Convention on Biological Diversity — Cartagena protocol on biosafety

SUMMARY OF:

Cartagena protocol on biosafety to the convention on biological diversity

Decision 2002/628/EC on the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety

WHAT ARE THE AIMS OF THE PROTOCOL AND THE DECISION?

The Cartagena protocol to the 1993 Convention on Biological Diversity (see summary) is based on the precautionary principle*. It aims to prevent any harm to biological diversity when living modified organisms* are transferred, handled or used, especially across borders (Regulation (EC) No 1946/2003 — see summary). It takes into account risks to human health.
The Council decision gives the EU’s legal approval to the protocol.

KEY POINTS

Each signatory to the protocol:

adopts the necessary and appropriate legal, administrative and other measures to implement their commitments;
ensures that the development, handling, transport, use, transfer and release of any living modified organisms prevents or reduces the risk to biodiversity;
may take additional measures to protect the conservation and sustainable use of biological diversity;
is encouraged to take account of the work and expertise of international bodies specialising in risks to human health;
may participate in bilateral, regional and multilateral agreements and arrangements, including with non-signatory countries, providing these do not lower levels of protection;
must apply appropriate mechanisms, measures and strategies to control identified risks;
cooperates to identify living modified organisms that could have harmful effects;
cooperates to develop human and institutional resources to protect biosafety* and raise public awareness;
must notify affected or potentially affected countries, the Biosafety Clearing-House and, if necessary, relevant international organisations of any incident in its jurisdiction which could cause cross-border harm;
ensures the safe handling, packaging, identification and transportation of exported living modified organisms, along with the necessary documentation;
provides the Biosafety Clearing-House with details of its national laws, risk assessments, decisions and other information the protocol requires;
implements appropriate domestic measures to prevent and penalise illegal trade in living modified organisms;
may withdraw from the protocol 1 year after giving written notification.

The protocol applies to all international movement, transit, handling or use of living modified organisms that could harm biological diversity and human health, except for human medicines covered by other international agreements or organisations.

An advanced informed agreement procedure applies to the first export of living modified organisms to be deliberately introduced into the environment, except for those already identified as not harmful to biodiversity or human health. This requires:

the exporting country to notify in writing beforehand the relevant importing authorities with specific details (set out in Annex I) of the shipment;
the importing authorities must acknowledge receipt of the notification within 90 days and decide whether the import may go ahead. They may:
- approve the import, with or without conditions,
- refuse the import,
- request additional information,
- decide more time is required to process the notification,
- change an earlier decision in the light of new scientific information,
- apply a simplified procedure in certain circumstances,
- allow certain information submitted by the notifier to remain confidential. This does not apply to a general description of the item, a summary of the risk assessment or measures to tackle an emergency.

A specific procedure applies to living modified organisms for direct use as food, feed or processing. A country which decides that an item may be used or sold on its domestic market, which might then also be exported, must provide detailed information (set out in Annex II) to other signatories through the Biosafety Clearing House.

The protocol provides for risk assessments based on scientifically sound methodologies (Annex III).

A national focal point in each country liaises with the secretariat established by the convention. Specified national authorities carry out the administrative tasks the protocol requires.

A Biosafety Clearing House is established to:

handle the exchange of scientific, technical, environmental and regulatory information;
help signatories, particularly those most in need, to implement the protocol;

The conference of the parties, involving all the convention’s signatories, reviews the protocol, assesses it every 5 years, recommends measures to be taken and sets up subsidiary bodies.

DATE OF ENTRY INTO FORCE

The protocol entered into force on 11 September 2003.

BACKGROUND

The United Nations Environment Programme’s Convention on Biological Diversity took effect on 29 December 1993.
The Cartagena protocol to the convention on biosafety was adopted in Montreal on 29 January 2000.
In 2013, by Decision 2013/86/EU, the Council concluded on behalf of the EU the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.
For more information, see:
- Cartagena Protocol on Biosafety (European Commission).

KEY TERMS

Precautionary principle: where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation (Principle 15 of the Rio Declaration on Environment and Development).

Living modified organism: any living organism with a novel combination of genetic material created by modern biotechnology.

Biosafety: the protection of human health and the environment from the possible adverse effects of the products of modern biotechnology.

MAIN DOCUMENTS

Cartagena protocol on biosafety to the convention on biological diversity (OJ L 201, 31.7.2002, pp. 50-65)

Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety (OJ L 201, 31.7.2002, pp. 48-49)