European Food Safety Authority

 

 

Dear Dr X,

I have received a complaint against the European Food Safety Authority (EFSA) from Mr Y on behalf of the Pesticide Action Network (PAN) Europe.

The complaint is about how EFSA replied to the complainant’s concerns about EFSA’s approach to risk assessment of plant protection products (pesticides). In particular, the complainant considers that EFSA, in its reply, failed to:

• address the complainant’s concern that it does not, in its current approach to risk assessment, consider properly the indirect effects of pesticides on biodiversity and ecosystems, even though suitable methods are already available for doing so; the complainant has shared with EFSA several scientific studies and relevant information which, in his opinion, EFSA has not properly replied to;
• react to the legal arguments put forward by the complainant that indirect effects should already be taken into account in EFSA’s risk assessment (the complainant refers to Article 4(3)(e)(iii) of Regulation 1107/2009[1]);
• provide sufficient explanations to demonstrate that the envisaged approach, focused on the definition of Specific Protection Goals, is an adequate solution to the problem. The complainant considers this approach to be selective and insufficient to protect biodiversity and ecosystems.

Moreover, the complainant argues that EFSA has taken into account indirect effects in the risk assessment of glyphosate and would like EFSA to explain why it is unable to adopt such an approach more systemically.

I have decided to open an inquiry into this complaint to obtain more detailed answers from EFSA in relation to some aspects raised by the complainant in its correspondence with EFSA.

In this context, I would be grateful if EFSA could reply to the questions set out in the Annex, within three months of the date of this letter.

Please note that I am likely to send your reply and related enclosures to the complainant for comments.[2]

The responsible inquiries officer is Mr Rutger van Kammen.

Attached to this letter, please find a copy of the complaint and the letter sent to the complainant.

Yours sincerely,

Emily O'Reilly
European Ombudsman

Strasbourg, 21/12/2023

 

Annex

1) EFSA explained in its replies to the complainant that it has already undertaken actions to advance the environmental risk assessment of pesticides towards a system-based approach. In the meantime, “considering the complexity of the topic”, EFSA said that interim solutions, such those proposed by the complainant, “may not be fully appropriate”. In its reply of 26 July 2023, EFSA further clarified that “until such a harmonised approach is available, a firm conclusion regarding risks due to indirect effects cannot be drawn and risk assessor can only flag the issue to risk managers, as performed in the evaluation of Glyphosate in 2017”.

• Could EFSA please explain, in more detail, why it considers that interim solutions for assessing the indirect effects of pesticides on biodiversity and ecosystems, such as those proposed by the complainant, “may not be fully appropriate”?
• Could EFSA please explain, in more detail, how it “flagged” the issue of risks due to indirect effects to risk managers in the evaluation of glyphosate in 2017 and why it did so in the risk assessment of this particular pesticide? Has EFSA adopted a similar approach in the evaluation of any other pesticide? If this is not the case, why not?

2) EFSA further noted that the above-mentioned actions to advance the environmental risk assessment of pesticides towards a system-based approach are based on a roadmap published in 2022, and that “a multiannual programme has been developed to address several needs”. EFSA then mentions several projects and calls that are ongoing or will be launched soon. Could EFSA please explain, in more detail, the content and scope of the multiannual programme, give an indicative timeline for its completion, and explain how and when it is likely to address the specific concerns raised by the complainant?

3) EFSA indicated in its replies to the complainant that the specific goals of an environmental risk assessment in terms of what to protect, where to protect it, over what time period and with what degree of certainty - the Specific Protection Goals (SPGs) - are currently being (re-) defined by the risk managers in a process initiated by the European Commission. Could EFSA please explain, in more detail, its role in that process, the link to the above-mentioned actions, and state of play/indicative timeline for the completion of the process for defining SPGs (to the extent that this information is available to EFSA)?

4) How is the issue of “indirect effects” addressed in the legal framework applicable to EFSA that is in force currently?

 

[1] Regulation 1107/2009 concerning the placing of plant protection products on the market: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1107

[2] If you wish to submit documents or information that you consider to be confidential, and which should

not be disclosed to the complainant, please mark them ‘Confidential’. Encrypted emails can be sent to our dedicated mailbox.Information and

documents of this kind will be deleted from the European Ombudsman’s files shortly after the inquiry has ended.