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History
The Cartagena Protocol on Biosafety was adopted on 29 January
2000 as a supplementary agreement to the Convention on Biological
Diversity. The Convention on Biological Diversity was adopted at
the 1992 Earth Summit in Rio de Janeiro. Today, 187 countries are
parties to the Convention.
Pursuant to Article 19, paragraph 3, of the Convention on
Biological Diversity, the Conference of the Parties, by its
decision II/5, established an Open-ended Ad Hoc Working Group on
Biosafety to develop a draft protocol on biosafety, specifically
focusing on transboundary movement of any living modified organism
resulting from modern biotechnology that may have adverse effect
on the conservation and sustainable use of biological diversity.
On 29 January 2000 in Montreal, the parties adopted the
Cartagena Protocol on Biosafety. As it’s name indicates,
termination of the negotiations and final adoption of the protocol
text had been foreseen to take place in Cartagena, Columbia in
February 1999, but this unfortunately did not happen. A year
later, in January 2000, the parties were successful in reaching an
agreement in Montreal.
Nearly 200 countries, including the EU Member States, have
signed the Cartagena Protocol and thereby declared their interest
in biosafety and willingness to ratify the protocol.
Content and aim of the Protocol
The Protocol seeks to protect biological diversity from the
potential risks posed by living modified organisms resulting from
modern biotechnology, i.e. organisms that are equivalent to genetically
modified organisms (GMOs).
The Protocol establishes an advance informed agreement
procedure for ensuring that countries are provided with the
information necessary to make informed decisions before agreeing
to the import of such organisms into their territory. The Protocol
contains reference to a precautionary approach and reaffirms the
precaution language in Principle 15 of the Rio Declaration on
Environment and Development. The Protocol also establishes a
Biosafety Clearing-House to facilitate the exchange of information
on living modified organisms and to assist countries in the
implementation of the Protocol.
Export and import
The provisions of the Protocol only concern import and export
of LMOs whereas national handling of LMOs is left for the Parties
to regulate in their national laws. The transboundary movement of
LMOs is the central issue of the Protocol, but the provisions are
different depending on what use the LMOs are destined for.
LMOs intended for intentional introduction/deliberate release
into the environment (art. 7-10)
The most stringent rules in the Protocol concern LMOs intended
for intentional introduction /deliberate release into the
environment. The principal rule is that agreement between importer
and exporter shall be made prior to the transboundary movement.
The importer shall have all relevant information about the LMO
available in order to enter into the agreement. The importer shall
conduct a risk assessment according to the detailed requirements
in art. 15 + annex II). The procedure for import/export of LMOs
intended for intentional introduction/deliberate release into the
environment is therefore named the ‘Advance Informed Agreement
procedure’ (AIA procedure).
LMOs intended for direct use as food or feed or for processing
(art. 11)
The Protocol presents other provisions concerning LMOs intended
for direct use as food or feed or for processing. According to
art. 11 all Parties to the Protocol shall make relevant
information about such LMOs available to other Parties and
potential importing countries within 15 days of the approval of
the LMO product. Information about new LMO approvals shall be
shared through the ‘biosafety clearing house mechanism’ (a
web-portal) or through written information to Parties who have not
access to the Internet on a regularly basis.
Potential importing countries will through the Clearing House
Mechanism get information of which LMOs intended for direct use as food or
feed or for processing each Party has approved. Importing
countries can subsequently take decisions whether to allow imports
of these LMOs without prior consent or whether future imports need
to await a risk assessment and express consent.
Pharmaceuticals for human use and LMOs intended for contained
use (art. 5-6)
The provisions of the Protocol do generally not cover
pharmaceuticals for human use and LMOs in transit.
Importing countries can take decisions whether to allow imports
of LMOs intended for contained use without prior consent or
whether future imports need to await a risk assessment and express
consent. If no such decisions are taken by importing Parties and
subsequently notified through the Clearing House Mechanism, export
can take place without further arrangements.
Accompanying documents (art. 18)
According to the Protocol, accompanying documents shall clearly
identify LMOs intended for intentional introduction/deliberate
release and for contained use.
For LMOs intended for direct use as food or feed or for
processing the accompanying document shall state that the LMOs are
not intended for intentional introduction/deliberate release into
the environment.
Unintentional transboundary movements of LMOs (art. 17)
The Protocol contains provisions concerning appropriate
measures that need to be taken in cases of unintentional
transboundary movements of LMOs that are likely to have
significant adverse effects on the conservation and sustainable
use of biological diversity and human health in other countries.
Clearing House Mechanism (art. 20)
The establishment of the ‘Biosafety Clearing House Mechanism’
is a crucial element of the Protocol. Each party to the Protocol
will set up a national web-site for information-sharing about
technical, scientific, environmental and legal experiences and
know-how on LMOs. The many national clearing houses will together
form the Biosafety Clearing House Mechanism. The
information-sharing will assist especially developing countries
and countries with economies in transition to information and risk
assessments on LMOs prior to import. The clearing house mechanism
is therefore crucial in order to facilitate safe transboundary
movement of LMOs between countries.
Capacity-building (art. 22)
An important provision of the Protocol deals with capacity
building. It contains obligations to co-operate in the development
and/or strengthening of human resources and institutional
capacities in biosafety and biotechnology. Parties to the Protocol
shall co-operate in order to develop these resources and assist
especially developing country Parties and Parties with economies
in transition in implementing the Protocol.
Public awareness and participation (art. 23)
The Protocol puts special attention to facilitating public
awareness and participation concerning the safe transfer, handling
and use of LMOs. This encompasses access to information on LMOs,
which may be imported and on the decision-making processes
regarding LMOs.
Status quo – ratification and implementation
The Protocol has been signed by nearly 200 countries, including
the EU Member States. Denmark ratified the Cartagena Protocol on
Biosafety on 27 August 2002. The Protocol enters into force on 11
September 2003. An updated list of countries signing and ratifying
the Protocol can be found on its official web-site.
The European Environment Ministers adopted the European Unions
legislative act on implementation of the Protocol on 13 June 2003.
This legislation is named "Regulation on the transboundary
movement of GMOs" and is expected to enter into force at
the beginning of October 2003.
Further information
The official web-site of the Cartagena Protocol on Biosafety
The text of the Cartagena Protocol on Biosafety
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