Debate: The proposed extension of glyphosate in the EU
Date: WEDNESDAY, 4 OCTOBER 2023
Speaker: Stella Kyriakides
Language: EN

First of all, I want to start my short intervention by stating that, without any doubt, human health and protection of the environment are the highest priorities for this Commission. Glyphosate is the most studied pesticide in the world. As a result, the renewal process, which started in 2019, involved an evaluation of the highest volume of scientific information for any active substance, including not only studies carried out by the applicants themselves, but also a large number of studies available in the open scientific literature. This evaluation required a large amount of resources from the four rapporteur Member States – namely France, Sweden, Hungary and the Netherlands – from the European Chemicals Agency, ECHA, and from the European Food Safety Authority, EFSA. I want to take this opportunity to thank them for their immense efforts. As you may know, last year, after a process involving a public consultation and an expert hearing, the ECHA Risk Assessment Committee unanimously agreed that there is no evidence to classify glyphosate as a carcinogen. This comes to confirm an earlier assessment of 2017. The risk assessment delivered by the rapporteur Member States was also subject to public consultation. This led to the submission of further evidence, also then considered by EFSA and all other Member States during the peer review process. In its final conclusions on the risk assessment, EFSA concluded that there are no critical areas of concern that would preclude renewal of approval. This key outcome underpins the Commission’s proposal to renew the approval. True, EFSA identified some data gaps and issues for which assessment could not only be finalised. However, this is the case with practically all EFSA conclusions for active substances. In their role as risk managers, the Commission and the Member States carefully assess the identified gaps and issues that have not been finalised, and they examine whether appropriate risk mitigation is available to ensure that human health and the environment are fully protected. Data gaps, therefore, do not mean that the approval cannot be renewed. For the renewal of approval of glyphosate, the Commission has proposed a number of conditions and restrictions. These are based on the results of the scientific assessment and take into account the fact that the responsibility for authorising plant protection products lies firmly with the Member States, in keeping with the subsidiarity principle. For example, our proposal requires that Member States look carefully at consumer exposure for succeeding crops. Similarly, it requires that Member States examine co-formulants, assess the need for protection of ground and surface water and any effects on small herbivores, and assess indirect effects on biodiversity. We also propose banning its use for desiccation. At the Standing Committee of 22 September 2023, many Member States welcomed the proposal. A few advocated further specific restrictions. However, the vast majority disagreed with this, noting in particular that there is no evidence in the scientific assessment that would require such further restrictions. And in any case, Member States will have the possibility to restrict the use of plant protection products, including glyphosate, at national or regional level if they consider this necessary in order to protect biodiversity. Honourable Members, renewal approval can be granted for a maximum of 15 years. At the same time, scientific research into glyphosate is ongoing, with new information published regularly. On the other hand, we have now assessed the substance twice in a relatively short period and have each time come to the same conclusion. Having weighed up these factors, the Commission considers that a 10-year renewal of approval is appropriate. Several Member States have asked for and suggested a 15-year renewal. The Commission has proposed renewal of approval for 10 years for the reasons I have already explained. Of course, I want to assure you that this does not mean we will stand idly by should new evidence emerge. I want to be very clear that we have undertaken and there will be permanent scrutiny. Whenever and whichever new evidence shows that the approval criteria are not met, we will take action immediately to amend and even withdraw the approval if this is warranted. I will conclude by emphasising one important point. The rapporteur, the Member States, the agencies and the Commission have acted with due diligence and in full compliance with the legislation and with complete transparency. I am fully aware that many of you are disappointed with the outcome of this assessment process. But as I have said many times at this podium from the beginning of my mandate, we must follow science as confirmed by our independent agencies, which follow existing rules. If we are to have robust, independent and evidence-based systems, we must abide by their results.