Format for CHEMICAL SAFETY REPORT [LOW VOLUME] USE

Transcription

1 Format for CHEMICAL SAFETY REPORT [LOW VOLUME] USE Legal name of applicant: [Legal name of applicant] Substance: [Include Annex XIV substance name, EC and CAS number] Use title: [Use title] Date CHEMICAL SAFETY REPORT i

2 DECLARATION We, [Applicant s name], request that the information blanked out in the public version of this document is not disclosed. We hereby declare that, to the best of our knowledge as of today ([DATE]) the information is not publicly available, and in accordance with the due measures of protection that we have implemented, a member of the public should not be able to obtain access to this information without our consent or that of the third party whose commercial interests are at stake. We further declare that we fulfil the criteria for using the special application format for [low volume] uses as defined in [relevant document or regulation]. Signature: Date, Place: [NAME, TITLE] DateFebruary 15 CHEMICAL SAFETY REPORT ii

3 Table of Contents DECLARATION... ii PART A SUMMARY OF RISK MANAGEMENT MEASURES DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED... 1 PART B IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES MANUFACTURE AND USES CLASSIFICATION AND LABELLING ENVIRONMENTAL FATE PROPERTIES HUMAN HEALTH HAZARD ASSESSMENT HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES ENVIRONMENTAL HAZARD ASSESSMENT PBT AND vpvb ASSESSMENT EXPOSURE ASSESSMENT Use / ES title Description of use Title section Source information Conditions of use affecting exposure Control of environmental exposure: Environmental Contributing Scenario Control of worker exposure: Worker Contributing Scenario Exposure estimation and reference to its source Environmental release and exposure: Environmental Contributing Scenario Worker exposure: Worker Contributing Scenario Combined workplace exposure [Potential for exposure during uses by consumers ] Potential for article service-life exposure RISK CHARACTERISATION... 6 DateFebruary 15 CHEMICAL SAFETY REPORT iii

4 Part A 1. SUMMARY OF RISK MANAGEMENT MEASURES 2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED 3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED 4. DECLARATION ON CONSUMER EXPOSURE Date CHEMICAL SAFETY REPORT 1

5 Part B 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES 1.2 Name and other identifiers of the substance EC number: EC name: CAS number CAS name Molecular formula: Molecular weight range: [Subsequent sub-sections do not need to be completed for an application for authorisation under the [low volume] special case since the physical and chemical properties of the Annex XIV substance are already known.] 2. MANUFACTURE AND USES case] 3. CLASSIFICATION AND LABELLING case since the classification and labelling information of the Annex XIV substance are already known] 4. ENVIRONMENTAL FATE PROPERTIES case since the environmental fate properties of the Annex XIV substance are already known] 5. HUMAN HEALTH HAZARD ASSESSMENT [For substances listed on Annex XIV under Article 57(a)(b)(c) i.e. CMR properties this section should reference the relevant RAC reference DNEL/dose-response. Similarly, where a substance is listed under Article 57(f) and the equivalent concern is related to human health this section should reference the relevant RAC reference DNEL/dose-response. This section is not required for an application for authorisation for an substance listed on Annex XIV under Article 57(d)(e) i.e. PBT properties, or those listed under Article 57(f) where equivalent concern relates to the environment.] 6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES case] 7. ENVIRONMENTAL HAZARD ASSESSMENT DateFebruary 15 CHEMICAL SAFETY REPORT 2

6 case since the environmental hazard properties of the Annex XIV substance are already known]. 8. PBT AND vpvb ASSESSMENT case since the PBT and vpvb properties of the annex XIV substance are already known]. 9. EXPOSURE ASSESSMENT [The content of this CSR can be sourced from an exposure scenario (ES) appended to an esds that is appropriate for the use applied for obtained from your supplier or from a downstream user CSR prepared by your company appropriate for the use applied for. Alternatively, in the absence of these data sources, the assessment conducted by your company to satisfy article 37(6) of the REACH regulation 1 or other available information can be used as the basis for the exposure scenario. Applicants are referred to ECHA guidance for downstream users for assistance in interpreting exposure scenarios contained in an esds or preparing a downstream user CSR (version 2.1, October 2014)] 9.1 Use / ES title <add text here suggested maximum of 100 words> 9.2 Description of use [Provide, using the text box below, a description (narrative) of the use for which an Authorisation is sought. Please explain what the Annex XIV substance is used for and the broader process context (i.e. what products / articles are produced). This text should also include brief details of the sequence of individual tasks that comprise the overall use and how these relate to the environmental / worker contributing scenarios that that are described in sections 9.4 and 9.5. Ensure that all tasks relevant to the use of the Annex XIV substance are included in the exposure scenario with particular reference to those that potentially lead to high exposure situations (e.g. maintenance, sampling, filling and transfer). Details of the specific operating conditions (OCs) of use and risk management measures (RMMs) associated with each environmental and worker contributing scenario should not be described in this section, but should be provided for individual environmental or worker contributing scenarios in appropriate sub sections of 9.4 and 9.5]. <add text / tables / images here suggested maximum of 1500 words> 9.3 Title section Source information [Describe, using the text box below, the source of the exposure scenario information provided in the tables below e.g. esds, DU CSR, workplace monitoring programme. Where data are from an esds please include the author, version, date received and registration number). In all cases justify why this source material is considered to be applicable to the use applied for, including any requirement for exposure scenario scaling, and describe any deviations for the source 2 1 Article 37(6) of the REACH regulation requires that where a downstream user does not prepare a chemical safety report (i.e. the uses <1 tonne / year) he shall consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that risks to human health and the environment are adequately controlled. 2 Exposure scenario scaling is described in ECHA guidance for downstream users (version 2.1 October 2014). Certain exposure scenarios have DateFebruary 15 CHEMICAL SAFETY REPORT 3

7 material and explain why these deviations were considered to be necessary (e.g. where information contained in the ES appended to an esds was considered to be too generic).] <add text here suggested maximum of 500 words> [Use the table below to list all the relevant contributing environmental and worker contributing scenarios that comprise the use applied for, including appropriate use descriptors where this is relevant. Add additional environmental or worker contributing scenarios as required to the table. Note that estimates of indirect exposure to humans via the environment are not required. In addition, environmental release and exposure estimates are only required for substances listed on Annex XIV according to Article 57(d)(e)(f) i.e. PBT, vpvb or equivalent concern properties]. Environment ECS Title Worker WCS Title WCS Title Use descriptors Use descriptors Use descriptors 9.4 Conditions of use affecting exposure [Applicants are referred to the practical examples of exposure scenarios available on the each website ( for guidance on the completion of these exposure scenario tables] Control of environmental exposure: Environmental Contributing Scenario 1 [Provide, using the text box below, a brief narrative description of the OCs / RMMs and organisational measures (such as training) that comprise the contributing scenario] <add text / tables /images here suggested maximum of 500 words> Amount used, frequency and duration of use Daily amount Annual amount Technical and organisational conditions and measures Conditions and measures related to treatment of waste (including article waste) Control of worker exposure: Worker Contributing Scenario 2 [Provide, using the text box below, a brief narrative description of the task and OCs / RMMs and organisational measures (such as training) that comprise the contributing scenario] been developed in order that various combinations of conditions of use can still be considered to result in safe use, even if these differ from the precise conditions of use described in the exposure scenarios. If applicable, suppliers should provide scaling information in the exposure scenario to help determine if a use is covered. DateFebruary 15 CHEMICAL SAFETY REPORT 4

8 <add text / tables /images here suggested maximum of 500 words> Product (article) characteristics (e.g. concentration / form / dustiness) Amount used (or contained in articles) per day, frequency (e.g. number of days per year) and duration of use/exposure (e.g. length of exposure per day); number of workers potentially exposed Technical and organisational conditions and measures Conditions and measures related to personal protection, hygiene and health evaluation Other conditions affecting workers exposure (e.g. location of use [indoors/outdoors], process temperature) Additional good practice [Add additional worker contributing scenario sub-sections, as required.] 9.5 Exposure estimation and reference to its source [Describe, using the text box below, the source of the exposure information provided in the tables below e.g. esds, DU CSR, workplace monitoring programme. Where data are from an esds please include the author, version, date received and registration number). In addition, please provide details of relevant occupational exposure limits (i.e. value and who derived them) and how their implementation is being achieved. Note that estimates of indirect exposure to humans via the environment are not required. In addition, please note that environmental release and exposure estimates are only required for substances listed on Annex XIV according to Article 57(d)(e)(f) i.e. PBT, vpvb or equivalent concern properties (and only where the equivalent concern relates to an environmental hazard). <add text / tables /images here suggested maximum of 500 words> Environmental release and exposure: Environmental Contributing Scenario 1 [environmental release and exposure estimates are only required for substances listed on Annex XIV according to Article 57(d)(e)(f) i.e. PBT, vpvb or equivalent concern properties (and only where the equivalent concern relates to an environmental hazard).] Release route Release rate Release estimation method and details Water Air Soil DateFebruary 15 CHEMICAL SAFETY REPORT 5

9 Protection target Freshwater Sediment (freshwater) Marine water Sediment (marine water) Sewage treatment plant Agricultural soil Exposure estimate (based on: modelling, environmental monitoring) Worker exposure: Worker Contributing Scenario 2 Route of exposure and type of effects Inhalation Dermal Combined routes Exposure estimate, including details of derivation method (i.e. measurements, analogous measurements, modelling) [Add additional worker contributing scenario sub-sections, as required] Combined workplace exposure [Provide, using the text box below, a description of the potential for combined exposure for the same group of workers over an 8 hour shift from the use applied for i.e. their potential for exposure as a consequence of undertaking the tasks described in the different WCS included in this application.] <add text / tables /images here suggested maximum of 500 words> Potential for article service-life exposure to industrial and professional users [Where the substance subject to authorisation is incorporated in articles as part of the use applied for please describe these articles, including the concentration of the Annex XIV substance in the article and the potential for exposure to industrial and professional users during the service-life of the article. A detailed exposure scenario is not required. Note that consumer uses of articles containing >0.1% of an Annex XIV substance are outside of the scope of the low volume special case and would require a standard application for authorisation] <add text / tables /images here suggested maximum of 500 words> 10. RISK CHARACTERISATION [Note that risk characterisation for environmental receptors and indirect exposure to humans via the environment is not required for an application for authorisation under the [low volume] special case. Risk characterisation for threshold substances should be calculated by dividing the predicted exposure concentration by the RAC reference DNEL for the Annex XIV substance. Risk characterisation for non-threshold substances listed on Annex XIV according to Article 57(a)(b)(c) i.e. CMR substances or non-threshold substances listed on Annex XIV according to DateFebruary 15 CHEMICAL SAFETY REPORT 6

10 Article 57(f) on the basis of human health hazards should be based on excess risk, calculated according to the RAC reference dose-response for the Annex XIV substance Risk Characterisation: Worker Contributing Scenario 2 Route of exposure and type of effects RCR 1 or excess risk 2 Inhalation Dermal Combined routes 1: Risk Characterisation ratio (RCR) is required for threshold substances 2: Excess risk is required for substances where it is not possible to derive a threshold [Add additional worker contributing scenario sub-sections, as required] DateFebruary 15 CHEMICAL SAFETY REPORT 7