Guidance on registration - ECHA - Europa

More documents

Recommendations

Info

78 <strong>Guidance</strong> on registration Version 2.0 May 2012 manufacturer must address the manufacture and all identified uses of the substance while an importer will have to address only the identified uses. All stages of the life-cycle of the substance resulting from the manufacture (if applicable) and the identified uses must be considered in the CSA, including, where relevant, the waste stage and the service life of articles. A CSA should include the following steps: Hazard assessment: - Human health hazard assessment - Physicochemical hazard assessment - Environmental hazard assessment - PBT/vPvB 13 assessment If the substance fulfils the criteria for any of the hazard classes or categories set out in Article 14 (4) or is assessed to be a PBT or vPvB the chemical safety assessment will have to include the following additional steps: Exposure assessment. - Generation of exposure scenario(s) - Exposure estimation Risk characterisation The different steps of the CSA are explained below although the assessment should have been done earlier in the process, while preparing the technical dossier. The reader should also consult the <strong>Guidance</strong> on information requirements and chemical safety assessment if in need of further help and advice. Those readers without any previous knowledge on risk assessment might find useful to refer first to the <strong>Guidance</strong> in a nutshell on chemical safety assessment to get familiarised with the concepts of the CSA. Note that ECHA has developed an IT tool called Chesar to help registrants perform a CSA and generate a CSR. This is explained in further detail in section 5.3.2. 5.3.1 Steps of the chemical safety assessment 5.3.1.1 Hazard assessment The assessment starts with the assessment of the physicochemical, human health and environmental hazards. In addition, the registrant has also to assess whether the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). As mentioned previously the hazard assessment should be performed on the basis of all available and relevant information which should be reported in the technical dossier. The registrant should rely particularly on the key studies identified in the technical dossier for the relevant endpoints. In addition to these key studies, information available in other studies could also be used by the registrant as supporting information or as part of a weight of evidence approach as described previously in section 5.2.4 of this guidance. 13 PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
<strong>Guidance</strong> on registration Version 2.0 May 2012 79 5.3.1.1.1 Human health hazard assessment The objective of the human health hazard assessment is to determine the classification and labelling of the substance and to define the level of exposure above which humans should not be exposed. This level of exposure is known as the derived no-effect level(s) (DNEL). The DNEL is regarded as an exposure level below which an adverse effect will not occur. It is derived from toxicity test results using appropriate assessment factors. While toxicity test results are reported in the technical dossier in the different endpoint study records, the DNEL values and the assessment factors used in their calculation should be reported in the endpoint summary records, as previously explained in section 5.2.4. <strong>Guidance</strong> on how to derive a DNEL is available in Chapter R.8 of the <strong>Guidance</strong> on information requirements and chemical safety assessment. The classification and labelling of the substance should be performed on the basis of information available in the endpoint study records as detailed in section 5.2.2. In conclusion, the main task of the registrant is to first document the human health assessment of the relevant endpoints in the endpoint summaries in IUCLID 5 and then to use this information in section 5 of the CSR. Please, note that for substances used in food contact materials within the scope of Regulation (EC) No 1935/2004 or in cosmetic products within the scope of Directive 76/768/ECC, the human health risk assessment does not need to consider these uses, as they are already taken into account in the aforementioned regulations. 5.3.1.1.2 Physicochemical hazard assessment The objective of the physicochemical hazard assessment is to determine the classification and labelling of the substance and to assess, as a minimum, the potential effects to human health for explosivity, flammability and oxidising potential. <strong>Guidance</strong> on how to assess physicochemical properties is available in Chapter R.7 of the <strong>Guidance</strong> on information requirements and chemical safety assessment. The classification and labelling of the substance should be performed on the basis of information available in the endpoint study records as detailed in section 5.2.2. A summary of the different effects and at least the explosivity, flammability and oxidising potential must be reported in section 6 of the CSR on the basis of the information available in the endpoint study records. 5.3.1.1.3 Environmental hazard assessment The objective of the environmental hazard assessment is to classify and label the substance and to determine a predicted no effect concentration (PNEC) below which adverse environmental effects in the environmental compartments are not expected to occur. <strong>Guidance</strong> on how to derive a PNEC is available in Chapter R.9 of the <strong>Guidance</strong> on information requirements and chemical safety assessment. The classification and labelling of the substance should be performed on the basis of information available in the endpoint study records as detailed in section 5.2.2. A summary of the different effects on the environmental targeted compartments (aquatic, terrestrial, atmospheric and micro-organisms of the sewage treatments systems) shall be reported in section 7 of the CSR on the basis of the information available in the technical dossier under the relevant IUCLID 5 endpoint study record. The result of the assessment, once finalised, should also be reported under the relevant endpoint summaries in IUCLID 5 as well as the calculated PNECs values. In addition to information on potential effects on the environment, the registrant has also to Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Page 1 and 2:
GUIDANCE Guidance
Page 3 and 4:
Guidance on regist
Page 5 and 6:
Guidance on regist
Page 7 and 8:
Guidance on regist
Page 9 and 10:
Guidance on regist
Page 11 and 12:
Guidance on regist
Page 13 and 14:
Guidance on regist
Page 15 and 16:
Guidance on regist
Page 17 and 18:
Guidance on regist
Page 19 and 20:
Guidance on regist
Page 21 and 22:
Guidance on regist
Page 23 and 24:
Guidance on regist
Page 25 and 26:
Guidance on regist
Page 27 and 28: Guidance on regist
Page 77: Guidance on regist
show all

Guidance on registration - ECHA - Europa

Create successful ePaper yourself

Delete template?

Save as template?