F1SCHEDULE 1Fees
Fees for application and evaluation of a plant protection product for authorisation1
Fees for product-related applications F3to a United Kingdom competent authority are in accordance with the following table, and each item is charged cumulatively.
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)F4... for a new product or change to an existing product— | |||||
4a | one product | 156 | ||||
4b | each additional product(4) | 52 | ||||
5 | F5. . . | |||||
5a | F5. . . | F5. . . | ||||
5b | F5. . . | F5. . . | ||||
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 F6to discuss potential product applications(16) | 5,200 | ||||
12 | F7. . . | |||||
F7. . . | F7. . . | |||||
F7. . . | F7. . . | |||||
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.
F83
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Where the application relates to a number of different products, this charge applies to each additional product.
F85
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F86
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
“Standard technical stream applications” are all applications other than F9items 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 F10....
F1117
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
The fee is equivalent to a specialist case fee and relates to requests from applicants for F12a 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.
F131A
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 | 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 | |
(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. | ||
Fees for application and evaluation of an active substance, safener F14, synergist or basic substance2
The fees F15chargeable by a Great Britain competent authority for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener F16, synergist or basic substance, are in accordance with the following table.
Item | Application | Fee(£) | |||||
|---|---|---|---|---|---|---|---|
Where an active substance, safener F17, 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 | F18. . . | F18. . . | |||||
3 | F19Co-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 | F20Co-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 | F20Co-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, F21basic 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.
F222
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
F23In 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. F24In 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 F25or 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;
F26c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
d
F27 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;
F28e
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
f
F29in 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
F29in relation to active substances, safeners or synergists, additional studies submitted to support an adverse data review.
F30h
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.
F31The 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 organisation3
The fees for the official recognition of a test facility or organisation F32by 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 substancesF334
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F2SCHEDULE 2Import tolerance F36fees and standalone MRL application fees
Sch. 2 substituted (6.4.2016) by The Plant Protection Products (Fees and Charges) (Amendment) Regulations 2016 (S.I. 2016/254), regs. 1, 2(3)
Words in Sch. 2 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 1 para. 15(2); 2020 c. 1, Sch. 5 para. 1(1)
F35Fees for import tolerances F341
F37Fees chargeable by a Great Britain competent authority for import tolerances are in accordance with the following table.
Item | Category | Fee(£) |
|---|---|---|
F39A1 | 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
F38This 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 F40active substances where toxicological endpoints have already been agreed F41and 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 F42active substances where relevant toxicological endpoints and residue definition have already been agreed F43and accepted in respect of the part of Great Britain to which the application relates.
F44Fees for multiple import tolerances for the same active substance are calculated on a modular basis with a charge applied for each crop.
F45Fees for standalone MRL applications2
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.
F46SCHEDULE 3Maximum 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.
Sch. 1 substituted (6.4.2016) by The Plant Protection Products (Fees and Charges) (Amendment) Regulations 2016 (S.I. 2016/254), regs. 1, 2(2)