Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA

Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA.

Harmonized methodology for retrospective dietary cumulative risk assessment (CRA) of pesticides was established by the European Commission (EC) and the European Food Safety Authority (EFSA) in 2018, in close collaboration with the Dutch National Institute for Public Health and the Environment (RIVM). An update of this regulatory methodology (RM) was proposed and adopted by EFSA in 2022 in a CRA on craniofacial alterations. This updated RM was implemented in version 10 of the MCRA software and validated as part of the first action defined in the third framework partnership agreements between EFSA and RIVM. This report describes the implementation of this updated methodology in the MCRA software for risk assessment. This is done from a proposed framework of standard regulatory actions (SRAs). SRAs offer a user-friendly and simple to use option for regulators to perform retrospective and prospective CRAs in MCRA according to agreed-upon RMs. In particular, this report provides guidance on the use of an SRA for a retrospective dietary CRA for craniofacial alterations according to the updated RM in MCRA version 10.

Detailed results of the comparison between reported by MCRA and EFSA’s SAS® software and MCRA formatted input files for the catalogues and secondary data are presented in the following annexes:

Annex A – Comparison of the MOET at different percentiles reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. 

Annex B – Comparison of risk-driver contributions reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. 

Annex C – MCRA formatted input data file containing the primary entity catalogues for the SRA on retrospective dietary CRA of craniofacial alterations. 

Annex D – MCRA formatted input data file containing the secondary data for the SRA on retrospective dietary CRA of craniofacial alterations. 

Annex E – MCRA formatted input data file containing the unit- variability factors for the Tier II calculations of the SRA on retrospective dietary CRA of craniofacial alterations. 

Annex F – MCRA formatted input data file containing the unit- variability factors for the Tier I calculations of the SRA on retrospective dietary CRA of craniofacial alterations.