Formats and templates
You can download the forms and templates below, to be used in the context of REACH.
- Annex XV report format (with explanations) for the identification of a Substance of Very High Concern
- Format of Annex XV restriction report
- Please note that an earlier document dealing with a "format for substance evaluation" has been replaced by the ECHA integrated quality management system (IQMS) document describing the procedure for substance evaluation
If you are a dossier submitter, the harmonised classification and labelling (CLH) template supports you to prepare proposals for CLH.
The template consists of two parts. The first contains:
- the identity of the substance
- 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 both documents and submit them to ECHA.
- CLH report template (with explanations)
(updated 01/12/2015 )
- Template of Annex I to the CLH report (with explanations)
- Combined CAR and CLH template
- If your substance is a biocidal active substance and you prepare a proposal for CLH under CLP Regulation and also a Competent Authority Report (CAR) under Biocidal Products Regulation (BPR) for (re)approval, the common template found in the link above (see also link under the BPR sub-section) should be used.
Common AR and CLH templateIf your substance is a plant protection product (PPP) active substance and you prepare a proposal for CLH under CLP Regulation and also an Assessment Report (AR) under PPP Regulation for (re)approval, the common template found in the following link should be used (link: https://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents_en)
- In other cases, the CLH report template provided at the top bullet-point of the CLP section should be used.
- Template for competent authority report
This is a common report template intended to be used for [draft/final] Competent Authority Reports (CAR) submitted under BPR and CLH reports (Proposal for Harmonised Classification and Labelling) submitted under CLP Regulation. The template aligns the current structure of the CAR with the information to be included in the CLH report and, therefore, facilitates the alignment of the two processes, which is crucial for the decision on approval under BPR. It also aims to facilitate the work for the evaluating Competent Authority and the CLH dossier submitter and, by that, save time and resources.
- BPR PAR template National authorisation
- BPR PAR template Union authorisation
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.