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5. In regulation 16 (applications for consent to market)—
(a)in paragraph (2)(a)—
(i)before “the information” insert “subject to paragraph (2A)”,
(ii)in paragraph (i), for “Schedule 1” substitute “Schedule 1A”,
(iii)in paragraph (ii) omit from “to the extent” to the end,
(b)in paragraph (2), after sub-paragraph (j) insert—
“(k)in respect of each subset of information required in this paragraph—
(i)summaries and results of studies referred to in the application, including an explanation of their relevance to the environmental risk assessment, as appropriate,
(ii)details of studies referred to in the application, including materials and methods used or reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out those studies.”.
(c)after paragraph (2) insert—
“(2A) The information specified in paragraph (2)(a) is only required to be provided if it is necessary for the completion of an environmental risk assessment in the context of a specific application, and the level of detail to be provided may vary according to the nature and the scale of the proposed release resulting from the marketing of a genetically modified higher plant.”.
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