Ghana
Country introduction:
The National Biosafety Authority (NBA) is the competent authority for biosafety regulation in Ghana. It was established based on the provisions of the Biosafety Act, 2011(Act 831) and operationalized in 2015. In 2019, the Biosafety (Management of Biotechnology) Regulations, 2019 (L.I. 2383) was also passed. The overarching mandate of the NBA is to regulate, oversee, and manage activities involving genetically modified organisms and related products in Ghana to ensure biosafety, protect human health, preserve biodiversity, and safeguard the environment, in accordance with the Biosafety Act, 2011 (Act 831) and international obligations including the Cartagena Protocol on Biosafety. The Authority regulates all activities involving GMOs in research, food, feed, processing, cultivation and trade.
Since its establishment, the NBA has developed standard operating procedures, application forms, checklists and guidelines on contained use and confined field trials, environmental release and or placing on the market, genome editing, stacked genes and compliance monitoring and inspection to enhance biosafety regulation of GMO related activities.
The CEO of the NBA is the National Focal Point for the Cartagena Protocol on Biosafety and the Biosafety Clearing House.
Since its establishment, the NBA has developed standard operating procedures, application forms, checklists and guidelines on contained use and confined field trials, environmental release and or placing on the market, genome editing, stacked genes and compliance monitoring and inspection to enhance biosafety regulation of GMO related activities.
The CEO of the NBA is the National Focal Point for the Cartagena Protocol on Biosafety and the Biosafety Clearing House.
Regulatory framework:
My country has a regulatory framework that requires the competent authority to conduct safety assessment of GM food.
Structure for GM food safety assessment:
My country has competent authority, agency, organization, ministry, department, committee, commission or a system/mechanism that is tasked to conduct or review GM food safety assessment.
Supplemental information (regulatory framework):
Relevant contact details:
National Biosafety Authority, working with the Food and Drugs Authority as the Regulatory Agency for Food safety.
GM food safety assessment guidelines:
My country follows the relevant Codex Guidelines or national/regional guidelines that are in line with the Codex Guidelines in conducting safety assessment of GM food.
Conduct of GM food safety assessment:
My country does not regularly conduct food safety assessment of GM food, but has conducted at least once in the past.
Supplemental information (assessment):
Regulation stacked events:
On a case-by-case basis, some stacked events may have reduced/simplified assessment requirements.
Supplemental information (stacked events):
The National Biosafety Authority has guidelines for the regulation of stacked genes.
The regulatory process outlines:
A. Stacking GM Events through conventional breeding where the single events have been approved.
Applicant submits a notification to the NBA with information required for approval of the higher order stack.
B. Stacking of GM Events through conventional breeding where one or more of the single events have not been approved.
Applicant submits complete application for the unapproved event and a notification for the higher order stack.
A simultaneous review process will be adopted for the unapproved single events and the higher order stack.
C. Stacking of GM Events through conventional breeding where none of the single events have been approved.
Applicants submit separate complete applications for all unapproved single events and a notification for the higher order stack.
A simultaneous review process will be adopted for all the unapproved single events and the higher order stack
For higher order stacks, the applicant will be required to provide:
Confirmation of gene expression levels of each of the single events
An assessment for possible interactions - synergistic or antagonistic
Confirmation of event intactness and stability
History of safe use of the single events / List of approvals issued by other countries
The approval of the higher order stack also covers the intermediates and their singles, where applicable.
Guidelines for Application on Genetically Modified Organism with Stacked Genes
GM food/feed production:
My country produces GM food or feed for commercial and research purposes.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information (production and trade):
LLP/AP incidents:
My country has not faced any LLP/AP situations in the last 10 years.
Supplemental information (LLP/AP incidents):
Labelling requirement:
My country has a mandatory and positive labeling regulation & allows a voluntary and negative labeling on GM food.
Supplemental information (labelling requirement):
Relevant links:
Upload relevant documents: