Re-registration of glyphosate is delayed due to the amount of additional information

TBayer Crop-Science licensee provided more info on where we stand with recognition/renewal of glyphosate.

5 year enrollment period

On 12 December 2017, the European Commission extended the EU approval of glyphosate for another 5 years after a positive vote by a qualified majority of member states. This meant that glyphosate can be used in the EU as an active ingredient in plant protection products until 15 December 2022.

In December 2019, the Glyphosate Renewal Group (GRG) submitted an application to continue the approval of glyphosate and glyphosate-containing products on the EU market. The GRG is a group of companies that pool their expertise to create a single dossier containing scientific studies and information on the safety of glyphosate. This dossier was submitted to the evaluating Member State’s Assessment Group for Glyphosate (AGG) in 2020.

Public hearing

The draft report on the assessment of the renewal of glyphosate – in technical terms dRAR – was ready in July 2021. The competent national authorities of the AGG Member States (France, Sweden, Hungary and the Netherlands) concluded that glyphosate meets the approval criteria regarding human health and that no chronic or acute risk is expected from their use.

The glyphosate dossier is more popular in the media with our northern neighbors because they are just one of the competent national authorities.

Following the draft renewal assessment report, a period of public consultation was launched: everyone had the opportunity to comment online. The report was then sent back to the European Food Safety Authority (EFSA) and to the other EU member states.

Timeline for approval of glyphosate in 2023. – Image: Bayer

Much more info added

The hearings added a significant amount of information to the dossier, which already contained much more scientific data than is normally available for such assessments. This was not only the case for the active substance glyphosate, it has already happened in the past with other active ingredients.

The additional information should be carefully examined by the competent national authorities of the AGG Member States, who are now updating the first draft assessment report on the renewal. In this context, EFSA and the European Chemicals Agency (ECHA) have revised the timetable for the remaining steps of the re-evaluation process.

Temporary administrative extension

The process to further extend the approval of glyphosate should normally be completed by 15 December 2022. However, due to the significant amount of information added to the dossier during the public consultation, EFSA will not be able to reach a conclusion in time. An administrative extension is therefore necessary and this temporarily until the end of 2023.

The timeline now set indicates that EFSA will publish its conclusions on the safety of glyphosate in July next year. In autumn 2023, the bill on whether or not to extend the approval of glyphosate will follow, followed by a discussion of this bill with experts from all European member states. A final decision must be made in December 2023.

We note that this concerns the re-registration of an active substance, not of commercial resources per se. There is therefore no direct connection between the administrative extension of the recognition of glyphosate and that of commercial products. In this connection, the date indicated on the current approval of the commercial products must still be observed. You can also find this information at www.fytoweb.be.

Tim Decoster

Not carcinogenic

The European Chemicals Agency already published its conclusions on the revision of the classification of glyphosate in August this year. Based on a comprehensive re-evaluation of scientific evidence, ECHA’s Risk Assessment Committee (RAC) concludes that classification of glyphosate as carcinogenic is not justified.

Furthermore, the RAC determined that the available scientific evidence does not meet the criteria for classifying glyphosate as a specific target organ toxicant or as a mutagenic or reproductive toxicant. The existing classification for eye irritation and chronic aquatic toxicity is retained.

TD

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