PRIMo v4 - EFSA Propose Changes to Pesticide Residues Intake Model
EAR expert comment: Webinar on revision 4 of the Pesticide Residues Intake Model (PRIMo v4)
Here, our Regulatory Expert (Residues), Paul Graham, comments on the upcoming changes to PRIMo presented by EFSA in a recent webinar…
The chronic and acute dietary consumer exposure to pesticide residues is estimated by using a calculation model developed by EFSA (PRIMo – Pesticide Residue Intake Model).
The most recent revision of this model, the Excel-based tool that can be used today, is PRIMo revision 3.1. The model is based on national food consumption figures and unit weights provided by Member States and implements internationally agreed risk assessment methodologies to assess the short-term (acute) and long-term (chronic) exposure of consumers.
EFSA are currently developing a new web-based version of the tool - PRIMo revision 4.
It will be online only, which EFSA claim will “introduce a new user interface and various improvements, such as the integration of new consumption data and allowing for more detailed exposure results”. They stated that “whereas PRIMo 3 relied on summary statistics of consumption reported by Member States, PRIMo 4 relies on EFSA's Comprehensive Database, where consumed amounts were converted to corresponding amounts of raw primary commodity”.
What’s new in PRIMo 4:
- Web-based tool on the EFSA R4EU platform
- Integration of most up-to-date dietary surveys, received by EFSA until 2018
- More detailed and harmonized definition of population classes, e.g. infants and toddlers
- Information on chronic exposure distribution, rather than point estimates
- Acute assessment normalised for individual consumption amounts and body weights
- Improved assessment for processed foods and minor commodities
- New food categories added, i.e. fish, drinking water and baby foods
- Consistency and interoperability with other domains, incl. FoodEx2
Data is entered manually into the web only interface but can also be uploaded through Excel templates. Currently, EFSA state that it will only be possible to save input/output data locally by downloading results – later, the format in which it has been downloaded can also be uploaded for retrieval of information.
Since March, public consultation began and will be open until 30th June 2023. It is expected that the final tool and technical report will be available by end of October 2023, but the implementation date is yet to be set. Once live, the tool will be freely accessible through self-registration (using the same credentials applicable to accessing Open EFSA public interface). EFSA have stated that “the registration is only required in view of user management. The tool is, however, available to any interested stakeholder, without any restrictions.”
There is also a possibility for integration into the IUCLID database and this is currently on the EFSA PSN agenda but not expected until 2024.
It is important to note that because of Great Britain leaving the EU, intakes for GB were not considered in the revision 4 of PRIMo. Only dietary surveys for Northern Ireland might be integrated in future versions of PRIMo. Applicants to GB should seek guidance from the UK authority (HSE).
Further information is available on the EFSA webpage, which includes access to the presentation slides and a recording of the live webinar - CLICK HERE
For support with consumer risk assessment and/or dossier preparation, contact Paul Graham
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