Summary of services offered
Denehurst provides extensive training support in a range of topics (see ‘Training’ page [link]), but in order to provide effective practical training services, it is necessary to actually ‘do’ the work as well.
Ideally, when performing actual work in preparing SDS, or determining classification, or preparing REACH dossiers, clients will be learning so that in future, they can do this work themselves and only need Denehurst for specific support or advice in complex situations.
As an example, preparing REACH Article 26 Inquiry Dossiers [link] or PPORDs [link] or even Poison Centre Notifications for the EU [link] are not difficult and for consultants to do this, a large part of the time needed is to obtain the relevant information from the sponsor. In these cases, Denehurst can talk through the processes either on line with screen-share or have a day on site to work through these together for the first examples.
If needing direct support, the following describes the types of service we can provide; and of course, in all these topics, on-site or remote training can be offers.
Classification and Labelling / GHS (CLP)
Advice can be provided on the appropriate classification and labelling in accordance with the GHS requirements in GB, Europe, Asia, Canada etc. More information can be found on the pages relating to SDS support [link] and GHS / CLP [link]
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 [link] 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. (See our policy on animal testing [link])
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.
Compliance with REACH, including ECHA / HSE decisions for further testing
ECHA and HSE review EU / GB REACH registration dossiers and ‘draft decisions’ or compliance statements are sent out to request further dossier improvements; although many of the comments are valid, some requests for more testing may not be necessary. ECHA are open to proposals from the registrants to rectify compliance issues, with new testing or new assessments. Denehurst provides this support and will make every effort to avoid new animal testing. We do not charge for advice and expert statements where it is to help avoid new animal tests.
Dossiers that are put forward to the full EU Community Rolling Action Plan (CoRAP) of dossiers 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.
Cosmetics
Safety reviews can be performed to meet requirements of GB or European Cosmetics Regulations and efficacy studies can be organised through third-party organisations if needed. Training is offered in the preparation of cosmetic product safety reports for EU and GB
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.
Exposure Scenarios
Support is offered to help in understanding Exposure Scenarios (ES) 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.
We are aware that many extended SDS are not fit for purpose and are simply many pages of writing that provide no useful information for the recipient. The HSE are looking to improve this process for GB REACH and Denehurst fully supports initiatives to ensure that recipients of chemicals are given useful documentation and not just many pages of writing.
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 [link]. Every effort is made to reduce the burden of animal testing [link] 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.
More information on the laboratory testing page [link]
Poison Centre Notification
For supply into the EU (including Northern Ireland, but not mainland GB), there is an obligation to Notify either national poison centres or to Notify ECHA for pan-EU supply. The most time consuming part of the process is entering details of mixtures and this is best done by the suppliers themselves.
Therefore, although this can be done by Denehurst, we recommend training in the process to allow in-house completion of this rather annoying and arguably pointless process.
REACH
Full support and training for REACH [link] is offered by Denehurst covering all areas, from legal requirements, supply chain issues, testing, data gap analysis, IUCLID, CSR etc.
See our REACH pages for more details [link]
Denehurst is also involved with REACHReady, a service provided by the Chemical Industries Association in the UK. More information can be found on the REACHReady web-site at http://www.reachready.co.uk/
Risk Assessment / CSR
GB / EU Chemical Safety Reports can be prepared in support of REACH Registrations. This includes review of data, liaison with the production sites and users of the chemicals as needed to ensure correct exposure scenarios are used and suitable risk management measures are found.
The Chesar TRA tool can be used as part of the procedure.
As well as preparing CSR [link], training [link] 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) [link] 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.
Independent advice can be provided to help in data share disputes to value data and to consider Opt-out Registration dossiers.
Training
Lecturing or in-house training is offered on all the topics listed above. A separate web-page describes the Training service in full [link], 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.
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.