Glyphosate: an EU regulatory roundup

Regulatory background

• Varying global conclusions on the carcinogenicity of glyphosate, sold as an active ingredient in the popular herbicidal product Roundup, have muddied conversations on how it should be regulated in the European Union. The International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO), deemed glyphosate to be “probably carcinogenic to humans” (Carcinogen 2A) in 2015. The U.S. and EU, however, have diverged from this conclusion. The Environmental Protection Agency (EPA) “found that glyphosate is unlikely to be a human carcinogen,” while the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) similarly felt in 2022 “that classifying glyphosate as a carcinogen is not justified.”
• Similar disagreements between member states concerning the true hazard of glyphosate have at times led to a chaotic processing of market authorization in the EU. In 2017, glyphosate was up for reapproval for the first time since the IARC deemed it a probable carcinogen. The Commission initially proposed that its approval last a decade, although it became clear that a compromised position of five years was necessary to secure enough votes from member states. This is a highly unusual amount of time for an active substance to be approved for in the EU where 15-year authorizations are the norm.
• It appears this five-year approval only delayed the EU’s reckoning with its regulation of glyphosate.On the eve of its approval lapsing in December 2022, EU member states once again could not agree on whether to approve or reject a renewal for glyphosate. Votes held in October and November 2022 failed to garner a qualified majority to approve or reject glyphosate’s renewed market authorization. A qualified majority requires that 55% of member states, representing at least 65% of the EU population, vote in favor.
• Some of this indecisiveness may be attributed to the fact that EFSA had yet to release its risk assessment of glyphosate by this time. Although it was originally planned that EFSA would have it finished before the expiration of glyphosate’s approval, the authority made clear in May 2022 that this would no longer be possible, postponing publication until 2023.
• With neither a clear mandate from member states nor a risk assessment from EFSA, the Commission unilaterally extended the approval of glyphosate for another year, citing a legal obligation to do so. In addition to claiming it was mandatory to take account of EFSA’s conclusions, article 17 of the Plant Protection Products Regulation (PPPR) (1107/2009/EC) was referenced as rationale for prolonging approval when a decision can’t be made by the expiration date. A one year extension was adopted, meaning glyphosate is currently approved until December 15, 2023.

Enter EFSA

• EFSA signaled its completion of the glyphosate risk assessment on July 6, 2023, before releasing the document in its entirety on July 26, 2023. While “no critical areas of concern” were identified, EFSA pinpointed data gaps despite reviewing over 2,400 studies. This lack of data prevented evaluation of all the applications of glyphosate EFSA had originally set out to assess. Note that EFSA defines a critical concern precisely as one which affects all investigated applications of an active substance. These different applications include the pre-sowing of various types of vegetables and the spot treatment of invasive plant species, among other activities. So, while EFSA was not able to draw definitive conclusions on all of these uses of glyphosate, it found little reason for concern regarding the applications it could adequately investigate.
• A close examination of the full risk assessment indicates exactly what these data gaps are. Assessment of one of the impurities in glyphosate could not be undertaken without more literature regarding its clastogenic potential, that is its capacity to cause DNA breakages. Consumer dietary risk could also not be adequately assessed due to fragmented data about the volume of glyphosate residue in rotational crops like carrots, lettuce, and wheat. The assessment of risk presented to aquatic plants could not be finalized due to a lack of information regarding their exposure to glyphosate spray drift.

Potential route to reapproval

• With EFSA having no qualms with the safety profile of glyphosate, this development could clear the way for its reapproval. The Commission has already initiated conversations with member states to do just that. On July 12, 2023, the EU executive told member states in the Standing Committee on Plants, Animals, Food and Feed (PAFF) that it feels the approval of glyphosate should be renewed, presenting them with a draft renewal report the following day. A leaked copy of this draft renewal report indicates that the PAFF committee will meet again in September for advanced discussions of, and potentially a vote on, this outcome. This is significant given that the thousands of pages of supporting documents that accompany EFSA’s risk assessment will not be released until October 2023.
• The Commission’s actions, its timing, and its level of transparency have all been criticized by NGOsand advocacy groups. Pesticide Action Network (PAN) Europe claims the Commission’s presentation to the PAFF committee was not included in the meeting agenda ahead of time and criticizes that the draft renewal report was provided to member states on July 13 before the full EFSA risk assessment was made available publicly on July 26. Of course, the fact that the September PAFF committee meeting takes place ahead of the October publication of supporting documents has proven controversial, as well. Critics feel the Commission is acting hastily and with the bare minimum of public disclosure on glyphosate’s approval.

Analysis

• It’s worth noting that EFSA, in its risk assessment, is not necessarily commenting on whether glyphosate should be classified as a carcinogen. This is a judgement that can be made solely by ECHA, which has already opined that a classification as a carcinogen would be a mistake. ECHA is tasked with evaluating an active substance’s hazard, while EFSA is charged with examining “the risk that exposure to a given substance may pose for humans, animals and the environment.” This means that ECHA concludes what adverse outcomes a substance is chemically capable of causing, while EFSA comments on how this hazard practically manifests in the real world given its likelihood for exposure. EFSA states repeatedly that it has “used ECHA’s hazard classification for the purposes of the EU risk assessment on glyphosate,” further indicating that it has taken glyphosate’s lack of capacity to cause cancer as a given when assessing its risk.
• There are numerous ways in which the consideration of glyphosate as an active substance has been exceptional. As previously mentioned, seeking market authorizations for a period of five or 10 years is unusual where the norm is a 15-year approval. Also atypical is the fact that multiple nations served as rapporteur member states (RMS) on the risk assessment of glyphosate. These nations are France, Hungary, the Netherlands, and Sweden who together make up the assessment group on glyphosate (AGG). The typical process is for the Commission to accept the voluntary nomination of a rapporteur and co-rapporteur state to oversee a risk assessment along with EFSA. In this case, however, no member state volunteered to take on either of these roles, presumably due to the extremely dense renewal dossier requiring an immense amount of effort to comprehensively examine. The Commission had to convince these four countries to be joint rapporteurs. In fact, EU law was altered in 2019 explicitly to allow multiple member states to serve as rapporteurs on this risk assessment. The EU adopted an amendment allowing for this on the same day the AGG was formed.
• Given the analysis above, it’s clear that the consideration and regulation of glyphosate has been the exception to numerous EU legislative trends and conventions. It would hardly be surprising if the regulation of this active substance, going forward, is similarly atypical.

Next steps

• As previously stated, the PAFF committee meeting in September will be the venue for the Commission to host advanced talks with member states regarding the potential reapproval of glyphosate. An examination of the provisional PAFF committee meeting schedule indicates this meeting will most likely take place on September 15, 2023 as this is the date dedicated to discussions of phytopharmaceuticals and related legislation. This was the same topic heading for the July PAFF committee meeting where the Commission presented on glyphosate and provided a draft renewal report. A decision will certainly have to be made on the subject before the expiration of glyphosate’s current market authorization on December 15, 2023.
• It is not totally clear how long a reapproval of glyphosate would last if it can be achieved; however, another five-year period is the most likely eventuality.

To contact the author of this piece, email Rayan Bhargava.
To contact the editor of this piece, email Scott Stephens.

Key Documents and Dates

• • Peer review of the pesticide risk assessment of the active substance glyphosate (July 26, 2023)
  • European Commission: Glyphosate information page