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Practical application of new methods of а plant genome transformation resulted in the need for strict regulation of the safety assessment process of genetically modified organisms of plant origin, intended for use in food. The devise of Genetically Modified Organisms (GMO) of plant origin safety assessment system, which is currently valid in the Russian Federation, was initiated in 1995-1996. Not only does the system accumulate all domestic and foreign experience, it also includes the latest scientific approaches, based on achievements of fundamental science. In the present article authors focused on issues of the basic legislative regulations of plant biotechnology in the Russian Federation, and approaches to the safety assessment of GM food and control over such food. GMO safety assessment is carried out at the stage of State registration. The subject of registration is novel food products derived from GMO, manufactured in the Russian Federation, as well as food products, entering the Russian Federation for the first time. In the system of medical and biological assessment of the GMO safety, along with general toxicological research, the study of specific types of toxicity in in vivo experiments takes a prominent place. In accordance with established research practice, which uses an integrated approach, and provides with the most complete and reliable information on potential reprotoxic, genotoxic, immunotoxic and allergenic effects of GMO, as well as enables to reveal possible unintended effects of genetic modification. From 1999 to 2016 22 GM lines passed the entire cycle of medical-biological investigations. By 2016 there had been amassed scientific foundation on GMO safety, which includes the analysis of result of research, carried out within the framework of GMO state registration in the Russian Federation, as well as domestic and international data, presented by scientific literature on the problem of biotechnological food safety, at both registration stage and post-registration monitoring stage. To sum up, in the Russian Federation the most essential issues, allowing to use GMO for food purpose have been resolved: 1) legislation, normative and methodical foundations, regulating safety assessment and control over GMO turnover, as well as ensuring customer awareness about presence of GMO in food products, have been created; 2) scientifically proven evidence on the lack of negative effects for human health, i.e. GMO safety has been amassed; 3) the possibility of control over GMO turnover throughout the food market of the country has been sustained.

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The paper gives an overview of basic approaches to assessing safety of genetically modified organisms (GMOs) that are used in food products manufacturing. It contains data on overall volumes of GMOs production in the world and outlines basic trends in development of GMOs safety assessment in the Russian Federation. In Russia a system for GMOs safety assessment was first created on the basis of domestic experience accumulated via medical and biological research on protein products of microbiological synthesis taking into account all the approaches that existed in the world. A combined algorithm was substantiated; the algorithm includes examinations of GMOs properties and obligatory examinations in vivo: toxicological ones performed via a chronic experiment on rats; allergic ones performed via a modeling experiment on rats; immunologic and genotoxic ones performed via experiments on mice. The system was developed further as, first of all, there was a search for biomarkers that allow to make toxicological research more sensitive; secondly, reproductive functions and offspring development were studied. Experts confirmed that parameters of apoptosis activity could be used as biomarkers; reproductive functions and offspring development were studied over several generations; the most sensitive parameters of rats' reproductive functions were determined under modeled toxic exposure; experts examined an influence exerted on reproductive functions by the seasonal factor and studied prenatal and postnatal development of offspring. New requirements to conducting medical and biological assessment of GMOs were formulated. Starting from 2011, reproductive toxicity of GMOs has been an obligatory part in the state certification of new GM products.Requirements to safety assessment of GMOs with combined features have been developed on the basis of domestic and international experience; these requirements correspond to regulation principles for GMOs application in food products.

Allergological studies form a crucial part in the novel food safety assessment. This publication presents the results of evaluation of methanotrophic bacteria denucleinized biomass (DNBM) Methylococcus capsulatus in an allergological experiment in vivo.