Legislation Details
- Full Title: Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products
- Law Type: Federal Law
- Law Number: 9 of 2020
- Issued Date: 28 May 2020
- Effective Date: 01 Jun 2020
- Official Gazette: No. 679
- Sector: Environment and Natural Resources
- Status: Active
- Number of Articles: 60
- Chapters/Parts: 0
- Amendments: 1
Summary
This Federal Law regulates the biosafety of genetically modified organisms (GMOs) and their products in the United Arab Emirates. Its purpose is to preserve human health and safety, ensure environmental protection, and safeguard local genetic resources and biodiversity from the risks associated with GMOs. The law establishes a framework for controlling the import, export, transit, circulation, development, manufacture, and production of GMOs and their products. It also sets out requirements for risk assessment, labeling, response measures, and monitoring and inspection. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 2) This legislation is important for businesses and individuals in the UAE as it regulates a wide range of activities involving GMOs, from research and development to commercial trade. Compliance with the law's provisions is crucial to mitigate potential risks to human health and the environment. Penalties for non-compliance can be severe, including fines and imprisonment. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17-19)
What is the scope and purpose of this law?
The provisions of this Federal Law apply to the importation, exportation, re-exportation, transit, circulation, development, manufacture, and production of GMOs or products thereof, as well as other products that include or are composed of a percentage equal to or greater than 0.9% of a genetically modified component. The Cabinet may amend this percentage threshold. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 3) The law's objectives are to: (1) preserve human health and safety from the risks of GMOs or their products; (2) ensure environmental protection with respect to the development, manufacture, production, transport, or circulation of GMOs or their products; (3) preserve local genetic resources and biological diversity from the risks arising from the release or introduction of GMOs or their products into the environment; (4) ensure control, reduction, elimination, or treatment of damages that occur or are likely to occur from GMOs or their products; and (5) regulate scientific research activities on GMOs. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 2)
What are the key definitions under this law?
The law provides the following key definitions:
- 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
- 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
(Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 1)
What are the main obligations and requirements?
The law imposes the following key obligations: 1. GMOs or their products may not be imported unless an authorization from the Competent Authority is obtained. If the import is for the first time, the approval of the Establishment is also required. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4) 2. The import of genetically modified animals, their products, or residues is prohibited, regardless of the percentage of the genetically modified component. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4) 3. GMOs or their products 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. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4) 4. For the export or re-export of GMOs or their products, a prior approval from the Establishment and an authorization from the Competent Authority must be obtained. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 5) 5. The release of GMOs or their contained use for research, development, education, and production purposes require a prior approval from the Establishment and an authorization from the Competent Authority. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 6)
What licensing, registration, or approval requirements exist?
The law establishes the following licensing, registration, and approval requirements: 1. Facilities manufacturing, producing, developing, or circulating GMOs or their products must be registered with the Establishment. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 8) 2. Facilities must obtain an authorization from the Competent Authority to develop, manufacture, produce, import, transit, re-export, export, or transfer GMOs or their products. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 8) 3. Organisms that are produced, manufactured, developed, circulated, exported, imported, transited, or transported must be registered with the Establishment. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 8) 4. The import of GMOs or their products for the first time requires the approval of the Establishment, in addition to the authorization from the Competent Authority. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4) 5. The release of GMOs or their contained use for research, development, education, and production purposes requires a prior approval from the Establishment and an authorization from the Competent Authority. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 6)
What rights and protections does this law provide?
The law does not explicitly mention any specific rights or protections granted to individuals, workers, businesses, or other parties. The focus of the legislation is on regulating the import, export, transit, circulation, development, manufacture, and production of GMOs and their products to preserve human health, safety, and the environment.
Which authorities or bodies are responsible for enforcement?
The key authorities and bodies responsible for the enforcement of this law are: 1. The Emirates Drug Establishment (the Establishment): The Establishment is responsible for various functions, including: - Approving the import of GMOs or their products for the first time - Granting approvals for the export, re-export, and contained use of GMOs or their products - Establishing a register for facilities, GMOs, and their products - Determining the conditions and controls for risk assessment - Monitoring and controlling GMOs or their products (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4, 6, 7, 9, 14) 2. The Competent Authority: The Local Concerned Authority in each Emirate of the UAE is responsible for: - Granting authorizations for the import, circulation, export, and re-export of GMOs or their products - Granting authorizations for the release or contained use of GMOs - Supervising the disposal or destruction of GMOs or their products in violation of the law - Coordinating with the Ministry for the disposal or destruction of GMOs or their products (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 4, 5, 6, 13, 14)
What are the penalties for non-compliance?
The law specifies the following penalties for non-compliance: 1. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who releases GMOs or uses them in a contained manner without obtaining the required prior approval and authorization. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17) 2. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who circulates, develops, manufactures, or produces GMOs or their products without obtaining the required authorization. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17) 3. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who imports or exports GMOs or their products without obtaining the required approval and authorization. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17) 4. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who fails to comply with the labeling requirements for GMOs or their products. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17) 5. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who fails to notify the Establishment and the Competent Authority regarding the release of GMOs or their products that may cause harm. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17) 6. Imprisonment for a period not exceeding one year and/or a fine not exceeding AED 1 million for any person who fails to dispose of, destroy, or return to the country of origin any GMOs or their products that are in violation of the provisions of this law. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 17)
What fees, charges, or financial provisions are specified?
The law does not specify any fees, charges, or other financial provisions related to the regulation of GMOs and their products. The legislation is focused on the legal and regulatory framework, rather than the financial aspects.
What exemptions or exceptions apply?
The law provides the following exemptions: 1. Products containing a genetically modified component in a percentage of less than 0.9% are excluded from the application of the law's provisions. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 3) 2. GMOs or manufactured products thereof that are pharmaceutical substances for humans, as well as the genetic modification of humans and human cells, are excluded from the application of the law's provisions. (Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products, 2020, Art. 3)
How are disputes resolved under this law?
The law does not specify any dispute resolution mechanisms or procedures. It is focused on the regulatory framework for the biosafety of GMOs and their products, rather than on dispute resolution.
What are the key deadlines and time limits?
The law does not specify any deadlines or time limits for the various requirements and procedures it establishes. The legislation is focused on the regulatory framework, without providing details on specific timelines.
How does this law interact with other UAE legislation?
The law references several other UAE federal laws and decrees that are related to its subject matter, including: - Federal Law No. (1) of 1972 Regarding the Competencies of Ministries and Powers of the Ministers - Federal Law No. (5) of 1979 Regarding Agriculture Quarantine - Federal Law No. (6) of 1979 Regarding Veterinary Quarantine - Federal Law No. (24) of 1999 Regarding the Protection and Development of the Environment - Federal Law No. (28) of 2001 Establishing the Emirates Authority for Standardization and Metrology - Federal Law No. (10) of 2015 Regarding Food Safety - Federal Decree No. (77) of 2014 Regarding the State's Accession to
Source Documents
This article analyses Federal Law Regarding the Biosafety of Genetically Modified Organisms (GMOs) and Their Products for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.