S.L. 549.60 Art. 4General obligations.

(1) GMOs may only be deliberately released or placed on the market in conformity with Part B or Part C of these regulations respectively.

(2) Any person shall, before submitting a notification under Part B or Part C, carry out an environment risk assessment. The information which may be necessary to carry out the environment risk assessment is laid down in Schedule III. GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment shall be taken into particular consideration when carrying out an environment risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall have taken place by the 31st December 2004 in the case of GMOs placed on the market according to Part C and by 31st December 2008 in the case of GMOs authorised under Part B.

(3) Potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, shall be accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Schedule II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.

(4) The competent authority shall be responsible for ensuring compliance with the requirements of these regulations, and it shall examine notifications under Part B and Part C for compliance with the requirements of these regulations and whether the assessment provided for in sub-regulation (2) is appropriate.

(5) The competent authority shall organise inspections and other control measures as appropriate, to ensure compliance with these regulations. In the event of a release of any GMO or placing on the market as or in products for which no authorisation was given, the competent authority shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform the public, the Commission and other Member States.