Systematic review of dermal and respiratory sensitising effects of micro-organisms

This publication announces a future negotiated procurement procedure titled "Systematic review of dermal and respiratory sensitising effects of micro-organisms," led by the European Commission's Directorate-General for Health and Food Safety (DG SANTE). This initiative is linked to the EU's Farm to Fork Strategy, aiming to enhance the market access of biocontrol active substances in plant protection products. The focus of the study is to review existing epidemiological data concerning the sensitising effects associated with micro-organisms, particularly in scenarios involving human exposure.

The contract duration is 12 months, with the expression of interest period starting on September 17, 2025, and closing on October 2, 2025. The indicative launch date for the negotiated procedure is set for October 3, 2025. The procedure type is categorized as a middle/low value contract, though specific funding amounts are not disclosed.

Eligible applicants include larger organizations with expertise in epidemiology, toxicology, and microbiology, as the opportunity does not accommodate Small and Medium Enterprises (SMEs). Both single applicants and consortiums may be acceptable, although this is not explicitly stated. Geographic eligibility likely encompasses EU Member States and potentially EEA countries.

The overarching goal of the study is to fill knowledge gaps regarding the sensitising potential of micro-organisms used in agricultural products, addressing regulatory challenges posed by the lack of validated assessment methods. This research aims to contribute to more science-based regulatory strategies that facilitate the adoption of biocontrol alternatives to chemical pesticides.

The information details indicate that applicants will be compensated for the services rendered, with the nature of support being fee-for-service arrangements. There are no specific co-funding requirements mentioned, and the procurement process is expected to follow a straightforward single-stage evaluation.

Finally, this announcement is not a call for tenders but rather serves to notify interested parties of an upcoming opportunity related to a crucial research initiative in health and food safety practices concerning plant protection products involving micro-organisms.

This is a publication announcing the contracting authority’s intention to publish a future negotiated low or middle value procedure, not a call for tenders. The procedure identifier is EC-SANTE/2025/LVP/0051-EXA. The title of the planned call for tenders is "Systematic review of dermal and respiratory sensitising effects of micro-organisms".

The description of the planned call for tenders is as follows: One of the actions derived from the Farm to Fork Strategy and the “Vision for Agriculture and Food - Shaping together an attractive farming and agri-food sector for future generations” is to facilitate access to market of biocontrol active substances used in plant protection products, such as micro-organisms used as active substances. Human exposure to micro-organisms may lead to sensitising reactions. However, no validated method to assess the sensitising potential of micro-organisms exists, leading to precautionary approaches such as default warning labelling of plant protection products containing micro-organisms and obligations to use personal protective equipment when applying such plant protection products. Providing more scientific clarity on how sensitising potential could be better characterised and predicted would result in streamlining risk assessment and regulatory processes, and eventually in a more tailored approaches on labelling and recommendations. The study envisages a review on epidemiological data on sensitising effects caused by micro-organisms in areas where humans might be exposed to micro-organisms, such as occupational areas that might involve manufacturing of micro-organisms such as for food, feed, pharmaceutical purposes. This study may lead to identify patterns in micro-organisms groups which caused sensitising reactions, which would support further activities such as validating methods to assess sensitising potential of micro-organisms.

The procedure type is a planned negotiated procedure for a middle/low value contract. The estimated total value is not specified. The lead contracting authority is the European Commission, DG SANTE Health and Food Safety. The main classification (CPV) code is 79314000 Feasibility study. The nature of the contract is for services. The maximum contract duration is 12 months. There is no framework agreement.

The milestones are as follows: The start date for expression of interest is 2025-09-17 Europe/Brussels. The deadline for expression of interest is 02/10/2025 05:59 Europe/Brussels. The indicative date of launch of the negotiated procedure is 2025-10-03 Europe/Brussels.

For expression of interest, submissions must be sent exclusively at the address for submission given below. The method of expression of interest is electronic. The address for expression of interest is "Express interest".

A frequently asked question (FAQ) is: Where can I find the procurement documents for calls for tenders with ‘ExA' in the reference? The answer is: References that feature an ‘ExA’ are not calls for tenders. They are a publication announcing the contracting authority’s intent to launch in the future a low or middle negotiated procedure. This was published on 03/10/2024 17:32.

In summary, this is a pre-announcement for a future negotiated procedure, not a call for tenders. The European Commission, DG SANTE, plans to launch a study to review the sensitising effects of micro-organisms, particularly in the context of biocontrol agents in plant protection products. The study aims to review epidemiological data to identify patterns in micro-organism groups that cause sensitising reactions. This information will help to improve risk assessment and regulatory processes related to plant protection products containing micro-organisms. The expression of interest period is scheduled for September/October 2025, with the negotiated procedure expected to launch shortly thereafter. Interested parties should monitor the provided link for further updates and the actual call for tenders when it is published.

Eligible Applicant Types: The information provided does not explicitly state the eligible applicant types. However, given the nature of the contract as a feasibility study related to health and food safety, it is likely that eligible applicants could include research institutes, universities, consulting firms, and other organizations with expertise in epidemiology, toxicology, microbiology, and risk assessment. The contracting authority is the European Commission, DG SANTE, which suggests that the applicants should be able to provide services to the European Commission.

Funding Type: The funding type is a service contract, specifically a planned negotiated procedure for a middle/low value contract. This implies a procurement process where the contracting authority seeks services from external providers.

Consortium Requirement: The information does not explicitly state whether a consortium is required or if a single applicant is sufficient. It is possible that both single applicants and consortia could be eligible, depending on the specific requirements outlined in the future call for tenders.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly stated. However, given that the contracting authority is the European Commission, it is highly likely that the geographic eligibility includes at least the EU member states. It is possible that the eligibility could extend to EEA countries, EU candidate countries, or other countries, but this is not specified in the provided text.

Target Sector: The target sector is primarily related to health and food safety, specifically concerning the safety of plant protection products containing micro-organisms. This includes aspects of agriculture, biotechnology, and regulatory science. The project is linked to the Farm to Fork Strategy and the "Vision for Agriculture and Food."

Mentioned Countries: No specific countries are mentioned. The relevant region is the EU, given the European Commission's involvement.

Project Stage: The project stage is focused on research and feasibility study. The aim is to review epidemiological data and identify patterns in micro-organism groups that cause sensitising reactions. This suggests an early stage of research aimed at providing scientific clarity and supporting future method validation.

Funding Amount: The funding amount is described as a "middle/low value contract." While no specific figures are given, this suggests a funding range likely under €200k, possibly even under €50k, but without more information, it is impossible to provide a more precise estimate.

Application Type: The application type is a planned negotiated procedure. This means that the contracting authority will likely invite a select number of potential contractors to submit proposals, rather than an open call for tenders. The first step is to express interest electronically.

Nature of Support: The beneficiaries will receive money in exchange for services rendered. The contract is for a feasibility study, so the support is financial compensation for the provision of research and analysis services.

Application Stages: The application process appears to involve at least two stages: an expression of interest, followed by a negotiated procedure. It is possible that there could be further stages within the negotiated procedure itself, such as proposal submission, evaluation, and contract award.

Success Rates: The success rates cannot be determined from the provided information. Negotiated procedures typically have lower success rates than open calls, as the number of invited applicants is limited.

Co-funding Requirement: The information does not explicitly state whether co-funding is required. It is likely that co-funding is not required, as the contract is for the provision of services to the European Commission.

Summary:

This is a pre-announcement of a future negotiated procurement procedure by the European Commission, DG SANTE, related to a feasibility study on the dermal and respiratory sensitising effects of micro-organisms. The study aims to review epidemiological data to better understand and characterise the sensitising potential of micro-organisms used in plant protection products. This initiative is linked to the Farm to Fork Strategy and seeks to streamline risk assessment and regulatory processes related to biocontrol active substances. The procedure is planned as a middle/low value contract, and the maximum contract duration is 12 months. The first step for interested parties is to express their interest electronically, with a deadline of October 2, 2025. The indicative date for the launch of the negotiated procedure is October 3, 2025. This is not a call for tenders, but rather an announcement of an upcoming opportunity to provide services to the European Commission in the area of health and food safety, specifically related to the risk assessment of micro-organisms in plant protection products. The main classification is feasibility study. The study envisages a review on epidemiological data on sensitising effects caused by micro-organisms in areas where humans might be exposed to micro-organisms, such as occupational areas that might involve manufacturing of micro-organisms such as for food, feed, pharmaceutical purposes. This study may lead to identify patterns in micro-organisms groups which caused sensitising reactions, which would support further activities such as validating methods to assess sensitising potential of micro-organisms.