials exist.
The Inquiry is made using IUCLID or can be on-line through REACH IT.
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.
There are continual updates to IUCLID
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.
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.
Opting out of joint registrations
Although this is the final option when agreement to share data at fair and equitable costs is impossible, there are options. There is a formal procedure to go through, including contact with ECHA and evidence that attempts have been made to reach agreement with the data holders.
If wanting to manufacture or supply over 1 tonne of a substance for your own trials or customer trials, it is possible to apply for a Production and Process Orientated Research and Development (PPORD) exemption. This can last 5 years and re-application for a further 5 years is possible if it can be justified (for example supplying intermediates to permit clinical trials of a pharmaceutical).
The dossier is prepared using IUCLID and submitted through REACH IT and an ECHA fee will apply. Part of the submission is a justification.
REACH Cost sharing
There are many things to consider when entering a SIEF agreement and cost sharing is perhaps the most contentious.
REACH Costs - valuing data and opting out
Although most SIEFs are working well, there are disputes of the cost of letters of access and this guide helps value the dossier to determine if the asking price is reasonable. If agreement cannot be reached, opting out of elements of the joint dossier is an option, but should not be undertaken lightly and may lead to legal action.
REACH Only Representative
Although Denehurst does not offer an Only Representative service to prevent potential conflicts of interest from support provided to other consulting organisations and helpdesk activities, advice can be given to help decide on the type of Only Representative needed. See guidance on choosing an OR
The decision is often based on commercial requirements and can be a regional office of a non-EU manufacturer, a sales agent, a consultancy or a law-firm. The only requirements under the REACH Regulation is that there must be a 'competent' person and it must have legal status in Europe. Competency is not defined.
In cases where confidentiality issues (eg formulation details) arise, it is possible to appoint an independent 'Trustee' . Denehurst offers a service to act as trustee between supplier and customer to independently verify confidential details.
Role in supply chain - importers, distributors, representatives etc
A frequent cause for confusion is defining who is actually the 'importer' and who takes responsibility under REACH or CLP. The simple answer is that there is a choice in many supply lines, but it is essential that each member of the supply chain understand their role and that one member of the supply line has taken responsibility before actual use of the substance. Non-EU suppliers have no legal responsibility to provide EU labelling or SDS (and indeed, most of REACH and all of CLP does not even recognise that non EU (EEA) organisations even exist.
SDS / e-SDS / MSDS
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).
(SIEF) Joint Registration
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 working in groups 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).
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