The Marine Works (Environmental Impact Assessment) Regulations 2007

Type Statutory-Instrument
Publication 2007-05-21
Last updated 2025-12-15
State In force
Department King's Printer of Acts of Parliament
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  • (1) The appropriate authority must, if it considers that it has not been provided with sufficient information to enable it to give a screening opinion, notify the applicant in writing of the matters on which it requires further information and the applicant must supply that further information to the appropriate authority within such period as the appropriate authority may reasonably require.
  • (2) The applicant must supply the appropriate authority with such number of additional copies of the documentation as the appropriate authority may reasonably require.
  • (3) The appropriate authority need not deal further with the request for a screening opinion until the applicant has complied with the requirements of sub-paragraphs (1) and (2).
  • (4) Where an applicant has failed to comply with the requirements of sub-paragraph (1) or (2) within such reasonable period as the appropriate authority has specified, or such longer period as the appropriate authority may reasonably allow—
  • (a) the regulator may treat the application to which the request relates as having been withdrawn, and
  • (b) the appropriate authority (if the regulator is not also the appropriate authority) may direct the regulator to do so.
  • (5) Where the appropriate authority must give a screening opinion under these Regulations, the authority must take into account in making that decision—
  • (a) any information provided by the applicant in accordance with paragraph 1(1);
  • (b) the results of any relevant EU environmental assessment which are reasonably available to the authority; and
  • (c) such of the selection criteria set out in Schedule 1 as are relevant to the project.

Consultation

4

  • (1) The appropriate authority must consult such of the consultation bodies as it considers appropriate before giving a screening opinion.
  • (2) When carrying out any consultation under sub-paragraph (1), the appropriate authority must allow the consultation body a reasonable period within which to respond, and that period must not be less than 28 days from the date of the letter to the consultation body from the appropriate authority or such other period as may be agreed between the consultation body and the appropriate authority.

Notification of a screening opinion

5

  • (1) Where the applicant requests a screening opinion under regulation 11(1) in accordance with paragraph 1(1), the appropriate authority must provide its screening opinion to—
  • (a) the applicant;
  • (b) if the appropriate authority is not also the regulator, the regulator; and
  • (c) such of the consultation bodies as it consulted in accordance with paragraph 4.
  • (2) The appropriate authority must provide the opinion as soon as possible within a period of 90 days beginning with the day on which the request is made.
  • (3) In exceptional cases, where the nature, complexity, location or size of the project demands a longer period for determination, the appropriate authority may extend the period specified in sub-paragraph (2), informing the applicant in writing of the reasons justifying the extension and of the date on which its screening opinion is expected.

Availability of screening opinions for inspection

6

  • (1) Subject to sub-paragraph (2), the appropriate authority must ensure that, as soon as possible after being sent to the applicant, its screening opinion is—
  • (a) publicised in such manner as it considers appropriate; and
  • (b) in the case of an activity requiring regulatory approval under the 1985 Act or the 2009 Act, made available on the relevant Public Register.
  • (2) Sub-paragraph (1) does not require disclosure of any excluded information.

SCHEDULE3 — Information to be included in an environmental statement

1

A description of the project and of the regulated activity, including in particular:

  • (a) a description of the location of the project and the regulated activity;
  • (b) a description of the physical characteristics of the whole project and regulated activity, including where relevant, requisite demolition works, and the land-use requirements during the construction and operational phases;
  • (c) a description of the main characteristics of the operational phase of the project and the regulated activity (in particular any production process): for instance, energy demand and energy used, the nature and quantity of the materials and natural resources (including water, land, soil and biodiversity) used;
  • (d) an estimate, by type and quantity, of expected residues and emissions (such as water, air, soil and subsoil pollution, noise, vibration, light, heat, radiation and quantities and types of waste produced during the construction and operation phases) resulting from the operation of the proposed project and the regulated activity.

2

A description of the reasonable alternatives (for example in terms of project design, technology, location, size and scale) studied by the applicant, which are relevant to the proposed project, the regulated activity and their specific characteristics, and an indication of the main reasons for selecting the chosen option, including a comparison of the environmental effects.

3

A description of the relevant aspects of the current state of the environment (baseline scenario), and an outline of the likely evolution thereof without implementation of the project, as far as natural changes from the baseline scenario can be assessed with reasonable effort on the basis of the availability of environmental information and scientific knowledge.

4

A description of the factors specified in regulation 21A(2)(a) to (e) likely to be significantly affected by the project and the regulated activity: population, human health, biodiversity (for example, fauna and flora), land (for example, land take), soil (for example, organic matter, erosion, compaction, sealing), water (for example, hydromorphological changes, quantity and quality), air, climate (for example, greenhouse gas emissions, impacts relevant to adaptation), material assets, cultural heritage, including architectural and archaeological aspects, and landscape.

5

A description of the likely significant effects of the project and the regulated activity on the environment resulting from, inter alia—

  • (a) the construction and existence of the project and the regulated activity, including, where relevant, demolition works;
  • (b) the use of natural resources, in particular land, soil, water and biodiversity, considering as far as possible the sustainable availability of these resources;
  • (c) the emission of pollutants, noise, vibration, light, heat and radiation, the creation of nuisances, and the disposal and recovery of waste;
  • (d) the risks to human health, cultural heritage or the environment (for example, due to accidents or disasters);
  • (e) the cumulation of effects with other existing or approved projects, taking into account any existing environmental problems relating to areas of particular environmental importance likely to be affected or the use of natural resources;
  • (f) the impact of the project on climate (for example, the nature and magnitude of greenhouse gas emissions) and the vulnerability of the project to climate change;
  • (g) the technologies and the substances used.

6

The description of the likely significant effects on the factors specified in regulation 21A(2)(a) to (e) must cover the direct effects and any indirect, secondary, cumulative, transboundary, short-term, medium-term and long-term, permanent and temporary, positive and negative effects of the project and the regulated activity. This description must take into account the environmental protection objectives in assimilated law or under the law of any part of the United Kingdom which are relevant to the project and the regulated activity.

7

A description of the forecasting methods or evidence used to identify and assess the significant effects on the environment including details of difficulties (for example, technical deficiencies or lack of knowledge) encountered compiling the required information and the main uncertainties involved.

8

A description of the measures envisaged to avoid, prevent, reduce or if possible offset any identified significant adverse effects on the environment and, where appropriate, of any proposed monitoring arrangements (for example, the preparation of a post-project analysis). That description must explain the extent to which significant adverse effects on the environment are avoided, prevented, reduced or offset, and must cover both the construction and operational phases.

SCHEDULE 4 — SCOPING OPINIONS

Request for a scoping opinion

1

A request for a scoping opinion must be accompanied by—

  • (a) a chart, plan or map sufficient to identify the location of the regulated activity and of other activities to be carried out in the course of the project;
  • (b) a brief description of the specific characteristics of the regulated activity and the project, including their nature, purpose, location and technical capacity;
  • (ba) an explanation of the likely significant effects of the regulated activity and the project on the environment;
  • (c) such other information or representations as the applicant may wish to provide or make.

Information required where another application has been made

2

Where the regulated activity is to be carried out in the course of a project in respect of which the applicant has made an application to a consenting authority other than the regulator, an applicant seeking a scoping opinion must—

  • (a) inform the appropriate authority and the regulator (if the regulator is not also the appropriate authority) of any such application;
  • (b) if any such consenting authority has requested an environmental statement in respect of that project, inform the appropriate authority and the regulator (if the regulator is not also the appropriate authority) of that request; and
  • (c) if so requested by the appropriate authority or the regulator, provide the appropriate authority with a copy of any environmental statement and of any other environmental information provided to any such consenting authority.

Payment of a fee for a scoping opinion

3

  • (1) The appropriate authority may require an applicant to pay a reasonable fee in respect of—
  • (a) the administrative expenses of providing a scoping opinion; and
  • (b) the cost of carrying out any examinations or tests that, in the opinion of the appropriate authority, are necessary or expedient to enable the appropriate authority to produce its scoping opinion.
  • (2) If the appropriate authority considers that it is appropriate to do so, it may—
  • (a) require the applicant to make a reasonable advance payment against the fee that it is entitled to charge for its scoping opinion;
  • (b) determine the balance of the fee payable after carrying out the work necessary to produce its scoping opinion in accordance with the remaining provisions of this Schedule; and
  • (c) require the applicant to pay the balance of the fee that it is entitled to charge prior to the notification of its scoping opinion.

Procedure for reaching a scoping opinion

4

  • (1) The appropriate authority must, if it considers that it has not been provided with sufficient information to enable it to give a scoping opinion, notify the applicant in writing of the matters on which it requires further information and the applicant must supply that further information to the appropriate authority within such period as the appropriate authority may reasonably require.
  • (2) The applicant must supply the appropriate authority with such number of additional copies of the documentation as the appropriate authority may reasonably require.
  • (3) The appropriate authority need not deal further with the request for a scoping opinion until the applicant has complied with the requirements of sub-paragraphs (1) and (2).
  • (4) Where an applicant has failed to comply with the requirements of sub-paragraph (1) or (2) within such reasonable period as the appropriate authority has specified, or such longer period as the appropriate authority may reasonably allow—
  • (a) the appropriate authority may treat the request as having been withdrawn;
  • (b) the regulator may treat the application to which the request relates as having been withdrawn; and
  • (c) the appropriate authority (if the regulator is not also the appropriate authority) may direct the regulator to treat the application as withdrawn.

Matters to be considered in reaching a scoping opinion

5

In reaching a scoping opinion, the appropriate authority must take into account—

  • (a) the specific characteristics of the project, including its location and technical capacity;
  • (b) the nature and purpose of regulated activities of the type concerned in the project;
  • (c) the environmental features likely to be affected by the project; and
  • (d) any information provided by the applicant about the project and the regulated activity.

Consultation

6

  • (1) The appropriate authority must consult such of the consultation bodies as it considers appropriate before giving a scoping opinion.
  • (2) When carrying out any consultation under sub-paragraph (1), the appropriate authority must allow the consultation body a reasonable period within which to respond and that period must not be less than 28 days from the date of the letter that the consultation body receives from the appropriate authority or such other period as may be agreed between the consultation body and the appropriate authority.

Notification of a scoping opinion

7

The appropriate authority must, as soon as reasonably practicable, provide its scoping opinion and a written statement of the reasons for its opinion to—

  • (a) the applicant;
  • (b) if the appropriate authority is not also the regulator, the regulator; and
  • (c) such of the consultation bodies as it consulted in accordance with paragraph 6.

Availability of scoping opinions for inspection

8

  • (1) Subject to sub-paragraph (2), the appropriate authority must ensure that, as soon as possible after being sent to the applicant, its scoping opinion is—
  • (a) publicised in such a manner as it considers appropriate; and
  • (b) in the case of an activity requiring regulatory approval under the 1985 Act or the 2009 Act, made available on the relevant Public Register.
  • (2) Sub-paragraph (1) does not require disclosure of any excluded information.

SCHEDULE 5 — CONSIDERATION OF REPRESENTATIONS FROM THE PUBLIC

1

  • (1) In relation to each representation made pursuant to the statement referred to in regulation 16(2)(g), the appropriate authority must consider whether or not the representation is capable of being dealt with in accordance with this Schedule.
  • (2) If the appropriate authority concludes that the representation is not capable of being dealt with in accordance with this Schedule—
  • (a) it must have such regard (if any) as it considers appropriate in all the circumstances to the representation when reaching its EIA consent decision; and
  • (b) the remaining provisions of this Schedule do not apply to the representation.

2

  • (1) If the appropriate authority concludes in accordance with paragraph 1(1) that the representation is capable of being dealt with in accordance with this Schedule, it must consider whether or not the representation is relevant to the EIA consent decision.
  • (2) If the appropriate authority concludes that the representation is not relevant to the EIA consent decision, it must consider whether it is relevant in some other way to the project in the course of which the regulated activity is to be carried out.
  • (3) If the appropriate authority concludes that the representation is not relevant to that project in any other way—
  • (a) it need not have any further regard to the representation; and
  • (b) the remaining provisions of this Schedule do not apply to the representation.
  • (4) If the appropriate authority concludes that the representation is relevant in some other way to the project in the course of which the regulated activity is to be carried out—
  • (a) it must copy the representation to the regulator and any consenting authorities in so far as the appropriate authority regards the representation as relevant to any of their functions that are relevant to compliance with any law of any part of the United Kingdom that implemented the EIA Directive;
  • (b) it need not have any further regard to the representation; and
  • (c) the remaining provisions of this Schedule do not apply to the representation.

3

  • (1) If the appropriate authority concludes in accordance with paragraph 2(1) that the representation is relevant to the regulated activity, it must consider whether the representation is capable of being addressed by an arrangement made between it, the applicant and the maker of the representation.
  • (2) If the appropriate authority concludes that the representation is capable of being addressed by means of such an arrangement, it may invite the applicant and the maker of the representation to enter into discussions with it and each other with a view to making the arrangement.
  • (3) If an arrangement is made—
  • (a) the appropriate authority must have regard to the arrangement when reaching its EIA consent decision; and
  • (b) the remaining provisions of this Schedule do not apply to the representation.

4

  • (1) If either—
  • (a) the appropriate authority concludes in accordance with paragraph 3(1) that the representation is capable of being satisfied by an arrangement made between it, the applicant and the maker of the representation but no such arrangement is made within a reasonable period, or
  • (b) the appropriate authority concludes in accordance with paragraph 3(1) that the representation is not capable of being satisfied by an arrangement made between it, the applicant and the maker of the representation,

the appropriate authority must consider whether the representation gives rise to a dispute that calls for resolution of a question of fact in order to enable it to make its EIA consent decision.

  • (2) If the appropriate authority concludes that the representation gives rise to such a dispute, it may, if it considers that it is appropriate to do so—
  • (a) instigate a local inquiry; or
  • (b) appoint a person whom it considers expert in the subject-matter of the dispute to report to it on the question of fact.
  • (3) If the appropriate authority concludes that the representation does not give rise to such a dispute or if it does not think that it is appropriate to instigate a local inquiry or appoint a person to report to it—
  • (a) it must have such regard (if any) as it considers appropriate in all the circumstances to the representation when reaching its EIA consent decision;
  • (b) the remaining provisions of this Schedule do not apply to the representation.

5

  • (1) If the appropriate authority instigates a local inquiry in accordance with paragraph 4(2)(a)—
  • (a) it must give notice of that inquiry in such manner as it thinks fit; and
  • (b) all persons interested are permitted to attend, and be heard at, the inquiry.
  • (2) The appropriate authority must not reach its EIA consent decision until the inquiry has been completed.
  • (3) The appropriate authority must have regard to the outcome of the inquiry when reaching its EIA consent decision.

6

  • (1) Subsections (2) to (5) of section 250 (power to direct inquiries) of the Local Government Act 197217 apply in relation to an inquiry instigated under paragraph 4(2)(a) and held in England or Wales as they apply in relation to an inquiry held under that section.
  • (2) Schedule A1 (provisions applicable to inquiries and investigations) to the Interpretation Act (Northern Ireland) 195418 applies in relation to an inquiry instigated under paragraph 4(2)(a) and held in Northern Ireland as it applies to an inquiry held under an enactment passed or made as mentioned in section 23 (inquiries and investigations) of that Act.
  • (3) The Town and Country Planning (Inquiries Procedure) (Scotland) Rules 199719 apply in relation to an inquiry instigated under paragraph 4(2)(a) and held in Scotland as they apply to an inquiry held under those Rules.

7

  • (1) If the appropriate authority appoints a person to report to it in accordance with paragraph 4(2)(b), it must—
  • (a) notify the applicant and the maker of the representation, and the regulator (if the appropriate authority is not also the regulator)—
  • (i) that it has so done; and
  • (ii) its reasons for doing so;
  • (b) send details of the appointed person and of the question of fact to the applicant and the maker of the representation and to the regulator (if the appropriate authority is not also the regulator).
  • (2) The appointed person must provide such opportunity for each of the applicant, the maker of the representation, the appropriate authority and the regulator (if the appropriate authority is not also the regulator) to address him orally or in writing, or both, as he considers expedient for the purposes of making his report.
  • (3) The appropriate authority must not reach its EIA consent decision until either the appointed person has made his report or a reasonable period has expired.
  • (4) The appointed person’s report to the appropriate authority should contain his findings of fact on the subject-matter of the dispute and should be sent to the appropriate authority and the regulator (if the appropriate authority is not also the regulator) and copied to the applicant and the maker of the representation.
  • (5) When reaching its EIA consent decision, the appropriate authority must—
  • (a) have regard to the appointed person’s report; and
  • (b) have such regard as the appropriate authority considers appropriate in all the circumstances to any representations made to the appointed person.

Signed

Ben Bradshaw — Minister of State — Department for Environment, Food and Rural Affairs — 2007-05-16

We concur,

Alan Campbell — Frank Roy — Two of the Lords Commissioners of Her Majesty’s Treasury — 2007-05-21

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations implement, in relation to certain marine works, Council Directive 85/337/EEC on the assessment of the effects of certain public and private projects on the environment (OJ L 175, 5.7.1985, p.40), as last amended by Directive 2003/35/EC of the European Parliament and of the Council providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice Council Directives 85/337/EEC and 96/61/EC (OJ L 156, 25.6.2003, p.17). In its amended form, Directive 85/337 is referred to in these Regulations as “the EIA Directive” (regulation 2(1)).

The marine works in relation to which these Regulations implement the EIA Directive are those for which a regulatory approval (as defined in regulation 2(1)) is required. These include harbour works previously covered by the Harbour Works (Environmental Impact Assessment) Regulations 1999 (S.I. 1999/3445), as amended by the Harbour Works (Environmental Impact Assessment) (Amendment) Regulations 2000 (S.I. 2000/2391).

In relation to such works, these Regulations also implement the provisions of Directive 2003/35/EC.

Regulation 3 provides for charges to be made in relation to functions carried out under these Regulations. There are also specific charging provisions in regulation 15, to enable the regulator or appropriate authority to charge for providing information to an applicant, and in Schedules 2 and 4, to enable the appropriate authority to charge for expenses incurred in providing a screening opinion or scoping opinion.

Part 2 (regulations 4 to 11) specifies the circumstances in which an environmental impact assessment is required in relation to marine works. In the case of marine works to be carried out in the course of a project of a type listed in Annex I to the EIA Directive, an environmental impact assessment is required unless one of the exceptions in regulation 9 or 10 applies (regulation 7). In the case of marine works to be carried out in the course of a project of a type listed in Annex II to the EIA Directive, an environmental impact assessment is required if the project would have significant effects on the environment, unless one of the exceptions in regulation 9 or 10 applies (regulation 8). Schedule 1 sets out the criteria that are to be used in determining whether or not a project would have significant effects on the environment.

Regulation 11 and Schedule 2 provide for screening opinions to be provided in which determinations as to whether or not an environmental impact assessment is required are to be given. Regulation 11 also provides for the relationship between the screening opinion process and the procedures that would otherwise apply to the application for a regulatory approval.

Part 3 (regulations 12 to 24) provides for the environmental impact assessment process itself. Regulation 12 and Schedule 3 require certain information and documentation to be provided for an environmental impact assessment to be carried out. Regulation 13 and Schedule 4 provide for scoping opinions (defined in regulation 2(1)) to be provided, in which the information to be provided can be determined in advance. Regulation 14 provides for additional information to be provided where necessary in order for the environmental impact assessment to be carried out. Regulation 15 provides for information held by a regulator or an appropriate authority to be provided to an applicant. Regulation 16 provides for public participation in the environmental impact assessment process by requiring applications to be publicised, so as to enable representations to be made by members of the public. Regulation 21 and Schedule 5 provide for the way in which such representations are taken into account as part of the environmental impact assessment process. Regulation 17 provides for information regarding applications to be provided to bodies with environmental responsibilities and for consultation to be carried out with those bodies. Regulations 18 and 19 provide for information regarding applications to be provided to other EEA States and regulation 20 provides for consultation with other EEA States. Regulation 22 makes provision in relation to the decision as to whether or not EIA consent for marine works is to be given, and regulation 23 provides for that decision to be notified to those who have taken part in the process and publicised. Regulation 24 provides for the effect of the EIA consent decision on the application and the subsequent procedure in relation to the application.

Part 4 (regulations 25 to 27) creates an offence of providing false information for the purposes of obtaining a regulatory approval.

Part 5 (regulations 28 to 30) contains miscellaneous provisions. Regulation 28 applies to Scotland only and provides that certain non-governmental organisations are deemed to have title and interest to sue in relation to the environmental impact assessment of marine works. Regulations 29 and 30 contain revocations, transitional provisions and savings.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available at www.defra.gov.uk and is annexed to the Explanatory Memorandum which is available alongside this instrument on the OPSI website.

Footnotes

1

1972 c.68. The enabling powers conferred by section 2(2) were extended by virtue of the amendment of section 1(2) of the European Communities Act 1972 by section 1 of the European Economic Area Act 1993 (c. 51). As regards functions transferred to the Scottish Ministers by the Scotland Act 1998 (c.46), these Regulations extend to Scotland pursuant to section 57(1) of that Act.

12

The Joint Nature Conservation Committee was re-constituted by section 31 of the Natural Environmental and Rural Communities Act 2006 (2006 c.16).

13

Natural England is constituted by section 1 of the Natural Environment and Rural Communities Act 2006 (2006 c.16).

14

Scottish Natural Heritage is constituted by section 1 of the Natural Heritage (Scotland) Act 1991 (1991 c.28).

Proposed activity which would otherwise be a regulated activity

2A

  • (1) Paragraph (2) applies where—
  • (a) an activity is proposed to be carried out which would be a regulated activity if carried out by a person other than the person who would be the regulator in relation to that activity; and
  • (b) the person by whom the activity is proposed to be carried out (“the relevant person”) is the person who would be the regulator in relation to that activity if it were carried out by any other person.
  • (2) Where this paragraph applies, these Regulations apply in relation to that proposal as if—
  • (a) the activity were a regulated activity, the relevant person had made an application for regulatory approval in respect of that activity and, in relation to the carrying out of that activity by that person, that person were also the regulator; and
  • (b) accordingly—
  • (i) references to the regulator’s dealing with the application or to a regulatory decision were references to determining whether to carry out the proposal;
  • (ii) references to granting a regulatory approval were references to a decision to proceed to carry out the proposal; and
  • (iii) references to treating the application as withdrawn were references to treating the proposal as abandoned.

Fees

Further provisions in relation to Article 2(4) of the EIA Directive

10A

  • (1) The Marine Management Organisation may not make a determination under regulation 10(1)(a)(i) unless the Secretary of State has given a direction under paragraph (2).
  • (2) The Secretary of State may direct that an environmental impact assessment is not required in relation to any regulated activity that is to be carried out in the course of a Schedule A1 project or a Schedule A2 project, if the Secretary of State is satisfied that—
  • (a) the Marine Management Organisation is the appropriate authority having the function of determining whether an environmental impact assessment is required in relation to the regulated activity;
  • (b) a direction that an environmental impact assessment is not required for the regulated activity can be justified in accordance with Article 2(4) of the EIA Directive (exemption for exceptional cases); and
  • (c) the regulated activity would not be likely to have significant effects on the environment of an EEA State.
  • (3) As soon as practicable after making any such direction, the Secretary of State must send a copy of the direction to—
  • (a) the Marine Management Organisation;
  • (b) where the Marine Management Organisation is not also the regulator, the regulator; and
  • (c) any relevant authority.
  • (4) The Natural Resources Body for Wales or examining authority may not make a determination under regulation 10(1)(a)(i) unless the Welsh Ministers have given a direction under paragraph (5).
  • (5) The Welsh Ministers may direct that an environmental impact assessment is not required in relation to any regulated activity that is to be carried out in the course of a Schedule A1 project or a Schedule A2 project, if the Welsh Ministers are satisfied that—
  • (a) the Natural Resources Body for Wales or examining authority is the appropriate authority having the function of determining whether an environmental impact assessment is required in relation to the regulated activity;
  • (b) a direction that an environmental impact assessment is not required for the regulated activity can be justified in accordance with Article 2(4) of the EIA Directive (exemption for exceptional cases); and
  • (c) the regulated activity would not be likely to have significant effects on the environment of an EEA State.
  • (6) As soon as practicable after making any such direction, the Welsh Ministers must send a copy of the direction to—
  • (a) the Natural Resources Body for Wales;
  • (b) where the Natural Resources Body for Wales is not also the regulator, the regulator; and
  • (c) any relevant authority.
  • (7) The Natural Resources Body for Wales must provide the Welsh Ministers with such information as they require to comply with the obligations referred to in regulation 10(3).
  • (8) For the purpose of this regulation, Article 2(4) of the EIA Directive is to be read as if—
  • (a) in the first sub-paragraph, the words “Without prejudice to Article 7,” were omitted;
  • (b) “Member States”, in both places where it occurs, were read as “appropriate authority”;
  • (b) in the second sub-paragraph, point (c) were omitted;
  • (c) the third and fourth sub-paragraphs were omitted.

Screening opinions

Fees in relation to the assessment etc. of the results of monitoring measures

24A

  • (1) A decision to grant regulatory approval which includes a monitoring condition may include a fee condition of the kind described in paragraph (3).
  • (2) For the purposes of this regulation, a monitoring condition is a condition requiring any measure to be taken relating to monitoring of a kind referred to in regulation 23(2)(b)(ii).
  • (3) A fee condition of the kind referred to in paragraph (1) is a condition as to the payment of a reasonable fee, determined in accordance with regulation 3(4) and (5), in respect of expenses incurred in assessing and interpreting the results of any monitoring measure.

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