REACH-IN – Registration, Evaluation, Authorisation and Restriction of Chemicals
Tools for REACH requirements
A systematic approach to applying REACH requirements to the co-formulants used in Plant Protection Products
The EU REACH legislation, Regulation (EC) No. 1907/2006, brings additional requirements on the use of chemicals across Europe and places a special emphasis on evaluating the safety of their uses to workers, consumers and the environment. The corresponding risk assessment framework is applicable to co-formulants used in Plant Protection Products. Article 10(a) requires the EU manufacturer or importer of chemical substances to develop a Chemical Safety Report (CSR) which demonstrates that all uses of a substance are safe. Article 37 requires the downstream user of substances to ensure their uses are within the safe conditions of use described by the supplier in the extended safety data sheet (e-SDS) or take appropriate actions to address this. Please refer to the website of European Chemical Agency (ECHA Website) for further information on company obligations.
CropLife Europe has defined a use map including appropriate use descriptors to describe the Plant Protection Product uses of co-formulants and developed corresponding tools for the assessment of their safe use for inclusion in the Chemical Safety Report (CSR). The use descriptors for the Crop Protection Scenarios are for inclusion in IUCLID and the e-SDS. They are intended for ease of communication up and down the supply chain and are the basis for the contributing exposure scenarios used in the assessment. Based on the use map, CropLife Europe has developed a series of tools which are specifically designed to estimate exposure of workers, consumers and the environment resulting from crop protection uses.
For professional workers (operators) and consumers (amateurs), a specific tool (CLE OWB v4.1 ) has been developed. OWB is a simple to use spreadsheet, which provides a more realistic assessment in comparison to the standard REACH tools (ECETOC TRA and CHESAR) as it is based on measured exposure data collected during representative crop protection uses. The output from OWB is automatically generated in a CSR template format.
To address the regional environmental exposure, the indirect exposure of humans exposed via the environment and secondary poisoning, CLE has developed Specific Environmental Release Categories (SpERCs), accompanied by guidance on how they should be used in conjunction with ECETOC TRA and CHESAR to assess the contribution of Plant Protection Product uses to the regional environmental concentrations of a substance used as a co-formulant.
For the local environmental assessment, the CLE Local Environmental Tool ( LET) has been developed. LET is a simple to use spreadsheet, which provides a local scale environmental assessment for crop protection uses not covered by the standard REACH exposure models that do not account for direct release of substances to agricultural soil. The latest version of LET also assesses the indirect exposure of humans via the local environment.
The table below shows the recommended tools developed by CLE for appropriately conducting a REACH risk assessment of co-formulants used in plant protection products. Details and explanations on the underlying data and approaches are available in the CLE guidance document. For further information and assistance, please contact CropLife Europe.
|CLE Guidance Document||CLE Guidance Document (April 2021)|
|Use Map||Use map|
Also available from ECHA here.
|OWB tool||CLE OWB v4.1|
CLE OWB v4.0 (new December 2018)
CLE OWB v3.3 (version: November 2015)
|Specific Environmental Release Categories (SpERCs)||SpERCs Factsheets |
CHESAR Import Files
Use of CLE SpERCs – explanatory note
Also available from ECHA here.
|CLE Local Environment Tool (LET)||CLE LET 4.0|
Background information on the CLE SpERCs, Generic Exposure Scenarios and the REACH-IN tools is provided in the following publications:
For topics related to Safety Data Sheets and the attachment of Exposure Scenarios, please see the CLP FAQs on the classification and labelling page of CLE:
CLE is making the tools on this webpage available for registrants of chemicals to aid them in the assessment of substances used as co-formulants in plant protection products in the context of REACH. The tools have been subjected to thorough testing; however, CLE does not guarantee that the tools work error-free. CLE offers no warranty either to the reliability of the tools and the provided information or to the conclusions or assumptions made by any user on the basis of the use of these tools or the use of such information or to the regulatory acceptance of the assessments conducted using the tools. All usage is at the discretion of the user and CLE is not liable for any consequences resulting from such use.
CLE is a member of DUCC, an active cross industry forum to exchange on REACH and CLP related matters. The scope of activities is broad but particularly focused on issues related to REACH chemical safety assessment.
Together with other downstream-user associations, ECHA and Members State competent authorities, DUCC has worked to tackle some of the most challenging areas in the implementation of REACH regulation, including sector use mappings, scaling, risk models and standard phrases for hazard communication. DUCC gives a credible voice to the community of downstream-users under REACH and enables them to work efficiently on downstream-users challenges.