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Federal Law on the Biosafety of Genetically Modified Organisms (GMOs) and the Products Thereof

The last update on this law was listed on 28 May 2020

Related legislations

Issued Date

28 May 2020

Effective Date

01 Jun 2020

Official Gazette Date

31 May 2020

Official Gazette No

679 (ملحق 1)

Legislation State

Active

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Article (1) Definitions

In application of this Law provisions, the following words and phrases shall have the meanings assigned to each of them unless the context otherwise requires:
State: The United Arab Emirates.
Ministry: The Ministry of Climate Change and Environment.
Minister: The Minister of Climate Change and Environment.
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.
Water Resources: Any material of plant, animal, microbial or other origin containing functional units of heredity of actual or potential value.
 Biosafety: Procedures followed for ensuring the safe use of modern biotechnology applications for both human and environment, with a view to reducing or eliminating the potential risks arising therefrom.
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 which has a new composition that contrasts its original one with genetic materials obtained through the use of modern biotechnology.
GMO Products: Products formulated with or containing GMO, derivatives or residues thereof, or other products containing them or a percentage of Genetically Modified Component.
 Genetically Modified Component: Any part containing the genetically modified code.
Modern Biotechnology: Application of techniques on DNA test tubes and direct injection of nucleic acid into cells or organelles, or merging cells until they become outside their taxonomic category and go beyond the normal physiological reproductive barriers or recombination. Modern biotechnology is not used in normal breeding and selection techniques.
Contained Use: The process that takes place within a facility, and that includes GMOs subject to specific measures that effectively prevent their contact with the external environment and their impact on such environment.
Release: Release of GMOs or Products thereof into the environment.
Circulation: Sale or offer for sale, storage or possession, whether permanently or temporarily.
Facility: The facility, establishments or any other utility, whether movable or immovable, permanent or temporary, authorised 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: Assessment 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 human and environment
Response Measures: Measures taken to prevent, minimise, control or mitigate damage.

Article (2) Objectives

This Law aims to the following:
1.Preserving human health and safety from the risks of GMOs or Products thereof.
2. Ensuring environmental protection in the area of developing, manufacturing, producing, transferring or circulating GMOs or Products thereof resulting from modern biotechnology.
3. Preserving local genetic resources and biological diversity from the risks of 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 for GMOs.

Article (3) Scope of Application

1. The provisions thereof shall apply to the import, export, re-export, transit, circulation, development, manufacture and production of GMOs or Products thereof, in addition to other products containing them or containing 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 provisions application thereof:
 A. Products containing a Genetically Modified Component less than 0.9%; and
 B. GMOs or manufactured products thereof that are pharmaceutical substances for human and the genetic modification of human and human cells.

Article (4) Importation, Transition and Circulation of GMOs or Products thereof

1. GMOs or Products thereof may not be imported unless permission from the Competent Authority is obtained. In addition, in case the import is for first time, the Ministry approval shall be required, and the Executive Regulation thereof shall determine the terms and conditions for implementing such procedure.
2. In all cases, Genetically Modified Animals, products thereof or residues thereof for which percentage of the Genetically Modified Component is in accordance with Clause 1 of Article 3 thereof shall not be imported.
3. The Ministry must be notified of any GMOs or Products thereof that transit the State prior to such process. The Executive Regulation thereof shall determine the conditions and procedures for transit and notification requirements.
4. GMOs or Products thereof in the State shall not be circulated unless permission from the Competent Authority is obtained, in accordance with the conditions and controls determined by the Executive Regulation thereof.

Article (5) Exportation and Re-exportation of the GMOs or Products thereof

In order to export or re-export the GMOs or Products thereof, a prior approval from the Ministry and permission from the Competent Authority shall be obtained, in accordance with the conditions and controls determined by the Executive Regulation thereof.

Article (6) Contained Use and Release

Upon releasing GMOs or Products thereof, or conducting the contained use of the GMOs for the purposes of research, development, education and production, a prior approval from the Ministry and permission from the Competent Authority shall be obtained, in accordance with the conditions and controls determined by the Executive Regulation thereof.

Article (7) Register

A register shall be established with the Ministry to register the Facilities, GMOs and Products thereof that are produced, manufactured, developed, circulated, exported, imported, transit or transported, and the Executive Regulations thereof shall determine the controls for implementing such Article.

Article (8) Facility Officer Obligations

The Facility Officer shall comply with the following:
1. Registering the Facility with the Ministry;
2. Obtaining permission 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, transit or transported.
The Executive Regulation thereof shall determine the conditions and controls of such Article and any other obligations.

Article (9) Risk Assessment

1. Risks shall be assessed according to scientific bases 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 analysing, assessing and managing risks shall be determined by a Resolution from the Minister.
 

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, he provides to the Ministry as confidential, provided that such request is justified. Should it is approved, then no person may use it or allow its use without the Applicant approval.

Article (11) Data Card

The importer, exporter, circulator, developer, manufacturer and producer of GMOs or Products thereof shall put a data card on each shipment and package, indicating that it contains GMOs or Products thereof, and any other data determined by the Executive Regulation thereof.

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 Ministry and the Competent Authority regarding the same. The Executive Regulation thereof shall determine the conditions and controls of the notification and the response measures.

Article (13) Eliminating GMOs

The importer, exporter, circulator, developer, manufacturer and the producer of GMOs or Products thereof shall eliminate, damage or return GMOs or Products that violate this Law provisions and Executive Regulation thereof, to the country of origin, at his own expense, and under supervision of the Competent Authority, in coordination with the Ministry.

Article (14) Monitoring, Control and Inspection

1. The Ministry and the Competent Authority shall monitor and control GMOs or Products thereof.
2. The Ministry and the Competent Authority shall inspect the Facility to assess its compliance with the provisions of this Law and Executive Regulation thereof.
3. The Executive Regulations thereof shall determine the controls for implementing such Article.
 

Article (15) Prohibitions

All the following shall be prohibited:
1. Release of GMOs, without obtaining a prior approval from the Ministry and permission from the Competent Authority;
2. Contained use of GMOs, without obtaining a prior approval from the Ministry and permission from the Competent Authority;
3. Circulating, developing, manufacturing and producing GMOs or Products thereof, in violation to the provisions and Executive Regulations thereof;
4. Transfer of GMOs or Products thereof, throughout the State, by any means without obtaining a prior approval from the Ministry and permission from the Competent Authority; and
5. Transfer of GMOs or Products thereof, with the Non-GMOs or the Non-Genetically Modified Products, in one conveyance or container.

Article (16) Civil Liability for Damages

The importer, exporter, circulator, developer, manufacturer, producer, and transporter of GMOs or Products thereof shall bear the liability for any damage caused by importing, exporting, re-exporting, transiting, trading, developing, manufacturing or producing GMOs or Products thereof.

Article (17) Administrative Sanctions

Without prejudice to the penalties established therein, the Ministry or the Competent Authority may apply the following administrative sanctions against the violating Facility:
1. Warning.
2. Temporary closure for a period not exceeding three months; or
3. Final closure.
The Executive Regulation thereof shall determine the controls and procedures of grievance from administrative sanctions.

Article (18) Cancellation of the Prior Approval and Permission and Circulation Suspension

The approval issued by the Ministry and the permission issued by the Competent Authority in accordance with the provisions thereof, shall be cancelled, in case of violating any of the provisions thereof. The Executive Regulation thereof shall determine any other cases, conditions and controls of cancellation.

Article (19) Penalties Application of Severe Punishment

The application of the penalties stipulated therein shall not prejudice any more severe penalty stipulated by any other Law.

Article (20)

Anyone violates the provision of Clause 2 of Article 4 thereof, 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 more than AED Four Million (AED 4,000,000), or with either of the two penalties.

Article (21)

Anyone 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 more than AED Three Million (AED 3,000,000), or with either of the two penalties.

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 more than AED Two Million (AED 2,000,000), or with either of the two penalties:
1. Releasing GMOs, without obtaining a prior approval from the Ministry and permission from the Competent Authority;
2. Conducting the contained use of GMOs, without obtaining a prior approval from the Ministry and permission from the Competent Authority; or
3. Circulating, developing, manufacturing or producing GMOs or Products thereof, in violation to the provisions and Executive Regulations thereof.

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 more than AED One Million (AED 1,000,000), or with either of the two penalties:
1. Transferring GMOs or Products thereof, throughout the State, by any means without obtaining a prior approval from the Ministry and permission from the Competent Authority; or
2. Transferring GMOs or Products thereof, with Non-GMOs or Non-Genetically Modified Products, in one conveyance or container.

Article (24)

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

Article (25) Law Enforcement

Any Officer determined by a Resolution issued by the Minister of Justice, by agreement with the Minister or the Competent Authority Director, shall have the capacity of law enforcement officer in proving the violations falling within their jurisdiction against the provisions of this Law and Executive Regulation thereof, and the Resolutions issued in implementation thereof.

Article (26) Fees

The Cabinet shall issue a Resolution, in which it determines the prescribed fees, in accordance with the provisions thereof.

Article (27) Executive Regulation

The Cabinet shall issue the Executive Regulation thereof, upon the Minister proposal, within twelve months as of the date of its issuance.

Article (28)

Any provision which violates or contradicts this Law provisions shall be repealed.

Article (29) Law Publication and Enforcement

This Law shall be published in the Official Gazette, and it shall be enforced from the day following the date of its publication.

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