THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 ARRANGEMENT OF REGULATIONS REGULATION PART I PRELIMINARY PROVISIONS 1. 2. Short Title Objective 3. 4. 5. Definitions Scope General Provisions 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. PART II HANDLING APPLICATIONS Application for permit Confidentiality Advertisement of Application Representations Modification of application or new information before decision Procedure after Receipt of Application Power to request additional Information Consideration of Application Permit Renewal of Permit Power to modify, suspend or cancel the Permit Communication of Decision to Suspend Permit PART III PART II: LABELING OF GENETICALLY MODIFIED FEEDS 18. 19. 20. Scope Labeling Requirements Status of Existing Products PART III MISCELANEOUS 21. 22. 23. 24. 25. Public Access Data Protection Emergency Measures Measures to Avoid the Unintended Presence of Genetically Modified Organisms Responsibilities of food or feed business operators The First Schedule: Information Relating to genetically modified food or feed The Second Schedule: Application Form The Third Schedule: The Permit DRAFT-20 OCTOBER 2014 1 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD OR FEED) REGULATIONS, 2014 LEGAL Notice No………… In exercise of the powers conferred by the section49 of the Biosafety Act, the Minister responsible for Science and Technology makes the following RegulationsTHE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD OR FEED) REGULATIONS, 2014 PART 1- PRELIMINARY Regulation 1: Short Title These Regulations may be cited as the Biosafety (Placing on the Market of a Genetically Modified Food or Feed) Regulations, 2014 Regulation 2: Objective The objective of this Regulation is to(a) provide the basis for ensuring a high level of protection of human and animal life, health and welfare, the environment and consumer interests in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market; (b) lay down procedures for the permit and supervision of genetically modified food and feed; (c) lay down provisions for the labeling of genetically modified food and feed. Regulation 3: Definitions For the purposes of this Regulation: ‘control sample’ means the genetically modified organism or its genetic material (positive sample) and the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample); ‘conventional counterpart’ means a similar food or feed produced without the help of genetic modification and for which there is a well-established history of safe use; ‘feed’ means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals; DRAFT-20 OCTOBER 2014 2 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 ‘food’ means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans; ‘genetically modified food’ means food containing, consisting of or produced from genetically modified organisms; ‘genetically modified feed’ means feed containing, consisting of or produced from genetically modified organisms; ‘genetically modified organism for food use’ means a genetically modified organism that may be used as food or as a source material for the production of food; ‘genetically modified organism for feed use’ means a genetically modified organism that may be used as feed or as a source material for the production of feed; ‘operator’ means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the food businesses or feed businesses under its control; ‘produced from genetically modified organisms’ means derived, in whole or in part, from genetically modified organisms; ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer. ‘pre-packaged food’ means any single or multiple item(s) for presentation as such consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, provided that the contents cannot be altered without opening or changing the packaging. PART II- HANDLING APPLICATIONS Regulation 4: Scope (1) These Regulations shall apply to: (a) Genetically modified organisms for food or feed use; (b) food or feed containing or consisting of genetically modified organisms; (c) food or feed produced from or containing ingredients produced from genetically modified organisms. (d) food or feed additives containing, consisting of or produced from genetically modified organisms. DRAFT-20 OCTOBER 2014 3 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (e) feed intended for animals that are destined for food production. (2) These Regulations do not apply to products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal plants; Regulation 5: General Provisions (1) Where a product is likely to be used both for food and feed purposes, the Minister shall not grant a permit for single use but shall grant a permit only where the applicant has fulfilled the requirements for both food and feed. (2) Where a permit has been issued for a genetically modified organism to be used in the production of food or feed, food or feed containing, consisting of or produced from that genetically modified organism will not need a permit under these regulations. Regulation 6: Application for a permit (1) Genetically modified food or feed shall not(a) have adverse effects on human health, animal health or the environment; (b) where it is a food, mislead the consumer; (c) where it is a feed, mislead a user; (d) differ from the food that it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer. (2) No person shall place on the market a genetically modified organism for food or feed use without a permit issued by the Minister in accordance with these regulations. (3) An application for a permit shall be made to the Minister in the form set out in the First Schedule to these Regulations and shall be accompanied by the following information(a) the name and the address of the applicant; (b) the designation of the food or feed and its specification, including the transformation event(s) used; (c) where applicable, a detailed description of the method of production and manufacturing; DRAFT-20 OCTOBER 2014 4 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (e) a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that the food or feed complies with the requirements referred to in regulation 4(1); (f) either an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics or a proposal for labeling the food or feed; (g) either a reasoned statement that the food or feed does not give rise to ethical or religious concerns, or a proposal for labeling; (h) where appropriate, the conditions for placing on the market the food or feed, including specific conditions for use and handling; (i) methods for detection, sampling (including references to existing official or standardized sampling methods) and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it, or feed; (j) samples of the food or feed and their control samples, and information as to the place where the reference material can be accessed; (k) where appropriate, a proposal for post-market monitoring regarding use of the food for human consumption or feed for animal consumption; (l) a summary of the dossier in a standardized form. (4) In the case of genetically modified organisms or food or feed containing or consisting of genetically modified organisms, the application shall also be accompanied by: (a) the complete technical dossier supplying the risk assessment where the placing on the market of the genetically modified organism has been authorized a copy of the a permit decision; (b) a monitoring plan for environmental effects conforming including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent. (5) The applicant may, in making an application, refer to data or results from an application previously given by another applicant provided that the data or results are not Confidential Commercial Information or that the said other applicant has agreed in writing to such reference and a copy of this agreement is included in the application. Regulation 7: Confidentiality DRAFT-20 OCTOBER 2014 5 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (1) An applicant may indicate which information submitted such applicant wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. (2) The Council shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision. (3) The following information shall not be considered confidential(a) name and composition of the genetically modified food or feed and, where appropriate, indication of the substrate and the micro-organism; (b) general description of the genetically modified organism and the name and address of the a permit-holder; (c) physical, chemical and biological genetically modified food or feed; characteristics of the (d) effects of the genetically modified food or feed on human and animal health and on the environment; (e) effects of the genetically modified food or feed referred on the characteristics of animal products and its nutritional properties; (f) methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed; (g) information on waste treatment and emergency response. (4) The Council shall take the necessary measures to ensure appropriate confidentiality of the information received under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment. (5) If an applicant withdraws or has withdrawn an application, the Council, shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information as to the confidentiality of which the Authority and the applicant disagree. Regulation 8: Advertisement of application (1) An applicant shall advertise once a week for two consecutive weeks with to be published in at least two newspapers circulated widely in Namibia a notice with the heading “PROPOSED PLACING ON THE DRAFT-20 OCTOBER 2014 6 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 MARKET OF A GENETICALLY MODIFIED ORGANISM FOR FOOD OR FEED” and containing the following information— (a) the name and address of the applicant; (b) the description of the genetically modified organism proposed to be placed on the market (c) the fact that an application has been submitted to the Council, and the purpose of the genetically modified organism. (d) the fact that further information on the placing on the market may be obtained from the Council, (e) the full title and address of the Council; (f) an invitation to the public to make written submissions in relation to the application; (g) the closing date for submissions, which shall not be earlier than fourteen days after the date of the last publication of the advertisement I the newspapers. Regulation 9: Representations (1) Any person may, within fourteen days beginning on the day of the last publication of the advertisement in the newspaper, make representations to the Council in relation to the application. (2) Representations under sub-Regulation (1) shall be made to the Council at its headquarters and the Council shall reduce the representation in writing; (3) The Council shall take into consideration the relevant comments submitted by the public in determining the application. Regulation 10: Modification of application or new information before decision (1)An applicant may modify an application before the Minister makes a final decision where (a) there is a modification of the proposed placing on the market; or (b) new information relevant to the proposed placing on the market; and (c) which could have consequences for the risks to human health, animal health or the environment. (2) Where the Council receives an amended application it shall deal with the amended application as if it were a new application in relation to the proposed placing on the market. DRAFT-20 OCTOBER 2014 7 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 Regulation 11: Procedure after receipt of application On receipt of an application the Council shall(a) evaluate the risk assessment and risk management plan submitted by the applicant; (b) invite submissions from the relevant institutions and agencies in relation to the application; (c) invite submissions from the public in relation to the application. (d) Within thirty days of receipt of the submissions from the relevant institutions, agencies and the public, submit its report and recommendations to the Minister for the final decision. Regulation 12: Power to request further information. (1) Where the Minister requests the Council for additional information, the Council shall in turn request the applicant to provide further information on the proposed placing on the market of a genetically modified organism. (2) Where the Council requests further information from an applicant, it shall give its reasons in writing for so doing. Regulation 13: Consideration of application (1) The Minister shall, within thirty days of receipt of a recommendation from the Council or thirty days after receipt of additional information, make a decision on the application. (1) The Minister’s decision may be either to grant a permit or refuse to grant a permit. (2) Where the Minister grants a permit, the Minister may, with due regard to the recommendations of the Council, impose conditions to which the permit is subject, in addition to such other condition as may be imposed by any other relevant institution or agency. (3) The Minister shall communicate his decision in writing, to the Council and to the applicant. (4) Where an application is denied, the Minister shall communicate his decision and the reasons for such refusal. Regulation 14: Permit (1) Where an application is granted, The Registrar shall issue the applicant with a permit. DRAFT-20 OCTOBER 2014 8 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (2) Every permit shall be in the form set out in the Second schedule to these Regulations and shall specify(a) the genetically modified organism to be placed on the market; (b) the conditions imposed; and (c) the validity period of the permit. (2) A permit granted under these Regulations shall be valid for 10 years and shall be renewable once. (3) The details of the authorized food or feed shall be entered in the Register. (4) Each entry in the Register shall mention the date of a permit and shall include the following particulars(a) the name and address of the applicant; (b) the designation of the food or feed, and its specification; (c) where applicable, the information required under the First Schedule to these Regulations; (d) the proposal for the labeling of the food and/or foods produced from it, or feed; (e) where applicable, any conditions or restrictions which should be imposed on the placing on the market and specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment and conditions for the protection of particular ecosystems and geographical areas; (f) the method for detection, including sampling, identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and in foods produced from it, or feed; an indication of where appropriate reference material can be accessed; (g) where appropriate a monitoring and evaluation plan. (6) The granting of a permit shall not lessen the general civil and criminal liability of any food operator in respect of the food concerned. Regulation 15: Renewal of a permit (1) A permit holder may renew a permit at the latest one year before the expiry date of the permit. (2) The application for the renewal of a permit shall be made to the Council and shall be accompanied by the following: (a) a copy of the permit for placing the food or feed on the market; DRAFT-20 OCTOBER 2014 9 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (b) a report on the results of the monitoring and evaluation, if so specified in the a permit; (c) any other new information which has become available with regard to the evaluation of the safety in use of the food or feed and the risks of the food or feed to the consumer, animal health or the environment; (d) where appropriate, a proposal for amending or complementing the conditions of the original a permit, inter alia the conditions concerning future monitoring. Regulation 16: Power to modify, suspend or cancel the Permit (1) Where the Minister has issued a permit to the applicant and the Council— (a) becomes aware of information which, in its view, could have significant consequences for the risks to human health, animal health or the environment, or (b) is notified of a proposed modification or (c) is informed of an unintended change or new information relevant to the genetically modified organism the Minister may, on the recommendation of the Council, (a) require the Permit Holder to comply with the conditions on he permit; (b) modify, suspend or cancel the permit. (2) The Council shall communicate the Minister’s decision to modify, suspend or cancel the permit, to the permit holder within seven days of such decision. (3) Once the Minister has, on the recommendation of the Council suspended a permit, the permit holder shall, ensure that the necessary conditions are complied with before the resumption of the placing on the market. Regulation 17: Communication of decision to suspend a Permit The Council shall, within seven days communicating the Minister’s decision to modify, suspend or cancel the permit, publish a notice in at least two newspaper of nationwide circulation, to inform the public of its decision to modify, suspend or cancel the permit. PART III LABELLING Regulation 18: Scope of the Part DRAFT-20 OCTOBER 2014 10 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (1) This section shall not apply to food or feed containing material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 0.9 percent of the food or feed and of each food or feed of which it is composed, provided that this presence is adventitious or technically unavoidable. (2) Genetically modified food and feed material that may be present in conventional food and feed as a result of adventitious or technically unavoidable presence during seed production, cultivation, harvest, transport or processing shall not be subject to the labeling requirements of these Regulations, provided that the proportion of this material is no higher than 0.9 percent.. Regulation 19: Labeling Requirement (1) No person shall place a feed on the market unless such feed are clearly labeling in an indelible manner. (2) a label shall contain the following information(a)the words ‘genetically modified (name of the organism)’ shall appear in parentheses immediately following the specific name of the feed; (b) for feed produced from genetically modified organisms, the words ‘ produced from genetically modified (name of the organism)’ shall appear in parenthesis immediately following the specific name of the feed; (c) as specified in the permit, any characteristic or property where a feed may give rise to ethical or religious concerns. (3) The labeling of genetically modified feed under these regulations that do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned. Regulation 20: Status of existing products (1) Products falling within the scope of this Part which have been lawfully placed on the market before the date of commencement of these Regulations, may continue to be placed on the market, used and processed provided that the operators responsible for placing on the market the products concerned shall, within six months after the date of commencement of these Regulations, notify the Council that the products were placed on the market before the date of commencement of these Regulations. (2) Within one year from the date of commencement of these Regulations and after verification that all the information required has been submitted and examined, the products concerned shall be entered in the Register. DRAFT-20 OCTOBER 2014 11 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (3) The Council shall cause the recall or removal, at the expense of the operator of any existing product that does not meet the requirements of these Regulations one year after the commencement of these Regulations. PART IV: MISCELLANEOUS PROVISIONS Regulation 21: Public access The Council shall avail to the public, any information relating to the application for a permit, supplementary information from the applicant, opinions from the public, monitoring reports and information from the a permit holder, excluding confidential information. Regulation 22: Data protection (1) The scientific data and other information in the application dossier may not be used for the benefit of another applicant for a period of 10 years from the date of the a permit, unless the other applicant has agreed with the a permit-holder that such data and information may be used. (2) On the expiry of this 10-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if the applicant can demonstrate that the food or feed for which it is seeking a permit is essentially similar to a food or feed already approved under this Regulation. Regulation 23: Emergency measures (1) Where it is evident that food or feed imported into Namibia is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the operator, the Council, shall immediately adopt one or more of the following measures, depending on the gravity of the situation: (i) suspension of the placing on the market or use of the food in question; (ii) suspension of the placing on the market or use of the feed in question; (iii) laying down special conditions for the food or feed in question; (iv) any other appropriate interim measure; (2) As soon as possible, and at most within 10 working days, the Council shall confirm, amend, revoke or extend the measures taken and the Council shall make the reasons for its decision public without delay. DRAFT-20 OCTOBER 2014 12 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 Regulation 24: Measures to avoid the unintended presence of genetically modified organisms (1) Every operator shall take appropriate measures to avoid the unintended presence of genetically modified organisms in other products. (2) The Council shall gather and coordinate information, observe the developments regarding coexistence and, on the basis of the information and observations, develop guidelines on the coexistence of genetically modified organisms and conventional crops. Regulation 25: Responsibilities of food or feed business operators (1) If a food or Feed business operator considers or has reason to believe that a food or feed which the operator has imported, produced, processed, manufactured or distributed is not in compliance with the requirements of these regulations, the operator(a) shall immediately initiate procedures to withdraw the food or feed in question from the market where the food or feed has left the immediate control of that initial food or feed business operator and inform the Council of the action taken. (b) shall effectively and accurately inform the consumers or users of the reason for its withdrawal, and if necessary, recall from the consumers or users products already supplied to them when other measures are not sufficient to achieve a high level of health protection. (2) A food or feed business operator responsible for retail or distribution activities which do not affect the packaging, labeling, safety or integrity of the food or feed shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the requirements of these regulations and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food or feed, cooperating in the action taken by producers, processors, manufacturers and the Council. (3) A food or feed business operator shall immediately inform the Council if it considers or has reason to believe that a food or feed that it has placed on the market may be injurious to human or animal health. (4) Every food or feed business operator shall inform the Council of the action taken to prevent risks to the final consumer or user and shall not prevent or discourage any person from cooperating, in accordance with the law, with the Council where this may prevent, reduce or eliminate a risk arising from a food or feed. DRAFT-20 OCTOBER 2014 13 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 (5) Every operator shall collaborate with the Council on action taken to avoid or reduce risks posed by a food or feed that they supply or have supplied. DRAFT-20 OCTOBER 2014 14 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 FIRST SCHEDULE R 5 (1)(C); R 6 (5) Information required concerning genetically modified organisms intended for direct use as food or feed (a) The name and contact details of the applicant for a decision for domestic use; (b) The name and contact details of the authority responsible for the decision; (c) Name and identity of the genetically modified organism. (d) Description of the gene modification, the technique used, and the resulting characteristics of the genetically modified organism; (e) Any unique identification of the genetically modified organism; (f) Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety; (g) Centers of origin and centers of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate; (h) Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety; (i) Approved uses of the genetically modified organism; (j) A risk assessment report; (k) Suggested methods for the safe handling, storage, transport and use, including packaging, labeling, documentation, disposal and contingency procedures, where appropriate DRAFT-20 OCTOBER 2014 15 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 SECOND SCHEDULE APPLICATION FORM APPLICATION TO PLACE ON THE MARKET A GENETICLLY MODIFIED FOOD OR FEED 1.0 GENERAL INFORMATION 1.1 APPLICATION TYPE (Tick the appropriate box) New Renewal Amended 1.2 Species Name 1.2.1 Latin Name 1.2.2 Common Name 1.3 Indicate whether any material will be used as feed 1.4 APPLICANT 1.4.1 Name of Applicant 1.4.2 Physical Address f Applicant 1.4.3 Registration Namibia Status in 1.4.4 Telephone Contacts 1.4.5 Facsimile and email 2.0 Description of the Genetically Modified Organism 2.1 Name of the Genetically Modified Food/Feed 2.2 Modified Traits Identification Modified Oil Composition Virus Resistance Nutritional Change Male Sterility/ Restoration Generation of Mutants Pharmaceutical Other (Specify) 2.3 Modified Trait(s) (Describe each specific novel trait associated with this genetically modified organism) 2.4 Characteristics of the Transformed Traits 2.4.1 Spatial and Temporal Expression DRAFT-20 OCTOBER 2014 16 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 Trait Expression 2.4.1.1 Constitutive Yes No If not constitutive, indicate the specific tissues in which he trait is expressed (green tissue, seed, pollen, roots, other) 2.4.1.2 Is the trait expressed during specific developmental stages Yes No If yes, when? 2.4.1.3 Is the trait inducible Yes No If Yes, How? 2.5 Description of the intended use of each genetically modified organism involved 2.6 Toxicity and Allergenicity of the Transformed Traits 2.6.1 To what extend are the transformed gene products toxic when ingested by humans, animals, birds, reptiles, and insects? 2.6.1.1 How has this been determined? 2.6.2 To what extend are the transformed gene products allergens? 2.6.2.1 How has this been determined 2.7 Source of the Genetically modified Food/Feed 2.7.1 Is the genetically modified organism imported or generated locally Imported Generated locally 2.7.2 If Imported please provide the details of authorization from country of origin 2.8 History of the Genetically Modified Food/Feed 2.8.1 Has the genetically modified food/feed been previously imported in Namibia 3.0 Suggested Methods for safe handling, storage, transport and DRAFT-20 OCTOBER 2014 17 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 use 4.0 Labeling Requirements 4.1 Name of the Genetically Modified Food/ Feed 4.2 Characteristics of the feed which is different from its conventional counterpart including composition, nutritional properties, intended use, implications for the health of certain species or categories of animals 5.0 Risk Management Plan 5.1 Describe your Risk Management Plan in the event of an accidental release into the environment of a genetically modified organism. 5.2. Describe your Risk Management Plan if after an accidental release into the environment there is a transformed plant material. 5.0 Monitoring Plan 5.1 Describe the frequency of the monitoring after placing on the market 5.2 Person responsible for monitoring 5.3 Describe the monitoring results to be recorded 5.4 Describe how the monitoring results will be Recorded 5.5 Describe the provisions to remove the genetically modified feed from the market where it is found to have adverse effects on the human health and the environment. 6.0 Undertaking by the Applicant (Attach Affidavit) 6.1 Name of Applicant 6.2 Signature of Applicant Declaration by Applicant I……….of Physical Address:……………, hereby declare that to the best of my knowledge and belief the particulars given in this application are true and correct Declared by……………………..this Day of…………………20… at…………………………… Before Me Commissioner for Oaths/ Magistrate/Judge Dated…………………….., 20… DRAFT-20 OCTOBER 2014 18 THE BIOSAFETY (PLACING ON THE MARKET OF A GENETICALLY MODIFIED FOOD AND FEED) REGULATIONS, 2014 THE THIRD SCHEDULE PERMIT TO PLACE ON THE MARKET A GENETICALLY MODIFIED FOOD/FEED PERMIT NUMBER DATE OF ISSUE: VALID UP TO: Pursuant to Regulation*** of the Biosafety (Placing on the Market of a Genetically Modified Food or Feed) Regulations, 2014, I, the Minister responsible for Science and Technology do grant this permit to place on the market a genetically modified food or feed. This permit is issued to the permit holder named in this permit. 1.0 Name Of Applicant 2.0 Intended Purposes Of Genetically Modified Organism The 2.1 Name And Address Of Supplier 2.3 Country Of Supplier 2.4 Country Of Destination 3.0 Identity of the modified organism genetically 4.0 Specification of the genetic modification This Permit is granted subject to the following conditions 1. 2. 3. 4. This permit is not transferable Issued under the authority of the Minister responsible for science and Technology this………..day of…………. 20… MADE THIS ………………………………………………………………………….2014 THE MINISTER RESPONSIBLE FOR SCIENCE AND TECHNOLOGY DRAFT-20 OCTOBER 2014 19
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