Formati i predlošci

REACH

The following forms and templates, to be used in the context of REACH, can be downloaded from this webpage.

 

Templates for a Chemical Safety Report (CSR)

 

 

Annotated templates for an Exposure Scenario (ES)

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:

1. Title
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.

 

 

 

Templates for applications for authorisation

 

CLP

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

Using Annex I is not mandatory, but it can be used to provide more detailed information or confidential information.

 

 

BPR

 

 

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.

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.