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ساري المفعولFederal Law

قانون البيئة / ESG في الإماراتقانون اتحادي في شأن السلامة الأحيائية من الكائنات المحورة وراثياً ومنتجاتها

قانون اتحادي إماراتي·Federal Law No. (9) of 2020

تاريخ الإصدار
28 مايو 2020
ساري المفعول من
1 يونيو 2020
المواد
30
آخر مزامنة
20 يوليو 2026
تنزيل PDFالمصدر الرسمي

ملخّص بلغة مبسّطة

  • ينظم استخدام الكائنات المعدلة وراثياً ومنتجاتها لحماية الصحة العامة والبيئة.
  • يشمل المستوردين والمنتجين والبائعين للمنتجات المعدلة وراثياً في الدولة.
  • يلزم بإجراء فحوصات السلامة والحصول على موافقات قبل استخدام أي كائن معدل.
  • ينشئ نظام مراقبة وتفتيش مستمر لأنشطة الكائنات المعدلة ومنتجاتها.
  • يفرض عقوبات على من يخالف قواعد السلامة أو يتعامل مع كائنات معدلة بدون ترخيص.

ينظم القانون سلامة الكائنات المعدلة وراثياً ومنتجاتها ويضع متطلبات حماية الصحة العامة والبيئة في الإمارات.

متزامن من البوّابة الرسمية للتشريعات الإماراتية · ملخّص تحريري من فريق LEXAI

النص على مستوى المادة

المواد الرئيسية

30 مواد

النص الإنجليزي معروض — الترجمة العربية قيد الإعداد.

  1. 1

    المادة 1

    Article (1) Definitions For the purpose of applying the provisions of this Law, the following words and expressions shall have the meanings assigned to each of them unless the context otherwise requires: State : The United Arab Emirates. Establishment : The Emirates Drug Establishment. Chairman : The Chairman of the Establishment. Competent Authority : The Local Concerned Authority in each Emirate of the State. Biodiversity : The variability among living organisms of all sources, including terrestrial and marine ecosystems, aquatic organisms, and ecological complexes that are a part thereof, including diversity among species, and between species and ecosystems. Genetic Resources : Any material of plant, animal, microbial or other origin containing functional units of heredity of actual or potential value. Biosafety : Measures followed for ensuring the safe use of modern biotechnology applications for both humans and environment, with a view to mitigating or eliminating the potential risks arising therefrom. Living Organism : Any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses, viroids, animals, plants, and microorganisms. Genetic Modification : Modifying genetic material by using modern biotechnology. Genetically Modified Organism (GMO) : A living organism that possesses a novel combination of genetic material, differing from its original genetic composition, obtained through the use of modern biotechnology.

    -- 3 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 4 GMO Products : Products formulated from or containing GMO, derivatives or residues thereof, or other products that include or are composed of a percentage of Genetically Modified Component. Genetically Modified Component : Any part containing the genetically modified code. Modern Biotechnology : In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or the fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. Contained Use : The activity that takes place within a facility, and that involves GMOs subject to specific measures that effectively prevent their contact with the external environment and their impact on such environment. Release : The introduction of GMOs or Products thereof into the environment. Circulation : Sale or offer for sale, storage or possession, whether permanently or temporarily. Facility : The facility, installation or any other premises, whether fixed or mobile, permanent or temporary, authorized to manufacture, produce, develop or circulate GMOs or Products thereof. Risks : Possibility of causing adverse effects as a result of exposure to the source of risk resulting from GMOs or Products thereof. Risk Assessment : The evaluation of the potential adverse effects of GMOs or Products thereof on the conservation and sustainable use of biological diversity and on the health and safety of humans and environment. Response Measures : Measures taken to prevent, minimize, control or mitigate damage.

    -- 4 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 5

  2. 2

    المادة 2

    Article (2) Objectives This Law has the following objectives: 1. Preserving human health and safety from the risks of GMOs or Products thereof; 2. Ensuring environmental protection with respect to the development, manufacture, production, transport, or circulation of GMOs or Products thereof resulting from modern biotechnology; 3. Preserving local genetic resources and biological diversity from the risks arising from the release or introduction of GMOs or Products thereof into the environment; 4. Ensuring control, reduction, elimination or treatment of damages that occur or are likely to be occurred by GMOs or Products thereof; and 5. Regulating scientific research activities on GMOs.

  3. 3

    المادة 3

    Article (3) Scope of Application 1. The provisions of this Law shall apply to the importation, exportation, re-exportation, transit, circulation, development, manufacture and production of GMOs or Products thereof, in addition to other products that include or are composed of a percentage equal to or greater than 0.9% of Genetically Modified Component. The Cabinet may issue a Resolution to amend such percentage. 2. The following shall be excluded from the application of the provisions of this Law: a. Products containing a Genetically Modified Component in a percentage of less than 0.9%; and b. GMOs or manufactured products thereof are pharmaceutical substances for humans and the genetic modification of humans and human cells.

    -- 5 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 6

  4. 3

    المادة 3

    Article (3) thereof, shall be prohibited. 3. The Establishment shall be notified of any GMOs or Products thereof transiting through the State prior to such transit. The Executive Regulation thereof shall determine the conditions and procedures for transit and the notification requirements. 4. GMOs or Products thereof in the State shall not be circulated unless an authorization from the Competent Authority is obtained, in accordance with the conditions and controls determined by the Executive Regulation thereof.

  5. 4

    المادة 4

    Article (4) Import, Transition and Circulation of GMOs or Products thereof 1. GMOs or Products thereof may not be imported unless an authorization from the Competent Authority is obtained. In addition, in case the import is conducted for first time, the Establishment’s approval shall be required, and the Executive Regulation thereof shall determine the controls and conditions for implementing such procedure. 2. In all cases, the import of Genetically Modified Animals, products thereof or residues thereof, whose genetically modified component percentages as specified in Clause (1) of

  6. 5

    المادة 5

    Article (5) Export and Re-export of the GMOs or Products thereof In order to export or re-export the GMOs or Products thereof, a prior approval from the Establishment and an authorization from the Competent Authority shall be obtained, in accordance with the conditions and controls determined by the Executive Regulation of this Law.

  7. 6

    المادة 6

    Article (6) Contained Use and Release Upon release of GMOs or Products thereof, or contained use of the GMOs for research, development, education and production purposes, a prior approval from the Establishment and an authorization from the Competent Authority shall be obtained, in accordance with the conditions and controls determined by the Executive Regulation of this Law.

    -- 6 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 7

  8. 7

    المادة 7

    Article (7) Register A register shall be established with the Establishment to register the Facilities, GMOs and Products thereof that are produced, manufactured, developed, circulated, exported, imported, transited or transported, and the Executive Regulations of this Law shall determine the controls for implementing this Article.

  9. 8

    المادة 8

    Article (8) Facility Manager’s Obligations The Facility Manager shall comply with the following: 1. Registering the Facility with the Establishment; 2. Obtaining an authorization from the Competent Authority to develop, manufacture, produce, import, transit, re-export, export or transfer GMOs or Products thereof; and 3. Registering Organisms that are produced, manufactured, developed, circulated, exported, imported, transited or transported. The Executive Regulation of this Law shall determine the conditions and controls of this Article and any other obligations.

  10. 9

    المادة 9

    Article (9) Risk Assessment 1. Risk assessment shall be conducted on a scientific basis consisting of identifying and describing the risk source in addition to assessing the extent of exposure to the risk source and describing the risks. 2. The conditions and controls for analyzing, assessing and managing risks shall be determined by a decision of the Chairman.

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    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 8

  11. 10

    المادة 10

    Article (10) Confidentiality of Information The importer, exporter, circulator, developer, manufacturer and producer of GMOs and Products thereof, may request to treat any of the information, they provide to the Establishment as confidential, provided that such request is justified. If approved, then no person may use it or allow its use without the Applicant approval.

  12. 11

    المادة 11

    Article (11) Labeling The importer, exporter, circulator, developer, manufacturer and producer of GMOs or Products thereof shall affix a label to each shipment and package, indicating that it contains GMOs or Products thereof, and any other data determined by the Executive Regulation of this Law.

  13. 12

    المادة 12

    Article (12) Response Measures The importer, exporter, circulator, developer, manufacturer, producer, and transporter of GMOs or Products thereof, which may cause harm in case of release, shall notify the Establishment and the Competent Authority regarding the same. The Executive Regulation of this Law shall determine the conditions and controls of the notification and the response measures.

  14. 13

    المادة 13

    Article (13) Disposing of GMOs The importer, exporter, circulator, developer, manufacturer and the producer of GMOs or Products thereof shall dispose of, destroy or return to the country of origin, at their own expense, any GMOs or Products thereof that are in violation of the provisions of this Law and the Executive Regulation thereof, and under the supervision of the Competent Authority, in coordination with the Ministry.

    -- 8 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 9

  15. 14

    المادة 14

    Article (14) Monitoring, Surveillance and Inspection 1. The Establishment and the Competent Authority shall monitor and control GMOs or Products thereof. 2. The Establishment and the Competent Authority shall inspect the Facility to assess its compliance with the provisions of this Law, its Executive Regulation and the resolutions in implementation thereof. 3. The Executive Regulations of this Law shall determine the controls for implementing this Article.

  16. 15

    المادة 15

    Article (15) Prohibitions All the following shall be prohibited: 1. Release of GMOs, without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; 2. Contained use of GMOs, without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; 3. Circulating, developing, manufacturing and producing GMOs or Products thereof, in violation to the provisions and Executive Regulations of this Law; 4. Transfer of GMOs or Products thereof, throughout the State, by any means without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; and 5. Transfer of GMOs or Products thereof, with non-genetically modified living organisms or the Non-Genetically Modified Products, in in the same means of transport or container.

    -- 9 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 10

  17. 16

    المادة 16

    Article (16) Civil Liability for Damages The importer, exporter, circulator, developer, manufacturer, producer, and transporter of GMOs or Products thereof shall be liable for any damage caused by importing, exporting, re- exporting, transiting, circulating, developing, manufacturing or producing GMOs or Products thereof.

  18. 17

    المادة 17

    Article (17) Administrative Penalties Without prejudice to the penalties prescribed in this Law, the Establishment or the Competent Authority may apply the following administrative penalties against the violating Facility: 1. Warning. 2. Temporary closure for a period not exceeding three months. 3. Permanent closure. The Executive Regulation of this Law shall determine the controls and procedures of grievance from administrative penalties.

  19. 18

    المادة 18

    Article (18) Revocation of the Prior Approval, Authorization and Suspension of Circulation The approval issued by the Establishment and the authorization issued by the Competent Authority in accordance with the provisions of this Law, shall be revoked, in the event of any violation of its provisions. The Executive Regulation thereof shall determine any other cases, conditions and controls of cancellation.

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    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 11

  20. 19

    المادة 19

    Article (19) Penalties Application of the Harsher Penalty The application of the penalties stipulated therein shall not prejudice any harsher penalty stipulated by any other Law.

  21. 20

    المادة 20

    Article (20) Whoever violates the provision of Clause (2) of Article (4) of this Law, shall be punished with imprisonment for not less than two years and with a fine of not less than AED Two Million (AED 2,000,000) and not exceeding than AED Four Million (AED 4,000,000), or with either of these two penalties.

  22. 21

    المادة 21

    Article (21) Whoever imports, exports or re-exports GMOs or Products thereof, in violation of this Law provisions, shall be punished with imprisonment for not less than six months and with a fine of not less than AED Two Million (AED 2,000,000) and not exceeding than AED Three Million (AED 3,000,000), or with either of these two penalties.

  23. 22

    المادة 22

    Article (22) Whoever commits one of the following violations, shall be punished with imprisonment for not less than six months and with a fine of not less than AED One Million (AED 1,000,000) and not exceeding AED Two Million (AED 2,000,000), or with either of these two penalties: 1. Releasing GMOs, without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; 2. Conducting the contained use of GMOs, without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; or 3. Circulating, developing, manufacturing or producing GMOs or Products thereof, in violation of the provisions of this Law and Executive Regulations thereof.

    -- 11 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 12

  24. 23

    المادة 23

    Article (23) Whoever commits one of the following violations, shall be punished with imprisonment for not less than three months and with a fine of not less than AED Five Hundred Thousand (AED 500,000) and not exceeding than AED One Million (AED 1,000,000), or with either of these two penalties: 1. Transporting GMOs or Products thereof, throughout the State, by any means without obtaining a prior approval from the Establishment and an authorization from the Competent Authority; or 2. Transporting GMOs or Products thereof, with Non-GMOs or Non-Genetically Modified Products, in the same means of transport or container.

  25. 24

    المادة 24

    Article (24) The penalties prescribed for the violations stipulated therein shall be doubled in cases of recidivism.

  26. 25

    المادة 25

    Article (25) Judicial Enforcement Any employee designated by a Resolution issued by the Minister of Justice, by agreement with the Chairman or the Head of the Competent Authority, shall have the capacity of a judicial enforcement officer in detecting the violations falling within their jurisdiction against the provisions of this Law and, its Executive Regulation f, and the Resolutions issued in implementation thereof.

  27. 26

    المادة 26

    Article (26) Fees The Cabinet shall issue a Resolution, in which it determines the prescribed fees, in accordance with the provisions of this Law.

    -- 12 of 13 --

    Federal Law of 2020 Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products 13

  28. 27

    المادة 27

    Article (27) Executive Regulation The Cabinet shall issue the Executive Regulation thereof, upon the Chairman proposal, within twelve months from the date of its issuance.

  29. 28

    المادة 28

    Article (28) Any provision which contradicts or conflicts with this Law provisions shall be repealed.

  30. 29

    المادة 29

    Article (29) Law Publication and Entry into Force This Law shall be published in the Official Gazette, and it shall enter into force from the day following the date of its publication. Khalifa Bin Zayed Al Nahyan President of the United Arab Emirates, Issued by Us at the Presidential Palace in Abu Dhabi: Date: Shawaal 5, 1441 AH Corresponding to: May 28, 2020 AD

    -- 13 of 13 --

ملاحظة: النص العربي لهذا التشريع هو النسخة المعتمدة رسمياً وفقاً لبوابة التشريعات الإماراتية الرسمية.

مواد هذا القانون(30)
  1. 1Article (1) Definitions For the purpose of applying the provisions of this Law,
  2. 2Article (2) Objectives This Law has the following objectives: 1. Preserving huma
  3. 3Article (3) Scope of Application 1. The provisions of this Law shall apply to th
  4. 3Article (3) thereof, shall be prohibited. 3. The Establishment shall be notified
  5. 4Article (4) Import, Transition and Circulation of GMOs or Products thereof 1. GM
  6. 5Article (5) Export and Re-export of the GMOs or Products thereof In order to exp
  7. 6Article (6) Contained Use and Release Upon release of GMOs or Products thereof,
  8. 7Article (7) Register A register shall be established with the Establishment to r
  9. 8Article (8) Facility Manager’s Obligations The Facility Manager shall comply wit
  10. 9Article (9) Risk Assessment 1. Risk assessment shall be conducted on a scientifi
  11. 10Article (10) Confidentiality of Information The importer, exporter, circulator,
  12. 11Article (11) Labeling The importer, exporter, circulator, developer, manufacture
  13. 12Article (12) Response Measures The importer, exporter, circulator, developer, ma
  14. 13Article (13) Disposing of GMOs The importer, exporter, circulator, developer, ma
  15. 14Article (14) Monitoring, Surveillance and Inspection 1. The Establishment and th
  16. 15Article (15) Prohibitions All the following shall be prohibited: 1. Release of G
  17. 16Article (16) Civil Liability for Damages The importer, exporter, circulator, dev
  18. 17Article (17) Administrative Penalties Without prejudice to the penalties prescri
  19. 18Article (18) Revocation of the Prior Approval, Authorization and Suspension of C
  20. 19Article (19) Penalties Application of the Harsher Penalty The application of the
  21. 20Article (20) Whoever violates the provision of Clause (2) of Article (4) of this
  22. 21Article (21) Whoever imports, exports or re-exports GMOs or Products thereof, in
  23. 22Article (22) Whoever commits one of the following violations, shall be punished
  24. 23Article (23) Whoever commits one of the following violations, shall be punished
  25. 24Article (24) The penalties prescribed for the violations stipulated therein shal
  26. 25Article (25) Judicial Enforcement Any employee designated by a Resolution issued
  27. 26Article (26) Fees The Cabinet shall issue a Resolution, in which it determines t
  28. 27Article (27) Executive Regulation The Cabinet shall issue the Executive Regulati
  29. 28Article (28) Any provision which contradicts or conflicts with this Law provisio
  30. 29Article (29) Law Publication and Entry into Force This Law shall be published in
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إجابات بلغة إنجليزية بسيطة، مع استشهاد يعود إلى المادة الدقيقة. استخدام مجاني، بدون تسجيل.

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