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Habriev, R.U. (2005) Guideline for Experimental (Preclinical) Studying of New Pharmacological Substances. 2nd Edition, Medicine, Moscow. Хабриев, Р.У. (ред.) (2005) Руководство по экспериментальному (доклиническому) изучению новых фармакологических веществ, 2-е издание, Медицина, Москва.

has been cited by the following article:

  • TITLE: Regulation of Genetically Modified Food Use in the Russian Federation

    AUTHORS: Nadezhda V. Tyshko, Elvira O. Sadykova

    KEYWORDS: Plant Biotechnology, GM Food, GMO Safety Assessment, GMO Legislative Regulation, GM Food Labelling, Control over GMO

    JOURNAL NAME: Food and Nutrition Sciences, Vol.7 No.9, July 25, 2016

    ABSTRACT: 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.