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

I will try and answer as many points as possible that have been raised, and I’m sure we will get the opportunity to come back to this important discussion. Several of you have raised the issue of the precautionary principle. I wanted to just say that the Commission always follows the precautionary principle, and this is precisely why we undergo strict and in-depth independent scientific assessments before the authorisation of any product. In the case of this substance, we did this when it was first authorised. We did it again when it was renewed for the first time. And we have done it again in the current renewal process. We work on the basis of evidence and of science and applicable EU rules, including the precautionary principles. I heard many honourable Members of this House mention the issue of WHO and IARC. The EU assessment and that of IARC – the International Agency for Research on Cancer – differ in particular as regards the use of different data sets. For example, the long-term toxicity and carcinogenicity that the ECHA took into account. It took into account more studies than IARC. And there are also methodological differences – because I looked into this – in the evaluation of the available evidence. As a result, some of the substances have been classified less severely by IARC as compared to ECHA and EFSA. Finally, IARC published its opinion on glyphosate – this was in 2015 – while the assessments of ECHA, according to the EU legislation, were done later. In fact, they were done in 2017 and 2022 and also considered the IARC opinion. It was also said by an honourable Member that we’re putting forward this proposal for approval with no restrictions. As I said in my opening remarks, and I would like to just say it again, for the renewal of approval of glyphosate, we propose a number of conditions and restrictions, and these are based on the results of the scientific assessment and do take into account that the responsibility for authorising public protection products lies firmly in the hands of the Member States. Several of you mentioned evidence of neurological diseases. In fact, Parkinson’s disease was specifically mentioned. I just wanted to tell you that this was also looked into. It is referred to in the process of the renewal assessment. It was referred to in the EFSA conclusion and that the evidence did not provide concern for this specific area. Is glyphosate carcinogenic? This was raised a number of times. EFSA and ECHA concluded twice – in 2017 and 2022 – that, based on the available evidence and taking the weight-of-evidence approach, there was no classification for carcinogenicity warranted for glyphosate. This was based on the scientific information and on the criteria set out by the EU regulation, which applies for all chemicals in the EU. The approach of the EU to assess the carcinogenicity of glyphosate is legally defined in the relevant chemicals regulation and consists of assessing each active substance and each marketed product separately. How were these findings examined? Well, I just wanted to share that all available information was examined by, as I said, the rapporteur Member States, ECHA and EFSA. And the renewal of glyphosate included an evaluation of what I would say – and this is why it was postponed – an unprecedented amount of data and the final conclusions based on the weight-of-evidence approach considering the whole body of evidence. It’s possibly not surprising that findings in one or even several individual studies are different when there’s such a huge amount of information available. Why 10 years? I have said this in my opening remarks. Renewals of approval are granted sometimes for 15 years but, in order to balance all the considerations, we decided to provide a renewal of approval for a period of 10 years. I want to say again that this does not mean that we will be standing by idly. If any new evidence emerges, we will be looking at it continually. There will be a permanent scrutiny and we will take action immediately, not only to amend, but also to withdraw this approval if it is warranted. Are we confident that EFSA’s assessment provides a solid basis for this proposal? It has been said before: glyphosate is possibly the most widely studied active substance. A significant amount of information has been added to this file which already contained far more data. In fact, EFSA organised discussions with experts from the Member States, from stakeholders, in order to ensure a rigorous scientific opinion. Finally, there were many comments that I heard very carefully on the impacts of biodiversity. Speaking with experts, they have agreed that indirect impacts of biodiversity are very complex and they can be caused by multiple factors. As a Commission, we have proposed that, where Member States identify possibly indirect effects on biodiversity, they should consider alternative control or prevention methods with less impact and set specific conditions and restrictions for the use of plant protection products, including glyphosate. I’m sorry I have taken over my time, but there were many, many points and I think it is important for us who are sitting here to try and address as many of these issues as possible. In ending, I just want to say that we have acted regularly – and I don’t think this should be overlooked – to prohibit substances that were found to be harmful. We have proposed an ambitious path forward to reduce dependency on chemical pesticides. I want to reiterate, as Commissioner for Health and Food Safety, in the strongest terms, that human health and the protection of the environment are really the highest priorities for this Commission. Again, thank you for a very important debate.