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Registration of trans genetically engineered plant varieties

 Registration of genetically engineered crop varieties is one of the essential steps to ensure the safety and effectiveness of plants that have been genetically modified. This process is carried out under the supervision of the National Committee for Biosafety, specifically the Committee for Registration of Agricultural Crops Varieties. This Committee aims to evaluate and examine crops to ensure their compliance with environmental and health standards, which contributes to protecting biodiversity and enhancing food security. In this article, we shall present the most important documents and procedures required to complete registration.

Required Documentation:

  • Permit Application Form (Genetically Engineered Crops Trading).

Required Procedures:

  1. The Company or entity wishing to trade in genetically engineered crop varieties obtains Permit Application from the Secretariat of the National Biosafety Committee, located at the Agricultural Genetic Engineering Research Institute, Agricultural Research Center, 9 Cairo University Street, Giza (12619).
  2. The applicant completes the Permit Application, which includes information about the genetically engineered material (in this case: crops), such as a detailed description of the genes or genetic material introduced into the variety, the method used in the genetic editing process, and other basic data detailed in the application. The applicant shall submit all studies that confirm the level of biosafety of the crop variety in terms of environmental and food safety and the lack of any kind of endangerments to humans, animals, plants, or the environment in all aspects; as well as an evidence of use of the crop variety in the country of origin.
  3. After the Secretariat of the National Biosafety Committee receives the application, it is presented to the National Biosafety Committee at the first meeting following the date of its submission, for consideration and deciding on whether or not to approve the trading permit, and the level of its circulation: (open field test, limited field test, or greenhouse test).
  4. If the National Biosafety Committee approves the trading of the crop variety and its circulation, the following procedures shall be taken:
  • If the genetically engineered plant variety was produced outside Egypt, and the foreign entity producing it or its representative in Egypt wishes to begin testing the variety within the limits of the trading level approved by the National Biosafety Committee, then this entity must obtain approval to import a limited quantity of the plant variety (usually seeds) in preparation for conducting tests (field trials) within the limits of the permitted trading level, by following the following methods:
  • If the genetically engineered crop variety was produced outside Egypt, and the foreign producer or its representative in Egypt wishes to test it within the limits of the trading level approved by the National Biosafety Committee, then they obtain the approval to import a limited quantity of the crop variety (usually seeds) to conduct tests (field trials) within the limits of the permitted trading level, through the following procedures:
  • The foreign producer or its representative in Egypt shall submit a request for approval to import a limited quantity of genetically engineered seeds, to the Supreme High Committee of Food Safety at the Ministry of Health, which is the competent authority for importing; after this request has been approved by the National Biosafety Committee. The request may be in the form of a Transfer Agreement Material or any other form, provided that it is clear and defined.
  • After the approval of the Supreme High Committee of Food Safety, and tests begin within the limits of the approved trading level, the National Committee for Biosafety has the right to inspect the tests – either at its own discretion or through official assignment by the Agricultural Engineering Research Institute, or the Agricultural Research Center – at any time to verify the safety of the application and adherence to the approved technical standards. The Committee may also take samples of the genetic material to conduct tests at the molecular level to confirm the nature of the genes introduced into the crop variety, as well as to reveal the degree to which these genes are shown.
  1. After the applicant completes the field tests (limited/open) under Egyptian conditions and verifies all biosafety and environmental considerations, and in case it wishes to trade this variety commercially, it can directly submit a registration request to the Secretariat of the Varieties Registration Committee at the Ministry of Agriculture and Land Reclamation after completing the relevant forms, which can be obtained from the Secretariat Office at the Central Administration for Seed Inspection and Certification at the Agricultural Research Center.

Registration Conditions 

  1. In order to register agricultural crop varieties and their hybrid parents, a genetic fingerprint must be made for them. A fingerprint copy shall be kept at the Registration Committee Secretariat, and another copy at the competent accreditation authority, for reference when necessary and to verify the identity of the variety during the stages of accreditation.
  2. The Technical Testing Committee shall undertake the genetic fingerprinting of the variety with the assistance of one of the equipped entities that has the necessary scientific and technical capabilities. 
  3. The registration applicant shall bear the costs of the genetic fingerprinting determined by the Agricultural Crops Varieties Registration Committee, and shall pay to its Secretariat in favor of the assistance entity that performs the genetic fingerprinting.

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