The EFSA guidance document published in October 2014 has been presented and discussed at the Standing Committee on Plants, Animals, Food and Feed between December 2014 and May 2015. It was adopted on 29 May 2015 and will apply to applications submitted from 1 January 2016.
The Standing Committee noted that for the acute risk assessment for bystanders and residents, the derivation of the corresponding toxicological reference value (AAOEL) is still outstanding. Similarly, no higher tier risk assessment schemes are available for residents and bystanders scenarios. For the approval of active substances under Regulation (EC) No 1107/2009, the risk assessment on residents and bystanders cannot be fully considered until a procedure for the derivation of the AAOEL and higher tier risk assessment schemes, identified as missing by the Standing Committee, are available.
No reference was made to the terms RVNAS (Reference Value Non acutely toxic Active Substance) and RVAAS (Reference Value Acutely toxic Active Substance) used in the latest version of the EFSA model released 24 April 2015. It has been confirmed that they correspond to the AOEL and AAOEL, respectively.
The Commission has confirmed that the details on the derivation of the AAOEL will not be available by January 2016. CRD have also confirmed that where an AAOEL has not been set, either because guidance on derivation is not in place, or on AAOEL is not required, a bystander assessment will not be expected.
For advice on risk assessment and further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
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