E-mail:
Country:
Montenegro
Organization/agency name (Full name):
Adm for Food Safety, Veterinary, and Phytosanitary
Contact person name:
Ana Velimirovic
Website:
Physical full address:
Serdara Jola Piletica 26, 81000 Podgorica, Montenegro
Phone number:
+38220201945
Fax number:
+38220201946
Country introduction
Summary:
In the Montenegro, GMO issues are regulated since 2001. when the first Law on Genetically Modified Organisms was adopted. New Law On Genetically Modified Organisms was published in the “Official Gazette of the Republic of Montenegro” no. 22/2008 from 2 April 2008. This Law entered into force eight days from the publishing date, thus on 10th April 2008. That law had regulated the conditions for contained use, deliberate release into the environment, and placing on the market of GMOs and products of GMOs. the Law underwent amandement in 2011.
As per Law on food Safety (Official Gazette of Montenegro no 57/2015 from 7th October 2015) the Government enacts more detailed regulations on GM foods in order to ensure a high level of protection of human health and to take effective measures to prevent the consequences that may be caused by food or feed.
Framework
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:
Montenegro has a well-defined regulatory framework that governs the assessment, approval, and monitoring of genetically modified organisms (GMOs) used in food and feed. The Law on GMO mandates a precautionary and case-by-case risk assessment approach before any GMO can be approved for production, import, or commercial use. Article 8 requires a scientific risk assessment for potential adverse effects on human health and the environment before a GM product is authorized. Articles 37–42 regulate the authorization process for GM food and feed, including requirements for safety assessment, labeling, and monitoring. Montenegro aligns with Codex Alimentarius Guidelines and EU regulatory principles in conducting GMO safety assessments. Although Montenegro has not yet received an official request for GM food production or import, the regulatory framework ensures that if such a request arises, a full safety assessment will be conducted before approval.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Several government bodies are responsible for reviewing and conducting safety assessments of GM food and feed in Montenegro:
1. Ministry of Agriculture, Forestry, and Water Management
Role: Oversees the overall regulation, risk assessment, and monitoring of GMOs in food and feed.
Responsibilities:
Implements risk assessment procedures for GM food/feed imports and approvals.
Issues permits for the use of GMOs in agriculture and food production.
Collaborates with national and international regulatory bodies on GMO safety policies.
Legal Basis: Article 11 (Law on GMO)
2. Ministry of Environmental Protection
Role: Responsible for environmental risk assessments of GMOs before approval.
Responsibilities:
Evaluates potential impacts of GMOs on biodiversity and ecosystems.
Monitors environmental safety of GM crops and feed if introduced.
Legal Basis: Article 11
3. Ministry of Health
Role: Conducts food safety assessments of GMOs and approves market authorizations.
Responsibilities:
Reviews potential health risks of GM food/feed.
Ensures compliance with food safety regulations and labeling requirements.
Conducts post-market monitoring and risk reassessment if necessary.
Legal Basis: Articles 37–42
4. National Biosafety Council (NSBS)
Role: Provides scientific and technical expertise in GMO risk assessment and policy recommendations.
Responsibilities:
Reviews and evaluates risk assessments before GMOs are approved.
Advises government ministries on GMO-related decisions.
Monitors new scientific developments in GM technology and food safety.
Legal Basis: Article 15
Assessment
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 has never conducted safety assessment of GM food and will not (be able to) conduct such assessment in the near future.
Supplemental information on the implementation:
Stacked events
Regulation of stacked events:
In my country, GM food/feed that contains stacked event(s) is considered as a new product even if all single events that are stacked have already approved.
Supplemental information on the stacked events:
Article 21 of the Law on GMO (Montenegro) states that the use of GMOs in confined systems, their deliberate introduction into the environment, placement on the market, and transit of GMOs or products containing, consisting of, or derived from GMOs are permitted under the conditions and in the manner prescribed by this law. The procedure for obtaining approval for the use of GMOs in confined systems, their deliberate introduction into the environment, placement on the market, and transit of GMOs or products containing, consisting of, or derived from GMOs is initiated based on an application submitted in written or electronic form. The applicant is required to submit a separate application for each GMO obtained by crossbreeding two or more GMOs using conventional methods. The applicant may start the use of a confined system, use of GMOs in a confined system, deliberate introduction into the environment, placement on the market, and transboundary movement of GMOs or products containing, consisting of, or derived from GMOs only after obtaining approval from the competent authority.
Thus, based on this article, GMOs obtained by crossbreeding two or more already approved GMOs are not automatically considered approved. Instead, a separate application must be submitted for each stacked event. Montenegro treats stacked GM events as new products, requiring independent risk assessments and approvals.
Production and trade
GM food/feed production:
My country does not produce any GM food or feed.
GM food/feed imports:
My country allows imports GM food or feed upon authorization.
Supplemental information on the production and trade:
According to Article 22 of the Law on GMO, the cultivation or commercial production of GMOs is prohibited unless experimental data from studies conducted within Montenegro demonstrate that they do not pose a risk to ecosystems.
According to Article 37 and Article 38, the import and placement on the market of GM food or feed require prior authorization from the competent authority. This includes a risk assessment, labeling, and monitoring procedures. Montenegro applies strict precautionary measures before allowing the importation of GM products.
LLP/AP incidents
LLP/AP incidents:
I do not know if my country has faced any LLP/AP issues in the last 10 years.
Supplemental information on the LLP/AP incidents:
Labelling requirement
Labelling requirement:
My country has a mandatory and positive labeling regulation on GM food (i.e., It contains GMO).
Supplemental information on the Labelling requirement:
According to Article 48, Montenegro enforces a mandatory positive labeling system, meaning that all food, feed, or products containing, consisting of, or derived from GMOs must be clearly labeled. The label must state:
"Genetically Modified Organism (GMO)"
"This product contains GMOs."
"This product consists of GMOs."
"This product is derived from GMOs."
A unique identification code for the GMO must be included on the packaging.
Any unlabeled GMO product is banned from the market.
GMO labeling applies to all food and feed products, whether imported or domestically produced. The law sets strict tracking and monitoring requirements for GMOs in the supply chain (Article 45). Falsely labeling a product as GMO-free or omitting GMO labeling is considered a violation.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment
Other relevant documents:
Country information last modified:
06/03/2025
