rom the 1980s, molecular biology began to develop extremely rapidly. By the end of the 20th century, molecular genetics and gene technology had made science capable of artificially changing the characteristics of living organisms by modifying the genetic program that controls the functioning of living organisms, as required. Today, there are significant opportunities for practical application in the fields of medicine, agriculture, the food industry and environmental protection. The first genetically modified plant was created in 1993. Since then, genetically modified plants are cultivated on several tens of millions of hectares in several countries (e.g. USA, Canada, Argentina, China). As a result, organisms with new characteristics that could not exist naturally and which cannot be created through traditional cross-breeding methods may enter our environment. Genetically modified organisms remain at the centre of heated debate both in Hungary and throughout the world today, because their production and use could cause many environmental, health-related and economic problems, something that is often mentioned on various scientific forums and in the media. Their direct and indirect effects may endanger biodiversity, which includes all forms of life from the simplest microbe to the largest mammals, and the whole biosphere, the balance of which, the composition of the atmosphere, the fertility of our soils, the cleansing of our waters, is assured by wildlife itself and by biodiversity.

Having recognised the above problems, at the UN Conference on the Environment and Development (the 1992 Earth Summit in Rio de Janeiro) the world adopted the Convention on Biological Diversity concerning the preservation and sustainable utilisation of wildlife and the equitable distribution of the assets gained from them. The Convention on Biological Diversity also deals with activities related to genetically modified organisms, and so detailed regulations were developed between 1995 and 2000 (Protocols), which were then adopted on 29 January 2000 under the name Cartagena Protocol, and which the Hungarian Minister for the Environment also signed in May 2000.

The Protocol came into force on 11 September 2003. The Hungarian National Assembly ratified the Protocol on 13 January 2004; it subsequently came into force in Hungary on 12 April 2004 and was published in Act CIX of 2004.

What does the Cartagena Protocol Concern?

The Protocol concerns the transboundary movement and handling of living, genetically modified organisms (so-called LMOs) and with those living, genetically modified organisms that may pose a danger to the preservation of biodiversity, its sustainable utilization or to human health.

The Objective of the Protocol

• to regulate the safe traffic, handling and utilization of live, genetically modified organisms with special regard to transboundary movements,

• to provide suitable protection to biodiversity, i.e. against negative effects on the preservation and sustainable utilization of wildlife, including risks to human health, while conforming to the cautionary principles set down in the Rio Declaration,

• to facilitate cooperation between governments, economic operators and society in the interests of increasing biological security.

The scope of authority of the Protocol includes all living, genetically modified organisms with the exception of pharmaceuticals used in treating humans (which are regulated by other treaties), in addition a simplified procedure exists for shipments of modified organisms which are to be used in contained systems (that do not enter the environment).

Our Most Important Responsibilities According to the Protocol

• A preliminary authorisation procedure must be performed prior to the first import of living, genetically modified organisms (e.g. live fish, seeds) that are destined to be released to the environment. In such cases it is the duty of the exporter to inform the importing country prior to transport in detail and in writing of the planned shipment containing living, genetically modified organisms. Having received such information, the importing country must decide within a predetermined period whether to allow the shipment into the country. If new scientific data emerges with regard to the possible adverse effects of living, genetically modified organisms, the importing party may at any time review and modify its decision with regard to the transport of such organisms across its borders.

• The Protocol prescribes a scientifically justified risk assessment procedure, which must in all cases occur before any decision on the importing of living, genetically modified organisms. The performance of the risk assessment study is the responsibility of the importing party, but it may also require that the exporting party perform the study and bear the related costs.

• An information system must be operated within the framework of the protocol (BCH: Biosafety Clearing House). This system is basically a website which facilitates the exchange of scientific, technical, legal and environmental knowledge relating to living, genetically modified organisms, and which helps decision-making, aids the Parties in realising the objectives of the Protocol and enables the public to access information on living, genetically modified organisms that have been declared importable according to the Protocol.

• The Protocol also prescribes that the public must be included in the decision-making process and that the results of decisions must also be made public.

• The Parties must assure the reporting of random movements across borders and the prevention and if possible the punishment of illegal shipments. In the case of an illegal shipment, the affected Party may demand that the country of origin of the shipment of living genetically modified organisms bear the costs of their return or destruction.

• In the case of live, genetically modified organisms destined for direct use in food, feed or for processing, labelling must include only the details of the contact person and that the shipment "may contain living, genetically modified organisms".

• In the case of end use and emission into the environment, shipment documentation must clearly indicate the shipment as being living, genetically modified organisms, and every requirement for their secure handling, storage, transport and utilization must be clearly determined. Contact person details must also be provided. In the case of end use, the accompanying documentation must also include information on where the organisms are being transported. In the case of emission into the environment, accompanying documentation must also include the typical characteristics of the organisms in question and their method of identification.

• Developing countries must be helped with financial and other methods to establish a suitable personnel and institutional background to successfully implement the Protocol.

• After the Protocol has come into force, the detailed regulations (e.g. liability and risk management following possible damages) in each thematic area shall be developed at the meetings of the Parties.

Historical Overview

According to Paragraph 3 of Article 19 of the Convention on Biological Diversity, the Conference of the Parties set up an Ad Hoc Working Group on Biosafety in its Resolution No. II/5. The task of the Working Group was to elaborate a draft of the Protocol on Biosafety, which concentrates specifically on the transboundary movement of modified organisms that result from modern biotechnology and which may have harmful effects on the preservation and sustainable use of biological diversity.

The Ad Hoc Working Group on Biosafety held six sessions during the period 1996-1999. As a result of their work, the Working Group presented the draft text of the Protocol so that the Protocol on Biosafety could be adopted at the first extraordinary meeting of the Conference of the Parties.

The first extraordinary meeting of the Conference of the Parties began on 22 February 1999 in Cartagena, Columbia. The Conference of the Parties was unable to complete its work in the time available, and the session was reconvened in Montreal, Canada on 24-29 January 2000, prior to which an unofficial meeting was held on 20-23 January 2000, also in Montreal.
On 29 January 2000, the Conference of the Parties adopted the Cartagena Protocol on Biosafety.
In its Resolution No. EM-I/3, the Conference of the Parties established the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP), which made the preparations required for the first meeting of the Parties to the Protocol.

The first session of the Intergovernmental Committee was held on 11-15 December 2000 in Montpellier, France, and the second was in Nairobi, Kenya on 1-5 October 2001. The third session of the ICCP was held on 22-26 April in The Hague, Holland.
The ad hoc Intergovernmental Committee was dissolved after the Protocol came into force and the Parties had held their first meeting. The detailed regulations on the implementation of the Protocol would now be decided at the meetings of the Parties.

Detailed information on the work of the ICCP may be found on the main website of the Cartagena Protocol.
The first meeting of the Parties took place in Kuala Lumpur, Malaysia, between 23 and 27 February 2004. 14 resolutions were adopted at the meeting. The sixth meeting of the Parties (MOP6) was held in India on 1-5 October 2012.

Signing and Ratification

The Cartagena Protocol on Biosafety was adopted on 29 January 2000 at the conference of the Parties to the Convention of Biological Diversity.

Hungary signed the Protocol on 24 May 2000. The document on ratification was deposited by the Ministry of Foreign Affairs at UN headquarters in New York on 13 January 2004. The Protocol came into force in Hungary on 12 April 2004.