Summary of services
Classification
and Labelling / GHS
Using new or existing data, whether for supply of substance or preparation, Denehurst
can advise on the appropriate classification and labelling in accordance with appropriate requirements in Europe, Canada or
Australia. Advice on GHS can also be offered. More information can be found on the page Safety Data Sheets and Labelling for Supply
Where data sets are
incomplete, data searches will be made and where possible, data will be read across data from similar for similar classes
of material. Only if there is no alternative will new Laboratory Testing be recommended.
Data review for existing substances ( REACH
/ HPV programmes)
Whether under the US HPV programme, EU Existing Substances Regulation or in preparation for REACH, Denehurst can collate and review data and then prepare a summary as required. Denehurst is also involved
in the CIA REACHReady project. More information can be found on the REACHReady web-site at http://www.reachready.co.uk
Data gaps can be identified
and attempts made to read across data from other substances. If necessary and no alternatives can be found, new
Laboratory Testing may need to be commissioned and help can be provided in selecting
a suitable laboratory and ensuring protocols meet requirements.
Detergents Regulation and other EU Legislation
In October 2005, the European Detergents Regulation came into effect . This tidied up a range of Directives covering
surfactants and detergents and being in the form of a 'Regulation' there is no scope for national variation.
Denehurst can offer
advice on the requirements for legislation in the EU that impacts on chemical supply, including toys, medical devices, food
contact and cosmetics.
Notification of New Chemical
Substances (NONs)
The key to a successful Notification project is a full understanding of the legal position of chemical
supply and determination of data requirements for the specific substance. Denehurst can offer independent advice in
this area and work directly with the relevant Competent Authority in the EU, Eastern Europe, Switzerland, Canada or Australia.
REACH is replacing the NONs legislation, with the last Notifications accepted in May 2008. However, the transition period
will be complex and advice is offered on possible business strategies.
More information on New Substances is provided in the Guidance documents page.
Other regions of the World,
including the Far East, can be covered through liaison with recommended consultant organisations placed in these locations.
Laboratory
testing
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.
REACH
This is the biggest single piece
of EU chemical legislation ever, cosolidating a number of Directives and causing a change in the away industry works.
REACH goes beyond the core chemical industry and will impact on all areas of manufacturing and supply. Full support
for REACH is offered by Denehurst
Risk Assessment
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.
The software EUSES 2 is used as part of the risk assessment procedure.
As well as preparing risk assessments (REACH chemical safety reports), training is also offered.
Safety Data Sheets
Safety Data Sheets can be prepared or reviewed for regulatory compliance. Guidance
for the compilation of Safety Data Sheets and Labelling for Supply 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.
A major problem faced by industry
is ensuring that the data provided by suppliers is correct and an important service offered by Denehurst is the peer review
and validation of SDSs. As an independent organisation, Denehurst can enter confidentiality agreements with suppliers
and review data that may otherwise be considered confidential.
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. GHS is changing the format and help can be given to meet new requirements.
Training
Lecturing or in-house training is offered
on all the topics listed above. A separate web-page describes the Training service in full.
Other Services
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.
