Regulation 4(1)

[F1SCHEDULE 1U.K.Fees

Textual Amendments

Fees for application and evaluation of a plant protection product for authorisationU.K.

1.  Fees for product-related applications [F2to a United Kingdom competent authority] are in accordance with the following table, and each item is charged cumulatively.

ItemChargeable itemFee(£)
1Administrative research and development application(1)52
2Extension of use application including administration, co-ordination and technical consideration1,768
3Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further229
4Administrative application(2)F3... for a new product or change to an existing product—
4aone product156
4beach additional product(4)52
5F4. . .
5aF4. . .F4. . .
5bF4. . .F4. . .
6Evaluation of a label in any application208
7Co-ordination of standard technical stream applications (7)(8)1,872
8Evaluation of simple reasoned cases in each of the following specialist areas—
8achemistry(9)416
8btoxicology(10)416
8coperator exposure(11)416
8dresidues and consumer exposure(12)416
8efate and behaviour in the environment(13)416
8fecotoxicology(14)416
8gefficacy(15)416
9Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—
9achemistry(9)780
9btoxicology(10)780
9coperator exposure(11)780
9dresidues and consumer exposure(12)780
9efate and behaviour in the environment(13)1,872
9fecotoxicology(14)1,872
9gefficacy(15)1,872
10Withdrawal 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 done104
11Pre-submission meetings [F5to discuss potential product applications] (16)5,200
12F6. . .
F6. . .F6. . .
F6. . .F6. . .
13Commenting 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.

F7(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Where the application relates to a number of different products, this charge applies to each additional product.

F7(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) “Standard technical stream applications” are all applications other than [F8items 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 F9....

F10(17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(18) The fee is equivalent to a specialist case fee and relates to requests from applicants for [F11a 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.

Textual Amendments

[F121A.  Fees for parallel trade applications to the Northern Ireland competent authority are in accordance with the following table, and each item is charged cumulatively.

ItemChargeable itemFee(£)
(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.]

1Preliminary consideration of an application to determine whether the application can proceed further229
2Parallel 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 use156

Textual Amendments

Fees for application and evaluation of an active substance, safener [F13, synergist or basic substance] U.K.

2.  The fees [F14chargeable by a Great Britain competent authority] for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener [F15, synergist or basic substance], are in accordance with the following table.

ItemApplicationFee(£)
Where an active substance, safener [F16, synergist or basic substance] is neither a biocontrol agent nor a pheromone
1Preliminary evaluation(1) of the admissibility of an application5,200
2F17. . .F17. . .
3 [F18Co-ordination of scientific advice and public consultation and finalising the draft assessment report]36,400
4Evaluation of a full data package(3)114,400
5Evaluation of a partial data package(4):
Band 17,800
Band 215,600
Band 331,200
Band 452,000
Band 572,800
Band 693,600
Band 7114,400
Where an active substance is a biocontrol agent
6Evaluation of a full data package (3)23,400
7 [F19Co-ordination of scientific advice and public consultation, and finalising the draft assessment report]7,800
8Evaluation of a partial data package(4):
Band 15,720
Band 211,700
Band 317,680
Band 423,400
Where an active substance is a pheromone
9Evaluation of a full data package(3)13,520
10 [F19Co-ordination of scientific advice and public consultation, and finalising the draft assessment report]7,800
11Evaluation of a partial data package:(4)
Band 13,380
Band 26,760
Band 310,140
Band 413,520
For all evaluations
12Meeting before the submission of an application in support of a new active substance, safener, synergist, [F20basic substance,] biocontrol agent or pheromone5,200

Notes

(1) The initial evaluation carried out in order to notify the applicant whether his or her application can proceed further.

F21(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) [F22In 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. [F23In 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 [F24or 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;

F25(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)[F26 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;

F27(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)[F28in 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)[F28in relation to active substances, safeners or synergists,] additional studies submitted to support an adverse data review.

[F29(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.]

[F30The 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.]

Textual Amendments

Fees for official recognition of a test facility or organisationU.K.

3.  The fees for the official recognition of a test facility or organisation [F31by a United Kingdom competent authority] are in accordance with the following table(1).

ItemActivityFee (£)
1Initial official recognition of the test facility2,080
2Renewal of an official recognition2,080
3Each re-inspection1,560

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.

Textual Amendments

Fees related to application for approval of basic substancesU.K.

F324.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Regulation 4(2)

[F33SCHEDULE 2U.K.Import tolerance [F34fees and standalone MRL application fees]

Textual Amendments

[F35Fees for import tolerances ]U.K.

[F361.]  [F37Fees chargeable by a Great Britain competent authority for import tolerances] are in accordance with the following table.

ItemCategoryFee(£)
[F38A1 Preliminary consideration of an application to determine whether the application can proceed further229
A2Co-ordination of applications1,872]
1Full Human health description(1)16,224
2Metabolism and residues evaluation(2)6,760
3Residues evaluation(3)2,028

Notes

(1) [F39This 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.]]

Textual Amendments

[F45Fees for standalone MRL applicationsU.K.

2.  Fees chargeable by a Great Britain competent authority for standalone MRL applications are in accordance with the following table.

ItemCategoryFee (£)
1Preliminary consideration of an application to determine whether the application can proceed further229
2Co-ordination of applications1,872
3Full human health description(1)16,224
4Metabolism and residues evaluation(2)6,760
5Residues 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.]

Textual Amendments

Regulation 4(2A)

[F46SCHEDULE 3U.K.Maximum residue level supplementary information fees chargeable by a Great Britain competent authority

Textual Amendments

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.

ItemCategoryFee (£)
1Preliminary consideration of application to determine whether the application can proceed further229
2Co-ordination of applications1,872
3Simple reasoned case(1)416
4Analytical method(2)416
5Toxicology(3)3,120
6Metabolism and residues evaluation(4)6,760
7Residues 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.]