Regulation on Genetically Modified Organisms and Their Products

ENFORCEMENT DATE: 26.09.2010

Institution: Ministry of Agriculture and Rural Affairs

Approval Date: 13.08.2010

Official Gazette Date: 13.08.2010

Official Gazette No: 27671

CHAPTER ONE: Purpose, Scope, Basis and Definitions

Purpose

Article 1 - (1) The purpose of this Regulation is to prevent risks that may arise from genetically modified organisms and their products obtained by using modern biotechnology within the framework of scientific and technological developments, and to protect human, animal and plant health as well as the environment and biological diversity by;

  • Regulating application, evaluation, decision, import, processing, export, labeling, monitoring, marketing, inspection and control related to genetically modified organisms and products for food and feed purposes,
  • Conducting trials of genetically modified organisms under controlled conditions in a limited specific area to prevent contact with the external environment for research, development and experimental purposes,
  • Determining procedures and principles regarding research, development, application, evaluation, decision, import, export, processing, labeling, marketing, monitoring, inspection, control and confined area activities related to genetically modified microorganisms and their products.

Scope

Article 2 - (1) This Regulation covers;

  • Application, evaluation, decision, processing, packaging, labeling, preservation, storage, transportation, marketing, import, export, transit, monitoring, inspection and control of genetically modified organisms and products for food and feed purposes,
  • Research, development and controlled condition trial studies of GMOs and their products to be imported or developed domestically,
  • Provisions regarding applications, evaluation, decision, import, export, processing, labeling, marketing, monitoring, inspection and control activities of genetically modified microorganisms and confined area conditions such as laboratories and facilities where confined area activities are conducted.

Basis

Article 3 - (1) This Regulation has been prepared based on the Biosafety Law No. 5977 dated 18/3/2010.

Definitions

Article 4 - (1) In this Regulation, the following terms mean;

  • a) Open area: All soil and water habitats,
  • b) Research institute: Institutes conducting research and development activities affiliated to Ministries,
  • c) Authorized research institution: Research institutes, institutions assigned by Ministries to conduct research, research institutions affiliated to universities and TÜBİTAK, and private sector research institutions authorized by the Ministry,
  • ç) Distinctive identity: A numeric and alphanumeric coding system including the code of each gene carried by each GMO,
  • d) Ministry: Ministry of Agriculture and Rural Affairs,
  • e) Simplified procedure: A simplified decision-making process based on existing information and previous risk assessments indicating no risk from GMOs and their products and no harm to human, animal and plant health, environment and biological diversity,
  • f) Applicant: The gene owner or importer who applies before the first import,
  • g) Biosafety: Safe conduct of activities related to GMOs and their products to protect human, animal and plant health as well as environment and biological diversity,
  • ğ) Biosafety information exchange mechanism: An information exchange system to facilitate the exchange of scientific, technical and practical information and documents related to GMOs and their products at national and international levels, to inform the public and to enable participation in decision-making processes,
  • h) Environmental risk assessment: The evaluation conducted within the scope of risk assessment based on the information and documents requested in Annex II and Annex III and additional information that may be requested by the Board regarding risks that GMOs and their products may cause directly or indirectly, immediately or delayed, on the environment due to experimental release, confined use or marketing,
  • ı) Evaluation: Risk assessment based on scientific principles, socio-economic evaluation, ethical evaluation if needed, and other evaluations requested by the Board to be considered in decision-making for each application related to GMOs,
  • i) Trial: The study conducted to test the claimed advanced features of GMOs and their possible effects on the environment under controlled conditions,
  • j) Experimental release: Conducting activities related to GMOs for experimental purposes under controlled conditions in a limited specific area to prevent contact with the external environment,
  • k) Threshold value: The lower limit determined by the Ministry in line with the Board's opinions, which requires labeling the product as GMO for approved genes,
  • l) Ethical evaluation: Evaluation conducted to determine the possible effects and consequences of releasing and using GMOs and their products on the ethical values of consumers, users and farmers,
  • m) GMOs and their products: GMOs, genetically modified microorganisms (GMMs), products partially or entirely obtained from GMOs, containing GMOs or consisting of GMOs,
  • n) Products obtained from GMOs: Products partially or entirely obtained from GMOs but not containing or consisting of GMOs,
  • o) Non-GMO equivalent product: Equivalent food or feed that has not undergone genetic modification technology and does not contain any GMO in any way,
  • ö) Genetically modified microorganism (GMM): Microorganisms whose genetic structure has been altered by methods or processes other than natural recombinations,
  • p) Genetically modified organism (GMO): Living organisms including plants, animals and microorganisms other than humans obtained by gene transfer using modern biotechnological methods,
  • r) Export: The removal of goods outside the Turkish Customs Territory or to free zones in accordance with the applicable export and customs legislation or other exit and procedures accepted as export by the Undersecretariat of Foreign Trade,
  • s) Relevant parties: Those involved in research, development, processing, marketing, monitoring, use, import, export, transport, storage, packaging, labeling, and storage activities related to GMOs and their products,
  • ş) Processing: Any activity that significantly changes the original form of GMOs and their products to enable their use for food and feed purposes,
  • t) Import: The procedure of bringing goods produced abroad into free circulation, whether paid or unpaid, subject to entry into free circulation regime procedures,
  • u) Permission: Import permission granted by the Ministry for GMOs and products to be imported for research and development purposes by authorized research institutions,
  • ü) Monitoring: Tracking and all kinds of observation, control and inspection at every stage throughout the processing and distribution chain of a GMO and product that has been determined to pose no risk and cause no harm to human, animal and plant health, environment and biological diversity,
  • v) Traceability: The backward tracking, identification and definition of GMOs and their products at every stage throughout the production and distribution chain,
  • y) Law: Biosafety Law No. 5977 dated 18/3/2010,
  • z) Confined area: Controlled laboratories and production facilities where adverse effects that may arise from genetically modified microorganisms or their products on human, animal and plant health, environment and biological diversity are completely prevented by biological, chemical and physical barriers,
  • aa) Confined use: Research, development, training and production activities in laboratories and facilities where adverse effects that may arise from genetically modified microorganisms or their products on human, animal and plant health, environment and biological diversity are completely prevented by biological, chemical and physical barriers,
  • bb) Decision: The decision given by the Board based on scientific risk assessment and socio-economic evaluation results regarding an application related to GMOs or their products,
  • cc) Accident: Unwanted escape processes during the use and transport of GMOs and their products that may cause short or long-term damage to the environment and human health,
  • çç) Committee: Committees established by the Board to conduct scientific evaluations,
  • dd) Board: Biosafety Board,
  • ee) Microorganism (MO): Cellular or non-cellular microbiological structures capable of reproduction and genetic material transfer, including viruses, viroids, cultured plant and animal cells,
  • ff) Treatment: Any process performed on GMOs considering measures to protect human, animal and plant health as well as environment and biological diversity such as packaging, labeling, transport and storage,
  • gg) Approval: Positive decision given by the Board based on scientific risk assessment, socio-economic evaluation and ethical evaluation if necessary regarding an application related to GMOs or their products,
  • ğğ) Marketing: Offering any product within the scope of this Regulation to the market, whether paid or unpaid,
  • hh) Risk assessment: A four-stage process including identification, characterization, evaluation and determination of risk elements of risks and risk sources that GMOs and their products may cause on human, animal and plant health, biological diversity and environment due to genetic modification by scientific methods such as tests, analyses and trials,
  • ıı) Risk communication: Sharing of information and opinions including explanations of risk assessors, risk managers and other relevant parties about hazards, risks, risk-related factors, risk perception, risk assessment findings and risk management decisions during the risk analysis process,
  • ii) Risk management: The process of taking measures, evaluating, selecting and implementing alternatives for appropriate control measures to ensure the use and treatment of GMOs and their products within permitted purposes and rules in consultation with relevant parties considering risk assessment and legal factors,
  • jj) Socio-economic evaluation: All studies based on scientific principles conducted to determine socio-economic costs arising from the effects of releasing and using GMOs and their products on biological diversity and users including farmers before a decision is made on the application,
  • kk) TAGEM: General Directorate of Agricultural Research,
  • ll) Transit passage: The shipment of products not in free circulation through the Turkish Customs Territory from a foreign country to another foreign country, from a foreign country to Turkey, from Turkey to a foreign country, or from one internal customs to another internal customs,
  • mm) TÜBİTAK: The Scientific and Technological Research Council of Turkey (ADDED CLAUSE OG: 29.05.2014 OG NO: 29014),
  • nn) GMO Contamination: GMOs that contaminate a product during primary production including production, manufacturing, processing, preparation, processing, packaging, transportation or storage, or due to environmental factors that cannot be technically prevented, avoided or are accidental, whether or not genetic modification technology has been applied.

CHAPTER TWO: General Provisions and Prohibitions

General Provisions

Article 5 - (1) The Ministry is authorized to take all kinds of measures including precautionary measures such as total or partial recall, transfer of ownership to the public, return of the product to its origin, temporary suspension of activity, destruction of the product, prohibition of marketing, trade and processing of products within the scope of this Regulation to protect human, animal, plant health as well as environment and biological diversity.

(2) Applications, application documents, scientific evaluation reports and decisions are announced to the public through the biosafety information exchange mechanism.

(3) Except for GMOs and products to be imported for research and development purposes, no additional document related to GMOs is required by customs authorities for products within the scope of this Regulation.

(4) Standards and conditions to be met by authorized research institutions for GMOs and their products, and conditions to be met by laboratories conducting analyses for monitoring, inspection and control purposes are determined by the Board.

Prohibitions

Article 6 - (1) Regarding products within the scope of this Regulation;

  • Marketing of GMOs and their products without approval,
  • Use or allowing use of GMOs and their products contrary to Board decisions,
  • Production of genetically modified plants and animals,
  • Use of GMOs and their products outside the purposes and areas determined by the Board within the scope of marketing,
  • Use of GMOs and their products in infant formulas, follow-up formulas, and complementary foods for infants and young children, (ADDED CLAUSE OG: 22.02.2012 OG NO: 28212)
  • Import and marketing of GMOs and their products containing antibiotic resistance genes used in human and animal treatments unless scientific research results on resistance genes in these products are determined by the Risk Assessment Committee report and Board decision to be not harmful to human, animal and plant health as well as environment and biological diversity, are prohibited.

CHAPTER THREE: Research and Development

Research and Development

Article 7 - (1) No application requirement is sought for research and development studies related to GMOs to be conducted domestically. However, it is mandatory to inform the Ministry about the subject and results of the research and development activity.

(2) Permission is obtained from the Ministry for GMOs and products to be imported for research, development and training purposes.

  1. Application is made to TAGEM with the application form in Annex-1 for permission.
  2. TAGEM completes the permission procedures within fifteen days and issues the permission document to the applicant to be submitted to the customs authority for completion of import procedures. Import procedures are carried out in accordance with the conditions specified in the permission.
  3. The quantity of material to be imported is determined by TAGEM.
  4. Information about the results of research and development activities conducted domestically with permitted GMOs and products is provided to the Ministry within three months following the completion of the activities.

CHAPTER FOUR: Application, Experimental Release, Confined Use of GMM, Evaluation and Decision, Simplified Procedure and Confidential Information

Application

Article 8 - (1) Before the first import of GMOs and their products within the scope of this Regulation, the gene owner or importer applies to TAGEM for each GMO contained, or for domestically developed GMOs and products, the real or legal persons who developed the GMO or are gene owners apply to TAGEM. Applications include information about the content of the application and the intended use of the GMO. Multiple use purposes can be applied for a GMO. When multiple use purposes are applied for, each purpose is considered a separate application.

(2) For applications to be marketed;

  • Distinctive identity information,
  • Requests related to the purpose of use and restrictions and supporting information and documents,
  • Information explaining the conditions of use and production in the country where the GMO and products were developed,