Food Irradiation Regulation

Authority: Ministry of Agriculture and Forestry
Approval Date: 03.10.2019
Official Gazette Date: 03.10.2019
Official Gazette No: 30907

CHAPTER ONE: Purpose, Scope, Basis and Definitions

Purpose

ARTICLE 1 - (1) The purpose of this Regulation is to determine the procedures and principles regarding the irradiation of food and food components with ionizing radiation in irradiation facilities, the marketing of irradiated food and food components, and their official controls.

Scope

ARTICLE 2 - (1) This Regulation covers the registration procedures of irradiation enterprises that have obtained an operating license certificate and the procedures and principles regarding the irradiation of food and food components with ionizing radiation in these facilities, the marketing of irradiated food and food components, and official controls.

(2) The provisions of this Regulation do not cover;

  • a) Foods exposed to ionizing radiation produced by measurement and control devices at maximum radiation energy levels of 10 MeV for X-rays, 14 MeV for neutrons, and 5 MeV in other cases, provided that the absorbed dose does not exceed 0.01 Gy for neutron-using control devices and 0.5 Gy for others,
  • b) Irradiated foods prepared for patients requiring sterile diets under medical supervision.

Basis

ARTICLE 3 - (1) This Regulation has been prepared based on the Veterinary Services, Plant Health, Food and Feed Law No. 5996 dated 11/6/2010 and the Decree Law No. 702 dated 2/7/2018 on the Organization and Duties of the Nuclear Regulatory Authority and Amendments to Some Laws.

Definitions

ARTICLE 4 - (1) In this Regulation;

  • a) Ministry: Ministry of Agriculture and Forestry,
  • b) Pest control: The elimination or reduction to ineffectiveness of the viability and reproductive activities of incidental insect eggs and larvae in foods,
  • c) Dose: The amount of ionizing radiation energy (Joule) transferred to a unit mass (kg) of a specific material (J/kg),
  • ç) Dosimetry: The method of measuring the absorbed radiation dose using dosimeters,
  • d) Dosimeter: A device or material with a reproducible, measurable response to radiation, used to measure the absorbed dose in a system,
  • e) General average absorbed dose: The average dose value calculated from the dose distribution determined by placing a sufficient number of dosimeters at strategic (points of minimum and maximum dose) and/or random points throughout the entire volume of irradiated products,
  • f) Food irradiation: Exposing foodstuff to ionizing radiation at a sufficient dose for a desired technological purpose and method,
  • g) Gray (Gy): Unit of absorbed ionizing radiation dose (1 Gray = 1 J/kg),
  • ğ) Irradiation facility: Buildings and additional structures containing sources, equipment, and systems designed and licensed for the safe irradiation of food with an appropriate radiation source,
  • h) Irradiation enterprise: Enterprises operating under the Food Enterprises Registration and Approval Regulation published in the Official Gazette No. 28145 dated 17/12/2011 and performing irradiation processes, as well as enterprises deemed appropriate by the Ministry for import purposes within the scope of this Regulation,
  • ı) License certificate: Authorization certificate issued by the Nuclear Regulatory Authority for the operation of irradiation facilities,
  • i) MeV: Million electron volt energy unit,
  • j) Microorganism: Bacteria, viruses, yeasts, molds, algae, parasitic protozoa, microscopic parasitic helminths,
  • k) NRA: Nuclear Regulatory Authority,
  • l) TAEK: Turkish Atomic Energy Authority.

CHAPTER TWO: Radiation Sources, Licensing and Registration Procedures, and Irradiation Enterprises

Radiation sources

ARTICLE 5 - (1) Foods may only be subjected to the following ionizing radiation sources:

  • a) Gamma rays emitted from sealed radioactive sources Cobalt-60 (Co-60) and Cesium-137 (Cs-137).
  • b) X-rays obtained from irradiators operating at 5 MeV or lower energy.
  • c) Electron beams obtained from irradiators operating at 10 MeV or lower energy.

Licensing and registration procedures

ARTICLE 6 - (1) Natural and legal persons who want to establish a food irradiation enterprise are obliged to obtain, respectively;

  • a) Operating license certificate from the NRA to operate the irradiation facility,
  • b) Enterprise registration certificate from the Ministry according to the Food Enterprises Registration and Approval Regulation.

Irradiation enterprises

ARTICLE 7 - (1) Food irradiation enterprises are obliged to comply with the provisions of the NRA legislation regarding the authorization of radiation facilities and applications in terms of radiation safety.

(2) Irradiation facilities must use one of the radiation sources specified in Article 5, have the necessary technological equipment, and be constructed in accordance with radiation safety and hygienic conditions.

(3) In irradiation enterprises;

  • a) Personnel employed in food irradiation must be provided with training on this subject,
  • b) Records of process control parameters during food irradiation and dosimetric measurements must be kept and preserved,
  • c) Records specified in Article 10 must be kept and preserved,
  • ç) To distinguish whether foods have been irradiated or not, an indicator that changes color upon irradiation must be affixed to the packaging of the food to be irradiated, which is mandatory.

CHAPTER THREE: Principles of Food Irradiation, Re-irradiation, and Records to be Kept

Principles of food irradiation

ARTICLE 8 - (1) Food irradiation shall be carried out according to the following principles:

  • a) At a specified irradiation dose for one or more of the purposes of preventing foodborne diseases, destroying spoilage-causing microorganisms, preventing or delaying decay, preventing food spoilage and extending product shelf life, reducing food losses due to sprouting, germination, and ripening, and inactivating organisms harmful to plants or plant products, under appropriate technological and hygienic conditions.
  • b) The necessary conditions for food irradiation are specified in ANNEX-1.
  • c) General hygiene rules specified in the Food Hygiene Regulation published in the Official Gazette No. 28145 dated 17/12/2011 shall be observed before, during, and after the irradiation process.
  • ç) The food to be irradiated and the materials and substances it contacts must comply with the provisions of the Turkish Food Codex Regulation published in the Official Gazette No. 28157 dated 29/12/2011 (third repeated issue) and be suitable for the irradiation process.
  • d) Radiation sources specified in Article 5 of this Regulation shall be used in the irradiation process.
  • e) The general average absorbed dose applied to the food shall be determined within the dose limits appropriate to the food group included in ANNEX-2 and the technological purpose.
  • f) The general average absorbed dose is calculated according to ANNEX-4 and the obtained value shall not exceed the maximum general average absorbed dose specified in ANNEX-2.
  • g) The dosimetric method used must comply with national/international standards.
  • ğ) The irradiation process may also be applied in partial doses. However, the total maximum general average absorbed dose must not be exceeded.
  • h) Any chemical treatment to be applied for the same purpose as food irradiation cannot be used together with the irradiation process.

Re-irradiation

ARTICLE 9 - (1) Re-irradiation may be performed only on low moisture content foods such as cereals, legumes, dried fruits irradiated solely for the purpose of pest control.

(2) The total doses applied in re-irradiation shall not exceed the maximum general average absorbed dose for the respective food group specified in ANNEX-2.

(3) The following situations are not considered re-irradiation of food:

  • a) Foods irradiated at low doses for quarantine purposes or for non-food safety purposes such as preventing sprouting of roots and tubers, and foods produced from these materials.
  • b) Irradiation of foods containing less than 5% irradiated components.
  • c) Partial dose irradiation specified in subparagraph (ğ) of the first paragraph of Article 8.

Records to be kept

ARTICLE 10 - (1) In irradiation enterprises, records for each batch of irradiated food shall be kept and preserved for at least 5 years, including the following:

  • a) Name, nature, and quantity of the irradiated food.
  • b) Batch number or expiration date/recommended consumption date provided by the enterprise requesting irradiation.
  • c) Process tracking number given by the irradiation enterprise.
  • ç) Food operator requesting the irradiation process.
  • d) Food operator receiving the irradiated food.
  • e) Date of irradiation.
  • f) Packaging material and form used during irradiation.
  • g) Data related to the control of the irradiation process, dosimetric controls performed, and especially details of the minimum and maximum limits, absorbed dose, type of ionizing radiation, and obtained results.
  • ğ) References related to initial dose validation measurements.

CHAPTER FOUR: Labeling, Transportation and Storage

Labeling

ARTICLE 11 - (1) Irradiation enterprises are obliged to issue a document indicating that the irradiation process has been performed. This document contains the information specified in subparagraphs (a), (b), (c), (ç), (d), (e), and (f) of the first paragraph of Article 10. This information appears on the packaging of the irradiated food or commercial documents during storage and transportation. This document is transferred to the operator requesting the irradiation along with the food.

(2) Labels of foods covered by this Regulation shall comply with the provisions of the Turkish Food Codex Food Labeling and Consumer Information Regulation published in the Official Gazette No. 29960 (repeated issue) dated 26/1/2017. In addition to the Turkish Food Codex Food Labeling and Consumer Information Regulation, the following rules shall be observed:

  • a) For foods offered to the final consumer or mass consumption places;
    • 1) On prepackaged irradiated foods, the expression "Irradiated" or "Irradiation process applied" and the green international food irradiation symbol "Radura" given in ANNEX-3 must be clearly visible on the main display area of the label,
    • 2) On irradiated foods sold without being prepackaged, the expression "Irradiated" or "Irradiation process applied" and the green international food irradiation symbol "Radura" given in ANNEX-3 must be on the label or accompanying commercial documents.
  • b) At the point of sale, for irradiated foods packaged upon consumer request or prepackaged for direct sale, the expression "Irradiated" or "Irradiation process applied" must be displayed in places visible to the purchaser or provided together with the food.
  • c) For foods not offered to the final consumer or mass consumption places, subparagraphs (1) and (2) of paragraph (a) apply.
  • ç) If the food contains an irradiated ingredient, the expression "Irradiated" or "Irradiation process applied" must appear immediately after the irradiated ingredient in the ingredient list on the label.
  • d) If the food contains an irradiated compound ingredient, the exceptions regarding the declaration of compound ingredients in Annex-4 Section 5 of the Turkish Food Codex Food Labeling and Consumer Information Regulation do not apply. Even if this compound ingredient is less than 2% in the final product, the expression "Irradiated" or "Irradiation process applied" must be indicated immediately after the irradiated ingredient in the ingredient list to emphasize the presence of the irradiated ingredient.

Transportation and storage rules

ARTICLE 12 - (1) The provisions of the Turkish Food Codex Regulation regarding the transportation and storage of foods shall apply to the transportation and storage of foods within the scope of this Regulation.

CHAPTER FIVE: Miscellaneous and Final Provisions

Traceability

ARTICLE 13 - (1) Food operators are responsible for ensuring traceability at all stages related to the supply of raw materials, import, export, production, processing, and marketing of irradiated food.

Official controls, import procedures

ARTICLE 14 - (1) Official controls are carried out by the Ministry within the scope of Law No. 5996, the Food and Feed Official Controls Regulation published in the Official Gazette No. 28145 dated 17/12/2011, and this Regulation.

(2) Inspection of irradiation facilities in terms of radiation safety is carried out by the NRA according to the legislation on authorization and inspection of radiation facilities and applications.

(3) Analyses related to food irradiation shall be performed in laboratories determined by the Ministry or TAEK laboratories according to nationally or internationally accepted analytical methods.

(4) Import of irradiated food or foods containing irradiated components is permitted only if the irradiation process is performed in irradiation enterprises approved by the Ministry. The criteria for approval and the list of approved irradiation enterprises are published on the Ministry's website.

(5) Irradiation enterprises approved by the European Union are accepted as approved irradiation enterprises by the Ministry and added to the list mentioned in the fourth paragraph. These enterprises may be subject to on-site inspection when deemed necessary.

(6) Determination of compliance criteria and related inspections mentioned in the fourth and fifth paragraphs are carried out in cooperation between the Ministry and relevant institutions.

(7) At the import stage, it is mandatory to present the name and address of the enterprise performing the irradiation process referred to in the fourth and fifth paragraphs and the documents specified in Article 10.

Administrative sanctions

ARTICLE 15 - (1) Administrative sanctions shall be applied to those who act contrary to this Regulation according to the relevant articles of Law No. 5996.

Compliance with European Union legislation

ARTICLE 16 - (1) This Regulation has been prepared taking into account the European Parliament and Council Directives No. 1999/2 dated 22/2/1999 on the approximation of laws of Member States relating to irradiated food and food ingredients and No. 1999/3 dated 22/2/1999 on the establishment of a Community list of irradiated food and food ingredients.

Repealed legislation

ARTICLE 17 - (1) The Food Irradiation Regulation published in the Official Gazette No. 23868 dated 6/11/1999 has been repealed.

Transitional provisions

PROVISIONAL ARTICLE 1 - (1) Food operators operating before the publication date of this Regulation must comply with the provisions of this Regulation by 31/12/2020.

(2) Food operators operating before the publication date of this Regulation must comply with the provisions of the repealed Food Irradiation Regulation until they comply with the provisions of this Regulation.

Entry into force

ARTICLE 18 - (1) This Regulation enters into force on the date of its publication.

Execution

ARTICLE 19 - (1) The provisions of this Regulation shall be executed by the Minister of Agriculture and Forestry.

NOTE: FOR ANNEXES, PLEASE REFER TO THE OFFICIAL GAZETTE