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The Plant Protection Products (Fees and Charges) Regulations 2011

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Regulation 4(1)

[F1SCHEDULE 1U.K.Fees

This Atodlen has no associated Memorandwm Esboniadol

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

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