Denehurst Chemical Safety Ltd
Classification and Labelling / GHS (CLP)
Advice can be provided on the appropriate classification and labelling in accordance with the requirements in Europe, Canada or Australia. Advice on GHS (EU CLP) can also be offered. More information can be found on the pages relating to SDS and CLP
Where data sets are incomplete, data searches will be made and where possible, data will be read across from similar classes of material. Only if there is no alternative will new Laboratory testing be recommended. Denehurst has a strict policy of avoiding new animal testing where-ever possible and will work with regulatory agencies to explore alternative strategies.
Compliance Audits and Systems
As well as REACH and CLP compliance for registration, classification, SDS etc, the regulatory framework in Europe includes many other aspects such as off-shore chemical use, biocidal products, consumer legislation, food contact etc. and those manufacturing or trading in chemical products need to ensure compliance.
Much of this is customer driven with awkward questions from those using the products wanting assurance that their uses are covered.
It is important to have a 'system' in place to monitor chemical substances and blended products and to ensure that those in your organisation know their respective roles.
Denehurst can provide independent advice to ensure systems cover a wide range of regulatory compliance audits.
CoRAP and Dossier compliance
ECHA are reviewing REACH registration dossiers and providing 'draft decisions' or compliance statements; these are mostly valid and ECHA are open to proposals from the registrants to rectify compliance issues, with new testing or new assessments. Denehurst provides this support.
Dossiers that are put forward to the full Community Rolling Action Plan (CoRAP) of dossier review face a more detailed assessment from national Competent Authorities and it is advised that meetings are held with the national agency during early stages to work with them.
Safety reviews can be performed to meet requirements of European Cosmetics Regulations and efficacy studies can be organised through third-party organisations if needed.
Data review for existing substances / Gap analysis
Denehurst can collate and review data and then prepare a summary as required. Data gaps can be identified and attempts made to read across data from other substances. If necessary and no alternatives can be found, new testing may need to be commissioned and help can be provided in selecting a suitable laboratory and ensuring protocols meet requirements.
Suppport is offered to help in understanding Exposure Scenarios and in writing your own ES. Before preparing an ES, it is first essential to understand the science behind them and to ensure that the effort taken to prepare documents results in something useful that the recipient will be grateful for. A lot of work is being performed to ensure extended-SDS (e-SDS) are suitable for the users.
Using well established links with Contract Research Organisations, testing for toxicology, physico-chemistry, ecotoxicology and environmental fate can be set up to meet appropriate regulatory requirements. Being independent, Denehurst can help place testing work with the Contract Research Organisations that provide the best service in specific areas.
Recommendations are made for specific facilities to meet the project requirements and to ensure compliance with the correct GLP and test guidelines.
Careful choice of laboratory and close monitoring of work can significantly reduce the cost and time of a test programme of Laboratory testing. Every effort is made to reduce the burden of animal testing and Denehurst does not commission animal work. Denehurst will work free of charge to help appeal against requests made by regulatory agencies for animal testing.
Full support and training for REACH is offered by Denehurst covering all areas, from legal requirements, supply chain issues, testing, data gap analysis, IUCLID, CSR etc.
Denehurst is also involved with REACHReady project. More information can be found on the REACHReady web-site at http://www.reachready.co.uk/
Risk Assessment / CSR
EU format Risk Assessments can be prepared for New and Existing Substances as well. This includes review of data, liaison with the production sites and users of the chemicals and submission to regulators to ensure correct exposure scenarios are used and suitable risk management measures are found.
EUSES and Chesar TRA tools can be used as part of the risk assessment procedure.
As well as preparing CSR (REACH chemical safety reports), training is also offered.
Safety Data Sheets / extended SDS
Safety Data Sheets can be prepared or reviewed for regulatory compliance. Guidance for the compilation of Safety Data Sheets (SDS) are provided on other pages. Support can be given in terms of reviewing or up-dating existing SDSs or preparing new documents. Advice can also be given for labelling.
Denehurst has extensive experience in working with US chemical suppliers who need to have internationally compliant SDSs (or MSDSs if in US) which must meet tough standards to reduce the risk of litigation in the US, but still provide correct classification details for Europe. The new Annex II requirements in Europe is making further changes and support can be given with extended SDS (known as e-SDS) as well as CLP.
SIEF and Consortia
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 on the SIEF support page.
Independent advice can be provided to help in data share disputes to value data.
Lecturing or in-house training is offered on all the topics listed above. A separate web-page describes the Training service in full, but the main principle behind this is to provide industry with the skills and tools to help themselves.
Mark and Gill are regular trainers for REACHReady and CHCS and also work with other organisations in the Europe, the US and Asia to run specific training for industry and government departments. Training covers all the topics covered on this page and example programmes can be provided on request. Contact us for more details
Links have been established with other consulting organisations to extend the range of services further than the expertise within Denehurst. This includes organisations working in different geographical regions as well as those specialising in other types of products.
Good working links have been established with technical translators.
Last updated June 2013