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The 'step-by-step' principle was introduced by Directive 2001/18/EC [1] where it appears as numbers (24) and (25) of the preamble: '(24) The introduction of GMOs into the environment should be carried out according to the "step by step" principle.
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However, this law does not establish a step-by-step principle.
There are different situations during the application phase when reference to the step-by-step principle may be of importance.
The overview of the three legislations shows that they starkly vary concerning the step-by-step principle.
Directive 2001/18/EC is the legal basis for the ERA of GMOs in the European Union and establishes the step-by-step principle.
The analysis of the legislation of China, the United States of America and Brazil showed a differentiated approach towards the step-by-step principle.
18 (4) of the same regulation refer to the environmental safety requirements of Directive 2001/18/EC [1]which also include the step-by-step principle.
In accordance with the step-by-step principle of Directive 2001/18/EC, the role of the LoC in the ERA of GMOs should go beyond any type of stop criterion.
The step-by-step principle shall ensure that the state of science and technology is developed throughout the previous steps such that an adequate risk assessment can be made.
These can be regarded as minimum postulates of the step-by-step principle: Submission of data on the parent organism, the recipient organism, the GMO and the effects of the GMO on human health, plant and animal health and the environment as listed in Art. 5 (3) and Annex III B Directive 2001/18/EC [1].
The step-by-step principle means that the containment of genetically engineered organisms is reduced and the scale of release is increased gradually, moving from the laboratory to large-scale field testing in several steps provided the data obtained at the earlier steps give no reason for concern.
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