Belarus | BCH-NR3-BY-109124 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)

published: 01 Nov 2015 last updated: 26 Nov 2015
General Information


Ministry of Natural Resources and Environmental Protection; the National Coordination Biosafety Centre of the Institute of Genetics and Cytology, NAS Belarus; Ministry of Agriculture and Food of the Republic of Belarus; Ministry of Health of the Republic of Belarus; the Belarusian State Accreditation Centre; the Institute of Microbiology, NAS Belarus; the Institute of Biophysics and Cell Engineering, NAS Belarus; the Forest Institute, NAS Belarus; the the Scientific and Practical Center for Potato, Fruit and Vegetable Growing; NAS Belarus the Scientific and Practical Center for Animal Breeding, NAS Belarus; the Central Botanical Garden, NAS Belarus; the Scientific and Practical Center for Foodstuffs; NAS Belarus; the Institute of Plant Protection, NAS Belarus; the Institute for Experimental Botany, NAS Belarus; the State Customs Committee of the Republic of Belarus; the Republican Scientific and Practical Centre of Hygiene; the Belarusian State Institute of Metrology; Aarhus Centre of the Republic of Belarus; the Biological Faculty of the Belarusian State University; the National Center of Hygiene, Epidemiology and Public Health; Laboratories for GMO Detection: the Institute of Genetics and Cytology, Brest Regional Center of Hygiene, Epidemiology and Public Health, Vitebsk Center for Standardization, Metrology and Certification, Gomel Center for Standardization, Metrology and Certification, Grodno Center for Standardization, Metrology and Certification, Mogilev Center for Standardization, Metrology and Certification.
EN

01 Oct 2011
29 Oct 2015
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is fully in place
EN
2006
EN
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • One or more sets of biosafety guidelines
  • Other laws, regulations or guidelines that indirectly apply to biosafety
Yes
EN
Yes
EN
Less than 10
EN
Yes
EN
By 2006 the National Biosafety Framework had been developed and established in the Republic of Belarus. The most important result of its establishment was the adoption of the Law on “Safety in Genetic Engineering Activities”, №96 dated January 9, 2006. The National legislation of the Republic of Belarus (laws, regulations, guidelines) can be entirely found on the Biosafety Clearing-House website (<a href="http://bch.cbd.int/database/results?searchid=642147">http://bch.cbd.int/database/results?searchid=642147</a>) in "Belarus" profile. Accession of the Republic of Belarus to the Customs Union of the Eurasian Economic Community (EurAsEC) resulted in the adoption of Technical Regulations of the Customs Union of the EurAsEC (Customs Union Commission Decision № 880 "On Food Safety" and № 881 " Food Products in Terms of their Labeling" of December 9, 2011), setting a threshold of 0.9% instead of 0% for the labeling of products containing genetically modified ingredients and establising the need to quantify GM components.<br />Over the past period from 2011 to 2015 on the basis of SSI "The Central Botanical Garden of the National Academy of Sciences of Belarus" and RUE "The Scientific and Practical Center of the National Academy of Sciences of Belarus for Potato, Fruit and Vegetable Growing" established trial fields, which meet safety requirements for the testing of transgenic plants under natural climatic conditions at their first release to the environment. 3 fields in total have been established in Belarus (the third - at the SSI "The Institute of Genetics and Cytology").<br />During the period from 2011 to 2015 NCBC sent 26 formal responses to the requests of governments and organizations of the Republic of Belarus. Prepared 5 policy notes and materials. Presented 4 proposals and issued 4 expert opinions on the content of GM ingredients in food products and seeds. On October 1, 2013 (CEI project) it organized the International Conference "Sharing Experience in the Field of Education and Raising Public Awareness of Biosafety Issues"; in the preparation of the Third National Report 2 national workshops were held - "Detection of GMO in the Republic of Belarus" and "Public Participation in Biosafety Issues." Two working meetings on "Requirements for the Documentation Required in the Release of Non-pathogenic Genetically Modified Organisms into the Environment" were held. NCBC participated in the organization and holding of 17 international and 18 national seminars and conferences on biosafety and biodiversity issues. During the preparation of the Third National Report inquiries about the detection of GM components, including unauthorized, in food and feed were sent to all the Republican Laboratories for GMO Detection (LDGMOs) in order to monitor the situation in the country for 2011-2015.<br />In 2011-2014 LDGMOs at the NCBC of the Institute of Genetics and Cytology performed work in the amount of 2456400 thousand Belarusian roubles ($ 287,096.00) for the determination of GM components in food and feed; participated in the interlaboratory collations of results for the accredited Laboratories for GMO Detection of the Republic of Belarus.<br />
EN
Article 5 - Pharmaceuticals
Yes
EN
Partially
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Yes
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
None
EN
None
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Article 12 – Review of decision
No
EN
No
EN
No
EN
None
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
Yes
EN
One or more
EN
Yes, always
EN
On 10.10.2008 the Treaty establishing a single customs territory and formation of the Customs Union of Belarus, Kazakhstan and the Russian Federation (the Eurasian Economic Community, EurAsEC) entered into force. In connection with the accession to the Customs Union of the EurAsEC Belarus adopted Technical Regulations of the Customs Union TR CU 021/2011 "On Food Safety" and TR CU 022/2011 "Food Products in terms of their Labeling", including 0.9% for GM products labeling (documents are in "Belarus" profile on the Biosafety Clearing-House website). Sec. 3.3. of Technical Regulations states that up to February 15, 2015 the production and release of products in circulation are allowed in accordance with the mandatory requirements previously established by the regulatory legal acts of the Customs Union of the EurAsEC, or the Law of the Member State of the Customs Union of the EurAsEC, subject to available documents on assessment (confirmation) of the product conformity specified mandatory requirements, issued or adopted prior to the entry into force of Technical Regulations. Currently, the Agreement on the Customs Union of the EurAsEC has become invalid in connection with the entry into force the Treaty on the Eurasian Economic Union (EAEU). By February 15, 2015 the transitional periods for the above Technical Regulations on food products had ended, and now Technical Regulations of the Customs Union of the EurAsEC CU TR 021/2011 and CU TR 022/2011 are in effect within a framework of the Technical Regulations of the EAEU Customs Union.<br />The Technical Regulations of the EAEU Customs Union in the field of LMOs circulation, as well as rules on GM products labeling are similar to the European Union Directives and Regulations on labelling and comply with the requirements in paragraph 1 of Article 14 of the Cartagena Protocol on Biosafety.<br />
EN
Article 20 of TR CU 021/2011 states that "Methods of examination (testing) and measurement of food products are specified in the List of Standards containing regulations and methods of examination (testing) and measurement, including the rules of sampling required for the application and enforcement of the requirements of these Technical Regulations and implementation of assessment (confirmation) of conformity of food products." For LMOs it is the Resolution of the Chief State Sanitary Inspector of RF of 30.11.2007 №80 "On Supervision over the Circulation of Food Products Containing GMOs" (together with "MR 2.3.2.2306-07.23.2. Food Products and Food Supplements. Biomedical Assessment of the Safety of Genetically Modified Organisms of Plant Origin. Methodological Guidlines", "MR 4.2.2304-07. Control Methods and Microbiological Factors. Food Products and Food Supplements. Methods of Identification and Quantification (Quantitative Determination) of Genetically Modified Organisms of Plant Origin. Methodological Guidlines", "MR 4.2.2305-07. 4.2.Control Methods. Biological and Microbiological Factors. Food Products and Food Supplements. Detection of Genetically Modified Microorganisms and Microorganisms Having Genetically Modified Analogues in Food Products by Real-Time Polymerase Chain Reaction (PCR) Methods and PCR with Electrophoretic Detection. Methodological Guidlines". This Regulation can be found in "Belarus" section on the website of the Biosafety Clearing-House.<br />The methodological base developed in the Customs Union is largely harmonized with the requirements of international organizations and the European Union and provides a level of protection not less than that defined in the Cartagena Protocol on Biosafety.<br />
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes
EN
Yes
EN
One or more
EN
One or more
EN
One or more
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
  • Field trial
  • LMOs for Contained use
Yes, always
EN
No
EN
5 or less
EN
Yes
EN
Yes
EN
Yes
EN
In addition to the previously adopted regulations and national methodologcal guidelines regulating the assessment of potential risks of LMOs to human health and the environment for the period covered by the report, in connection with the accession of the Republic of Belarus to the Customs Union of the Eurasian Economic Community, Belarus approved a list of standards containing rules and methods of examination (testing) and measurement, including biomedical evaluation of the safety of genetically modified organisms of plant origin at the first entry on the market of the Customs Union. Requirements for the biomedical evaluation are set out in the methogological guidelines 2.3.2.2306-07 "Biomedical Assessment of the Safety of Genetically Modified Organisms of Plant Origin", approved by the Resolution of the Chief State Sanitary Doctor of the Russian Federation dated November 30, 2007 № 80. It should be noted that the methodological guidelines developed earlier in the Republic of Belarus and the Customs Union are similar to the requirements to the nature of information on genetically modified plants to be provided by applicants, as well as the biomedical assessment carried out by the applicant. They are based on the recommendations of international organizations in this field, such as the WHO, as well as on the national experience of such research gained in the study of toxicology and allergology of untransformed organisms. These standards are currently in effect within a framework of the Eurasian Economic Union (EAEU).<br />However, the newly established methodological recommendations give a fuller description of the system of biomedical research in case of release of new genetically modified plants on the market of the country. An important distinction is also in that all biomedical research is of long-term nature (sampling of biological material for research is conducted on the 30th and 180th day of the experiment).<br />
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
Yes
EN
Never
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
Yes
EN