Check against delivery.
I am pleased to attend this plenary session – to talk about a substance which has generated a great deal of interest and debate – namely glyphosate.
Ms President, I hope that you will allow me a bit of time to insist on this point as it was repeatedly requested by various Members of this House who ask for the debate today.
I believe it is of utmost importance to reply as precisely as possible to the specific questions raised by the Honourable Members.
As you know, glyphosate is the most frequently used active substance in herbicide products in Europe as it is on the national markets since the 1970s already. It was previously subject to national approval processes.
Since 1 July 2002, this substance has been approved for use at European Union level, after a review assessment.
It is currently under evaluation as regards a possible renewal of its approval.
This evaluation is done following the procedures laid down in the EU legislation concerning pesticides. This is a very strict legislation, which you wisely contributed to put in place.
In April 2015, in accordance with this legislation, a comprehensive assessment of all available data was carried out by the Rapporteur Member State, Germany. This assessment included both studies that industry legally has to submit and independent peer-reviewed scientific literature.
This assessment was then also peer reviewed by all other EU Member States and the European Food Safety Authority (EFSA).
An agency of the World Health Organisation (WHO), the International Agency for Research on Cancer (IARC), also carried out an assessment and concluded, in March 2015, that glyphosate is a "probable" carcinogen to humans (Group 2a).
This is why, taking into account public concern, I asked EFSA to ensure that the IARC assessment was fully considered in the EU peer review of glyphosate.
In November 2015, EFSA concluded, in contrast to IARC, that glyphosate is unlikely to pose a carcinogenic hazard to humans.
But, the same conclusion was also reached by all - but one - regulatory agencies in EU Member States.
In 2016-2017, the same conclusions were also reached by agencies in Japan, New Zealand, Canada and Australia.
In May 2016, the Joint FAO/WHO Meeting on Pesticide Residues also reached the conclusion, taking into account the work of IARC, which was only a first step in the WHO assessment.
Let me remind you that - even without mentioning tobacco, solar radiation or processed meat -, alcoholic beverages are, for instance, classified by IARC in Group 1 as "carcinogenic to humans", contrary to glyphosate. But only glyphosate is high on the agenda in public debates.
Does it mean that I should label processed meat or alcoholic beverages as carcinogenic, or even ban them?
In 2016, the Commission discussed a possible renewal of the approval of glyphosate with the Member States.
Following the divergent opinions between IARC and EFSA on the carcinogenic potential of glyphosate, the Commission took a cautious approach, also in light of public concern. And we always use this precautionary approach.
We therefore made a proposal to extend the expiry date of glyphosate until 31 December 2017 (at the latest) to enable the European Chemicals Agency (ECHA) to deliver its opinion on the hazard properties of glyphosate, based on a proposal from the Rapporteur Member State, namely Germany.
In parallel, in April 2016, your House adopted a Resolution asking to renew glyphosate for seven years.
As always, the Commission was very attentive to this expression of the European Parliament's position. We took good note of your support for a renewal of the approval based on the scientific assessment conducted in the EU.
Lastly, on 15 March 2017 the Risk Assessment Committee (RAC) of ECHA concluded that glyphosate is not to be classified as:
nor as mutagenic
nor toxic for reproduction.
In recent weeks, various sources have reported on the so-called "Monsanto papers".
First, the facts: According to media reports and correspondence sent to the Commission, a US State Court ordered the release of documents following a freedom of access to documents request.
I will now turn to your first question.
You rightly pointed at a very important aspect: "in light of public concern, to ensure credible and independent scientific findings". In this field like in others, I heard and I listened to public concerns and many questions are legitimate and I am happy to provide you, once again with answers.
From 2014 when I took office, I have indeed received a lot of letters, messages, emails concerning glyphosate, together with a European Citizens' Initiative registered in January this year, a request for a urine sample last year, and even a citizens' Monsanto tribunal.
We are working on this. For some people, glyphosate is the symbol of intensive agriculture, and strongly linked to GMOs. This debate is broader than glyphosate, but this is why the need to maintain a strong scientific assessment in this context is crucial.
We always take very much into account public concern. This is why we asked EFSA and ECHA to indicate which impact the allegations, if confirmed, would have on the Agencies' overall assessment and conclusions on glyphosate.
Both, ECHA and EFSA reached the same conclusion:
EFSA confirmed "that even if the allegations regarding ghost writing proved to be true, there would be no impact on the overall assessment as presented in the EFSA Conclusion on glyphosate".
ECHA confirmed that "the information contained in the so-called “Monsanto papers” did not have an impact on the overall assessment as presented in the draft Opinion of the Committee for Risk Assessment (RAC) on 15 March 2017."
This is because:
"EU experts had access to the raw data and to theoriginal study reportsindependent and not on another interpretation of it".
In contrast, the articles mentioned were study reviews summarising or substantiating the industry position on glyphosate that had been presented elsewhere.
These study reviews were known and are not new as they were mentioned in the Declaration of Interests of the participating experts.
In other words, the study reviews have limited weight in the overall scientific assessment of glyphosate and would not normally on their own be sufficient for a conclusion to be reached on a harmonised classification.
The statements of both agencies are available online since last week.
Overall, there is thus broad convergence between the European and international community of scientists on the fact that glyphosate is not carcinogenic.
While individual persons might continue to disagree with this overwhelming convergence of scientific opinions, this cannot put into question the robustness of our system and we should proceed with the renewal of the approval of glyphosate, as there is no reason to doubt the safety of the substance.
Therefore, the Commission decided, in light of public concern, to propose a renewal for 10 years.
In parallel, three very clear recommendations to Member States were adopted last year:
Ban the co-formulant called Tallowamine from glyphosate based products;
Minimise the use in public parks, public playgrounds and gardens; and
be attentive to the pre-harvest use of glyphosate.
Let me also recall that even if glyphosate is approved at EU level, it is within the responsibility of Member States to authorise plant protection products containing glyphosate at national level and decide on the conditions of use.
The Commission is therefore not the only one to decide when it comes to pesticides.
Now, on your second sub-question on investigation, let me stress that, in the case you refer to, the Commission does not have any proof that the allegations are correct.
Let me turn now to your second question.
I can confirm that the way in which data and information is provided to the regulatory authorities and shared with the public for consideration of the approval of substances will be examined in the context of the REFIT evaluation of the EU pesticides legislation.
Indeed the Commission is specifically asking the contractor that will conduct an external study in the preparation of the REFIT evaluation to look into this issue.
This is actually reflected in the Terms of References which are publicly available, as everything we do.
As the REFIT evaluation of the EU pesticide legislation and the fitness check of the General Food Law are still ongoing, it is too early to make assumptions or consider a different course of action at this stage.
However, I would like to stress that the outcome of the fitness check of the General Food Law will also be publicly available once completed and the outcome of the REFIT evaluation of the EU pesticide legislation will be presented to this Parliament.
In the meantime, I am aware that Parliament is preparing an own-initiative report on the implementation of the plant protection products Regulation.
The Commission will of course carefully examine this report and its conclusions once it is finalised and will consider these during the preparation of the REFIT evaluation.
I would now like to turn to your third question
Let me start by first highlighting that the process of examining the claims made by companies to exclude the public release of certain information is directly managed by EFSA and Member States.
Such claims are considered in conjunction with the rules outlined in the plant protection products Regulation and relevant rulings of the European Court of Justice.
In this context, the Court of Justice rulings of November 2016 in relation to the implementation of the Aarhus Convention in the EU concerned two important issues:
Access to confidential information related to the manufacture and detailed composition of substances, in this case concerning the original approval of glyphosate; and
Disclosure of studies on substances and formulated products submitted to Member States in the context of product authorisation.
1. In the first ruling, the Court of Justice referred the case back to the General Court and the proceedings before that Court are still pending.
As regards the protection of confidentiality and the access to the information at issue in that case, the Commission is awaiting the outcome. And I can assure you that I welcome initiatives to have more clarity in this field.
2. In the second case, the Court of Justice defined information on emissions into the environment with regards to studies submitted for active substances in plant protection and biocidal products. The Commission and Member States are currently assessing the consequences of this judgement.
I would like to emphasise the following:
First, at my request, the companies applying for the renewal of the approval of glyphosate made available to Members of Parliament and Stakeholders the key studies underlying the assessment of glyphosate in a reading room.
In addition, EFSA provided Members of Parliament and Stakeholders with access to raw data from a number of key studies following a request for access to documents.
This access is on top of the extensive documentation that had already been made available, as part of the standard procedures, by EFSA during the peer review of glyphosate.
Therefore, one can only conclude that there has been a particularly high level of transparency in the specific case of glyphosate, in the light of public concern.
I understand this might not be enough to some of you in this House and I am also aware that a complaint is about to be lodged to the European Court of Justice. Once again, I can only welcome the increased clarity that the Court would give on the matter.
Let me now turn to your fourth and last question.
You asked: "Which measures is the Commission taking to finance research and innovation with regard to alternative sustainable and cost-efficient solutions for plant protection?".
I would like to stress that the Commission, through its research and innovation programmes – such as the 7th Framework Programme and Horizon 2020 – supports a broad body of research in plant protection to identify new low-risk products and biological control techniques.
This is what I highlighted again last week in a very interesting conference in Parliament on Biological low-risk pesticides.
Let me stress again that in the 7th Framework Programme over EUR 100 million was invested by the European Union in cooperative research projects and coordination support actions in the areas of:
Integrated Pest Management,
risk assessment and diagnostics.
Furthermore, specifically in relation to alternatives to chemical herbicides, a Horizon 2020 initiative, supported by a EUR 7 million EU contribution, is currently looking at strategies, tools and technologies for sustainable weed management.
So, as you can notice, a lot of money has been invested already in terms of research and development.
With regard to sustainable plant protection more specifically, the need to find alternatives to traditional chemical solutions is also reflected in the Sustainable Use of Pesticides Directive, which aims at: 1) reducing the risks and impacts of pesticide use on human health and the environment and 2) at promoting the use of integrated pest management and of alternative approaches or techniques such as non-chemical alternatives to pesticides.
The Commission audits Member States to monitor implementation of the Directive and also encourages Member States to share best practice, identify challenges and ensure harmonisation.
The Commission is also undertaking several actions to increase the availability of low-risk products.
These actions include the prioritisation of the assessment for the renewal of potentially low-risk substances and the amendment of the low-risk criteria to facilitate their identification.
I thank you for your attention.