A chemical safety assessment is required for any substance manufactured or imported at 10 or more tonnes per year, including an exposure assessment and risk characterisation for all identified hazards.
The assessment needs to cover the whole of the life cycle of the substance. In order to achieve this, ECHA recommend that you co-operate with downstream users to build an accurate picture of the substance. This will enable the construction of realistic and useful use descriptions and exposure scenarios.
ECHA have highlighted three key requirements for the CSA:
- The uses must be described in concrete terms, with detailed descriptions of processes and activities covered by each exposure scenario. Simply supplying the use descriptors is not sufficient.
- The conditions of use for environmental assessment must be explicit.
- Joint registrants should co-ordinate their efforts to ensure a transparent CSR, which is consistent with the Technical dossier. This is important since the CSR is not only subject to compliance checking, but it also used to inform other regulatory processes by ECHA and member states, such as substance evaluation and prioritisation for Authorisation.
IT Solutions for CSA & CSR Generation
ECHA have released a new suite of tools to aid in the generation of the CSA and CSR: CHESAR 2.0 was released at the end of June 2012 and enables CSA’s to be performed on an IUCLID 5.4 dataset (IUCLID 5.4.1 was released on 22nd October 2012. http://iuclid.eu/index.php?fuseaction=home.news&type=public&id=61)
An updated version of the CSR generator IUCLID 5.4 plug-in was released in July 2012 followed by CHESAR 2.1 in October 2012 which introduced exposure estimation tools (ECETOC TRA consumer). CHESAR 2.2 is planned for release in the first quarter of 2013 and will support the generation of exposure scenarios.
As part of the support ECHA are providing for the 2013 registration deadline, illustrative examples of exposure scenarios (http://echa.europa.eu/web/guest/support/practical-examples-of-exposure-scenarios) and chemical safety reports (http://echa.europa.eu/documents/10162/13634/csr_illustrative+example_en.pdf) are available from the ECHA website.
To manage dossier preparation and compliance projects check out H2 Compliances own project management software element1.
This process is the ‘E’ in REACH; it is intended to verify suspected hazards and risks for specific substances of concern and subsequently identify risk management measures for the use of the substances.
This process is the joint responsibility of ECHA and the Member State Competent Authorities; substances of concern are placed on the Community Rolling Action Plan (CoRAP), this list contains the substances to be evaluated over the next three year period and is updated annually.
Inclusion of a substance on the CoRAP has no legal impact for the registrants in the first instance. Following evaluation of the substance by the responsible member state, ECHA may request that further information is submitted from the registrants before a decision concerning appropriate risk measures can be made. This process is extended, with the draft member state decision due within 12 months of the CoRAP being published.
The evaluation must be completed within 12 months of the CoRAP publication OR 12 months of further information requested being submitted. This could mean a time period of over 4 years if a 2 year carcinogenicity study is deemed necessary as part of the evaluation.
Once the evaluation is completed there are several risk management measures which could be applied:
- no further action;
- revised harmonised classification and labelling;
- identification of the substance for the Candidate list (SVHC) and possible prioritisation for Authorisation;
- a proposal for Restriction.
Which RMM is chosen will depend upon the risk that the substance presents for either human health or the environment.
Registrants should be aware if their substance is on the CoRAP and be prepared to co-ordinate with each other and co-operate with the responsible Member State in order to ensure the smooth operation of the process.
It is suggested that Registrants of CoRAP substances engage proactively with the responsible Member State early in the process to discuss any planned dossier updates or pending studies which may impact upon the evaluation. The CoRAP list of substances, identifying the MS contact details can be found on the ECHA website: http://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table
The underlying message from both the sessions on Registration and Evaluation at the last ECHA stakeholders day was that submission of the Registration dossier is only the first step of ensuring the safe use of the substance. Dossiers need to be kept updated as new hazards or risks emerge or the uses of the substance change.
If you are in doubt about your particular obligations or would like to save time and have the H2 Compliance experts prepare your registration dossiers please contact us today for a free consultation today.