28. A consent to market genetically modified organisms granted by the Secretary of State under section 111(1) of the Act shall specify—
(a)the scope of the consent, including the identity of the genetically modified organisms to be marketed and their unique identifier,
(b)the period of validity of the consent,
(c)the conditions for marketing the product, including any specific conditions of use, handling and packaging of the genetically modified organisms, and conditions for the protection of particular ecosystems or environments or geographical areas as applicable,
(d)that the applicant shall make control samples available to the Secretary of State on request,
(e)the labelling requirements, in accordance with paragraph 8 of Schedule 3, which shall include a requirement to notify the Secretary of State of any new commercial name of the product after consent has been given, and
(f)monitoring requirements which shall be in accordance with the monitoring plan, and shall include the time period of the monitoring plan, an obligation that the applicant shall submit [F1monitoring reports in the relevant format set out in the Annexes to Commission Decision 2009/770/EC] and, where appropriate, any obligations on any person selling the product or any user, which may include an obligation to provide information at an appropriate level on the location of the genetically modified organisms that are grown.
Textual Amendments
F1Words in reg. 28(f) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(13); 2020 c. 1, Sch. 5 para. 1(1)
29.—(1) Section 112 of the Act (consents: limitations and conditions) is amended as follows.
(2) In subsection (1) (power of Secretary of State or National Assembly for Wales to impose limitations and conditions) at the end insert “ for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the activity permitted by the consent ”.
(3) In subsection (5) (implied condition when releasing or marketing)—
(a)in paragraph (b) (obligation to notify Secretary of State or National Assembly for Wales of new information etc)—
(i)after “Secretary of State” insert “ forthwith ”,
(ii)omit sub-paragraph (ii), and
(iii)after that sub-paragraph insert—
“(iii)any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released;”,
(b)for paragraph (c) (duty as regards preventing damage to environment) substitute—
“(c)take such measures as are necessary to prevent damage to the environment being caused as a result of the release or, as the case may be, the marketing of the organisms;”,
and
(c)after that paragraph insert—
“(d)notify the Secretary of State of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in paragraph (b)(iii) above; and
(e)in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Secretary of State.”.
30. In section 119 of the Act (onus of proof as regards techniques and evidence) in subsection (1) (accused to prove use of best available techniques) after “the accused to prove” insert
“the matters described in subsection (1A) below.
(1A) The matters referred to in subsection (1) above are—
(a)in the case of an offence under section 118(1)(c) above consisting in a failure to comply with the general condition implied by section 112(5)(c) above—
(i)that no measures, other than the measures taken by him, were necessary to prevent damage being caused to the environment from the release or, as the case may be, marketing of the organisms, or
(ii)in a case where he took no measures, that no measures were necessary; and
(b)in any other case,”.
31.—(1) The Secretary of State may only vary or revoke a consent to market genetically modified organisms under section 111(10) of the Act without the agreement of the holder of the consent where new information has become available which the Secretary of State considers would affect the assessment of the risk of damage being caused to the environment by the release.
(2) The Secretary of State must not revoke or vary a consent to market genetically modified organisms under section 111(10) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive.]
Textual Amendments