Call for data to submit data covering residue and toxicological data gaps for glufosinate

The purpose of this call for data is to offer interested parties (e.g. food business operators, national food authorities, research institutions, academia) and/or other stakeholders, the opportunity to provide additional existing data on glufosinate previously not assessed in the EU, covering residue and toxicological data gaps according to the latest data requirements and criteria for identifying endocrine disrupting properties in order to investigate whether additional data are available.

Specific objectives

In detail, EFSA is launching a call for data to collect:

• additional toxicological data previously not assessed in the EU fulfilling the data gaps identified by Germany during the completeness check and reported in the word file ‘Data call tox - glufosinate’ prepared by Germany. As a matter of fact, considering that the last comprehensive EU review of toxicological data took place more than 15 years ago, the toxicological reference values should be reconsidered in accordance with the latest scientific developments as described above;
• information on Good Agricultural Practices (GAPs) authorised in non-EU countries and the supporting residue data (supervised residue trials and any additional data not yet evaluated at EU level such as metabolism studies, standard hydrolysis studies, storage stability studies, etc) for the crops listed in the excel file ‘Data call MRLs - glufosinate’. It is underlined that GAPs leading to MRLs higher than the existing EU MRLs should not be submitted via this process but under Article 6 of Regulation (EC) No 396/2005. 

Data sought and data submission format

Interested parties are requested to go through the above mentioned files, providing the missing studies highlighted in the word file ‘Data call tox - glufosinate’ and in column G ‘action’ of the excel file ‘Data call MRLs - glufosinate’.
The toxicological and residues studies must have been finalised before the beginning of the call for data.
In addition, EFSA kindly invites interested parties to submit the Good Agricultural Practices (GAPs) authorised in non-EU countries by using one of the following templates for GAPs reporting form attached to this data call, using the naming convention given:

• ‘yyyymmdd_GAP_form_[country]_glufosinate_conventional crops’
• ‘yyyymmdd_GAP_form_[country]_glufosinate_tolerant BAR'
• ‘yyyymmdd_GAP_form_[country]_glufosinate_tolerant PAT’

It is highlighted that only GAPs clearly reported by using the GAP form will be considered for the assessment. Further information on how to compile the form is given in the first sheet of the GAP form file. Please refer to the .zip folder called 'GAP forms' at the bottom of this page.

Deadline for submission of data

Interested parties and stakeholders should submit data by 10/04/2025 complying with the information described in this call. 

Confidentiality

In order to comply with its requirements for proactive transparency, EFSA must, inter alia, make public the information on which its scientific outputs are based, as outlined in Article 38(1)(d) of Regulation (EC) No 178/2002, the “General Food Law” (GFL) and Article 6(1)(i) of EFSA’s Practical Arrangements concerning transparency and confidentiality (“EFSA’s Practical Arrangements”). Information/data received in the context of the present call are subject to the afore-mentioned proactive transparency requirements insofar as they will constitute information on which scientific outputs, including scientific opinions, are based.

However, in accordance with Articles 39-39e of the GFL confidential status may be awarded to information the disclosure of which might potentially harm the information owner to a significant degree. Provided that the conditions set out in Articles 39-39e and further detailed in EFSA’s Practical Arrangements are satisfied, EFSA must not make public any information/data for which confidential treatment has been requested and duly justified pending its confidentiality assessment where urgent action is essential to protect human health, animal health or the environment. 

Submission of information/data

Interested business operators and/or parties should submit the information/data in electronic format exclusively via the tool Submission Builder “Portalino” (available here). 
Submission of data in any other form (email, third party e-submission platforms, etc) will not be accepted. 
Information on how to use Portalino and submit confidentiality requests is available here. Information regarding confidentiality can be found in the User Guide on Confidentiality. 
Interested business operators and/or interested parties should submit the following information to EFSA via Portalino, clearly stating: 

• in the Subject of the submission: Call for data on Glufosinate EFSA-Q-2024-00518;
• The contact details (name of contact person, name of company/organisation, e-mail address and telephone number) of the person responsible for the data submission and, if applicable, the list of interested business operators and/or interested parties represented and their contact details.

When sharing information/data with EFSA, certain parts of the information/data may be requested to be treated as confidential provided that:

1. the information falls within the scope of the closed list of information items listed in the Annex to EFSA’s Practical Arrangements and
2. the confidentiality request is accompanied by a verifiable justification that demonstrates how the public disclosure of the information/data for which confidential status is requested would harm your interests to a significant degree.
3. When claiming confidentiality for some of the information/data, both a non-confidential (public dissemination) and a confidential version of the information/data must be submitted as indicated here. A separate confidentiality request must be submitted for each document and for each legal ground under which information is claimed confidential. A precise description of the information/data claimed confidential must be provided to enable a clear identification and the information/data claimed confidential must be earmarked in the confidential version and redacted in the non-confidential version.

For submissions which do not contain any confidential information, only a non-confidential (public dissemination) version needs to be uploaded to Portalino.

Please note that EFSA may, where legally possible, use or re-use relevant information or data (e.g., technical, toxicological data) for the assessment of the same or another substance/topic under the same or a different legal or regulatory framework from the one mentioned above.