REACHModus 2 - Services up to Registration
REACHModus 2 includes advice, support and representation in Substance Information Exchange Fora (SIEF) for and on behalf of the client. It is focused on ensuring that...
REACHModus 2 is broken down into the following modules.
| SIEF Participation | H2 Compliance offers varying degrees of support when it comes to SIEF participation and activities. We are able to fully represent the client within the SIEF, jointly represent with the client or simply provide advice in the background. Such a range of support is necessary as diiferent companies have differing levels of resources and requirements to deal with information exchange activities. |
| Literature Review | Literature searching and review is an important SIEF activity in order to determine the availability of physico-chemical, biological and environmental substance information. The literature review is an essential acivity in order to fill substance information gaps and minimise the need for further testing. H2 Compliance can provide and manage this service to the SIEF or to individual registrants. |
| Base Testing - Annexes 7 & 8 | If after the literature review, it is found that gaps in information still exist for the physico-chemical and environmental parameters, base testing for those gaps can proceed in accordance with Annexes 7 & 8. H2 Compliance can provide cost-effective and certified base testing services to the SIEF and to individual registrants if required. |
| Testing Proposal - Annexes 9 & 10 | If gaps in biological and exposure information still exist, testing may not proceed prior to agreement by the European Chemicals Agency (ECHA). A testing proposal must be submitted to ECHA stating the rationale for the testing to proceed. H2 Compliance can offer various biological and exposure substance testing programmes to the SIEF. |
| Hazard Assessment | A critical element of SIEF activities is to identify the hazardous properties of individual substances in an effort to adequately assess the risks involved with their use. H2 Compliance offers full hazard assessment support to SIEF's or to individual registrants. |
| Downstream Use Inquiry | It is only when the downstream uses are identified that accurate exposure scenarios and risk charecterisation can be determined. H2 Compliance can partially or fully manage a downstream use inquiry campaign with downstream users or can advise the client on best practice. |
| Exposure Assessment | Exposure assessment activities are complex in nature and open to many variables. H2 Compliance is working with world-class exposure scenario experts and is pleased to add this service to our repertoire. |
| Final Exposure Scenario | The output from the hazard and exposure assessment and risk characterisation is a final exposure scenario. The final exposure scenario is then detailed within an annex of the safety data sheet and documented in the chemical safety report with the hazard assessment (should tonnage band of the substance be greater than 10 tonnes). H2 Compliance can provide guidance on the compilation of a final exposure scenario and how it may be added to the safety data sheet and chemical safety report. |
| Classification & Labelling | An important activity of the SIEF is to identiy and agree upon the classification and labelling details for a substance. The classification and labelling information should then be adapted into the safety data sheet and labelling for the client's relevant substances and products. H2 Compliance can provide advice on classification and labelling protcol to the SIEF and general advice on Globally Harmonized System of Classification and Labelling of Chemicals (GHS). |
| Registration Dossier | H2 Compliance can assist a business to compile the registration dossier within the SIEF and at an individual basis. The dossier is submitted to ECHA via IUCLID 5 and is fed into REACH-IT for data assimilation. |