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7. International regulatory instruments

7.1 Codex Alimentarius

In July 2003, the Codex Alimentarius Commission adopted the following texts:

· Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology

The purpose of these principles is to provide an overarching framework for undertaking risk analysis of the safety and nutritional aspects of foods derived from biotechnology. The “tracing of product” is referred in the text as a specific tool to facilitate risk management measures.

The key elements of the principles are:

- there should be a pre-market food safety assessment, on a case-by-case basis, for foods derived from biotechnology. The assessment should be based on sound science, obtained using appropriate methods and analysed using appropriate statistical techniques. The data and information used in this assessment should be of a quality that would withstand scientific peer review;

- the food safety assessment is based on a comparative analysis with a “conventional counterpart” to ensure that the resulting biotechnology food is no less safe than the foods normally consumed by the population;

- risk management measures should be proportional to the risks identified in the safety assessment and may include measures such as labelling, post-market monitoring and product tracing; and

- the definitions used in the Principles for the [Food Safety] Risk Analysis for Foods Derived from Modern Biotechnology are the same as those in the Cartagena Protocol on Biosafety (CPB), so that the Codex texts on food safety and the CPB text on biosafety and environmental protection are mutually compatible and supportive.

· Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants

This guideline, which is based on the above “Principles”, describes the methodology for conducting a safety assessment specifically for foods derived from recombinant-DNA plants. The basic approach for the safety assessment is the comparative approach based on the concept of “substantial equivalence”, thus focusing on the difference between foods derived from recombinant-DNA plants and their conventional counterpart. It pays special attention to the question of allergenic potential of new genetically modified (GM) plant varieties. An annex outlining the evaluation of allergenicity was also agreed.

· Codex Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms

Based on the above “Principles”, this guideline describes the methodology for conducting safety assessment specifically for foods derived from recombinant-DNA micro-organisms. The basic approach is similar to the guideline of recombinant-DNA plants, however, elements peculiar to micro-organisms were highlighted.

The key elements of the guidelines are:

- a detailed step-by-step guidance on how to undertake a safety assessment, including the nature of the data to be collected and the elements in the decision-making process that allows food produced using recombinant-DNA micro-organisms to be considered suitable for human consumption;

- they allow comparison of the safety assessments undertaken by different national authorities;

- they allow national authorities that do not wish to do their own (rather expensive) safety assessments to use the safety assessments of other government authorities provided that these assessments are in line with the Codex Guidelines;

- they provide a basis for future food safety assessments that may be undertaken by FAO and WHO, if FAO and WHO decide to undertake case-by-case safety assessments.

7.2 Cartagena Protocol on Biosafety

The Cartagena Protocol is a legally binding international instrument that regulates the transboundary movement of living modified organisms (LMOs) resulting from modern biotechnology with the objective of protecting the environment. The backbone of the Protocol is the advance informed agreement (AIA), requiring consent prior to the shipment and introduction of an LMO into the environment of an importing country.

The Protocol establishes a harmonized set of international rules and procedures designed to ensure that countries are provided with the relevant information, through the “Biosafety Clearing-House”. This Internet-based information system enables countries to make informed decisions before permitting the import of LMOs. The Protocol also ensures that LMO shipments are accompanied by appropriate identification documentation. The Protocol entered into force on 11 September 2003. It is important to note that, at present, there are no internationally agreed frameworks for considering ethical aspects relating to the use of modern biotechnology.

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