REACH-IN
Tools for REACH requirements:
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.
ECPA has defined 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 Report1. These tools are specifically designed to estimate exposure of workers, consumers and the environment resulting from crop protection uses. (Click here to download the ECPA Guidance Document)
For operators, workers and bystanders, a specific tool (ECPA OWB) has been developed. ECPA OWB is a simple to use spreadsheet tool, which provides a more realistic assessment in comparison to the use of ECETOC Targeted Risk Assessment (TRA) as it is specifically designed to assess crop protection uses. In addition, it allows the user to take account of RMMs such as PPE and RPE in the exposure estimation. The output from ECPA OWB is automatically generated in a CSR template format. (Click here to download the ECPA OWB)
The environmental assessments, conducted to achieve the registration of Crop Protection Products under Directive 91/414/EEC or Regulation 1107/2009, sufficiently address direct environmental exposure of soil and water arising from the use of plant protection products. ECPA has developed a statement which can be incorporated directly into the relevant sections of the Chemical Safety Report. (Click here to download the ECPA Waiver Statement)
To address the indirect exposure of humans exposed via the environment and by secondary poisoning, ECPA has developed Specific Environmental Release Categories (SpERCs) which were incorporated in the ECETOC TRA. The ECPA Guidance Document (above) explains how the ECETOC TRA should be used to generate an output for the CSR. (Click here to download the SpERC Fact Sheet)
ECPA has defined Use Descriptors for the crop protection scenarios to be included in IUCLID5 and the e-SDS. These are intended for ease of communication up and down the supply chain and are not intended for use in the standard REACH tools. (Click here to download the Use Descriptor Document)
The table below provides a summary of the ECPA recommended approach for each chapter of the CSR. Further details and explanations are available in the ECPA Guidance Document.
For further information and assistance, please contact kerry.gamble@syngenta.com
| CSR CHAPTERS | ECPA RECOMMENDED APPROACH | |
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9.1.2.1 10.1.1.1 |
Proffessional worker exposure (farmer exposure for PPP uses) | |
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9.1.2.2 10.1.1.2 |
Consumer exposure (amateur exposure for ppp uses) | |
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9.1.2.3 10.1.1.3 |
Indirect exposure of humans via the environment |
ECETOC TRA |
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9.1.2.4.1 - 9.1.2.4.6 10.1.2.1 10.1.2.2 |
Environmental exposure (exclusing secondary poisoning) Aquatic compartment (excluding secondary poisoning) Terrestrial compartment (excluding secondary poisoning) |
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9.1.2.4.1.7 10.1.2.1 10.1.2.2 |
Exposure concentration relevant for the food chain (secondary poisoning) Aquatic compartment (secondary poisoning only) Terrestrial compartment (secondary poisoning only) |
ECETOC TRA |
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9.3 |
Regional exposure conditions |
ECETOC TRA (included in above calculations) |
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10.1.2.4 |
Microbiological activity in sewage treatment systems | Not relevant for PPPs |
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The context, overview and demonstration of these tools were presented at the 2010 REACH-In Workshop and can be viewed here in this video playlist.
