CHAPTER IVCOMMON PROVISIONS

Article 30Confidentiality

1

The applicant may indicate which information submitted under this Regulation it wishes to be treated as confidential on the ground that its disclosure might significantly harm its competitive position. Verifiable justification must be given in such cases.

2

Without prejudice to paragraph 3, the F1Food Safety Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.

3

Information relating to the following shall not be considered confidential:

a

name and composition of the GMO, food or feed referred to in Articles 3(1) and 15(1) and, where appropriate, indication of the substrate and the micro-organism;

b

general description of the GMO and the name and address of the authorisation-holder;

c

physico-chemical and biological characteristics of the GMO, food or feed referred to in Articles 3(1) and 15(1);

d

effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on human and animal health and on the environment;

e

effects of the GMO, food or feed referred to in Articles 3(1) and 15(1) on the characteristics of animal products and its nutritional properties;

f

methods for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food or feed referred to in Articles 3(1) and 15(1);

g

information on waste treatment and emergency response.

F24

Notwithstanding paragraph 2, the Food Safety Authority must on request supply the appropriate authority with all information in its possession.

5

The use of the detection methods and the reproduction of the reference materials, provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to the GMOs, food or feed to which an application refers, shall not be restricted by the exercise of intellectual property rights or otherwise.

F36

The appropriate authority and the Food Safety Authority must take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

F47

If an applicant withdraws or has withdrawn an application, the Food Safety Authority and the appropriate authority must respect the confidentiality of commercial and industrial information, including research and development information, as well as any information in respect of which a claim of confidentiality is disputed.