REACH-IN – Registration, Evaluation, Authorisation and Restriction of Chemicals
Tools for REACH requirements (latest updated version: December 2018)
A systematic approach to applying REACH requirements to the co-formulants used in Plant Protection Products
REACH legislation, Regulation 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. This assessment of substances includes co-formulants used in Plant Protection Products. Article 10(a) requires the EU manufacturer or importer to develop a Chemical Safety Report (CSR) which demonstrates that all uses of a substance are safe. Article 37 requires the downstream user to ensure their uses are within the safe use described by the supplier in the e-SDS or take appropriate actions to address this. Please refer to the ECHA Website for further information on company obligations.
ECPA has defined a use map including appropriate use descriptors to describe the Crop Protection uses of co-formulants and developed corresponding tools to be used to assess 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, ECPA 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 (ECPA OWB v4.0) has been developed. ECPA 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 data from measured crop protection uses. The output from ECPA 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, ECPA has developed Specific Environmental Release Categories (SpERCs). A cover letter explains how the ECETOC TRA and CHESAR should be used, in conjunction with the ECPA SpERCs, to generate an output for the CSR.
For the local environmental assessment, the ECPA Local Environmental Tool (ECPA LET) has been developed. ECPA LET is a simple to use spreadsheet, which provides a local scale environmental assessment for crop protection uses which is not covered by the standard REACH exposure models.
The table below provides a summary of the ECPA recommended tools for appropriately conducting a REACH risk assessment of co-formulants used in plant protection products. Further details and explanations are available in the guidance document. For further information and assistance, please contact firstname.lastname@example.org.
|ECPA Guidance Document||ECPA Guidance Document (November 2018)|
|Use Map||Use map|
Also available from ECHA here.
|OWB worker exposure model||ECPA OWB v4.0 (new December 2018)|
ECPA OWB v3.3 (version: November 2015)
|SpERCs for calculation of regional scale PECs with ECETOC TRA, Chesar, or EUSES||SpERCs Factsheets (version: September 2017)|
CHESAR Import Files
Use of ECPA SpERCs – explanatory note
Also available from ECHA here.
|ECPA Local Environment Tool (LET) for calculation of local scale PECs||ECPA LET (last updated version: January 2017)|
(regional concentrations calculated outside LET can be imported)
You may be also interested in the following publications:
- Development of REACH Generic Exposure Scenarios for Substances Used as Coformulants in Plant Protection Products
- REACH Worker Exposure Model for Co-formulants Used in Plant Protection Products
For topics related to Safety Data Sheets and the attachment of Exposure Scenarios, please see the CLP FAQs on the classification and labelling page.
ECPA is making the tools on this webpage available for users 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, ECPA does not guarantee that the tools work error-free. ECPA 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 ECPA is not liable for any consequences resulting from such use.
ECPA 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. DUCC gives a credible voice to the community of downstream-users under REACH and enables them to work efficiently on downstream-users challenges.
REACH 2018: Are you affected by the deadline?
If you manufacture chemical substances or import them from outside the EU above one tonne per year, you may have registration obligations under REACH. Additionally, if you manufacture or import a product (mixture, article), it may contain substances that need to be registered individually.
If you have pre-registered substances that you manufacture or import from outside the EU above one tonne but not more than 100 tonnes per year and have not already registered them, the REACH registration deadline of 31 May 2018 concerns you.
If you haven’t yet pre-registered your substance, late pre-registration may still be an option until 31 May 2017.
Learn more at ECHA’s REACH 2018 page.