Regulation on Genetically Modified Organisms and Their Products

CHAPTER ONE

Purpose, Scope, Basis and Definitions

Purpose

ARTICLE 1 - (1) Within the framework of scientific and technological developments, the purpose of this Regulation is to determine the procedures and principles for the prevention of risks that may arise from genetically modified organisms and their products obtained through the use of modern biotechnology, and for the protection of human, animal and plant health together with the environment and biological diversity, regarding;

Application, evaluation, decision, import, processing, export, labelling, monitoring, placing on the market, inspection and control of genetically modified organisms and products intended for food and feed,
The conducting of trials of activities to be carried out for research, development and experimental purposes related to genetically modified organisms, under controlled conditions and within a confined, specified area, in a manner that prevents contact with the external environment,
Research, development, application, evaluation, decision, import, export, processing, labelling, placing on the market, monitoring, inspection, control and contained-use activities related to genetically modified microorganisms and their products.

Scope

ARTICLE 2 - (1) This Regulation;

Covers the application, evaluation, decision, processing, packaging, labelling, preservation, storage, transport, placing on the market, import, export, transit passage, monitoring, inspection and control of genetically modified organisms and products intended for food and feed,
The research, development and trial studies under controlled conditions of GMOs and products to be imported or developed domestically,
And the contained-area conditions such as laboratories and facilities where application, evaluation, decision, import, export, processing, labelling, placing on the market, monitoring, inspection and control activities and contained-area activities related to GMMs will be carried out, together with the provisions concerning them.

Basis

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

Definitions

ARTICLE 4 - (1) In this Regulation;

Open area: All soil and water habitats,
Research institute: Institutes carrying out research and development activities affiliated with the Ministries,
Institution authorized for research: Research institutes, institutions of the Ministries assigned to carry out research, institutions conducting research affiliated with universities and TUBITAK, and private sector research institutions authorized by the Ministry,
Unique identifier: A numeric and alphanumeric coding system that also includes the code of each gene carried by each GMO,
Ministry: The Ministry of Agriculture and Rural Affairs,
Simplified procedure: The simplified decision-making process based on existing information and a previously conducted risk assessment indicating that there is no risk that may arise from GMOs and their products and no harm to human, animal and plant health or to the environment and biological diversity,
Applicant: The gene owner or importer who submits the application before the first import,
Biosafety: The safe conduct of activities related to GMOs and their products in order to protect human, animal and plant health and the environment and biological diversity,
Biosafety clearing house mechanism: The information exchange system to be established for the purpose of facilitating the exchange at national and international level of scientific, technical and practical information and documents related to GMOs and their products, and for informing the public and ensuring its participation in the decision-making process,
Environmental risk assessment: The assessment carried out within the scope of risk assessment, in accordance with the information and documents requested in Annex II and Annex III and any additional information and documents that may be requested by the Board, of the risks that the experimental release, contained use or placing on the market of GMOs and their products may directly or indirectly, immediately or with delay, cause to the environment,
Evaluation: The risk assessment and socio-economic assessment to be carried out by the Committees on scientific principles, together with the ethical assessment where necessary and other assessments to be requested by the Board, to be taken into account in forming a decision for each application related to GMOs,
Trial: The study carried out to test under controlled conditions the alleged characteristics of GMOs and their possible effects on the environment,
Experimental release: The conduct of activities to be carried out for experimental purposes related to GMOs, under controlled conditions and within a confined, specified area, in a manner that prevents contact with the external environment,
Threshold value: The lower limit, determined by the Ministry in line with the opinions of the Board, requiring the labelling of the product as GMO for approved genes,
Ethical assessment: The assessment carried out to determine the possible effects and consequences of the release into the environment and use of GMOs and their products on the ethical values of consumers, users and farmers,
GMO and its products: GMO, GMM, products obtained partly or wholly from GMOs, products containing GMOs or consisting of GMOs,
Products obtained from GMOs: Products obtained partly or wholly from GMOs but not containing GMOs or not consisting of GMOs,
GMO-free equivalent product: Equivalent food or feed to which genetic modification technology has not been applied and which does not contain GMOs in any way,
Genetically modified microorganism (GMM): Microorganisms whose genetic structure has been altered by means or processes other than natural recombination,
Genetically modified organism (GMO): A living organism, including plants, animals and microorganisms other than humans, obtained by gene transfer using modern biotechnological methods,
Export: The taking of goods out of the Customs Territory of Turkey or to free zones in accordance with the export legislation and customs legislation in force, or other exit transactions and procedures that will be accepted as export by the Undersecretariat of Foreign Trade,
Concerned parties: Those engaged in activities such as research, development, processing, placing on the market, monitoring, use, import, export, conveyance, transport, storage, packaging, labelling and warehousing related to GMOs and their products,
Processing: Any activity carried out to enable the use of GMOs and their products for food and feed purposes and which significantly changes the original state of the product,
Import: The subjecting of goods produced abroad, acquired for consideration or free of charge, to the procedures of the regime of release for free circulation,
Permit: The import authorization granted by the Ministry for GMOs and their products to be imported for research and development purposes by institutions authorized for research,
Monitoring: The follow-up at every stage throughout the processing and distribution chain and all kinds of observation, control and inspection of a GMO and its product placed on the market that has been determined to have no risk that may arise from GMOs and their products and no harm to human, animal and plant health or to the environment and biological diversity,
Traceability: The retrospective follow-up, identification and definition at every stage throughout the production and distribution chain of GMOs and their products,
Law: The Biosafety Law No. 5977 dated 18/3/2010,
Contained area: Controlled laboratories and production facilities in which adverse effects that may arise from genetically modified microorganisms or their products on human, animal and plant health and on the environment and biological diversity are completely prevented by biological, chemical and physical barriers,
Contained use: Research, development, training and production activities in laboratories and facilities in which adverse effects that may arise from genetically modified microorganisms or their products on human, animal and plant health and on the environment and biological diversity are controlled by being completely prevented through biological, chemical and physical barriers,
Decision: The decision taken by the Board, based on the results of the risk assessment and socio-economic assessment carried out on scientific principles regarding an application made concerning GMOs or their products,
Accident: Undesired escape processes that may cause harm in the long or short term to the environment and human health during the use and conveyance of GMOs and their products,
Committee: The committees established by the Board to carry out scientific assessments,
Board: The Biosafety Board,
Microorganism (MO): Cellular or non-cellular microbiological structures, including viruses, viroids, cultured plant and animal cells, capable of reproduction and of transferring genetic material,
Treatment: Any procedure carried out on a GMO, such as packaging, wrapping, labelling, conveyance and storage, taking into account the measures to be taken for the protection of human, animal and plant health and the environment and biological diversity,
Approval: The favourable decision taken by the Board, based on the results of the risk assessment and socio-economic assessment carried out on scientific principles, together with the ethical assessment to be carried out where necessary, regarding an application made concerning GMOs or their products,
Placing on the market: The supply to the market for consideration or free of charge of any kind of product within the scope of this Regulation,
Risk assessment: The four-stage process covering the identification, characterization, evaluation by scientific methods such as testing, analysis and trial of the risks and the source of risk that GMOs and their products, due to the genetic modification, may cause to human, animal and plant health, biological diversity and the environment, and the determination of risk elements,
Risk communication: The sharing of information and views, including explanations of the risk assessment findings and risk management decisions, among risk assessors, risk managers and other relevant parties during the risk analysis process, concerning hazard, risk, risk-related factors and the perception of risk,
Risk management: The measures taken in order to ensure the use and treatment of GMOs and their products within the permitted purposes and rules, by consultation with the relevant parties taking into account the risk assessment and legal factors, and the process of evaluating, selecting and applying alternatives concerning control measures that may be appropriate,
Socio-economic assessment: All studies carried out on scientific principles to determine, before a decision is made on the application, the socio-economic costs that will arise from the effects on biological diversity and on users and farmers during the process of the release into the environment and use of GMOs and their products,
TAGEM: The General Directorate of Agricultural Research,
Transit passage: The dispatch of products not in free circulation, passing through the Customs Territory of Turkey, from a foreign country to a foreign country, from a foreign country to Turkey, from Turkey to a foreign country, or from one internal customs office to another internal customs office,
TUBITAK: The Scientific and Technological Research Council of Turkey,
(Added:OG-29/5/2014-29014) GMO contaminant: Refers to GMOs that, in a product to which genetic modification technology is applied or not applied, contaminate during production, manufacture, processing, preparation, treatment, packaging, wrapping, transport or storage, including the primary production stage, or due to environmental factors, in a manner that cannot technically be prevented or avoided or that occurs accidentally.

CHAPTER TWO

General Provisions and Prohibitions

General provisions

ARTICLE 5 - (1) The Ministry is authorized to take all kinds of measures and to make arrangements, including precautionary measures such as the total or partial recall, transfer of ownership to the public, return of the product to its origin, temporary suspension of the activity, destruction of the product, and prohibition of its supply to the market, trade and processing, regarding products falling within the scope of this Regulation for the purpose of protecting human, animal and plant health and the environment and biological diversity.

(2) Applications, application documents, scientific assessment reports and decisions are announced to the public through the biosafety clearing house mechanism.

(3) Apart from GMOs and their products to be imported for research and development purposes, no additional document concerning the GMO is required by the customs administrations for products within the scope of this Regulation.

(4) The standards and conditions to be ensured for GMOs and their products at institutions authorized for research, and the conditions to be sought at laboratories that will carry out analyses for monitoring, inspection and control purposes, are determined by the Board.

Prohibitions

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

The placing on the market of GMOs and their products without obtaining approval,
The use of GMOs and their products, or allowing them to be used, contrary to the decisions of the Board,
The production of genetically modified plants and animals,
The use of GMOs and their products outside the purpose and area determined by the Board within the scope of placing on the market,
The use of GMOs and their products in baby foods and infant formulae, follow-on foods and follow-on formulae, and supplementary foods for infants and young children,
(Added:OG-22/2/2012-28212) Where GMOs and their products contain resistance genes to antibiotics used in the treatment of humans and animals, the import and placing on the market of these products is prohibited unless it is determined by a report of the Risk Assessment Committee and a decision of the Board that the results of scientific research concerning the resistance genes in these products are not harmful to human, animal and plant health or to the environment and biological diversity.

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 carried out domestically. However, it is mandatory to provide information to the Ministry on the subject and the result of the activity to be carried out for research and development purposes.

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

For the permit, an application is made to TAGEM with the application form in Annex-1.
TAGEM completes the permit procedures within fifteen days and gives the permit document to the concerned party to be submitted to the customs administration so that the import procedures can be completed. Import procedures are carried out in accordance with the conditions specified in the permit obtained.
The quantity of material to be imported is determined by TAGEM.
Within three months following the completion of the research and development activity carried out domestically related to GMOs and their products whose import has been permitted, the Ministry is informed of the result.

CHAPTER FOUR

Application, Experimental Release, Contained 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, an application is made to TAGEM by the gene owner or importer for each GMO it contains, and for a domestically developed GMO and its product, by the natural and legal persons who develop the GMO or own the gene. In applications, information on the content of the application and the purpose for which the GMO will be used are stated. An application for the use of a GMO for more than one purpose may be made. Where an application is made for use for more than one purpose, a separate application is deemed to have been made for each purpose.

(2) In applications to be made for placing on the market;

Unique identifier information,
The request concerning the purpose of use and restrictions and the information and documents supporting this request,
Information and documents explaining the conditions of use and production in the country where the GMOs and their products were developed,
Information and documents related to risk management,
The transport, preservation and conveyance conditions of the GMOs and their products subject to the application,
The requested document showing that the release into the environment and the placing on the market for consumption purposes of the GMOs and their products has been permitted in the country where they were developed, that the permit granted continues, that their production and consumption continue, and that they have been on the market for the period determined by the Ministry,
Excluding the information specified in Annex-2 Parts III A and III B or Annex-3 Parts II C and II D depending on the characteristics of the organism subject to the application,
Other information and documents to be announced by the Board are submitted.

(3) For the application of domestically developed GMOs and their products, information and documents other than subparagraphs (c) and (e) of the second paragraph are submitted.

(4) The applications received are forwarded to the Board by TAGEM.

(5) The Board evaluates the application within ninety days at the latest and sends the result to TAGEM. TAGEM notifies the applicant of the result within fifteen days from the application. The time spent for the provision of additional information and documents is not taken into account in the calculation of the ninety-day period.

(6) The Board announces the applications made through the biosafety clearing house mechanism.

(7) The Board may request additional information and documents concerning the application in cases it deems necessary.

(8) Where additional information and documents concerning the application are requested by the Board, if the information and documents are not provided within the period determined by the Board, the procedure is terminated and the file is returned to the applicant.

(9) Applications are rejected where the GMOs and their products;

Threaten human, animal and plant health and the environment and biological diversity,
Eliminate the right of choice of the producer and consumer,
Cause the disruption of the ecological balance of the environment and of the ecosystem,
Where there is a risk of the GMOs and their products spreading into the environment,
Endanger the continuity of biological diversity,
Are rejected in cases where it is understood that the applicant does not have sufficient technical equipment to apply the measures aimed at ensuring biosafety.

(10) The expenses related to the evaluation procedures of the applications are deposited by the applicant into the account determined by the Ministry.

Experimental release

ARTICLE 9 - (1) For an experimental release application, in addition to those specified in subparagraphs (a), (b), (c), (d), (e), (f) and (h) of the second paragraph of Article 8,

For genetically modified organisms other than plants, the information in Annex-2,
For genetically modified plants, the information in Annex-3 is submitted.

(2) The open-area, greenhouse and laboratory conditions to be carried out within the scope of experimental release and the measures to be taken during the studies and the rules to be observed are determined by the Board.

(3) GMOs and their products to be imported within the scope of experimental release and GMOs and their products to be obtained as a result of the trials to be carried out may not be made subject to trade.

(4) Trials within the scope of experimental release are carried out by research institutes assigned by the Ministry. Within this scope, research institutes may, where necessary, cooperate with universities and TUBITAK provided that they obtain permission from the Ministry.

(5) The procedures and principles related to the trials are determined by the Board.

Contained use of GMM

ARTICLE 10 - (1) For an application for the contained use of a GMM, in addition to those specified in subparagraphs (a), (b), (c), (d), (e), (f) and (h) of the second paragraph of Article 8,

Whether transfer or allowing use will be permitted, and if permitted, the conditions to be observed,
It is mandatory to submit the information and documents excluding Annex-2 Parts III A and III B depending on the characteristics of the organism subject to the application.

(2) The standards, conditions and rules to be observed of the contained areas where research, development and industrial activities with the GMM will be carried out under controlled conditions in a contained area;

International rules and standards,
The risk classification of microorganisms,
The adequacy of the design and operation of the contained area and of the activity to be carried out with the GMM in this area in terms of measures that will not create biosafety risks,
The measures that will prevent the biosafety risks that may be caused by accidents occurring during the contained-area activity carried out with the GMM,
Are determined by the Board taking into account the matters related to the internationally harmonized contained-area standards that the concerned parties carrying out activities with the GMM must fulfil.

Evaluation and decision

ARTICLE 11 - (1) The decision-making period starts after the notification to be made to the applicant by TAGEM in accordance with the fifth paragraph of Article 8, and this period may not exceed two hundred and seventy days. The time spent due to a request for additional information or documents is not taken into account in the calculation of the decision-making period.

(2) For each application, a risk assessment including environmental risk assessment, a socio-economic assessment and, in cases deemed necessary by the Board, an ethical assessment are carried out. The reports prepared by the risk assessment committee, the socio-economic assessment committee and the ethics committee concerning the applications made related to GMOs and their products are forwarded to the Board.

(3) The matters to be taken into account in the preparation of the reports by the risk assessment committee, the socio-economic assessment committee and the ethics committee, and the procedures and principles to be observed, are determined by the Board.

(4) It is mandatory for the applicant to provide all kinds of information and documents requested for use in risk assessment by the Board and the committees, together with the results of field trials including laboratory, greenhouse and field tests, food analyses, toxicity and allergy tests, as well as other tests deemed necessary.

(5) Based on the results of the reports of the risk assessment committee and the socio-economic assessment committee for the GMOs and their products subject to the application, the risk management principles are determined by the Board. The applicant is responsible for the preparation and implementation of the risk management plan.

(6) The procedures and principles related to the food and feed analyses, toxicity and allergy tests concerning GMOs are determined by the Board.

(7) The procedures and principles concerning the risk assessment, including environmental risk assessment, of a GMO intended to be released for experimental purposes are determined by the Board taking into account;

The cumulative effects of GMOs in the long term on human and animal health and on the elements of the environment such as flora, fauna, soil fertility, soil organic matter structure, the food and feed chain and biological diversity, together with the analysis results related to antibiotic resistance genes,
The data obtained as a result of comparing the modified characteristic of the GMO and the use of the GMO under the same conditions with a GMO-free equivalent product in terms of possible risks,
The risk assessment result obtained through the evaluation of the available scientific and technical data on scientific principles and in a transparent manner,
The result of the evaluation, in the risk assessment of each application, of the possible changes that GMOs may show depending on their type, intended uses and the environment into which they will potentially be released, and of other information that will be needed,
Where new information emerges concerning the effects of GMOs and the use of GMOs on human and animal health and the environment, the findings as to whether the risk has changed and whether it is necessary to make changes in the risk management plan or whether the risk assessment should be carried out again are taken into account.

(8) The reports prepared by the risk assessment committee, the socio-economic assessment committee and the ethics committee are announced to the public by the Board through the biosafety clearing house mechanism.

(9) The procedures and principles related to obtaining the opinion of the public are determined by the Board. The Board forms its final decision taking into account the opinions of the public as well.

(10) The decision shall include;

The period of validity of the decision,
The procedures to be applied in import,
The purpose of use,
The data necessary for risk management and market inspection,
The conditions of monitoring,
The conditions of documentation and labelling,
The rules of packaging, transport, preservation and conveyance,
The conditions of processing, waste and residue treatment and destruction,
Safety and emergency measures,
And matters related to how reporting concerning monitoring will be carried out.

(11) The Board finalizes its favourable decision, together with the reasons, the reasons for dissenting votes if any, and the signatures, within thirty days at the latest from the date of the meeting, and submits it to the Ministry. Decisions of the Board enter into force upon their publication in the Official Gazette.

(12) Where the decision is unfavourable, the decision is notified in writing to the applicant by the Ministry. Where the applicant has new information that may lead to the modification of the unfavourable decision, the applicant may, within sixty days, apply to the Ministry and request that this decision be reconsidered. In this case, the Board reconsiders the decision within sixty days taking into account the new information submitted, and forwards the results to the Ministry to be notified to the applicant.

(13) The applicant may apply to the Ministry and request an extension at least one year before the expiry of the period of validity. This request is evaluated by the Board and the result is sent to the Ministry to be notified to the applicant. Where the result is not notified to the applicant within the period of one year, the permit period is extended until a decision is made.

(14) The decision concerning the application is also valid for subsequent imports. However, in order for the import to be carried out, the provisions of other relevant legislation are also fulfilled.

(15) The unique identifier given by the Board concerning each GMO is recorded by the Ministry. The documents concerning the recorded GMO are kept by the applicant and the Ministry for a period of twenty years.

Simplified procedure

ARTICLE 12 - (1) For applications based on existing information and a previously conducted risk assessment, including environmental risk assessment, indicating that there is no risk that may arise from GMOs and their products and no harm to human, animal and plant health or to the environment and biological diversity, the Board may decide to apply the simplified procedure, also taking into account the results of the socio-economic assessment.

(2) For an application for the simplified procedure, an application is made to TAGEM. The application received is forwarded to the Board by TAGEM. The Board discusses the procedures concerning whether the application will be accepted at its first meeting following the application.

(3) For the application for the simplified procedure to be accepted;

The submission of official documents showing that the release into the environment and the placing on the market for consumption purposes of the GMOs and their products has been permitted in the country where they were developed or registered,
The submission of official documents showing that the permit granted continues, that they are on the market, and that their production and consumption continue,
That the taxonomy and biology of the living organism transferred with the gene source are known,
That there is sufficient information on the possible effects of the GMO on human, animal, environmental health and biological diversity,
That information is available indicating that there is no adverse effect obtained from previously conducted risk assessments that may be used concerning the relationship of the GMO with other living organisms,
That detailed methods and data are available for the identification of the transferred genetic material and its determination within the living organism into which it was transferred,
The submission of the previously conducted risk assessment and, if any, the socio-economic and ethical assessment results,
The submission of the information and documents to be determined by the Board is mandatory.

(4) Where the application is accepted, the Board sends the file received to the Committee for evaluation.

(5) The Committee carries out its evaluation within the period determined by the Board and submits its report to the Board. The Board makes its decision at the first meeting following, and notifies the result to the Ministry within fifteen days.

(6) Where the decision is favourable, the Ministry sends the decision received to the Prime Ministry within fifteen days at the latest to be published in the Official Gazette.

(7) Where an objection is made to an unfavourable decision with new information and documents; the Board discusses the objection at its first meeting. It determines the procedures to be carried out concerning the objection and the period within which the procedures will be completed, and forwards the result to the Ministry to be notified to the applicant. The Ministry notifies the result to the applicant within fifteen days at the latest.

(8) The matters related to the application and evaluation for the simplified procedure are determined by the Board.

Confidential information

ARTICLE 13 - (1) The applicant notifies in writing its request concerning the information it wants to be kept confidential. Before deciding to grant this request, the Ministry exchanges information with the applicant on the confidentiality request. Following this discussion, the Ministry takes the necessary measures concerning the request and notifies the applicant.

(2) Regarding applications;

The name and address of the applicant or importer,
The purpose of use of the GMOs and their products, the characteristics they possess, the unique identifier information, the known and scientific names, the organism from which the transferred gene was taken, the country of origin of the recipient and donor organism, the general description of the transfer method,
The method and plans to be applied in emergencies,
The summary of the risk assessment may not be considered as confidential information.

CHAPTER FIVE

Import, Export and Transit Passage

Import

ARTICLE 14 - (1) The following matters are taken into account in the import of GMOs and their products that are deemed appropriate to be placed on the market as food and feed after the necessary evaluations have been carried out by the Board:

A document drawn up by the competent authorities of the country of origin or the country of loading concerning the quantity of GMOs and their products to be imported and the type of gene they contain, or an analysis report obtained from an internationally accredited laboratory, is requested from the importing company.
The Ministry carries out analyses for inspection and control purposes.
The import of products deemed appropriate as a result of inspection and control is permitted.
Records of products whose import as GMO has been permitted by the Ministry are kept on a company and GMO basis.

(2) The import of products in which, as a result of the controls carried out by the Ministry at the import stage, an unapproved GMO or an approved GMO not complying with the other conditions stipulated by the Board or the Ministry within the scope of the Law is detected, is not permitted.

(3) Products to be imported free of charge and offered for public consumption are evaluated within the scope of this Regulation.

(4) The customs entry points of GMOs and their products are determined by the Ministry after obtaining the opinion of the Undersecretariat of Customs.

(5) The import of GMOs to be used within the scope of experimental release is carried out in accordance with the principles specified in the decision.

(6) The import of GMOs and their products other than food and feed is carried out by cooperation with the relevant Ministry, institutions and organizations in line with the decision of the Board.

(7) In the import of products obtained from GMOs and products containing components obtained from GMOs, the condition that the GMO from which these products were obtained has been approved is sought.

Export

ARTICLE 15 - (1) In export, the procedure is carried out in line with the request of the recipient country.

(2) Records of products whose export as GMO has been permitted by the Ministry are kept on a company and GMO basis.

(3) The customs exit points of GMOs and their products are determined by the Ministry after obtaining the opinion of the Undersecretariat of Customs. Transit passage

ARTICLE 16 - (1) For the transit passage of GMOs and their products, a permit is obtained from the Ministry for each passage.

(2) In transit passages, the document and identity control concerning the product quantity, origin, the type of GMO it contains, the means of conveyance, the measures taken, and the exit customs information is carried out by the Ministry.

(3) In transit passages, whether the necessary measures have been taken to prevent the contamination of the environment by GMOs and their products and whether the means of conveyance are sealed is checked by the Ministry and records are kept.

(4) Transit passages are carried out in accordance with the conditions specified in the written permit granted by the Ministry and with the Customs Law No. 4458.

CHAPTER SIX

Processing, Storage, Labelling, Monitoring, Traceability, Inspection and Control of GMOs and Their Products and Sampling and Analysis

Processing and storage

ARTICLE 17 - (1) GMOs and their products are processed and stored on separate lines. In cases where this is not possible, the necessary cleaning is carried out on the processing line and in the warehouses by the concerned parties in order to prevent contamination that may arise from GMOs and their products, and this is recorded.

(2) GMM production is produced and stored under the contained-area conditions and standards determined by the Board, taking into account the risk classifications.

(3) The concerned parties are obliged to present to the Ministry during inspection and control that the conditions of processing, waste, residue, treatment and destruction determined by the Board are applied, in order to prevent the risks that may arise from GMOs and their products and to protect human, animal and plant health and the environment and biological diversity and to ensure sustainability.

(4) Where GMOs and their products are processed or treated domestically, the food and feed business operator, regarding GMOs and their products;

The documents concerning from whom and in what quantity it was obtained, in order to follow up its distribution and sale,
The documents concerning the purpose of use of the products,
Keeps the GMO and Products Registration Form in Annex-4 for each product and batch purchased, processed or made subject to exchange, and presents it to the Ministry when necessary.

Labelling of foods

ARTICLE 18 - (1) Where foods within the scope of this Regulation have been obtained from an approved GMO above the threshold value determined by the Ministry, or contain a component obtained from an approved GMO, or contain a GMO, or consist of a GMO, in addition to the requirements in the Turkish Food Codex;

For foods on whose label it is not mandatory to have a list of components, the phrase "genetically modified" or "produced from genetically modified ........." is stated clearly visible on the label.
Where the food contains more than one component; the phrases "genetically modified ....." or "produced from genetically modified ........." are placed in parentheses in the list of components, immediately after the relevant component, in the same font size.
For foods containing a component indicated by a group name in the list of components, the phrases "contains genetically modified ........." or "contains ....... produced from genetically modified ......." are placed in parentheses in the same font size, immediately after the group name.
The labels of bulk foods within the scope of this Regulation are kept in places where the consumer can see them or are offered to the consumer together with the food.
Where foods within the scope of this Regulation differ from GMO-free equivalent foods in terms of composition, nutritional effects or nutritional value, or purpose of use, it is mandatory to state these matters on the label, and for the foods in question that differ in nutritional component, it is mandatory to carry out nutritional labelling.
Where foods within the scope of this Regulation differ from GMO-free equivalent foods, warnings concerning the consumer groups for whom consumption may pose a health risk are stated on the label.
Where there is no GMO-free equivalent of foods within the scope of this Regulation, information concerning the nature and characteristics of the food in question is stated on the label in accordance with the provisions specified in the Turkish Food Codex.
Statements expressing that they do not contain a GMO, do not consist of a GMO, or are not obtained from a GMO may be placed on the labels of GMO-free equivalent foods.

Labelling of feeds

ARTICLE 19 - (1) Where feeds within the scope of this Regulation contain a GMO or consist of GMOs or have been obtained from approved GMOs above the threshold value determined by the Ministry, in addition to the label requirements in the Veterinary Services, Plant Health, Food and Feed Law No. 5996, each feed is labelled as follows.

Next to the special name of the feed containing a GMO or consisting of GMOs, the phrase "genetically modified ........." is placed in parentheses. This phrase may also be placed as a footnote below the feed component list. In this case, the character size of the text may not be smaller than the character size of the products specified in the list.
Next to the name of the feed obtained from a GMO, the phrase "obtained from genetically modified ........." is placed in parentheses. This phrase may also be placed as a footnote below the feed component list. In this case, the character size of the text may not be smaller than the character size of the products specified in the list.
A document containing the label information is kept together with bulk feeds within the scope of this Regulation.
Where feeds within the scope of this Regulation differ from their GMO-free equivalent, the composition, nutritional characteristics, purpose of use, and health-related warnings for a specific animal species or category are kept on the label.
Where there is no GMO-free equivalent of feeds within the scope of this Regulation, information concerning the structure and characteristics of that feed is kept on the label.
Statements expressing that they do not contain a GMO, do not consist of a GMO, or are not obtained from a GMO may be placed on the labels of GMO-free equivalent feeds.

Labelling of other products apart from food and feed

ARTICLE 20 - (1) Other products apart from food and feed materials are labelled, in addition to the provisions of the relevant legislation, in accordance with the conditions specified in the decision of the Board.

Monitoring and traceability

ARTICLE 21 - (1) The concerned parties are obliged to keep the form in Annex-4 and to have a record system concerning the form in order to ensure the traceability, until it reaches the final consumer, of the GMOs and their products and the products obtained from GMOs that they have labelled in accordance with Articles 18, 19 and 20.

(2) Whether the conditions specified in the decision document of the Board concerning GMOs and their products are observed is monitored by the Ministry. In accordance with the monitoring results, the Ministry takes action in accordance with the provisions of the Biosafety Law together with the provisions of the Veterinary Services, Plant Health, Food and Feed Law.

(3) In order to ensure traceability, a declaration is made to the Ministry, the necessary records are kept and the labelling rules are observed in the import and free circulation of GMOs and their products.

(4) The concerned parties are obliged to state the type of GMO and the product quantity of the GMOs and their products made subject to exchange in documents such as the dispatch invoice or delivery note used at the stages of processing, storage and placing on the market, starting from the import stage.

(5) The concerned parties are jointly and severally responsible for ensuring monitoring and traceability within the scope of this Regulation. The relevant parties at the stage at which traceability could not be ensured are held responsible.

Inspection and control

ARTICLE 22 - (1) The inspection and control of GMOs and their products and products obtained from GMOs are carried out by the Ministry in accordance with the provisions of this Regulation together with the Veterinary Services, Plant Health, Food and Feed Law.

(2) After GMOs and their products are placed on the market, whether the conditions specified in the decision of the Board are observed is controlled and inspected by the Ministry.

(3) Where the conditions specified in the decision are violated or new scientific information emerges indicating that any risk concerning GMOs and their products may arise, the decision may be cancelled by the Board. GMOs and their products whose Board decision has been cancelled are recalled by the concerned parties. Those determined by a decision of the Board to have an adverse effect on human, animal, plant health and the environment and biological diversity are destroyed immediately, while the ownership of those for which no adverse effect is determined is transferred to the public. The expenses and other costs incurred for the measures to be taken by the Ministry pursuant to this paragraph are collected from the concerned parties, taking into account their fault and responsibility.

(4) Records related to the inspection and control carried out concerning GMOs and their products and products obtained from GMOs falling within the scope of this Regulation are kept by the Ministry.

Sampling, analysis and evaluation (Amended heading:OG-29/5/2014-29014)

ARTICLE 23 - (1) Samples are taken from GMOs and their products and products obtained from GMOs and their analysis is carried out in accordance with the Veterinary Services, Plant Health, Food and Feed Law.

(2) Analysis procedures are carried out by laboratories determined by the Ministry.

(3) (Added:OG-29/5/2014-29014) The Ministry determines sampling, analysis and evaluation methods taking into account national and international regulations.

(4) (Added:OG-29/5/2014-29014) Where 0.9% or less GMO is detected in a product as a result of analysis, this situation is evaluated as a GMO contaminant.

(5) (Added:OG-29/5/2014-29014) In products with a GMO contaminant, where the genes detected as contaminants have been approved by the Biosafety Board, the products may be used in accordance with the purpose of the approval.

CHAPTER SEVEN

Various and Final Provisions

Regulation repealed

ARTICLE 24 - (1) The Regulation on the Import, Processing, Export, Control and Inspection of Genetically Modified Organisms Intended for Food and Feed and Their Products, published in the Official Gazette No. 27388 dated 26/10/2009, has been repealed.

Ongoing procedures

PROVISIONAL ARTICLE 1 - (1) Procedures concerning GMO applications not finalized on the date this Regulation enters into force are finalized in accordance with the legislation relevant on the date of application.

Transitional provisions

PROVISIONAL ARTICLE 2 - (1) In this Regulation, for the provisions referring to the Veterinary Services, Plant Health, Food and Feed Law, until the Law No. 5996 enters into force, the provisions of the Law on the Adoption with Amendments of the Decree Law on the Production, Consumption and Inspection of Foods No. 5179 dated 27/5/2004 and of the Feed Law No. 1734 dated 29/5/1973 are applied.

Entry into force

ARTICLE 25 - (1) This Regulation enters into force on 26/9/2010.

Execution

ARTICLE 26 - (1) The provisions of this Regulation are executed by the Minister of Agriculture and Rural Affairs. Official Gazette in which the Regulation was Published Date 13/8/2010 Number 27671 Official Gazettes in which the Regulations Amending the Regulation were Published

Date 22/2/2012 and number 28212
Date 29/5/2014 and number 29014

ANNEX-1

Application Form for Import Permit for Research Purposes for GMOs and Their Products

Name and Surname of the applicant and other researchers Institution Title Address Telephone No Fax No
GMO Biological Characteristics Known Name Scientific/Latin Name Taxonomic characteristics Pathological Ecological Physiological
The modified characteristic(s) of the organism 2
The place where the requested activity will be carried out 2
Summary information about the Research / Study / Project 2
CVs and publications 2
Undertaking that the provisions of the Regulation will be observed 2

1: The information of the other researchers will be provided on a separate page together with their signatures. 2: This will be attached to this form and written separately for each item.

ANNEX-2

INFORMATION REQUIRED IN APPLICATIONS CONCERNING THE EXPERIMENTAL RELEASE OF GENETICALLY MODIFIED ORGANISMS OTHER THAN PLANTS

GENERAL INFORMATION Name and address of the applicant Field of activity of the applicant Name, qualifications and experience of the responsible persons Institutional technical capacity of the applicant Unique identifier number Intended purpose of use of the GMO
INFORMATION CONCERNING THE GMO: Characteristics of the donor, recipient or parent organism or organisms: Scientific name, Taxonomy, Other names (such as common name, strain name), Phenotypic and genetic markers, The degree of relationship between the donor and recipient or parent organisms, Description of the diagnosis and detection techniques, The sensitivity, reliability and specificity of the quantitative detection and diagnosis techniques, Description of the geographic distribution and natural habitat of the organism, including information about natural predators, prey, parasites and competitors, symbiotic organisms and hosts, Organisms to which the genetic material is known to be transferred under natural conditions, Verification of the genetic stability of the organism and the factors affecting it, Pathological, ecological and physiological characteristics: The risk classification according to the international system, to be evaluated in terms of the protection of human, animal and environmental health and biological diversity, The lifespan of a generation in natural ecological systems, the sexual or asexual reproduction cycle, Information about survival, including their condition according to the seasons, and the ability to form different structures in order to survive, Pathogenicity: Infectivity, toxicity, virulence, allergenicity, pathogenicity, possible vectors, host range including non-target organisms. Possible activation of latent viruses (proviruses). Ability to colonize other organisms, Resistance to antibiotics and the potential use of these antibiotics in humans and domestic organisms for disease prevention and treatment, Involvement in environmental processes: Matters such as production, nutrient cycling, decomposition of organic matter, respiration. Structure of local vectors: Sequence, Mobilization frequency, Specificity, Presence of resistance genes. Information about modifications previously made in the genetic structure. Characteristics of the vector Structure and source of the vector, The sequence of the vectors and other non-coding genetic segments used in constructing the GMO and the transposons used to regulate the vector and additional function inserted into the GMO, The mobilization frequency and/or genetic transfer capabilities of the inserted vector and the methods for their detection, Information about the extent to which the vector is limited to the DNA necessary to perform the intended function. Characteristics of the modified organism Information concerning the modification in the genetic structure: Methods used to make the modification, Methods used to construct the inserts, to place them into the recipient or to delete a sequence, Construction and identification of the insert and/or vector, Information about whether the insert is free of any unknown sequence and the extent to which the inserted sequence is limited to the DNA necessary to perform the intended function, Methods and criteria used for selection, The sequence, functional identity and location of the nucleic acid segments in question that have been modified/inserted/deleted, particularly concerning any known harmful sequence. Information about the final GMO: Description of the genetic or phenotypic characteristics and in particular of the new characteristics and traits that emerge or will no longer emerge, The structure and quantity of any remaining vector and/or donor-organism nucleic acid in the final state of the modified organism, The stability of the organism in terms of genetic characteristics, The rate and level of expression of the new genetic material. Method of measurement and its sensitivity, The activity of the expressed proteins, Description of the diagnosis and detection techniques, including the techniques used for the diagnosis and detection of the inserted sequence and the vector, The sensitivity, reliability and specificity of the quantitative detection and diagnosis techniques, Information about previous releases or uses of the GMO, Assessments concerning human, animal and plant health: The toxic and allergic effects of the GMOs and/or their metabolic products, Comparison of the modified organism with the donor, recipient and, where necessary, parent organism in terms of pathogenicity, Colonization ability, If the organism is pathogenic for immunocompetent humans: the diseases caused by pathogenicity and the pathogenicity mechanism, including recovery and virulence, Infectivity, Infective dose, Host range, possibility of change, Possibility of survival in hosts other than humans, Presence of vectors and routes of spread, Biological stability, Forms of antibiotic resistance, Allergenicity, Availability of suitable treatments. Other product hazards.
INFORMATION CONCERNING THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT Information about the release Description of the proposed release, including the intended and foreseen products, The foreseen date of the release and the time planning of the trials, including the frequencies of the release and the duration for which they will continue, Tasks to be carried out for the preparation of the site before release, The size of the site, The methods to be used for the release, The quantities of the GMOs to be released, Measures to be taken in case of disturbances at the site to be released (the type and method of planting, mining, irrigation and other activities), Measures to be taken for the protection of workers during the release, Procedures to be carried out at the site after release, The methods foreseen for the elimination or inactivation of the GMOs and their wastes at the end of the trial, Information about previous releases of the GMO carried out in particular at different scales and in different ecological systems, and their results. Matters Concerning the Environment to be Taken into Account in the Planning of the Release and Information to be Provided:* The geographic location of the site and information concerning the precise location, Physical and biological proximity to humans and other significant biota in the region, Proximity to significant biotopes, protected areas or drinking water reserves, The climatic characteristics of the regions likely to be affected, Geographic, geological and pedological characteristics, Flora and fauna, including plant crops grown in the vicinity of the site, farm animals and migratory species, Description of the target and non-target ecosystems likely to be affected, Comparison of the natural habitat of the recipient organism with the site proposed for release, Known planned developments or changes concerning land use in the region that may affect the environmental impact of the release.
INFORMATION CONCERNING THE INTERACTIONS BETWEEN GMOs AND THE ENVIRONMENT Characteristics affecting survival, reproduction and spread Biological characteristics affecting survival, reproduction and spread, Known or estimated environmental conditions that may affect survival, reproduction and spread (such as wind, water, soil, heat, pH), Specific factors to which there is sensitivity. Interactions with the environment The foreseen habitat of the GMOs, Studies concerning the behaviour and characteristics of the GMOs and their ecological effects, carried out in artificially created living environments, growth chambers, greenhouses and other simulated natural environments, Ability to transfer genetic material: Transfer of genetic material from the GMOs to organisms in the affected ecological systems after release; Transfer of genetic material from local organisms to the GMOs after release; The possibility of post-release selection leading to the emergence of unexpected and/or undesired characteristics in the modified organism, Measures applied in order to ensure and confirm genetic stability. Description of the genetic characteristics that may prevent or minimize the spread of genetic material, methods for verifying genetic stability, Biological routes of spread; known or potential forms of interaction with the dispersal agent, including respiration, digestion, surface contact and nesting, Description of the ecological systems into which the GMOs may spread, The potential for excessive population increase in the environment, The competitive advantage of the GMOs in relation to the unmodified recipient or parent organism or organisms, Identification and description of the target organisms, The foreseen mechanism and outcome of the interaction between the released GMOs and the target organism or organisms, Identification and description of the non-target organisms that may be adversely affected by the release of the GMO, and the foreseen mechanism of any identified adverse interaction, The possibility of post-release change in biological interactions or in the host range, Known or estimated interactions with non-target organisms present in the environment, including competitors, prey, hosts, symbiotic organisms, predators, parasites and pathogens, Known or estimated involvement in biogeochemical processes, Other potential interactions with the environment.
INFORMATION ABOUT MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY PLANS Monitoring techniques Methods for following up the GMOs and monitoring their effects, The specificity, sensitivity and reliability of the monitoring techniques used to identify the GMOs and to distinguish them from the donor, recipient and, where appropriate, parent organisms, Techniques for detecting the transfer of the given genetic material to other organisms, The duration and frequency for which monitoring will continue. Control of the release Methods and procedures for preventing and/or minimizing the spread of the GMOs beyond the release site or the area designated for use, Methods and procedures for protecting the release site from violations by unauthorized individuals, Methods and procedures for preventing other organisms from entering the site. Waste treatment The type of waste produced, The expected quantity of waste, Description of the foreseen treatment. Emergency plans Methods and procedures for controlling the GMOs in the event of unexpected spread, Methods for cleaning the affected areas, for example for the destruction of the GMOs, Methods for the disposal or restoration to a healthy state of the plants, animals and soils exposed during or after the spread, Methods for isolating the area affected by the spread, Plans for the protection of human health and the environment in the event that undesired effects occur.

*: The information in this part will be provided after the application is accepted for Experimental Release applications.

Page 1

ANNEX-3

INFORMATION TO BE REQUESTED IN APPLICATIONS CONCERNING THE EXPERIMENTAL RELEASE OF GENETICALLY MODIFIED PLANTS (GMP)

GENERAL INFORMATION Name and address of the applicant Field of activity of the applicant Name, qualifications and experience of the responsible persons Institutional technical capacity of the applicant Unique identifier number Intended purpose of use of the GMP
A. INFORMATION CONCERNING THE RECIPIENT AND PARENT PLANTS Full name: Family name, Genus, Species, Subspecies, Name or identification information of the variety or line, Common name. Information concerning reproduction: The mode or modes of reproduction, Specific factors affecting reproduction if any, The lifespan of a generation. Survival: The ability to form structures for survival or dormancy, Specific factors affecting survival. Spread: The routes and degree of spread (for example, information on whether fertile pollen and/or seeds decrease according to increasing distances, and if they decrease, how they decrease) Specific factors affecting spread. The geographic distribution of the plant. For plant species not grown in Turkey, the description of the natural habitat of the plant, including information about its natural pests, parasites, competitors and symbiotic organisms. In connection with the GMO, information about the potential interaction of the plant with the organisms in the ecological system where it is usually grown or in another one, including information about toxic effects on humans, animals and other organisms.
INFORMATION CONCERNING THE MODIFICATION IN THE GENETIC STRUCTURE Information about the methods used to make the modification in the genetic structure. The nature and source of the vector used. The size and source (name) of the donor organism or organisms and the intended function of each part forming the region intended to be used for insertion.
INFORMATION CONCERNING THE GENETICALLY MODIFIED PLANT Information about the characteristic or characteristics inserted or modified and their traits. Information about the sequences actually inserted or deleted Methods used for the characterization of the size and structure of the insert; information about the parts of the vector inserted into the GMP or about any remaining carrier or foreign DNA fragment in the GMP, In the case of deletion, the size and function of the deleted region or regions, The copy number of the insert, The locations of the inserts in the plant cells (maintained with or without addition to the chromosome, chloroplasts, mitochondria) and methods for their detection. Information about the expression of the insert: Information about the developmental expression of the insert throughout the life cycle of the plant and the methods used for its characterization; The parts of the plant in which the insert is expressed (for example roots, stem, pollen) Information about how the genetically modified plant differs from the recipient plant in terms of the following: The mode/modes and/or rate of reproduction, Spread, Survival. The genetic stability of the insert and the phenotypic stability of the GMP. Any change in the ability of the GMP to transfer genetic material to other organisms. Information about any toxic, allergic and other harmful effects on human health arising from the modification made in the genetic structure. Information about the safety of GMPs concerning animal health; in particular where the GMP is intended to be used in feeds, concerning any toxic, allergic or other harmful effects arising from the modification in the genetic structure. The interaction mechanism between the genetically modified plant and the target organisms. The potential changes in the interaction of the GMP with non-target organisms arising from the modification in the genetic structure. Potential interactions with the abiotic environment. Description of the detection and diagnosis techniques for the genetically modified plant. Information about previous releases of the genetically modified plant.
INFORMATION CONCERNING THE RELEASE SITE* The location and size of the release site. Description of the ecosystem of the release location, including climate, flora and fauna. Proximity to officially recognized biotypes or protected areas that may be affected.
INFORMATION CONCERNING THE RELEASE The purpose of the release. The foreseen date or dates of the release and the duration for which it will continue. The method to be used when genetically modified plants are released. Methods for preparing and managing the release location before, during and after the release, including planting practices and harvesting methods. The approximate number of plants (or plants per m2).
INFORMATION ABOUT CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS Any precautionary measure taken: measures to prevent the dispersal of any organ of the GMP capable of reproduction (for example pollen, seeds, tuber) Description of the methods for the treatment of the site after release. Description of the methods for the post-release disposal of the genetically modified plant material, including wastes. Description of the monitoring plans and techniques. Description of any emergency plan. Methods and procedures for protecting the site.

*: The information in this part will be provided after the application is accepted for Experimental Release applications.

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