EFSA and ECHA Preparing for 2022 Glyphosate Review

16.06.2021 - Two EU authorities, the European Food Safety Agency (EFSA) and the European Chemicals Agency (ECHA), are poised to begin reviewing a draft assessment of the safety of glyphosate. The license for the active ingredient in the Monsanto-developed Roundup herbicide comes up for renewal at the end of 2022, and the opinions will form the basis for a decision by the European Commission.

The assessment, which runs to around 11,000 pages, was drawn up for the EU by a special committee of national authorities of France, Hungary, the Netherlands and Sweden – known as the Assessment Group of Glyphosate (AGG) – on the basis of evidence submitted by the companies seeking renewed market approval.

As a first step, EFSA and ECHA will organize parallel consultations on the draft, and the results will be opened for public comment from the first week of September 2021. It will be the responsibility of ECHA’s Committee for Risk Assessment (RAC) to review the classification of glyphosate under the Classification, Labelling and Packaging (CLP) Regulation.

After ECHA has adopted its opinion, EFSA will finalize its peer review and publish its conclusions, which are expected in late 2022. Based on this risk assessment, the Commission will decide on the renewal.

The classification of chemicals under CLP is based solely on the hazardous properties of a substance and does not take account of the likelihood of exposure to the substance. This is an important point that often clouds the issue in discussions of whether glyphosate is a hazard or even a carcinogen, as thousands of cancer sufferers filing lawsuits against Bayer, current owner of the Roundup franchise, have claimed. The analysis of safe exposure levels is part of the risk assessment process led by EFSA. 

Currently, glyphosate has a harmonized EU classification as causing serious eye damage and as toxic to aquatic life with long-lasting effects, prior to and following the assessment by ECHA in 2017. It is not classified according to germ cell mutagenicity, carcinogenicity or reproductive toxicity at present, and the proposal from the four member states does not foresee a change.

This does not mean that a vote on glyphosate will go off smoothly, however. The European Parliament and Council will also have a word to say, and the Commission’s five-year extension of the glyphosate license in 2017 followed a protracted and at times acrimonious discussion. Environment and health safety groups have consistently taken issue with the EU’s renewal decisions, and some have recommended strengthening EFSA’s mandate to align its findings with the European Medicines Agency (EMA) in an effort to improve pesticide safety.

In 2017, altogether 18 of the then 28 EU states, including the UK, nodded off on the Commission's proposal to renew the license. Nine, including France, voted against it, and one abstained. In that year, controversy arose in Germany over the then-agriculture minister’s casting the deciding vote in the Council to recommend renewal over the opposition of the environment minister.

Independent of the EU-wide license renewal, member states are free to restrict the use of controversial chemicals on their own territory. Germany’s current environment minister has proposed a nationwide ban on glyphosate by 2023, though the national elections in September potentially could lead to a change of plans.

Author: Dede Williams, Freelance Journalist