Widespread fragmentation

Microbiome Research & Innovation is widely fragmented across scientific disciplines but also within regulatory contexts, hindering the efficient use of viable microbiome products and therapies. Currently, microbiome research is a subset of research within other fields and rarely it is considered at a top level within funding programs and food safety legislation, leaving it in a disadvantaged position compared to major research sectors. On top of that, the lack of common standard operating practices poses a major problem to advancement in research and the implementation of methods and protocols. Incoherent research languages, methods, protocols, data handling, etc. create problems in validating research results and concurrently in developing regulations that facilitate the commercialization of applications.

Regulative gaps

Trusting relationships between researchers, industry, suppliers, consumers and the public are an essential prerequisite for the introduction of innovative microbiome-based applications. Under the current legal framework, building this trust is challenging. This is due to three main reasons in particular: 1) unclear and divergent safety and efficacy standards, 2) unharmonized classifications and definitions of new microbiome products and 3) expensive, complicated and time-consuming registration procedures for biocontrol agents.

Modernization of existing policies. The EU should take a front-runner role in pursuing a coherent and aligned policy and funding approach considering the interdependencies between different microbiomes in humans, animals, plants and environments.

Better research coordination on an international level, including more long-term funding for large-scale trials, better infrastructures, human resource and maintenance support.

Creating consistent food microbe laws for food production, processing and consumption can help overcome current incoherencies and gaps.

To ensure the safe production, application and consumption of microbiome-based products, common safety and efficacy standards need to be established.

International agreement should be sought on the implementation of the Nagoya Protocol in relation to microbiome research, as existing concerns around securing intellectual property may hinder investment and research translation.

EU-wide knowledge exchange platforms need to be established through workshops, expert panels and clear, transparent and openly available reference documents.

Given the current hype on the microbiome in the media, serious investment in school and adult education is demanded, to ensure microbiome literacy. Improved technology assessment capacities can help manage expectations that may arise from overselling the scope of microbial innovation.

Consumer rights must be respected by ensuring transparency through the implementation of clear labeling rules for microbiome products. The active involvement of citizens in microbiome education and communication activities, will enable informed choices and foster trust.