Call for data for determination of natural background concentrations of trace elements (Co, Cu, I, Mn, Mo, Se or Zn) in the environment

The purpose of this call for data is to offer interested parties (e.g., feed business operators, national environmental authorities, research institutions, academia, European Agencies, European research centres) and/or other stakeholders, the opportunity to submit documented information (published and/or unpublished) relevant to the determination of natural background concentrations of trace elements (cobalt, copper, iodine, manganese, molybdenum, selenium or zinc) in different environmental compartments (soil, freshwater, freshwater sediment and marine sediment) of the EU member states,^[1] and European Free Trade Association (EFTA) countries, and candidate EU member states (Albania, Bosnia and Herzegovina, Georgia, Nord Macedonia, Moldavia, Montenegro, Serbia, Turkey, and Ukraine). 

Specific objectives

• Specific Objective 1: concentrations of trace elements (cobalt, copper, iodine, manganese, molybdenum, selenium or zinc) in European soil.
• Specific Objective 2: concentrations of the abovementioned trace elements in freshwater in European freshwater bodies (e.g., streams, lakes, ponds, ditches…)
• Specific Objective 3: concentrations of the abovementioned trace elements in freshwater sediment of European freshwater bodies.
• Specific Objective 4: concentrations of the abovementioned trace elements in marine sediment in coasts of the countries specified above, including fjords and estuaries.

Data sought and data submission format

EFSA kindly invites interested parties to submit information as outlined below for each specific objective.

• Measured concentrations of cobalt, copper, iodine, manganese, molybdenum, selenium or zinc in the relevant compartments: soil, freshwater, freshwater sediment and marine sediment. The measurement unit and if the result is on dry mater basis or “as is”.
• Indicate if the data have been published and, if this is the case, please provide the corresponding reference.
• The method of analysis of the trace element, if total concentration of the trace element was measured or a particular chemical species of the trace element (e.g., total copper versus Cu(+I) or Cu(+II)).
• Sampling should have been done within the last 15 years (2009 onwards). The date of sampling, the place (coordinates; or nationality and municipality) are also needed.
• Preferred samples are from pristine areas (areas not affected by point or diffuse sources of pollution). Indicate if the sample originates from a pristine area or not.
• In relation to freshwater compartment (objective 2), supporting (meta)data on water pH, water hardness (e.g., total hardness, mg CaCO3/L, or mmol/L, German degrees (dGH/ ˚dH)) and dissolved organic carbon (mg/L) are highly appreciated.
• In relation to sediment samples (marine or freshwater, objectives 3 and 4), supporting (meta)data on porewater pH, texture (% of clay [<2 µm], % silt [2 – 63 µm], and % sand [>63 µm]) and content of organic matter (%) are highly appreciated.

The data should be submitted in excel format. Sending data in pdf format should be avoided. Note that EFSA has prepared also a reporting tool which you can download at the bottom of this page (please see the DOCUMENTS section). This table can be used on a voluntary basis, containing all parameters described above.

Ad hoc meeting with interested stakeholders

On 06 November 2024 (from 3 to 4 pm, UTC+1), EFSA is holding an ad hoc meeting (teleconference) with interested stakeholders on “Environmental Risk Assessment of trace elements used as feed additives”. The aim of this meeting is to present the EFSA’s call for data mentioned above, to explain each section of the call, and what type of information EFSA is looking for. The meeting will also be the occasion for interested stakeholders to seek clarification on the call, on how to submit data, and ask questions on what information EFSA is expecting to receive.
Aspirant participants should express their interest via an EU Survey by 4/11/2024. They need to have an understanding on the scientific matter and/or be willing to submit relevant data to the advertised call. To ensure a fruitful discussion during the meeting, participants are kindly advised to thoroughly check the content of the call for data in advance.

The meeting will have a duration of 1 hour (divided approximately in 30 minutes presentation from EFSA representatives and 30 minutes questions and answers plenary discussion with participants).

Deadline for submission of data

Interested parties and stakeholders should submit data by 23/01/2025 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” (tool available here).
Submission of data in any other form (email, third party e-submission platforms, etc) will not be accepted. More information on “How to register in Portalino” is available at the bottom of the call published on EFSA website.
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 Environmental concentrations of trace elements-EFSA-Q-2024-00482
• 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 should 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.