Foodstuffs, Cosmetics and Disinfectants Act, 1972
R 385
Genetically Modified Organisms Act, 1997 (Act No. 15 of 1997)RegulationsGenetically Modified Organisms Regulations, 20104. Scientifically based risk assessment |
| (1) | No person shall undertake an activity unless a suitable and sufficient assessment of the potential adverse effects to the environment, human and animal health and safety has been made. |
| (2) | Any risk assessment shall be conducted in a scientifically sound manner, taking into consideration recognised risk assessment methods and techniques that are currently applied at national, regional and international level. |
(3) Any risk assessment shall entail, as appropriate, the following steps—
| (a) | Identification of any potential adverse effect resulting from the novel genotypic and/or phenotypic characteristics of the genetically modified organism. |
| (b) | An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the potential receiving environment to the genetically modified organism. |
| (c) | An evaluation of the consequences should these adverse effects be realized. |
| (d) | An estimation of the overall risk posed by the genetically modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized. |
| (4) | A risk assessment shall be conducted on a case-by-case approach and shall include the consideration and evaluation of all available relevant scientific information, including expert advice of, and guidelines developed by, relevant international organizations. |
| (5) | The applicant shall provide data on which the risk assessment was based together with the application, to the registrar. |
| (6) | Lack of scientific knowledge or scientific consensus shall not be interpreted as indicating a particular level of risk, an acceptable risk or an absence of risk. |
