Call for data on the use of 3-nitrooxypropanol in ruminants 

EFSA-Q-number: EFSA-Q-2026-00024
Published: 03/02/2026
Deadline for submission of data: 31/03/2026

Background

The European Food Safety Authority (EFSA) received a mandate for a scientific opinion under Regulation (EC) No 1831/2003 on additives for use in animal nutrition – safety for the target species of 3-nitrooxypropanol (4c1). In order to ensure a comprehensive assessment, EFSA launches a public call for all potentially relevant available data (published, unpublished or newly generated data) from interested parties. EFSA will then consider the relevance of the information provided for the risk assessment. The submission of the requested information is without prejudice to the final opinion of the FEEDAP Panel.

The additive 3-nitrooxypropanol is authorised as a zootechnical feed additive, in the functional group “substances which favourable affect the environment (reduction of enteric methane production). This request follows the reporting by the Danish authorities of clinical signs of digestive and metabolic disorders in dairy cows in approximately 1/4th of the dairy farms which started using the additive 3-nitooxypropanol (approximately 400 out of 1600 farms) since December 2025.

The objective of the scientific opinion is to assess whether the authorisation of the additive 3-nitrooxypropanol still meets the conditions set out by Regulation (EC) No 1831/2003 as regards the safety for the target species. 

Overall objective

The purpose of this call for data is to request interested parties (e.g., food business operators, national food authorities, research institutions, academia) and/or other stakeholders, in any juristriction, to submit documented information (published and/or unpublished) relevant to the safety of 3-nitrooxypropanol for dairy cows and cows for reproduction. 

Specific objectives

• Specific Objective 1: collection of data from dairy farms using 3-nitrooxypropanol
  EFSA is looking for data related to the health status and zootechnical performance of dairy cows and cows for reproduction in farms using the feed additive 3-nitrooxypropanol. The data, collected at farm level, should be preferably related to the periods before the use of the additive, during the use of the additive and, if relevant, after the suspension of the use of the additive. 
• Specific Objective 2: collection of data and/or information related to the use of 3-nitrooxypropanol in ruminants 
  EFSA is looking for any other data and/or information related to the use of 3-nitrooxyporpanol in ruminants. The data/information should ideally be related to the effects of the additive on the health status and the zootechnical performance of ruminants receiving the additive. 
   

Data sought and data submission format

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

• Specific Objective 1: collection of data from dairy farms using 3-nitrooxypropanol
  The call refers to data related to the zootechnical performance (including milk quality) and health status of dairy cows and cows for reproduction, collected at farm level. The data should, ideally, include the records of the relevant parameters in the period before the use of 3-nitrooxypropanol and during its use. In case the use has been suspended, also the data related to the period from the suspension of its use should be submitted. 
  The list of the data/information requested is detailed in the Questionnaire. The interested parties are invited to report the average values for the parameters requested (if available) in the questionnaire. However, it is important that all the information reported are accompanied by raw data, which could be submitted in different formats, as detailed in the questionnaire.
  The interested parties are invited to download, complete and submit the Questionnaire and relevant raw data to EFSA as described below.
   
• Specific Objective 2: collection of data and/or information related to the use of 3-nitrooxypropanol in ruminants 
  The call refers to data related to the zootechnical performance and health status of ruminants. The data can be collected at farm level (for ruminants other than dairy cows and cows for reproduction) or could be derived from any other source such as:
  • not published reports on the use of 3-NOP in farms (in this case, also data for dairy cows and cows for reproduction could be submitted), 
  • data collected at local, regional or national level by organisations and/or authorities, 
  • reports of evaluations of the effects of 3-nitrooxypropanol on the health status or the zootechnical performances from other scientific bodies,
  • results of experimental studies,
  • case studies.

The information/data should be submitted to EFSA as detailed below.

Deadline for submission of data

Interested parties and stakeholders should submit data by 31/03/2026 complying with the requirements 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 granted 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 shall 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.

As mentioned above, EFSA’s proactive transparency obligations require publication of any data used in EFSA’s Scientific Outputs. To ensure compliance with EFSA’s transparency requirements and avoid possible disclosure of confidential information interested parties may claim:

1. Confidentiality Requests for Personal Data and CBI

If your submission includes Personal Data (e.g.  name and surname, email address) or Confidential Business Information (CBI) (e.g. commercial links to producers, information revealing sourcing, market shares or business strategy, the manufacturing/production process), please: 

• Submit via Portalino both a confidential version (in which confidential information has been earmarked but remains visible) and a non-confidential version (in which confidential information has been irreversibly redacted) of the completed form.  
• Submit via Portalino a separate confidentiality request for each part of your data that you want to claim confidential, using applicable legal grounds listed below.

You may claim confidentiality 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 has to be uploaded to Portalino. Additional information can be found in the User Guide on Confidentiality.

2. Portalino Registration Process
To submit data via Portalino, follow these steps:

1. Register in Connect.EFSA using this form
2. Create a profile in Portalino by sending an email to servicedesk [at] efsa.europa.eu with the following info:
   1. a.    scope: Call for 3-nitrooxypropanol in ruminants EFSA-Q-2026-00024
      b.    full name, business/personal email
      c.    in the heading of the email please insert: Call for 3-nitrooxypropanol in ruminants EFSA-Q-2026-00024

Note: Registration may take a few days, so we encourage you to start the process immediately to meet the deadline. When accessing the Portalino, you will use the email and log-in info created by EFSA during the steps above (e.g. ending with “@net.efsa.europa.eu”).

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”.

Submission of data in any other form (email, third party e-submission platforms, etc) will not be accepted. 

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 3-nitrooxypropanol in ruminants EFSA-Q-2026-00024
• 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.

Information on how to use Portalino is available here.

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.

Correspondence

Please address any enquiries to RAL [at] efsa.europa.eu.