(1) The food business operator (manufacturer/importer) of a GM-food shall submit an application as per the format prescribed by the Food Authority along with necessary documents and fee to the Food Authority.
(2) If the application is for a GMO referred to as in clause (a) of sub-regulation (2) of regulation 1, clearance from Genetic Engineering Appraisal Committee (GEAC), the national competent authority for the environmental risk assessment shall be submitted to the Food Authority.
(3) If a GMO referred to as in clause (a) of sub-regulation (2) of regulation 1 is to be used as seeds or other plant-propagating material (cultivation), food business operator shall parallelly submit an application to the for compliance to Rules 1989 for ‘The manufacture, use, import, export and storage of hazardous micro-organisms, genetically engineered organisms or cells rules, 1989. The application may be submitted in the relevant Form IIB, Application for environmental approval of transgenic plants (Genetically Modified Plants) of GEAC.
(4) In order to prepare its opinion, the Food Authority shall verify that the particulars and documents submitted by the applicant are in accordance with the information sought and examine whether the food is safe for human consumption.
(5) The Food Authority may direct the applicant to submit additional supporting documents, data or clarifications, if required, within a specific time limit.
(6) In giving its decision, the Food Authority shall endeavour to respect a time limit not exceeding six months from the receipt of a valid application. Such a time limit shall be extended whenever supplementary information from the applicant as provided for in sub-regulation (4) of regulation 4 is sought.
(7) The Food Authority may either grant approval or reject the application as per the format prescribed by the Food Authority on the basis of the safety assessment of the food.
(8) The food business operator shall, after grant of approval obtain a license as per the procedure specified in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
(9) After an approval has been issued in accordance with this Regulation, the authorised holder and the parties concerned shall comply with any conditions or restrictions which have been imposed in the approval and shall in particular make sure that products not covered by the approval are not placed on the market as food.
(10) The food business operator may file an appeal before the Chairperson of the Food Authority, within 30 days of receiving the letter of rejection.
(11) The Food Authority may, for reasons to be recorded in writing, suspend or revoke any approval granted to any food business operator.
(12) If a food business operator has reason to believe that the GM-food for which the approval was granted poses any risk to health, he shall immediately suspend the manufacture, import, sale, or distribution of such an article of food and take steps to recall the same under intimation to Food Authority in accordance with the provisions of the Food Safety and Standards (Food Recall Procedure) Regulations, 2017.
(13) A GMO, with a ‘Unique Identifier Nine-digit Code' of the Organisation for Economic Cooperation and Development (OECD) that is approved for food use by the Food Authority, will require no further approvals. However, if the GMO is to be used as seed or other plant-propagating material, approval is required from GEAC.
(14) GMOs as referred to in clause (a) and (b) of sub-regulation (2) of regulation 1 shall not be used as ingredients in infant foods.