Cartagena Protocol on Biosafety (2000)

The Cartagena Protocol on Biosafety is an international agreement under the Convention on Biological Diversity. It sets rules for moving living modified organisms (LMOs) safely from one country to another. LMOs are living things, such as seeds or microbes, whose genes have been changed using modern biotechnology. The Protocol gives an importing country the right to know about such organisms in advance and to say "no" if it judges them risky to its nature or people's health.

Why does it exist?

From the 1990s, companies began selling genetically modified (GM) crops, such as insect-resistant cotton and herbicide-tolerant soybean. Many countries, especially developing countries, worried about the unknown effects. A GM plant could cross-breed with wild relatives and spread its new genes. It could harm useful insects or upset local ecosystems. But poorer countries often lacked labs and laws to test these organisms. They wanted a rule that exporters must inform them first. The Protocol was made to give them this protection.

Where did it come from?

Article 19(3) of the CBD asked countries to consider a protocol on the safe handling of LMOs. Negotiations began in 1996. A special meeting in Cartagena, Colombia, in February 1999 failed to agree, but the Protocol kept the city's name. It was finally adopted in Montreal on 29 January 2000 and came into force on 11 September 2003, after 50 countries ratified it.

Later, in 2010, countries adopted an extra agreement on who pays for damage: the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. It came into force on 5 March 2018.

What does "precautionary approach" mean here?

The Protocol is built on the precautionary approach from Principle 15 of the 1992 Rio Declaration. In simple words: "If you are not sure something is safe, you may stop it, even without full scientific proof of harm." The Protocol says that lack of full scientific certainty does not stop a country from restricting an import to avoid possible harm. Think of a new medicine: a careful doctor does not give it to a patient until there is good evidence it is safe.

How does it work? The two main routes

1. Advance Informed Agreement (AIA) procedure (Articles 7–10): this applies the first time an LMO meant to be released into the environment (for example, GM seeds for planting) is sent to a country.
2. The exporter must first send a written notice to the importing country with details of the organism.
3. The importing country studies it, using a scientific risk assessment (Article 15 and Annex III).
4. It then gives a decision: allow, allow with conditions, or ban. The export cannot happen before this "yes".
5. Simpler route for LMOs used as food, feed or for processing (LMO-FFPs, Article 11): for example, GM corn imported to be eaten or crushed into oil, not planted. Here no prior notice to each country is needed. Instead, a country that approves such a product for domestic use must post the decision on a shared online system within 15 days. Importing countries can then take their own decisions under their national rules.

Other key provisions

• Biosafety Clearing-House (BCH, Article 20): an online database where countries share their decisions, laws and risk assessments about LMOs. It works like a common notice board for the world.
• Handling, packaging and labelling (Article 18): shipments of LMOs must be properly marked. LMO-FFP shipments must state that they "may contain" LMOs and are not meant for release into the environment.
• Exemptions: the Protocol does not cover LMOs that are human medicines (pharmaceuticals) dealt with by other international bodies. LMOs only passing through a country (in transit) or used in closed labs have lighter rules.
• Meeting of the Parties: the Protocol's governing body is the COP of the CBD acting as the "Meeting of the Parties" (COP-MOP). Its 12th meeting is held alongside CBD COP17 in Yerevan in October 2026.
• Parties: more than 170 countries have joined [Unverified exact count]. Major GM crop exporters such as the United States (not even a CBD Party), Canada and Argentina have not joined.

India's position and Indian examples

India became a Party to the Cartagena Protocol on 11 September 2003, the day it came into force. It is also a Party to the Nagoya-Kuala Lumpur Supplementary Protocol (since 5 March 2018). India's own rules on GM organisms are older than the Protocol. They come under the Environment (Protection) Act, 1986, through the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1989 (the "Rules, 1989").

• The Genetic Engineering Appraisal Committee (GEAC), under the Ministry of Environment, Forest and Climate Change, approves the release of GM organisms into the environment.
• The Review Committee on Genetic Manipulation (RCGM), under the Department of Biotechnology, oversees research-stage work.
• Bt cotton (2002) is the only GM food-chain crop approved for commercial farming in India. Bt brinjal was put under a moratorium (a temporary stop) in 2010. GM mustard (DMH-11) got GEAC approval for environmental release in October 2022, and the matter has been before the Supreme Court.
• The Food Safety and Standards Authority of India (FSSAI) regulates GM food products.

Commonly confused concepts

• Cartagena Protocol vs Nagoya Protocol: Cartagena is about the safety of GM organisms (biosafety). Nagoya is about sharing benefits from genetic resources (ABS).
• Nagoya Protocol vs Nagoya-Kuala Lumpur Supplementary Protocol: both were adopted in Nagoya in 2010, but the Supplementary Protocol is part of the biosafety system (liability for damage by LMOs), not benefit-sharing.
• LMO vs GMO: an LMO is a living GM organism that can grow or reproduce (a seed). Processed GM products like soybean oil are not "living" and are not LMOs.
• AIA vs prior informed consent under the Rotterdam Convention: the Rotterdam Convention (1998) is about trade in hazardous chemicals and pesticides, not GM organisms.
• GEAC vs RCGM: GEAC approves environmental release; RCGM handles lab and research-level approvals.

Issues, criticism and the way forward

• Missing big exporters: the countries that grow and export the most GM crops are not Parties. So much of world GM trade is outside the Protocol's rules.
• Trade vs caution: exporters argue that strict rules are hidden trade barriers that clash with World Trade Organization rules. Supporters say the precautionary approach is needed for new and uncertain technology.
• New technologies: gene-edited crops (using tools like CRISPR) and synthetic biology raise new questions. In 2022, India exempted certain gene-edited plants without foreign DNA (SDN-1 and SDN-2) from the strict GM rules, and released two gene-edited rice varieties in 2025.
• Weak capacity: many developing countries lack labs to detect LMOs in imports and to do risk assessments.
• Way forward: strengthening the Biosafety Clearing-House, building testing capacity, clear labelling, and agreeing common approaches for gene editing and synthetic biology.

Concepts to Know

• Biotechnology / genetic engineering: changing an organism's genes in a lab, for example adding a bacterial gene to cotton so the plant makes its own insect poison (Bt cotton).
• Biosafety: steps to make sure GM organisms do not harm nature or human health.
• Transboundary movement: moving something from one country into another.
• Risk assessment: a scientific study of what could go wrong if an organism is released, and how likely and serious the harm would be.
• Liability and redress: deciding who is responsible for damage (liability) and how the damage is repaired or paid for (redress).
• Gene editing: making small, precise changes to an organism's own genes, often without adding any foreign gene.