Cap. 607

An Ordinance to give effect to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity; to control the release into the environment, and the import and export, of genetically modified organisms; and to provide for incidental and related matters. [1 March 2011] L.N. 170 of 2010(Format changes—E.R. 4 of 2023) (Enacting provision omitted—E.R. 4 of 2023) Part 1 Preliminary 1. Short title (Amended E.R. 4 of 2023)(1) This Ordinance may be cited as the Genetically Modified Organisms (Control of Release) Ordinance.(2) (Omitted as spent—E.R. 4 of 2023) 2. Interpretation (1) In this Ordinance—adverse biosafety effect (生物安全不利影響), in relation to a GMO, means any adverse effect of the GMO on the conservation and sustainable use of biological diversity;applicant (申請人), in relation to a GMO approval application or variation request, means the person in whose name the application or request is made;approved GMO (核准基因改造生物) means a GMO that is approved for release into the environment by—(a) a decision of the Director under section 10(1)(a), 11(5)(a) or 12(1); or(b) a decision of the Administrative Appeals Board on an appeal lodged under section 43(1);authorized officer (獲授權人員) means an authorized officer appointed under section 29;Biosafety Clearing-House (生物安全資料交換所) means the clearing-house mechanism established under Article 20 of the Protocol;competent authority (主管當局)—(a) in relation to a place that is a Party, means the authority designated by the place to perform, on behalf of the place, the administrative functions required of the place under the Protocol;(b) in relation to a place that is not a Party, means the authority designated by the place to perform, on behalf of the place, the administrative functions that are similar or equivalent to those required of a Party under the Protocol;Conference of the Parties (締約方大會) means the Conference of the Parties established under Article 23 of the Convention;confidential information (機密資料) means any proposed confidential information that is not to be entered in the register according to—(a) a decision of the Director under section 15(1)(a) or 16(3)(a); or(b) a decision of the Administrative Appeals Board on an appeal lodged under section 43(1);Convention (《公約》) means the Convention on Biological Diversity done at Rio de Janeiro on 5 June 1992, as amended from time to time;Director (署長) means—(a) the Director of Agriculture, Fisheries and Conservation;(b) the Deputy Director of Agriculture, Fisheries and Conservation; or(c) an Assistant Director of Agriculture, Fisheries and Conservation;export (輸出) means to take, or cause to be taken, out of Hong Kong;export notification (輸出通知書) means a notification sent for the purposes of section 23(1)(a);genetically modified organism and GMO (基因改造生物) mean a living organism that possesses a novel combination of genetic materials obtained through the use of modern biotechnology;GMO approval application (基因改造生物核准申請) means an application made under section 8(1);import (輸入) means to bring, or cause to be brought, into Hong Kong;living organism (活生物體) means a biological entity capable of transferring or replicating genetic materials, including sterile organisms, viruses and viroids, but does not include a human being;modern biotechnology (現代生物技術) means the application of in vitro nucleic acid techniques (including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles), or techniques involving the fusion of cells beyond the taxonomic family, that—(a) overcome natural physiological reproductive or recombination barriers; and(b) are not techniques used in traditional breeding and selection;non-disclosure request (不披露要求) means a request made under section 14(1);Party (締約方) means a contracting party to the Protocol and includes a place to which the Protocol applies;pharmaceutical product (藥劑製品) means a pharmaceutical product within the meaning of section 2(1) of the Pharmacy and Poisons Ordinance (Cap. 138);prescribed fee (訂明費用), in relation to a matter provided for in this Ordinance, means the fee specified in Schedule 5 in respect of the matter; proposed confidential information (建議機密資料) means any information specified under section 14(2)(b) in a non-disclosure request;Protocol (《議定書》) means the Cartagena Protocol on Biosafety to the Convention on Biological Diversity done at Montreal on 29 January 2000, as amended from time to time;Protocol instrument (《議定書》文書) means—(a) a decision adopted by the Conference of the Parties serving as the meeting of the Parties to the Protocol by virtue of Article 29 of the Protocol; or(b) a notification made to the Biosafety Clearing-House by a competent authority;register (紀錄冊) means the register established and maintained by the Director under section 27;Secretary (局長) means the Secretary for Environment and Ecology;(Amended L.N. 144 of 2022)specified form (指明表格) means a form specified under section 48;variation request (更改要求) means a request made under section 11(1) or (2).(2) For the purposes of this Ordinance, a GMO is in transit if—(a) it is brought into Hong Kong solely for the purpose of taking it out of Hong Kong; and(b) it remains at all times in or on the vessel, vehicle, train or aircraft in or on which it is brought into Hong Kong.(3) For the purposes of this Ordinance, a GMO is in transhipment if—(a) it is brought into Hong Kong solely for the purpose of taking it out of Hong Kong; and(b) it is or is to be removed from the vessel, vehicle, train or aircraft in or on which it is brought into Hong Kong and—(i) returned to the same vessel, vehicle, train or aircraft for the purpose of being taken out of Hong Kong; or(ii) transferred to another vessel, vehicle, train or aircraft for the purpose of being taken out of Hong Kong. 3. Meanings of released into environment and contained use (1) For the purposes of this Ordinance, a GMO is released into the environment if—(a) it is not in contained use; and(b) it is exposed to a condition in which it may grow or reproduce.(2) For the purposes of this Ordinance, a GMO is in contained use if—(a) it is involved in an operation that is undertaken within a facility, installation or other physical barrier; and(b) it is controlled by specific measures that effectively limit its contact with, and its impact on, the environment. 4. Ordinance applies to Government (1) Subject to subsections (2) and (3), this Ordinance applies to the Government.(2) Neither the Government, nor any public officer in the officer’s capacity as such, is liable to be prosecuted for an offence against this Ordinance.(3) No prescribed fee is payable by any Government department that does not operate under a trading fund within the meaning of the Trading Funds Ordinance (Cap. 430). Part 2 Release of GMOs into Environment and Import of GMOs Intended for Release Division 1 Restrictions on Release of GMOs into Environment and Import of GMOs Intended for Release 5. Restrictions on release into environment and maintenance of lives of GMOs (1) This section does not apply to or in relation to a GMO that is a pharmaceutical product for use by human beings.(2) A person must not knowingly cause a GMO to be released into the environment, unless each of the conditions specified in subsection (4) is complied with.(3) A person must not knowingly maintain the life of a GMO that is in a state of being released into the environment, unless each of the conditions specified in subsection (4) is complied with.(4) The conditions specified for the purposes of subsections (2) and (3) are—(a) the GMO is an approved GMO;(b) the approval is entered in the register under section 18;(c) every condition (if any) for the approval of the GMO, as set out in the register, has been complied with.(5) A person who contravenes subsection (2) or (3) commits an offence and is liable to a fine at level 6 and to imprisonment for one year. 6. Notification to Director of certain releases of GMOs (1) This section applies where a person who has control of a GMO knows that—(a) if the GMO is an approved GMO—(i) the GMO has been released into the environment; and(ii) any condition for the approval of the GMO, as set out in the register, has not been complied with;(b) if the GMO is not an approved GMO but is exempted under section 46 from the application of section 5—(i) the GMO has been released into the environment; and(ii) any condition for the exemption of the GMO, as set out in the register, has not been complied with; or(c) if the GMO is not an approved GMO and is not exempted under section 46 from the application of section 5—(i) the GMO has been released into the environment; and(ii) the GMO is not a pharmaceutical product for use by human beings.(2) As soon as practicable after the person knows of the release, the person must, by written notice, inform the Director of the release.(3) Subsection (2) does not require a person to inform the Director of the release if—(a) another person also has control of the GMO; and(b) that other person has informed the Director of the release in compliance with that subsection.(4) A person who contravenes subsection (2) commits an offence and is liable to a fine at level 5 and to imprisonment for 6 months.(5) A notice under subsection (2) must contain the information set out in Parts 1 and 2 of Schedule 1.(6) On receiving a notice under subsection (2), the Director may—(a) direct an authorized officer to enter, during reasonable hours, the place or premises in or on which the GMO was released to dispose of the GMO; or(b) direct the person to dispose of the GMO. 7. Restrictions on import of GMOs intended for release into environment (1) This section does not apply to or in relation to—(a) a GMO that is in transit or transhipment;(b) a GMO that is intended—(i) for direct consumption as food or feed; or(ii) for processing; or(c) a GMO that is a pharmaceutical product for use by human beings.(2) A person must not knowingly import a GMO that is intended for release into the environment unless—(a) the GMO is an approved GMO;(b) the approval is entered in the register under section 18; and(c) every condition (if any) for the approval of the GMO, as set out in the register, has been complied with.(3) A person who contravenes subsection (2) commits an offence and is liable to a fine at level 6 and to imprisonment for one year. Division 2 Approval of GMOs 8. Application for approval of GMOs for release into environment (1) A person may apply to the Director for approval of a GMO for release into the environment.(2) A GMO approval application must—(a) be in the specified form;(b) contain the information set out in Part 1 of Schedule 2; and(c) be accompanied by—(i) a report on a risk assessment carried out, or caused to be carried out, by the applicant in accordance with Schedule 3, on the possible adverse biosafety effect of the GMO; and(ii) the prescribed fee payable on the application.(3) If the GMO is to be imported, the GMO approval application must also contain the information set out in Part 2 of Schedule 2. 9. Acknowledgement of receipt of GMO approval applications (1) Within 90 days after receiving a GMO approval application, the Director must issue a written acknowledgement to the applicant confirming the receipt of the application.(2) An acknowledgement must state—(a) the date on which the Director received the application; and(b) whether the application contains, on the face of it, the information set out in Part 1, or Parts 1 and 2, of Schedule 2, as the case requires. 10. Approval of GMOs (1) Within 270 days after receiving a GMO approval application, the Director must—(a) decide whether the GMO is approved for release into the environment; and(b) give the applicant a written notice of the decision.(2) The Director must not approve a GMO for release into the environment unless the Director is satisfied that the possible adverse biosafety effect of the GMO is acceptable or manageable.(3) On approving a GMO for release into the environment, the Director may attach any condition that the Director thinks fit to the approval.(4) If the Director refuses to approve a GMO for release into the environment or attaches a condition to an approval, the Director must state the reason for the decision in the notice given under subsection (1).(5) The Director may, before the expiry of the period within which a decision must be made on a GMO approval application under subsection (1), extend that period by written notice to the applicant.(6) A notice under subsection (5) must—(a) specify the duration of the extended period; and(b) set out the reason for the extension.(7) If the Director has, by written notice, required an applicant to provide additional information or supporting documents under section 19(1), the number of days falling within the period specified in subsection (8) must be disregarded in calculating the 270-day period or the extended period for the purposes of subsection (1).(8) The period is the one—(a) beginning with the date of the written notice; and(b) ending with the date on which the additional information or supporting documents required were received by the Director. 11. Request for variation of decisions on GMO approval applications (1) If the Director refuses to approve a GMO for release into the environment under section 10(1), the applicant under the GMO approval application may, on any of the grounds specified in subsection (3), request the Director to vary the decision by approving the GMO for such release with or without conditions.(2) If the Director approves a GMO for release into the environment with conditions under section 10(1), the applicant under the GMO approval application may, on any of the grounds specified in subsection (3), request the Director to vary the decision by cancelling or varying the conditions.(3) The grounds specified for the purposes of subsections (1) and (2) are—(a) a change in circumstances that may influence the Director’s assessment on the possible adverse biosafety effect of the GMO has occurred;(b) additional scientific or technical information that may influence the Director’s assessment on the possible adverse biosafety effect of the GMO has become available.(4) A variation request must—(a) be in the specified form; and(b) be accompanied by—(i) relevant information in support of the request; and(ii) the prescribed fee payable on the request.(5) Within 90 days after receiving a variation request, the Director must—(a) decide whether to confirm or vary the decision on the GMO approval application; and(b) give the applicant a written notice of the confirmation or variation and the reason for it. 12. Variation of decisions on GMO approval applications or variation requests on Director’s own initiative (1) The Director may, on his or her own initiative on any of the grounds specified in subsection (2), vary the decision made on a GMO approval application or variation request under section 10(1)(a) or 11(5)(a) by—(a) cancelling or varying any condition attached to, or adding any condition to, the approval of the GMO; or(b) revoking the approval of the GMO.(2) The grounds are—(a) a change in circumstances that influences the Director’s assessment on the possible adverse biosafety effect of the GMO has occurred;(b) additional scientific or technical information that influences the Director’s assessment on the possible adverse biosafety effect of the GMO has become available;(c) the Director considers it in the public interest to do so.(3) After varying a decision on a GMO approval application or variation request under subsection (1), the Director must give the applicant a written notice of the variation and the reason for it.(4) If—(a) the approval of a GMO is revoked under subsection (1)(b); and(b) the GMO has been released into the environment under the approval,the applicant under the GMO approval application must, within the period specified in the notice of variation under subsection (3), inform the Director of the release by written notice.(5) A notice under subsection (4) must contain the information set out in Part 1 of Schedule 1.(6) A person who contravenes subsection (4) commits an offence and is liable to a fine at level 5.(7) If the approval of a GMO is revoked under subsection (1)(b), the Director may, by the notice of variation under subsection (3), give the applicant under the GMO approval application any direction that the Director thinks fit on the safekeeping or disposal of—(a) the GMO; or(b) any container containing the GMO.(8) A person given a direction under subsection (7) must, subject to section 43(5), carry out the direction at the person’s cost within the period specified in the notice.(9) A person who contravenes subsection (8) commits an offence and is liable to a fine at level 6. Division 3 Entry of Information and Decisions on GMO Approval Applications and Variation Requests in Register 13. Entry of information on GMO approval applications and variation requests (other than that specified in non-disclosure requests) in register (1) Within 14 days after the Director is satisfied that a GMO approval application contains, on the face of it, the information set out in Part 1, or Parts 1 and 2, of Schedule 2, as the case requires, the Director must enter the information in the register.(2) If, after entering any information in the register under subsection (1), the Director receives further information from the applicant—(a) on the GMO approval application; or(b) on a variation request on the Director’s decision on that application, the Director must enter the further information in the register within 14 days after receipt of it.(3) Subsections (1) and (2) do not apply in relation to any information that is specified in a non-disclosure request. 14. Making of non-disclosure requests (1) When providing any information to the Director for the purposes of a GMO approval application or variation request, the applicant may request the Director not to enter the information in the register.(2) A non-disclosure request must—(a) be in the specified form;(b) specify the information that the Director is requested not to enter in the register; and(c) set out the justifications for the request.(3) Subsection (1) does not apply in relation to the following information—(a) the name and address of the applicant;(b) a general description of the GMO;(c) a summary of the risk assessment on the possible adverse biosafety effect of the GMO; and(d) any proposed methods and plans for dealing with the possible adverse biosafety effect of the GMO in emergency circumstances. 15. Director’s decisions on non-disclosure requests (1) Within 30 days after receiving a non-disclosure request on a GMO approval application or variation request, the Director must—(a) decide—(i) that none of the proposed confidential information is to be entered in the register;(ii) that only some of the proposed confidential information is to be entered in the register; or(iii) that all of the proposed confidential information is to be entered in the register; and(b) give the applicant a written notice of the decision and the reason for it.(2) The Director may decide not to enter certain proposed confidential information in the register if the Director is satisfied that—(a) entering the information would adversely affect the applicant’s interest; and(b) not entering the information would not be contrary to the public interest. 16. Review of Director’s decisions on non-disclosure requests (1) An applicant under a GMO approval application or variation request who is aggrieved by a decision of the Director under section 15(1)(a)(ii) or (iii) may, within 14 days after receiving notice of the decision, request the Director to review the decision.(2) A request for review must—(a) be in the specified form;(b) set out the justifications for the request; and(c) be accompanied by the prescribed fee payable on the request.(3) Within 30 days after receiving a request for review, the Director must—(a) decide on the request; and(b) give the applicant a written notice of the decision and the reason for it. 17. Entry of non-confidential information in register (1) Subject to subsection (4), if no request has been made under section 16(1) within the 14-day period for reviewing the Director’s decision on a non-disclosure request, the Director must, as soon as practicable after the expiry of that period, enter the non-confidential information in the register.(2) Subject to subsection (4), if—(a) a request has been made under section 16(1) for reviewing the Director’s decision on a non-disclosure request; and(b) no appeal has been lodged under section 43(1) within the 28-day period against the Director’s decision on the request for review, or an appeal so lodged has been withdrawn or abandoned, the Director must, as soon as practicable after the expiry of that period, or after the appeal has been withdrawn or abandoned, as the case may be, enter the non-confidential information in the register.(3) Subject to subsection (4), if an appeal has been lodged under section 43(1) against the Director’s decision on a request for review under section 16(1) and the appeal has not been withdrawn or abandoned, the Director must, as soon as practicable after the appeal has been decided, enter the non-confidential information in the register.(4) The Director must not, in relation to a GMO approval application, enter any non-confidential information in the register before other information received for the purposes of the application has been so entered under section 13(1).(5) In this section—non-confidential information (非機密資料), in relation to a GMO approval application or variation request, means any proposed confidential information specified in the non-disclosure request that is to be entered in the register—(a) in the case of subsection (1), according to the decision of the Director under section 15(1)(a)(ii) or (iii);(b) in the case of subsection (2), according to the decision of the Director under section 16(3)(a);(c) in the case of subsection (3), according to the decision of the Administrative Appeals Board. 18. Entry of decisions on GMO approval applications and variation requests in register (1) If no appeal has been lodged under section 43(1) within the 28-day period against the Director’s decision under section 10(1)(a), 11(5)(a) or 12(1), the Director must, as soon as practicable after the expiry of that period, enter that decision in the register.(2) If an appeal has been lodged under section 43(1) within the 28-day period against the Director’s decision under section 10(1)(a), 11(5)(a) or 12(1), the Director must—(a) as soon as practicable after the appeal has been withdrawn or abandoned, enter that decision in the register; or(b) as soon as practicable after the appeal has been decided, enter the Director’s decision as confirmed, varied or reversed by the Administrative Appeals Board in the register. Division 4 Provisions Supplementary to Divisions 2 and 3 19. Provision of additional information or supporting documents on GMO approval applications and variation requests (1) For the purpose of determining a GMO approval application or variation request, the Director may, by written notice, require the applicant—(a) to provide additional information or supporting documents on the application or request; and(b) to appear before the Director to answer any question raised, or provide any clarification required, by the Director.(2) The Director may require an applicant under a GMO approval application to provide additional information or supporting documents under subsection (1) even though the acknowledgment under section 9(1) states that the application contains, on the face of it, the information set out in Part 1, or Parts 1 and 2, of Schedule 2, as the case requires. 20. Withdrawal of GMO approval applications or variation requests (1) An applicant under a GMO approval application or variation request may, in writing, withdraw the application or request at any time before the Director makes a decision on the application or request.(2) If a GMO approval application or variation request is withdrawn under subsection (1), the Director must cease to process the application or request. 21. Withdrawal of information or document provided (1) An applicant under a GMO approval application or variation request may, in writing, withdraw any information or document provided for the purposes of the application or request at any time before the Director makes a decision on the application or request.(2) Where any information or document provided for the purposes of a GMO approval application or variation request is withdrawn under subsection (1), the Director must continue to process the application or request as if the information or document had not been provided. Part 3 Export of GMOs Intended for Release into Environment 22. Application of this Part This Part does not apply to or in relation to—(a) a GMO that is in transit or transhipment;(b) a GMO that is intended—(i) for direct consumption as food or feed; or(ii) for processing; or(c) a GMO that is a pharmaceutical product for use by human beings. 23. Restrictions on export of GMOs intended for release into environment (1) A person must not knowingly export a GMO that is intended for release into the environment unless—(a) the person has sent to the competent authority of the place to which the GMO is to be exported a notification of the export; and(b) the person has received from that authority the approval (whether or not with conditions attached) for that export.(2) Subsection (1)(a) does not apply if prior notification to the competent authority for exporting the GMO to the place is not required under the legal or regulatory requirements of that place.(3) Subsection (1)(b) does not apply if prior approval from the competent authority for exporting the GMO to the place is not required under the legal or regulatory requirements of that place.(4) An export notification must contain the information set out in Schedule 4.(5) A person who contravenes subsection (1) commits an offence and is liable to a fine at level 6 and to imprisonment for one year.(6) In any proceedings for an offence under subsection (5), a certificate purporting to be issued by or on behalf of the competent authority of a place outside Hong Kong certifying that prior notification to, or approval from, as the case requires, that authority for exporting the GMO to the place is, or is not, required under the legal or regulatory requirements of that place is admissible as evidence of the matters stated in the certificate. 24. Copies of export notifications and approvals to be sent to Director (1) Within 14 days after sending an export notification, a person must send to the Director—(a) a copy of the notification; and(b) a declaration by the person that—(i) the copy is a true copy of the notification; and(ii) the information contained in the notification is true and correct to the best of the person’s knowledge and belief.(2) Within 14 days after receiving from the competent authority of a place outside Hong Kong an approval mentioned in section 23(1)(b), a person must send to the Director—(a) a copy of the approval; and(b) a declaration by the person that the copy is a true copy of the approval.(3) A declaration under subsection (1)(b) or (2)(b) must be in the specified form.(4) A person who contravenes subsection (1) or (2) commits an offence and is liable to a fine at level 5. Part 4 Documentation Requirements for Import and Export of GMOs 25. Application of this Part This Part does not apply to or in relation to a GMO that is a pharmaceutical product for use by human beings. 26. Documentation requirements for import and export of GMOs (1) When being imported or exported—(a) GMOs that are intended for direct consumption as food or feed, or for processing;(b) GMOs that are intended for contained use; and(c) GMOs that are intended for release into the environment, must be accompanied by the documents prescribed by regulations made under section 50(1).(2) Subsection (1) does not require GMOs falling within paragraph (a) or (b) of that subsection to be accompanied by the prescribed documents if—(a) the GMOs are imported or exported in a lot together with other living organisms;(b) the GMOs are unintentionally mixed with those other living organisms; and(c) the percentage of the quantity of the GMOs to the total quantity of living organisms in the lot does not exceed the prescribed percentage.(3) If subsection (1) is not complied with, the person who imports or exports the GMOs commits an offence and is liable to a fine at level 3.(4) In any proceedings for an offence under subsection (3), it is a defence for the person charged to establish that the person did not know and could not with reasonable diligence have known that GMOs falling within subsection (1)(a), (b) or (c) were being imported or exported.(5) In subsection (2)(c)—prescribed percentage (訂明百分比) means—(a) the percentage prescribed by regulations made under section 50(1) for the purposes of that subsection in relation to GMOs falling within subsection (1)(a) or (b); or(b) if no percentage is prescribed, 0%. Part 5 Register 27. Director must establish and maintain register (1) The Director must establish and maintain a register for the purposes of this Ordinance.(2) The Director may keep the register in such form as the Director considers appropriate.(3) The register must be available for inspection by members of the public, free of charge—(a) through the Internet; and(b) at the office of the Agriculture, Fisheries and Conservation Department during normal business hours. 28. Contents of register (1) The register must contain—(a) subject to subsection (3)—(i) every GMO approval application, and any information received by the Director for the purposes of the application; and(ii) every variation request, and any information received by the Director for the purposes of the request;(b) every decision of the Director made under section 10(1)(a), 11(5)(a) or 12(1);(c) every decision of the Administrative Appeals Board on any appeal lodged against a decision of the Director made under section 10(1)(a), 11(5)(a) or 12(1); and(d) every exemption granted by the Secretary under section 46. (2) The register may also contain any other information relating to the administration of this Ordinance or implementation of the Protocol that the Director considers appropriate.(3) The register must not contain—(a) any confidential information in relation to a GMO approval application or variation request; or(b) any GMO approval application or variation request, or any information provided for the purposes of the application or request, that has been withdrawn before it is to be entered in the register in accordance with section 13. Part 6 Enforcement 29. Appointment of authorized officers The Director may, in writing, appoint any public officer of the Agriculture, Fisheries and Conservation Department not below the rank of Field Officer II to be an authorized officer for the purposes of this Ordinance. 30. Powers to search vessels, detain persons, etc. (1) An authorized officer may stop, board and search any vessel, vehicle, train or aircraft (other than a ship of war, military vehicle or military aircraft) if the officer reasonably suspects that an offence under section 5, 7 or 23 has been, is being or is about to be committed in or on the vessel, vehicle, train or aircraft.(2) If an authorized officer reasonably suspects that a person has committed, is committing or is about to commit an offence under section 5, 7 or 23, the officer may without warrant—(a) stop and search the person, and search the property of the person, for anything that is likely to be relevant (whether by itself or together with anything else) to the investigation of the offence; and(b) detain the person for a reasonable period while the officer inquires about the suspected commission of the offence. 31. Powers to inspect place or premises, take copies of documents, etc. for verifying compliance with this Ordinance (1) If an authorized officer reasonably suspects that a GMO is being kept in any place or premises, the officer may, for the purpose of verifying compliance with this Ordinance, without notice—(a) enter and inspect the place or premises during reasonable hours;(b) require the production of, inspect and examine any thing that the officer reasonably suspects to be, or to contain, a GMO; and (c) require the production of, inspect, examine and take copies of any document that is related to compliance with this Ordinance, or any document that relates to the nature or origin of the GMO.(2) Subsection (1) does not empower an authorized officer to enter—(a) any premises that are used wholly or principally for dwelling purposes; or(b) any part of any premises that is used wholly or principally for dwelling purposes. 32. Powers to enter and search place or premises on issue of warrant (1) A magistrate may issue a warrant authorizing an authorized officer to enter and search any place or premises if satisfied by information on oath that there are reasonable grounds to suspect that—(a) an offence under this Ordinance has been, is being or is about to be committed in or on the place or premises; or(b) there is in or on the place or premises any thing that is or contains evidence of the commission of an offence under this Ordinance.(2) Unless otherwise specified in it, a warrant continues in force until the purposes for which the entry is necessary have been satisfied.(3) An authorized officer authorized by such a warrant to enter and search any place or premises—(a) may at the time specified in the warrant or, if no time is specified, at any time enter and search the place or premises, using necessary force; and(b) may remove any thing that obstructs the entry and search.(4) An authorized officer may also detain any person found in or on the place or premises, for such period as is reasonably required to permit the search to be carried out, where the person might prejudice the purpose of the search if not so detained.(5) An authorized officer entering any place or premises under a warrant may take with the officer such persons as may be necessary.(6) This section does not prejudice any powers of entry and search conferred on police officers under any other law. 33. Powers to seize, remove and detain things (1) An authorized officer may seize, remove and detain any thing that the officer reasonably suspects to be or to contain evidence of the commission of an offence under this Ordinance.(2) An authorized officer does not incur any civil liability in respect of anything done or omitted to be done by the officer in good faith in the exercise or purported exercise of any power under this section. 34. Powers to take samples and carry out tests (1) An authorized officer may, for the purpose of verifying compliance with this Ordinance or obtaining evidence of the commission of an offence under this Ordinance—(a) take a sample of any thing that the officer reasonably suspects to be, or to contain, a GMO;(b) require any person in control of such thing to provide a sample of it; and(c) take any photographs of the thing.(2) An authorized officer who takes a sample under subsection (1) must issue a receipt for the sample, but is not required—(a) to pay for it; or(b) to return it to the person from whom it was taken. (3) An authorized officer may arrange to carry out any necessary test in respect of a sample taken under subsection (1) to ascertain—(a) whether the sample is or contains a GMO;(b) if the sample is or contains a GMO—(i) the identity of the GMO; and(ii) the quantity and percentage of the GMO in the sample.(4) A certificate of analysis issued by an accredited laboratory on a sample taken under subsection (1) may be tendered in evidence in any proceedings under this Ordinance and is evidence of the facts stated in it unless the contrary is proved.(5) In this section, accredited laboratory (獲認可實驗所) means a laboratory accredited under the Hong Kong Laboratory Accreditation Scheme managed by the Commissioner for Innovation and Technology on behalf of the Government. 35. Power to require identification (1) If an authorized officer reasonably suspects that a person has committed, is committing or is about to commit an offence under section 5, 7, 23, 26 or 44, the officer may without warrant stop the person or, where the person is in or on a vessel, vehicle, train or aircraft (other than a ship of war, military vehicle or military aircraft), stop and board the vessel, vehicle, train or aircraft for the purposes of requiring that person—(a) to state the person’s name and address; and(b) to produce the person’s proof of identity for inspection.(2) In this section, proof of identity (身分證明文件) means proof of identity within the meaning of section 17B of the Immigration Ordinance (Cap. 115). 36. Power to require production of documents related to import or export If an authorized officer reasonably suspects that a GMO is being imported or exported, the officer may, for the purpose of verifying compliance with section 26, require a person who has control of the thing suspected to be the GMO to produce any document that is related to the import or export of the thing for inspection. Part 7 Disposal and Forfeiture of Things Seized 37. Director’s power to dispose of certain things after seizure (1) If any of the things specified in subsection (2) has been seized under section 33, the Director may, after the seizure, dispose of the thing in any way (except by way of sale).(2) The things are—(a) any live animal—(i) that, for any reason, it is not practicable for the Director to keep in captivity; or(ii) that is likely to die or to be subject to unnecessary suffering if it is kept in captivity;(b) any live plant that, for any reason, it is not practicable for the Director to keep; and(c) any thing—(i) that, for any reason, it is not practicable for the Director to keep; or(ii) that is perishable. 38. Return and forfeiture of things seized in respect of offences under section 5, 7 or 23 (1) If a person is convicted of an offence under section 5, 7 or 23, any thing seized under section 33 in connection with the offence that is a GMO or contains a GMO is to be forfeited to the Government.(2) If a person is convicted of an offence under section 5, 7 or 23, the court or magistrate may order any thing seized under section 33 in connection with the offence that is not a GMO or does not contain a GMO—(a) to be returned to the person from whom it was seized or to its owner; or(b) to be forfeited to the Government.(3) If an offence is prosecuted under section 5, 7 or 23 and no defendant in the proceedings is convicted of the offence, the court or magistrate may order any thing seized under section 33 in respect of which the prosecution is brought—(a) to be returned to the person from whom it was seized or to its owner; or(b) to be forfeited to the Government.(4) This section does not apply to a thing seized under section 33 if it has been disposed of under section 37. 39. Return and forfeiture of things seized in respect of offences under other sections (1) If an offence is prosecuted under a provision of this Ordinance other than section 5, 7 or 23, the court or magistrate may, whether or not any defendant in the proceedings is convicted of the offence, order any thing seized under section 33 in respect of which the prosecution is brought—(a) to be returned to the person from whom it was seized or to its owner; or(b) to be forfeited to the Government.(2) This section does not apply to a thing seized under section 33 if it has been disposed of under section 37. 40. Return and forfeiture of things seized if no prosecution for offences (1) If a thing has been seized under section 33 but no prosecution has been brought in respect of that thing under this Ordinance, an authorized officer may apply to the court or magistrate for an order in respect of that thing.(2) On an application under subsection (1), the court or magistrate may, subject to subsection (3), order the thing concerned—(a) to be returned to the person from whom it was seized or to its owner; or(b) to be forfeited to the Government.(3) The court or magistrate must, if satisfied that the owner of the thing concerned is unknown or cannot be found, order the thing to be forfeited to the Government.(4) This section does not apply to a thing seized under section 33 if it has been disposed of under section 37. 41. Director’s powers to dispose of and to give directions on disposal of forfeited things (1) The Director may dispose of in any way (except by way of sale) any thing that is forfeited to the Government under this Part in such manner as the Director thinks fit.(2) If—(a) a person has been convicted of an offence under section 5, 7 or 23; and(b) a thing in connection with the offence has been forfeited to the Government under section 38(1) or (2), the Director may, by written notice, direct the person to dispose of the thing through repatriation or destruction.(3) A person given a direction under subsection (2) must, subject to section 43(5), carry out the direction at the person’s cost within the period specified in the notice.(4) A person who contravenes subsection (3) commits an offence and is liable to a fine at level 6. 42. Compensation for seizure etc. (1) Subject to subsection (2), if a thing has been seized under section 33, the Government is liable to compensate the owner of the thing for any loss suffered by the owner—(a) by reason of the seizure; or(b) by reason that the thing dies, perishes or deteriorates, or is lost or damaged, during the time when the thing is seized or detained.(2) The owner is not entitled to compensation for the loss if—(a) the owner has been convicted of an offence under this Ordinance in relation to the thing; or(b) the thing is forfeited to the Government by an order of the court or magistrate under section 38, 39 or 40 (except where the thing is forfeited pursuant to section 40(3)).(3) In any proceedings against the Government in respect of a claim for compensation on any of the grounds referred to in subsection (1), the amount of the compensation recoverable is an amount that is just and equitable in all the circumstances of the case, including the conduct and comparative blameworthiness of—(a) the owner of the thing seized;(b) the person in charge of the thing at the time when it was seized;(c) the agents of the persons specified in paragraphs (a) and (b); and(d) authorized officers, public officers and other persons concerned.(4) No proceedings are maintainable in respect of a claim for compensation on any of the grounds referred to in subsection (1) unless the proceedings are commenced—(a) in the case of a claim for compensation in respect of any thing that was seized but subsequently returned to its owner by order of the court or magistrate or by any person having authority to return the thing to the owner, not later than 6 months after the return of the thing;(b) in the case of a claim for compensation on the ground that the thing died, perished or deteriorated, or was lost or damaged, during the time when the thing was seized or detained, not later than 6 months from whichever of the following is the earlier—(i) the discovery by the owner of the existence of the ground;(ii) the date on which the owner could, by the existence of reasonable diligence, have discovered the existence of the ground.(5) A claim for compensation under this section may be made—(a) in the Small Claims Tribunal, if the claim is within the jurisdiction of the Tribunal; or(b) in the District Court, irrespective of the amount claimed. Part 8 Miscellaneous Provisions 43. Appeals (1) If an applicant under a GMO approval application or variation request is aggrieved by a decision under section 10(1)(a), 11(5)(a), 12(1) or 16(3)(a), or a direction under section 12(7), the applicant may, within 28 days after receiving notice of the decision or direction, appeal to the Administrative Appeals Board against that decision or direction.(2) If a person who is directed under section 41(2) to dispose of a thing is aggrieved by the direction, the person may, within 28 days after receiving notice of the direction, appeal to the Administrative Appeals Board against that direction.(3) After lodging an appeal under subsection (1), the applicant must, pending the Administrative Appeals Board’s decision on the appeal, cause the GMO to which the appeal relates to be kept in a manner that effectively limits its contact with, and its impact on, the environment.(4) Subsection (3) does not apply if the GMO has already been released into the environment.(5) If an appeal is lodged against a direction referred to in subsection (1) or (2), the applicant or person is not required to carry out the direction pending the Administrative Appeals Board’s decision on the appeal. 44. Offences on obstruction and failure to comply with requirements (1) On performing any function or duty, or exercising any power, under this Ordinance, an authorized officer must produce written evidence of the officer’s identity.(2) A person commits an offence if the person—(a) wilfully obstructs an authorized officer from performing any function or duty, or exercising any power, under this Ordinance; or(b) without reasonable excuse, fails to comply with any requirement imposed by an authorized officer under this Ordinance.(3) A person who commits an offence under subsection (2) is liable to a fine at level 6 and to imprisonment for 6 months. 45. Provision of false information (1) A person commits an offence if the person, in respect of a GMO approval application or variation request, or in purported compliance with this Ordinance, produces any document, furnishes any information or makes any statement that the person—(a) knows or believes to be false;(b) does not believe to be true; or(c) knows or believes to be misleading in a material particular.(2) A person who commits an offence under subsection (1) is liable to a fine at level 6 and to imprisonment for 6 months. 46. Secretary’s power to grant exemptions (1) The Secretary may, by notice published in the Gazette, exempt any person, any group or description of persons, or any GMO from the application of section 5, 7 or 23.(2) An exemption may take effect generally or for any purposes or by reference to any circumstances, and either conditionally or unconditionally.(3) The Secretary must not grant an exemption under subsection (1) unless the Secretary is satisfied that the possible adverse biosafety effect that may result from the exemption is acceptable or manageable. 47. Expert group (1) The Secretary must establish an expert group consisting of—(a) members who are public officers; and(b) members who are not public officers and who are appointed from different sectors, including the farming, biotechnology, environmental protection, academic and trading sectors.(2) Members are appointed by the Secretary.(3) The Director may refer any question in connection with the administration of this Ordinance, including the processing of individual GMO approval applications, variation requests and non-disclosure requests, and the granting of exemptions, to the expert group, or individual members of the group, for advice. 48. Director’s power to specify forms The Director may specify any form to be used for the purposes of any matter provided for in this Ordinance. 49. Secretary’s power to amend Schedules The Secretary may, by order published in the Gazette, amend Schedule 1, 2, 3, 4, 5 or 6. 50.

Secretary’s power to make regulations (1) The Secretary may make regulations for all or any of the following purposes—(a) to prescribe the documents required to accompany GMOs falling within section 26(1)(a), (b) or (c) when those GMOs are being imported or exported;(b) to prescribe the percentage referred to in paragraph (a) of the definition of prescribed percentage in section 26(5);(c) to enable any part of a Protocol instrument to have the force of law in Hong Kong with or without modification;(d) to provide generally for the better carrying out of the purposes of this Ordinance.(2) A regulation under subsection (1) may—(a) make different provisions for different circumstances and provide for a particular case or class of case;(b) be made so as to apply only in specified circumstances; and(c) contain such incidental, supplementary, consequential, transitional or saving provision as may be necessary or expedient in consequence of the regulation.(3) A regulation under subsection (1) may provide—(a) that it is an offence for a person to contravene a provision of the regulation; and(b) that such an offence is punishable by a fine not exceeding level 6 and imprisonment for a term not exceeding 6 months. 51. Prescribed fees paid not refundable Any prescribed fee paid under this Ordinance is not refundable. Part 9 Transitional Provisions 52. Interpretation In this Part—*commencement date (生效日期) means the date on which this Ordinance comes into operation;released GMO (已釋出的基因改造生物) means a GMO that was released into the environment before the commencement date;transitional period (過渡期) means the 6-month period beginning on the commencement date. Editorial Note: * Commencement date: 1 March 2011. 53. Maintenance of lives of released GMOs during transitional period During the transitional period, section 5 does not prohibit a person from knowingly maintaining the life of a released GMO that is in a state of being released into the environment. 54. Notification of or application for approval of released GMOs during transitional period (1) If a person, during the transitional period, knowingly maintains the life of a released GMO that is in a state of being released into the environment, the person must, before that period expires—(a) inform the Director of the maintenance by written notice; or(b) submit a GMO approval application in accordance with section 8 in respect of the released GMO.(2) A person who contravenes subsection (1) commits an offence and is liable to a fine at level 1.(3) On receiving a notice under subsection (1)(a), the Director may—(a) direct an authorized officer to enter the place or premises in or on which the released GMO was maintained during reasonable hours to dispose of the GMO; or(b) direct the person to dispose of the released GMO.(4) Section 5 does not prohibit a person who has informed the Director of the maintenance of a released GMO under subsection (1)(a) from knowingly maintaining the life of the GMO that is in a state of being released into the environment, during the period from the date of the notice to the date when the GMO is disposed of. (5) Section 5 does not prohibit a person who has submitted a GMO approval application under subsection (1)(b) from knowingly maintaining the life of the released GMO that is in a state of being released into the environment, during the period from the date of the application to the date when the decision on the application is entered in the register under section 18.(6) A notice under subsection (1)(a) must contain the information set out in Schedule 6. Part 10 (Omitted as spent—E.R. 4 of 2023) 55. (Omitted as spent—E.R. 4 of 2023) Schedule 1 [ss. 6, 12 & 49]Information to be Contained in Written Notices on Release of GMOs Part 1 1. The name and identity of the GMO 2. The location, date and time of release into the environment of the GMO 3. The circumstances under which the GMO was released 4. The use of the GMO 5. The quantity or volume of the GMO released 6. Any other available information relating to the release of the GMO 7. The name, address and contact details of the person making the notification Part 2 8. The taxonomic status of the GMO 9. The characteristics and traits of the GMO 10. Any available information on the possible adverse biosafety effect of the GMO 11. Any possible risk management measures on the release of the GMO into the environment 12. Any other available information relating to the GMO(Amended E.R. 4 of 2023) Schedule 2 [ss. 8, 9, 13, 19 & 49]Information to be Contained in GMO Approval Applications Part 1 1. The name, address and contact details of the applicant 2. The name and identity of the GMO 3. The intended date of release into the environment of the GMO 4. The taxonomic status, common name and point of collection or acquisition of the recipient organism or parental organism of the GMO, and characteristics of that recipient organism or parental organism related to possible adverse biosafety effect 5. The centre of origin and centre of genetic diversity, if known, of the recipient organism of and, if applicable, the parental organism of the GMO and a description of the habitats where that recipient organism and parental organism may persist or proliferate 6. The taxonomic status, common name and point of collection or acquisition of the donor organism of the GMO, and characteristics of that donor organism related to possible adverse biosafety effect 7. Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the GMO 8. Intended use of the GMO or products from the GMO, namely, processed materials that are of genetically modified organism origin and that contain detectable novel combinations of replicable genetic materials obtained through the use of modern biotechnology 9. The quantity or volume of the GMO to be released and, if applicable, imported 10. Suggested methods for the safe handling, storage, transport and use of the GMO, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate Part 2 11. The place from which the GMO is to be imported into Hong Kong 12. The name, address and contact details of the exporter in that place 13. The intended date of export of the GMO from that place, if known 14. The domestic classification of the biosafety level of the GMO in that place, if any 15. The regulatory status of the GMO in that place and, if the GMO is banned in that place, the reason for the ban 16. The result and purpose of any notification made to competent authorities of other places regarding the export of the GMO to those other places(Amended E.R. 4 of 2023) Schedule 3 [ss. 8 & 49]Requirements on Risk Assessment on Possible Adverse Biosafety Effects of GMOs 1. Risk assessment must be carried out in a scientifically sound and transparent manner, and may take into account expert advice of, and guidelines developed by, relevant international organizations. 2. Risks associated with the GMO or products from the GMO, namely, processed materials that are of genetically modified organism origin and that contain detectable novel combinations of replicable genetic materials obtained through the use of modern biotechnology, must be considered in the context of the risks posed by the non-modified recipient or parental organism in the likely potential receiving environment. 3. Risk assessment must entail, as appropriate, the following steps—(a) an identification of any novel genotypic and phenotypic characteristics associated with the GMO that may have an adverse effect on biological diversity in the likely potential receiving environment;(b) an evaluation of the likelihood of the adverse effect being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the GMO;(c) an evaluation of the consequences should the adverse effect be realized;(d) an estimation of the overall risk posed by the GMO based on the evaluation of the likelihood and consequences of the adverse effect being realized;(e) a recommendation as to whether or not the risks are acceptable or manageable, including, if necessary, identification of strategies to manage those risks;(f) where there is uncertainty regarding the level of risk, obtaining further information on the specific issues of concern or implementing appropriate risk management strategies or monitoring the GMO in the likely potential receiving environment. 4. Risk assessment must take into account the relevant technical and scientific details regarding the characteristics of the following subjects—(a) recipient organism or parental organism: biological characteristics of the recipient organism or parental organism, including information on taxonomic status, common name, origin, centre of origin and centre of genetic diversity, if known, and a description of the habitat where that recipient organism or parental organism may persist or proliferate;(b) donor organism: the taxonomic status, common name, source, and other relevant biological characteristics of the donor organism;(c) vector: characteristics of the vector, including its identity, if any, and its source or origin, and its host range;(d) insert and modification—(i) if modification was introduced through the application of in vitro nucleic acid techniques: genetic characteristics of the inserted nucleic acid and the function it specifies, and characteristics of the modification introduced;(ii) if modification was introduced through the application of techniques involving the fusion of cells: characteristics of the modification introduced;(e) GMO: identity of the GMO, and the differences between the biological characteristics of the GMO and those of the recipient organism or parental organism;(f) detection and identification of the GMO: suggested detection and identification methods and their specificity, sensitivity and reliability;(g) information relating to the intended use of the GMO: information relating to the intended use of the GMO, including new or changed use compared to the recipient organism or parental organism;(h) likely potential receiving environment: information on the location, and geographical, climatic and ecological characteristics, including relevant information on biological diversity and centre of origin of the likely potential receiving environment. Schedule 4 [ss. 23 & 49]Information to be Contained in Export Notifications 1. The name, address and contact details of the exporter in Hong Kong 2. The place to which the GMO is to be exported from Hong Kong 3. The name, address and contact details of the importer in that place 4. The name and identity of the GMO 5. The intended date of export and release into the environment of the GMO, if known 6. The taxonomic status, common name and point of collection or acquisition of the recipient organism or parental organism of the GMO, and characteristics of that recipient organism or parental organism related to possible adverse biosafety effect 7. The centre of origin and centre of genetic diversity, if known, of the recipient organism of and, if applicable, the parental organism of the GMO and a description of the habitats where that recipient organism and parental organism may persist or proliferate 8. The taxonomic status, common name and point of collection or acquisition of the donor organism of the GMO, and characteristics of that donor organism related to possible adverse biosafety effect 9. Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the GMO 10. Intended use of the GMO or products from the GMO, namely, processed materials that are of genetically modified organism origin and that contain detectable novel combinations of replicable genetic materials obtained through the use of modern biotechnology 11. The quantity or volume of the GMO to be exported and released 12. A current risk assessment report regarding the proposed release of the GMO into the environment in that place 13. Suggested methods for the safe handling, storage, transport and use of the GMO, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate 14. The regulatory status of the GMO in Hong Kong and, if a GMO approval application has been submitted in respect of the GMO and approval of the GMO is refused, the reason for the refusal 15. The result and purpose of any notification made by the exporter to other places regarding the export of the GMO(Amended E.R. 4 of 2023) Schedule 5 [ss. 2 & 49]Prescribed Fees Item Description Amount 1. Prescribed fee payable on a GMO approval application $14,250 2. Prescribed fee payable on a variation request $1,890 3. Prescribed fee payable on a request for review on a non-disclosure request $1,010 Schedule 6 [ss. 49 & 54]Information to be Contained in Written Notices on Release or Maintenance of Released GMOs 1. The name and identity of the GMO 2. The location, date and time of release into the environment or maintenance of the GMO 3. The circumstances under which the GMO was released or maintained 4. The use of the GMO 5. The quantity or volume of the GMO released or maintained 6. Any other available information relating to the release or maintenance of the GMO 7. The name, address and contact details of the person making the notification(Amended E.R. 4 of 2023)