agrochemical testing
Industry Focus
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Jeannette Paulussen, Koen Hendriks, and Sofia Sola Sancho

New EU Agrochemical Regulations: What We Have Learned

An update on the effect of EU food safety regulations

On March 27 2021 Regulation (EU) 2019/1381 introduced new rules on transparency and sustainability of the EU risk assessment in the food chain. According to the European Union (EU), “Such risk communication should strengthen citizens' trust that the risk analysis is underpinned by the objective of ensuring a high level of protection of human health and consumers' interests.”

So now for just over half a year Charles River has been working with the changes implemented by this regulation, mainly for agrochemicals, together with industry and authorities, to ensure that EU risk managers are kept abreast of agrochemical studies at every stage of the process. Here is what we have learned so far.

Data management regulations for agrochemical testing

Due to the requested transparency and sustainability in the new regulation, studies on agrochemicals need to be entered in the European Food Safety Authority (EFSA) database by both the company who created the new product and us, the contracted research organization. Despite some hiccups in the beginning this seems to work quite well, though we are still working out issues like whether we should report studies when we are not sure if the agrochemical in question will be marketed in the EU.

In addition to this, we now use the International Uniform ChemicaL Information Database (IUCLID) to write and submit renewals of agrochemical active dossiers to the authorities for evaluation. Although IUCLID itself is not directly creating an issue, all parties need time to make themselves familiar with this system.

As IUCLID was already in use for a long time prior to this regulation, it needed to be adapted to the data requirements for agrochemicals and plant protection products. IUCLID itself is not easily readable, but it can generate more user-friendly reports based on templates in the system. The formatting of these reports, like those generated in old MCA and MCP word documents, could be improved.

Currently manual adjustments need to be made to these extracted word documents to improve accuracy and readability. Preferably, the applicant would perform these extracts knowing all necessary information has been included in IUCLID to prevent double work. Therefore, the applicant should consider additional time before deadlines to ensure everything can be submitted correctly.

Issues with uploading data

For the submission itself, uploading the exported dossier in the EFSA portal can result in some challenges. Small differences compared to what many of us are used to with the ECHA ‘portals’ (REACH-IT, R4BP) can result in not being able to get it through the required virus check that EFSA performs on these dossiers. For example, the file size of the dossier might be incompatible with the EFSA portal. This can be nerve wrecking as often legal deadlines apply, although in communication with EFSA this usually gets easily sorted.

IUCLID gets updated twice a year currently, and with that certain things change which may cause confusion for both the evaluators and the applicants. For example, additional information is required or certain fields in study summaries are deleted or changed. This may result in IUCLID validation warnings that became apparent after the IUCLID update, which subsequently need to be addressed, resulting in unexpected additional work for the applicant.

These changes have been driven by the fact that more transparency is required, and the dossier will become publicly available. This should always be kept in mind by the applicant when making the dossier and filling the information in IUCLID. Furthermore, the confidentiality claims in IUCLID should be taken very seriously to prevent confidential information from being disseminated. However, how confidentiality claims applied in the IUCLID dossier are subsequently addressed before disseminating, is currently not yet always clear nor straightforward.  

Having lots of experience using IUCLID for REACH, we know that some of these challenges can be easily overcome (though they may be time consuming). The current way of summarizing studies guarantees easy dissemination of the records but requires more time to finalize a submission by the applicant, as well as additional time from the evaluating authorities. Furthermore, a change in mind set from all parties is necessary to ensure this becomes a success. Having only started this process last year, this will definitely be a source of ongoing debate in 2022.