4.—(1) As part of the identification and evaluation of the potential adverse effects referred to in Part A of this schedule, the environmental risk assessment must identify the intended and unintended changes resulting from the genetic modification and must evaluate their potential to cause adverse effects on human health and on the environment.
(2) Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.
(3) Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.
(4) Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.
5.—(1) Long-term effects of a genetically modified organism are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a genetically modified organism or from an extensive use of a genetically modified organism in time and space.
(2) The identification and evaluation of the potential long-term adverse effects of a genetically modified organism on human health and on the environment must take into account the following—
(a)the long-term interactions of the genetically modified organism and the receiving environment,
(b)the characteristics of the genetically modified organism which become important on a long- term basis, and
(c)data obtained from repeated deliberate releases or placings on the market of the genetically modified organism over a long period.
(3) The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introduction of this schedule must also take into account the genetically modified organisms deliberately released or placed on the market in the past.
6.—(1) In order to carry out an environmental risk assessment for an application to which Part 3 of these Regulations applies, the applicant must collate already available data from scientific literature or from other sources, including monitoring reports, and must generate the necessary data by performing, where possible, appropriate studies. Where applicable, the applicant must justify in the environmental risk assessment why generating data by studies is not possible.
(2) The environmental risk assessment for applications to which Part 2 of these Regulations applies must be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the applicant.
(3) Where data generated outside the United Kingdom is provided in the environmental risk assessment, its relevance to receiving environment(s) in the United Kingdom must be justified.
(4) Data provided in the environmental risk assessment for applications to which Part 3 of these Regulations applies, must comply with the following requirements—
(a)where toxicological studies carried out to assess risk to human or animal health are provided in the environmental risk assessment, the applicant must provide evidence to demonstrate that they were conducted in facilities which comply with—
(i)if carried out in [F2Great Britain], [F3assimilated] law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances,
(ii)if carried out in a member State of the EU [F4or in Northern Ireland], EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, or
(iii)if carried out elsewhere, the ‘OECD Principles on Good Laboratory Practice’,
(b)where studies other than toxicological studies are provided in the environmental risk assessment, they must—
(i)comply with the principles of Good Laboratory Practice laid down in [F5assimilated] law, where relevant, or
(ii)be conducted by organisations accredited under the relevant ISO standard, or
(iii)in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards,
(c)information on the results obtained from the studies referred to in sub-paragraphs (a) and (b) and on the study protocols used must be reliable and comprehensive and must include the raw data in an electronic format suitable for carrying out statistical or other analysis,
(d)the applicant must specify, where possible, the size of effect that each study performed intends to detect and justify it,
(e)the selection of sites for field studies must be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the genetically modified organism may be released. The selection must be justified in the environmental risk assessment, and
(f)the non-genetically modified comparator must be appropriate for the relevant receiving environment(s) and must have a genetic background comparable to the genetically modified organism. The choice of the comparator must be justified in the environmental risk assessment.
Textual Amendments
F2Words in sch. 1 para. 6(4)(a)(i) substituted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(i)
F3Word in sch. 1 para. 6(4)(a)(i) substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 2(4)
F4Words in sch. 1 para. 6(4)(a)(ii) inserted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(ii)
7. The following must apply to the environmental risk assessment of a genetically modified organism containing stacked transformation events in applications to which Part 3 of these Regulations applies—
(a)the applicant must provide an environmental risk assessment for each single transformation event in the genetically modified organism or refer to already submitted applications (or equivalent notifications) for those single transformation events,
(b)the applicant must provide an assessment of the following aspects—
(i)the stability of the transformation events,
(ii)the expression of the transformation events, and
(iii)the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events, and
(c)where the progeny of the genetically modified organism can contain various sub-combinations of the stacked transformation events, the applicant must provide a scientific rationale justifying that there is no need to provide experimental data for the concerned sub-combinations, independently of their origin, or, in the absence of such scientific rationale, must provide the relevant experimental data.]