WG1 evaluates existing and emerging biofilm technologies, including 3D-printed devices, to identify models suitable for regulatory standardization. By collaborating with biotech companies, it develops methods to modernize biofilm regulatory science tools and support global innovation.



The WG1 objectives:



1. Screening of available methods for biofilm analysis and publication of a review or perspective article (D3, D4, D5).

2. Screening of biofilm-forming platforms (models), publication of a review article (D3, D4, D6).

3. Selection of high-field applicability methods for this network (WG1 and WG2) (D3, D4, D7).

4. Selection of the most relevant models for growing biofilms for discussions in WG2 (D3, D4, D8).

5. Joint discussions and meetings with Biotechnology companies on developing relevant technologies applicable to biofilm research (D3, D4, D9).

6. Arranging the meetings necessary in order to plan, conduct and coordinate the above activities.



WG2 bridges gaps between research and regulation by translating biofilm lab data into actionable regulatory insights. It creates decision-making frameworks, aligns stakeholders through workshops, and establishes guidelines for risk assessment models that protect health and the environment.



WG2 objectives:



1. Analyse existing guidelines and risk assessment models used by regulators to make decisions about antimicrobials intended to protect and improve public health (D11).

2. Creating a decision-making framework that considers data generated by new methods of analysis and what is necessary to collect for decisions that support public health claims (D11-D12).

3. Workshops for regulators and industry to align on decision-making frameworks and recommendations for data necessary to support risk assessment models and decision-making (D12-D15).

4. Training modules/lectures (onsite and online) and cyclic webinars for graduates and post- graduates covering subjects such as metrology and standardisation, MIABE, overview of active groups and committees and help/facilitation of involvement in the groups, principles of regulatory sciences (D12-D15).

5. Workshops for academics (graduates and post-graduates) and innovators to discuss the practical implications of what types of product label claims may be supported (D12-D15)

6. Workshops for all stakeholders, allowing academics and innovators to share cutting-edge research findings, technologies, and methodologies directly with regulators and industry participants (D12-D15).

7. Arranging the meetings necessary to plan, conduct and coordinate (with WG1) the above activities.



Each country has its own regulatory office and pathway for registering products with specific label claims. Understanding who the decision makers are and the best way to disseminate the guidance generated in WG1 and WG2 is non-trivial. This WG aims to develop strategies to communicate the developed knowledge and create forums surrounding how best to educate the broader scientific and regulatory communities to promote the development and acceptance of standardised biofilm test methods in health care, the built environment, and industrial systems.



WG3 objectives:



1. Present the results at international conferences attended by industrial representatives (in the form of lectures, posters, and flyers) (D17).

2. Engage in specialised forums, facilitating discussion with national and international decision-makers (D17).

3. Publish general information, as well as scientific publications, on the website of RegulatoryToolBox and on social media (X(Twitter)/LinkedIn/Facebook) (D16).

4. Increase the scientific, evidence-based literature in the field (via publications in peer-reviewed journals, research projects, etc.) (D17).

5. Organise annual conferences and workshops that target regulatory stakeholders (as described on WG1, WG2, WG3) (D17, D18).

6. Organise a final RegulatoryToolBox conference at the end of the action (D18).



Biofilm Regulatory Toolbox (RegulatoryToolBox) is a European initiative aimed at integrating advanced biofilm research into regulatory frameworks. The project develops standardized methods, tools, and guidance to support evidence-based decision-making in healthcare, industry, and environmental protection, while fostering collaboration between scientists, regulators, and industry stakeholders.

COST Actions are EU-funded research networks connecting scientists across Europe and beyond. They support collaboration through meetings, workshops, and scientific exchanges to drive innovation and policy impact.

Action Title: Building Consensus on Biofilm Regulatory Decision-Making Acronym: RegulatoryToolBox Action Number: CA23152  Open Call Collection: OC-2023 (CA23152-26914) novation and policy impact.