Country information about GM food safety assessment
Introduction national biosafety regulations:
The development of the GMO safety assessment currently used in the
Russian Federation started in 1995–1996. The methodological approaches to comprehensive complex medical and biological assessment of GMOs were developed in the Russian Federation with due regard for international and national experience as well as new scientific approaches based on the achievements of contemporary fundamental science: genomic and proteomic analysis, detection of DNA damage or mutagenic activity, identification of products of free-radical modifications of DNA or other sensitive biomarkers.
GMO safety assessment is carried out for the state registration. Any novel food derived from plant GMO produced in Russia or imported into Russia for the first time is subject to the state registration . Guidance for safety assessment is specified in MU 188.8.131.526-07 “Medico-Biological Safety Assessment of Plant Genetically Modified Organisms”.
According to the accepted regulations,the human health assessment of a novel GMO to be placed on the domestic market includes the following:
■ Molecular assessment includes analysis of genetic construction, genetic modification method, and the gene expression level.
■ Technological assessment includes determination of organoleptic and functional properties, analysis of technological characteristics of the finished products.
■ Human health safety assessment includes several sections of required assessments: analysis of compositional equivalence and toxicological,genotoxicological, and allergological safety studies.
■ Methods for identification include qualitative and quantitative assay of GMO in food (studies targeted at determination of correspondence of these methods to those used in Russia in order to provide monitoring of use and labeling of GM food).
The list and the scope of required studies is determined on the basis of analysis of information of the GMO submitted for registration; however, the above-mentioned studies are required. If significant changes in the GMO’s genome, proteome, or metabolome are shown, additional studies may be required to determine: biological value and absorbency reproductive effect; gonadotoxic, embryotoxic, teratotoxic effect; potential carcinogenic effect; lifetime, etc.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment
Information on stacked events
Authorizatiom mechanisms for stacked events will be ready soon.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
FSBI «Institute of Nutrition» RAMS Viktor A. Tutelyan Ustinsky proezd, 2/14 109240 Moscow, RUSSIA E-mail: firstname.lastname@example.org Tel.:+7 495 698-53-60