The Genetically Modified Organisms(Contained Use) Regulations 2000

Disclosure of information provided pursuant to regulation 21

23.—(1) The information provided pursuant to regulation 21 shall not be treated as relevant information for the purposes of section 28 of the 1974 Act.

(2) Subject to paragraph (3), where a person indicates that information provided by him pursuant to regulation 21 should be kept confidential on one or more of the grounds set out in regulation 4(2)(a) to (c) and (e) of the Environmental Information Regulations 1992—

(a) he shall give full justification for that indication to the competent authority; and

(b) after consulting that person, the competent authority shall decide which, if any, information shall be kept confidential and shall inform that person of its decision.

(3) Subject to paragraph (7), paragraph (2) shall not apply to the following information, which shall not be kept confidential—

(a) the name and address of the person providing the information;

(b) in the case of an accident relating to an activity involving genetic modification of a micro-organism—

(i) the location of the accident,

(ii) the general characteristics of genetic modification of the micro-organism,

(iii) the class of the activity involving genetic modification of the micro-organism,

(iv) the containment measures, and

(v) the evaluation of actual and foreseeable effects, in particular any harmful effects on human health and the environment.

(4) Information which the person providing that information has indicated should be kept confidential and in relation to which the competent authority has not yet made a decision under paragraph (2)(b) and information which the competent authority has decided shall be kept confidential shall not be disclosed except to the extent necessary to enable the competent authority to comply with its obligations under regulation 21(2).

(5) Where the competent authority has made a decision under paragraph (2)(b) that certain information shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the competent authority informed the person providing the information of its decision, except to the extent necessary to enable the competent authority to comply with its obligations under regulation 21(2).

(6) A person who receives information by virtue of paragraph (4) or (5) shall not use that information except for the purposes of the competent authority.

(7) Notwithstanding paragraph (3), where the competent authority is satisfied on the basis of detailed evidence submitted to it by the person providing the information and, where appropriate, after consultation with that person, that it is necessary to withhold, for the time being, certain of the information specified in paragraph (3) in order to protect his intellectual property rights, the competent authority shall withhold that information to the extent that, and for so long as, it is necessary to protect those rights.

(8) Subject to paragraph (9), where, pursuant to paragraph (2) or (7), a person has indicated—

(a) that certain information is confidential; or

(b) withholding information is necessary in order to protect his intellectual property rights,

he shall forthwith inform the competent authority in writing of any change in circumstances which may affect the justification given under paragraph (2)(a) or the evidence submitted under paragraph (7), as the case may be.

(9) Paragraph (8) shall not apply if the competent authority has informed the person providing the information that the information in question is not be be kept confidential or withheld.

(10) Where—

(a) the competent authority has decided to keep information confidential pursuant to paragraph (2)(b) or has withheld information pursuant to paragraph (7); and

(b) the person who provided the information has informed the competent authority of a change in circumstances pursuant to paragraph (8),

the competent authority shall, after consulting that person where appropriate, review whether the information in question should continue to be kept confidential, and shall inform that person of the result of that review.

(11) In this regulation, “general characteristics” in relation to a genetically modified micro-organism has the same meaning as it has in regulation 22.