S.L. 549.60 Art. 11Sectoral legislation. Duty to comply with Part C.

(1) Regulations 12 to 19 shall not apply to any GMO as or in products, as far as they are authorised by any relevant legislation which provides for a specific environment risk assessment, to be carried out in accordance with the principles set out in Schedule II and on the basis of information specified in Schedule III, without prejudice to additional requirements provided for by the relevant legislation, and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in these regulations, or in any other relevant regulations concerning medicinal products for human and veterinary use.

(2) Without prejudice to Schedule I B and subject to the exclusions in sub-regulation (1), a person shall not place on the market any product containing or consisting of a genetically modified organism unless:

(a) consent in writing has been received from the competent authority under Part C, or

(b) consent in writing has been received from the competent authority of another Member State in accordance with Part C of the Directive, and the conditions attached to the consent have been complied with.