Regulation of the Use of Microorganisms and their Metabolites in the Food and Feed Industry: Integration Law Aspects

Legal regulation in the field of using genetic technologies in the food and feed industry is a complex and multifaceted process that requires a balance between the possibility of developing and implementing high-tech solutions, while ensuring safety (including food safety) and compliance with ethical standards. Thus, the use of microorganisms and their metabolites for food and feed production requires transparent standards defining the permissible ranges of genetic modifications to mitigate risks to both human and animal health and the environment. In Russia, the current legislation lacks the definition of a “producer strain”, which creates legal uncertainty. In the EU, a comprehensive system for assessing the safety and authorization of microorganisms and their metabolites used as food or technological additives is applied. Given the increasing role of microorganisms modified by genome editing technologies in the food and feed industry, as well as the task of forming a common market within the Eurasian Economic Union (EAEU), a balanced approach to regulating this sphere is needed. Such an approach should support biotechnology development while ensuring protection of human health and the environment, as well as the consistency of national laws of the participating countries. This article aims to analyze and compare the main principles and approaches of legal regulation in the EU and the EAEU regarding the use of producer strains. The regulation of the use of microorganisms obtained by genome editing should incorporate the requirements for risk assessment, authorization, and labeling, and to consider the specifics of regulating the use of microorganism metabolites as food and technological additives. Further analysis of the experience accumulated in the EU and other jurisdictions (e.g., the USA) and the adaptation of best regulatory practices to the EAEU conditions, including the creation of safety assessment systems and harmonization of requirements, will facilitate the development of a common market and increase the competitiveness of products from EAEU member states.

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