Formaatit ja mallit
The following forms and templates, to be used in the context of REACH, can be downloaded from this webpage.
- Chemical Safety Report - (Section 9 and 10) for non PBT/vPvB substances
- The CSR template (section 9 and 10) suggests how the information as required in Annex I of REACH can be reported.
- For section 1 to 8 of the CSR it is suggested to report the information according to the structure generated by the IUCLID CSR plug-in.
- An example of how the information can be reported for the full CSR is available here - (see Illustrative CSR example).
- Chemical Safety Report - (Section 9 and 10) for substances (considered as) PBT/vPvB
In case of difficulty navigating the template Table of Contents, please consult these instructions
Note that two templates are provided as the information regarding the exposure assessment for the environment for substances being (considered as) PBT/vPvB is slightly different.
An explanatory note on the new templates can be found at the following link:
- IUCLID Report Generator
IUCLID can be used to generate a CSR (Part A and part B, sections 1 to 8) directly from data stored within IUCLID. This is described in the help system of IUCLID, under Functionalities of IUCLID 6, which is also available in PDF format on the IUCLID website at https://iuclid6.echa.europa.eu/documentation.
An illustrative example of a CSR using the formats mentioned above is available at the following link: http://echa.europa.eu/support/practical-examples-of-chemical-safety-reports
The annotated templates show downstream users what they can expect to see in an exposure scenario for a substance. They may also be useful for registrants to understand how to structure the ES for communication. The templates follow the recommended structure and describe the type of information that is included in each section. They present different types of exposure scenarios, for industrial, professional and consumer uses.
An ES for communication typically consists of 4 sections:
2. Conditions of use affecting exposure
3. Exposure estimation and reference to its source
4. Guidance for Downstream Users on how to evaluate whether he works inside the boundaries set by the ES
Please note that:
- The format is not specified in the legal text. However, the templates shown here present the recommended structure based on practical experience and moves toward a harmonised format within the industry,
- Some elements of the template are subject to further development. These are identified in explanatory footnotes,
- Comments are included in black font to indicate the type of information contained in the sections,
- Examples are included in blue italics to illustrate the type of information. Examples correspond in most cases to the ES illustrative example and are not intended to be consistent with each other, but serve to illustrate the different sections.
- Annotated ES template - industrial
- Annotated ES template - professional
- Annotated ES template - consumer
An illustrative example of exposure scenarios for communication can be found at the following link:
Since the CLP Regulation entered into force, manufacturers, importers and downstream users of substances have also been allowed to propose a harmonised classification and labelling for a substance.
For this purpose, if you are a manufacturer, importer or downstream user, you should use the harmonised classification and labelling (CLH) report template below.
The template consists of two major parts. The first contains:
- the identity of the substance,
- the proposed CLH,
- a history of the previous classification and labelling,
- justification that action is needed at Community level
- identified uses
- data sources
- physicochemical properties of the substance, and
- the hazard assessment by the dossier submitter.
The second part, Annex I, contains:
- the detailed study summaries of the studies forming the basis of the CLH proposal.
You should prepare and submit both documents to ECHA.
- CLH report template (with explanations)
- ECHA no longer accepts CLH dossiers using old versions of the CLH report template as from 01/01/2018. Please use the latest version available on our website for potential new submissions of CLH dossiers.
- Template of Annex I to the CLH report (with explanations)
Weight of Evidence/Uncertainty Template
The template and background document for weight of evidence/uncertainty is intended for use in human health and environmental hazard assessments. It can assist to:
- - harmonise the use of weight of evidence and uncertainty assessment within ECHA processes;
- - increase transparency in regulatory decision making (REACH and CLP regulations and the BPR);
- - facilitate the use and integration of alternative methods and all available information in hazard assessment.
The template contains instructions on what is expected under each section. It also provides links to the background document and to other relevant guidance documents.
WHO/IPCS Mode of Action Analysis Framework Templates
The following templates for mode of action analysis are based on the WHO/IPCS Mode of Action Framework and intended for use for both human health and/or environmental mode of action analysis. This framework provides a generic approach to the principles commonly used for evaluating mode of action. It outlines in a structured format the elements to be considered in analyzing whether available data support a particular mode of action.
- WHO/IPCS Templates Mode of Action Analysis (with instructions to relevant Guidance documents)
- WHO/IPCS Templates Mode of Action Analysis (clean version))
In order to import the mode of action analysis / human relevance framework in IUCLID related toxicological endpoint summaries, the user imports the template in html format in the corresponding text field in IUCLID available below.