Statutory Instruments
2011 No. 2132
Pesticides
Fees And Charges
The Plant Protection Products (Fees and Charges) Regulations 2011
Made
25th August 2011
Laid before Parliament
2nd September 2011
Coming into force
24th September 2011
The Secretary of State is designated for the purposes of section 2(2) of the European Communities Act 1972( 1 ) in relation to the common agricultural policy of the European Union( 2 ), measures in the veterinary and phytosanitary fields for the protection of public health( 3 ), and in relation to the environment( 4 ).
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973( 5 ).
In accordance with section 56(1) of the Finance Act 1973 the Treasury consents to the making of these Regulations.
Title and commencement
1. —(1) These Regulations may be cited as the Plant Protection Products (Fees and Charges) Regulations 2011 and, subject to paragraph (2), come into force on 24th September 2011.
(2) Regulations 3(2) and 6 come into force on 26 th November 2011.
Interpretation
2. —(1) In these Regulations—
“authorisation holder” means the holder of a valid authorisation or permit for a plant protection product—
issued in accordance with Regulation 1107/2009, or
deemed to be issued in accordance with that Regulation,
unless there is a nominated sales representative for that plant protection product, in which case it means that person;
“Great Britain competent authorities” means—
in relation to England, the Secretary of State;
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers;
...
“import tolerance” has , in relation to Great Britain, the same meaning as in the MRL Regulation;
“liability period” means the period between 1 April in any year and 31 March in the following year;
“MRL compliance” means, in relation to products placed on the market in Great Britain, compliance with the requirements of Article 18 of the MRL Regulation;
“the MRL Regulation” means—
in relation to Great Britain, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ;
in relation to Northern Ireland, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC as it has effect in EU law
“ MRL supplementary information requirement ” means information requested by a Great Britain competent authority in accordance with Article 14(3) of the MRL Regulation;
“nominated sales representative” means any person who has agreed in writing with the holder of a valid authorisation or permit for a plant protection product, issued in accordance with Regulation 1107/2009 or deemed to be issued in accordance with that Regulation, to be a sales representative for the authorised or permitted plant protection product and to pay the charge under these Regulations;
“Northern Ireland competent authority” means the Department of Agriculture, Environment and Rural Affairs;
“Regulation 1107/2009” means—
in relation to Great Britain, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council;
in relation to Northern Ireland, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council as it has effect in EU law;
“ standalone MRL application ” means an application to a Great Britain competent authority which is only for the setting, modification or deletion of a maximum residue level of an active substance;
“United Kingdom competent authorities” means—
in relation to England, the Secretary of State;
in relation to Wales, the Welsh Ministers;
in relation to Scotland, the Scottish Ministers;
in relation to Northern Ireland, the Department of Agriculture, Environment and Rural Affairs.
(2) Expressions used in both these Regulations and Regulation 1107/2009, other than “authorisation holder”, have the same meaning in these Regulations as they have in Regulation 1107/2009.
Functions in Article 74(1) of Regulation 1107/2009: Northern Ireland
3. —(1) The functions ... referred to in Article 74(1) of Regulation 1107/2009 are to be performed by the Northern Ireland competent authority .
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees
4. —(1) A United Kingdom competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating applications made to it for the—
(a) authorisation of plant protection products;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) official recognition of a test facility or organisation,
and such fees are payable in accordance with paragraphs 1 and 3 respectively of Schedule 1.
(1A) A Great Britain competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating applications made to it for the approval of active substances, safeners, synergists or basic substances, and such fees are payable in accordance with paragraph 2 of Schedule 1.
(1B) The Northern Ireland competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating parallel trade applications made to it and such fees are payable in accordance with paragraph 1A of Schedule 1.
(2) A Great Britain competent authority may charge fees for applications for import tolerances and standalone MRL applications under Article 7 of the MRL Regulation and such fees are payable in accordance with Schedule 2.
(2A) A Great Britain competent authority may charge fees for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation and such fees are payable in accordance with Schedule 3.
(3) The fees in these Regulations apply in relation to any activity carried out after they come into force, provided no invoice has been issued under the Plant Protection Product (Fees) Regulations 2007( 6 ) or the Plant Protection Products (Fees) Regulations (Northern Ireland) 2004( 7 ) in relation to that work.
(4) Fees are payable by the applicant, on invoice, to the relevant competent authority.
(5) The relevant competent authority is under no obligation to process or to issue a decision in respect of an outstanding application if there are outstanding fees in relation to it.
(6) In paragraph (5), “outstanding application” means any application for which a fee has been charged under the Plant Protection Products (Fees) Regulations 2007, the Plant Protection Products (Fees) Regulations (Northern Ireland) 2004 or under these Regulations.
(7) Any unpaid fee may be recovered by the relevant competent authority as a civil debt.
Charge in relation to Regulation 1107/2009 and the MRL Regulation
5. A United Kingdom competent authority may make an annual charge in respect of any costs incurred by it, or on its behalf—
(a) associated with any work carried out within the scope of Regulation 1107/2009; or
(b) arising from obligations under the MRL Regulation,
other than for collecting and processing information, or monitoring the effect of the use of plant protection products, for which a charge has been made under section 18(2)(b) or (c) of the Food and Environment Protection Act 1985( 8 ).
Charge for work under the Plant Protection Products (Sustainable Use) Regulations 2012
6. A United Kingdom competent authority may make an annual charge in respect of any costs incurred by it, or on its behalf, in relation to carrying out work pursuant to obligations under the Plant Protection Products (Sustainable Use) Regulations 2012 .
Liability to pay the charge
7. —(1) In respect of a given liability period a charge shall be payable by an authorisation holder, on invoice, to a United Kingdom competent authority.
(2) A United Kingdom competent authority shall not charge for any costs under paragraph (1) in respect of which a fee is payable under regulations 4(1), 4(1A) or 4(1B) and Schedule 1, ... regulation 4(2) and Schedule 2 or regulation 4(2A) and Schedule 3 .
(3) A United Kingdom competent authority may exclude an authorisation holder from the requirement to pay a charge where that authority decides it would be uneconomical to collect that charge.
(4) Where an authorisation holder becomes liable to pay a charge in accordance with paragraph (1) at any time during the liability period, that person will be liable to pay a charge for the whole of that liability period.
(5) If an authorisation holder fails to pay the charge in full, the United Kingdom competent authority may suspend any or all of the authorisations or permits for plant protection products held by the authorisation holder or for which the authorisation holder is the nominated sales representative.
(6) Any unpaid charge may be recovered by a United Kingdom competent authority as a civil debt.
Calculation of charge
8. —(1) The United Kingdom competent authorities must calculate the amounts which authorisation holders are liable to pay under regulations 5 and 6 in accordance with the following paragraphs.
(2) Where an authorisation holder is liable to pay a charge in respect of more than one plant protection product, the authorisation holder shall be treated as one authorisation holder for the purposes of calculating the charge and collecting payments.
(3) The United Kingdom competent authorities will calculate the charge payable by an authorisation holder by applying a percentage to the authorisation holder’s annual turnover. Except where paragraphs (3A) to (3C) apply, the percentage must be calculated by applying the following formula—
A/B x 100% = the percentage
where—
=
the total costs incurred in the liability period, and
=
the total annual turnover.
(3A) For a charge payable to the Welsh Ministers as United Kingdom competent authority in respect of the liability period ending 31st March 2019, the percentage referred to in sub-paragraph (3) must be calculated by applying the following formula—
where A and B have the meanings given in sub-paragraph (3).
(3B) Sub-paragraph (3C) applies where, for the liability period ending 31st March 2019, an authorisation holder is liable to pay a charge to both the Secretary of State and the Welsh Ministers as United Kingdom competent authorities in relation to Wales.
(3C) Where this sub-paragraph applies—
(a) for the charge payable to the Welsh Ministers, the percentage referred to in sub-paragraph (3) must be calculated by applying the formula set out in sub-paragraph (3A);
(b) for the charge payable to the Secretary of State, the percentage referred to in sub-paragraph (3) must be calculated by applying the following formula—
where A and B have the meanings given in sub-paragraph (3).
(4) An authorisation holder must provide a United Kingdom competent authority with evidence of its annual turnover for a given liability period on request.
(5) If insufficient evidence of annual turnover is submitted or if no evidence is submitted by an authorisation holder, the annual turnover will be such figure as the United Kingdom competent authorities consider reasonable.
(6) In this regulation—
“total costs incurred” means the costs referred to in regulations 5 and 6, excluding any costs in respect of which a fee is payable under—
regulations 4(1), 4(1A) or 4(1B) and Schedule 1,
regulation 4(2) and Schedule 2, or
regulation 4(2A) and Schedule 3;
“total annual turnover” means the annual turnover of all authorisation holders;
“annual turnover” means the amounts derived from sales in the financial year ending between 1 st October and 30 th September the following year, the latter date being in the calendar year in which the liability period starts by—
the holder of a valid authorisation or permit for a plant protection product issued in accordance with Regulation 1107/2009 or of a valid authorisation or permit for a plant protection product deemed to be issued in accordance with that Regulation, and
any nominated sales representative for the authorised or permitted plant protection product;
“amounts derived from sales” includes the costs of packaging, containers and labelling and excludes value added tax and returned products;
“sales” means the sales of authorised or permitted plant protection products in the United Kingdom.
Revocation
9. The following regulations are revoked—
(a) The Fees for Assessment of Active Substances (Third Stage Review) Regulations 2005( 9 );
(b) The Fees for Assessment of Active Substances (Fourth Stage Review) Regulations 2005( 10 ); and
(c) The Plant Protection Products (Fees) Regulations 2007.
Signed by the authority of the Secretary of State for Environment, Food and Rural Affairs.
Henley
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
We consent
James Duddridge
Angela Watkinson
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation 4(1)
SCHEDULE 1 Fees
Fees for application and evaluation of a plant protection product for authorisation
| Item | Chargeable item | Fee(£) | ||||
|---|---|---|---|---|---|---|
| 1 | Administrative research and development application (1) | 52 | ||||
| 2 | Extension of use application including administration, co-ordination and technical consideration | 1,768 | ||||
| 3 | Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further | 229 | ||||
| 4 | Administrative application (2) ... for a new product or change to an existing product— | |||||
| 4a | one product | 156 | ||||
| 4b | each additional product (4) | 52 | ||||
| 5 | . . . | |||||
| 5a | . . . | . . . | ||||
| 5b | . . . | . . . | ||||
| 6 | Evaluation of a label in any application | 208 | ||||
| 7 | Co-ordination of standard technical stream applications (7) (8) | 1,872 | ||||
| 8 | Evaluation of simple reasoned cases in each of the following specialist areas— | |||||
| 8a | chemistry (9) | 416 | ||||
| 8b | toxicology (10) | 416 | ||||
| 8c | operator exposure (11) | 416 | ||||
| 8d | residues and consumer exposure (12) | 416 | ||||
| 8e | fate and behaviour in the environment (13) | 416 | ||||
| 8f | ecotoxicology (14) | 416 | ||||
| 8g | efficacy (15) | 416 | ||||
| 9 | Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas— | |||||
| 9a | chemistry (9) | 780 | ||||
| 9b | toxicology (10) | 780 | ||||
| 9c | operator exposure (11) | 780 | ||||
| 9d | residues and consumer exposure (12) | 780 | ||||
| 9e | fate and behaviour in the environment (13) | 1,872 | ||||
| 9f | ecotoxicology (14) | 1,872 | ||||
| 9g | efficacy (15) | 1,872 | ||||
| 10 | Withdrawal of an application for a product specified in items 2, 4, 5, 7, 12 or 13 before any work other than preliminary consideration has been done | 104 | ||||
| 11 | Pre-submission meetings to discuss potential product applications (16) | 5,200 | ||||
| 12 | . . . | |||||
| . . . | . . . | |||||
| . . . | . . . | |||||
| 13 | Commenting on draft study protocols (18) | 416 | ||||
Notes
(1) Application for authorisation under Regulation 1107/2009 not involving evaluation of technical information or data.
(2) Application for authorisation under Regulation 1107/2009 involving no technical consideration.
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) Where the application relates to a number of different products, this charge applies to each additional product.
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(7) “Standard technical stream applications” are all applications other than items 1-4, 10 and 11 .
(8) The co-ordination of applications for new products or a change to an existing product.
(9) Chemistry covers assessment of the technical specification of the active substance, safeners and synergists in the product and the physico-chemical properties of the product.
(10) Toxicology covers assessment of the mammalian metabolism and toxicology of the active substance, safeners and synergists in the product and determination of the types of hazard to which the product can give rise.
(11) Operator exposure additionally covers exposure of other persons resulting from the product use.
(12) Consumer exposure covers exposure of consumers resulting from consumption of produce from treated crops, treated produce or products derived from either, including products from animals to which any such matter has been fed.
(13) Fate and behaviour in the environment covers the potential environmental exposure from product use, including the identity and quantity of the active substance, metabolites, degradation products and reaction products, safeners and synergists which may be available in the soil, water or air and are of toxicological or environmental significance.
(14) Ecotoxicology covers the assessment of the potential impact on non-target species likely to be at risk from exposure to the product, including the active substance, and toxicologically or environmentally significant metabolites, degradation products and reaction products, safeners and synergists.
(15) Efficacy covers the assessment of whether a product consistently controls the target pest and whether the product adversely affects the treated crops, following crops or treated produce.
(16) Pre-submission meetings may be held at the request of the applicant prior to the submission of an application ....
(17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(18) The fee is equivalent to a specialist case fee and relates to requests from applicants for a United Kingdom competent authority to comment on the study design in advance of the data being generated and an application being submitted. For particularly complex protocols requiring significant specialist input it may be necessary to charge a data module fee in the relevant specialist area.
1A. Fees for parallel trade applications to the Northern Ireland competent authority are in accordance with the following table, and each item is charged cumulatively.
| Item | Chargeable item | Fee(£) |
|---|---|---|
(1) Application for a parallel trade permit for other than personal use. | ||
(2) Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009. | ||
| 1 | Preliminary consideration of an application to determine whether the application can proceed further | 229 |
| 2 | Parallel trade applications— | |
| (a) co-ordination of application for a new product or change to an existing product involving parallel trade (1) | 728 | |
| (b) parallel trade verification (2) | 208 | |
| (c) parallel trade permit for personal use | 156 | |
Fees for application and evaluation of an active substance, safener , synergist or basic substance
2. The fees chargeable by a Great Britain competent authority for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener , synergist or basic substance , are in accordance with the following table.
| Item | Application | Fee(£) | |||||
|---|---|---|---|---|---|---|---|
| Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone | |||||||
| 1 | Preliminary evaluation (1) of the admissibility of an application | 5,200 | |||||
| 2 | . . . | . . . | |||||
| 3 | Co-ordination of scientific advice and public consultation and finalising the draft assessment report | 36,400 | |||||
| 4 | Evaluation of a full data package (3) | 114,400 | |||||
| 5 | Evaluation of a partial data package (4) : | ||||||
| Band 1 | 7,800 | ||||||
| Band 2 | 15,600 | ||||||
| Band 3 | 31,200 | ||||||
| Band 4 | 52,000 | ||||||
| Band 5 | 72,800 | ||||||
| Band 6 | 93,600 | ||||||
| Band 7 | 114,400 | ||||||
| Where an active substance is a biocontrol agent | |||||||
| 6 | Evaluation of a full data package (3) | 23,400 | |||||
| 7 | Co-ordination of scientific advice and public consultation, and finalising the draft assessment report | 7,800 | |||||
| 8 | Evaluation of a partial data package (4) : | ||||||
| Band 1 | 5,720 | ||||||
| Band 2 | 11,700 | ||||||
| Band 3 | 17,680 | ||||||
| Band 4 | 23,400 | ||||||
| Where an active substance is a pheromone | |||||||
| 9 | Evaluation of a full data package (3) | 13,520 | |||||
| 10 | Co-ordination of scientific advice and public consultation, and finalising the draft assessment report | 7,800 | |||||
| 11 | Evaluation of a partial data package: (4) | ||||||
| Band 1 | 3,380 | ||||||
| Band 2 | 6,760 | ||||||
| Band 3 | 10,140 | ||||||
| Band 4 | 13,520 | ||||||
| For all evaluations | |||||||
| 12 | Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone | 5,200 | |||||
Notes
(1) The initial evaluation carried out in order to notify the applicant whether his or her application can proceed further.
(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) In relation to active substances, safeners or synergists, a full data package comprises the complete dossier (the information referred to in paragraphs 1 and 2 of Article 8 of Regulation 1107/2009) to support one or more representative use of one product. In relation to basic substances, a full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance. Where a data package also contains a large number of extra study reports submitted to refine risk assessments, to characterise metabolites or to support additional uses of the product or basic substance , these studies will be treated as an additional partial data package. See also note (4).
(4) The size of a partial data package is banded as a proportion of a full data package. The proportion is estimated on the basis of the amount of time required to evaluate the data and to conduct the necessary risk assessments. Applicants will be notified of the appropriate Band prior to an evaluation taking place. Partial data packages include one or more of the following—
(a) additional data over and above a ‘standard’ core dossier for example situations where there are significantly more metabolites, or very large novel studies to be evaluated;
(b) additional study submissions during evaluation required to clarify the initial dossier;
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(d) in relation to active substances, safeners or synergists, data to support the extension of the approval of an active substance, safener or synergist under Regulation 1107/2009 once the initial approval period has expired or to change the conditions of approval during the approval period;
(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(f) in relation to active substances, safeners or synergists, large data packages in one or more areas of the risk assessment that have been submitted in support of product related applications (e.g. re-registration and new product applications under Regulation 1107/2009) that significantly exceed the size for which the standard fees specified in the product-related application fees table (paragraph 1, items 9a-g above) are payable.
(g) in relation to active substances, safeners or synergists, additional studies submitted to support an adverse data review.
(h) in relation to basic substances, resubmissions (for example where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission);
(i) in relation to basic substances, data to support a change to the conditions of approval of the basic substance.
The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.
Fees for official recognition of a test facility or organisation
3. The fees for the official recognition of a test facility or organisation by a United Kingdom competent authority are in accordance with the following table (1) .
| Item | Activity | Fee (£) |
|---|---|---|
| 1 | Initial official recognition of the test facility | 2,080 |
| 2 | Renewal of an official recognition | 2,080 |
| 3 | Each re-inspection | 1,560 |
Notes
(1) Article 29(3) of Regulation 1107/2009 requires that compliance with certain authorisation requirements is established by official or officially recognised tests and analyses.
Fees related to application for approval of basic substances
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 4(2)
SCHEDULE 2 Import tolerance fees and standalone MRL application fees
Fees for import tolerances
1. Fees chargeable by a Great Britain competent authority for import tolerances are in accordance with the following table.
| Item | Category | Fee(£) |
|---|---|---|
| A1 | Preliminary consideration of an application to determine whether the application can proceed further | 229 |
| A2 | Co-ordination of applications | 1,872 |
| 1 | Full Human health description (1) | 16,224 |
| 2 | Metabolism and residues evaluation (2) | 6,760 |
| 3 | Residues evaluation (3) | 2,028 |
Notes
(1) This category is mainly for active substances not currently approved in respect of the part of Great Britain to which the application relates. In certain cases it may also include active substances still being reviewed if toxicological endpoints have not yet been agreed and accepted in respect of that part of Great Britain.
(2) This category is for active substances where toxicological endpoints have already been agreed and accepted in respect of the part of Great Britain to which the application relates , but the residue definition has only been established for crop groups unrelated to the intended use or imported produce.
(3) This category is for active substances where relevant toxicological endpoints and residue definition have already been agreed and accepted in respect of the part of Great Britain to which the application relates .
Fees for multiple import tolerances for the same active substance are calculated on a modular basis with a charge applied for each crop.
Fees for standalone MRL applications
2. Fees chargeable by a Great Britain competent authority for standalone MRL applications are in accordance with the following table.
| Item | Category | Fee (£) |
|---|---|---|
| 1 | Preliminary consideration of an application to determine whether the application can proceed further | 229 |
| 2 | Co-ordination of applications | 1,872 |
| 3 | Full human health description (1) | 16,224 |
| 4 | Metabolism and residues evaluation (2) | 6,760 |
| 5 | Residues evaluation (3) | 2,028 |
Notes
(1) This category is mainly for active substances not currently approved in respect of the part of Great Britain to which the application relates. In certain cases it may also include active substances still being reviewed if toxicological endpoints have not yet been agreed and accepted in respect of that part of Great Britain.
(2) This category is for active substances where toxicological endpoints have already been agreed and accepted in respect of the part of Great Britain to which the application relates but the residue definition has only been established for crop groups unrelated to the intended use.
(3) This category is for active substances where relevant toxicological endpoints and residue definition have already been agreed and accepted in respect of the part of Great Britain to which the application relates.
Fees for multiple standalone applications for the same active substance are calculated on a modular basis with a charge applied for each crop or combination of maximum residue levels.
Regulation 4(2A)
SCHEDULE 3 Maximum residue level supplementary information fees chargeable by a Great Britain competent authority
Fees chargeable by a Great Britain competent authority for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation are in accordance with the following table.
| Item | Category | Fee (£) |
|---|---|---|
| 1 | Preliminary consideration of application to determine whether the application can proceed further | 229 |
| 2 | Co-ordination of applications | 1,872 |
| 3 | Simple reasoned case (1) | 416 |
| 4 | Analytical method (2) | 416 |
| 5 | Toxicology (3) | 3,120 |
| 6 | Metabolism and residues evaluation (4) | 6,760 |
| 7 | Residues evaluation (5) | 2,028 |
Notes
(1) This category is for an MRL supplementary information requirement to provide additional information on aspects of the data already evaluated or to provide evidence of the commercial availability of standards for MRL compliance.
(2) This category is for an MRL supplementary information requirement to provide an analytical method for MRL compliance.
(3) This category is for an MRL supplementary information requirement to address the toxicological relevance of a metabolite identified in plants or products of animal origin.
(4) This category is for an MRL supplementary information requirement to address plant or livestock metabolism or any other nature of residue study.
(5) This category is for an MRL supplementary information requirement to provide additional residue trials or any other magnitude of residue study including monitoring data.
Fees for multiple submissions to address MRL supplementary information for the same active substance are calculated on a modular basis with a charge applied for each MRL supplementary information requirement. Large or novel studies to address MRL supplementary information requirements will incur an additional fee, as a multiple of the original fee, if significant extra work is required over and above the usual level for the module in question.
1972 c. 68 . The power of the Secretary of State, as designated Minister, to make Regulations that (i) extend to Scotland remains exercisable by virtue of section 57(1) of the Scotland Act 1998 (c.46) ; (ii) extend to Northern Ireland remains exercisable by virtue of article 3(2) of the European Communities (Designation)(No 3) Order 2000 ( S.I. 2000/2812 ), article 2(3) of the European Communities (Designation) (No 2) Order 1999 ( S.I. 1999/2027 ) and article 2(a) of the European Communities (Designation) Order 2008 ( S.I. 2008/301 ); and (iii) apply in Wales remains exercisable by virtue of article 6(1) of the European Communities (Designation) (No 5) Order 2010 ( S.I. 2010/2690 ), article 5(1) of the European Communities (Designation) (No.2) Order 2008 ( S.I. 2008/1792 ) and article 2(a) of the European Communities (Designation) Order 2008 ( S.I. 2008/301 ).