The Plant Protection Products (Fees and Charges) Regulations 2011

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 commencementU.K.

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 26th November 2011.

InterpretationU.K.

2.—(1) In these Regulations—

“authorisation holder” means the holder of a valid authorisation or permit for a plant protection product—

(a)

issued in accordance with Regulation 1107/2009, or

(b)

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;

[F1“Great Britain competent authorities” means—

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales, the Welsh Ministers;

(c)

in relation to Scotland, the Scottish Ministers;]

F2...

“import tolerance” has [F3, 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;

[F4“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;]

[F5“the MRL Regulation” means—

(a)

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;

(b)

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]

[F6“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;

[F7“Northern Ireland competent authority” means the Department of Agriculture, Environment and Rural Affairs;]

[F8“Regulation 1107/2009” means—

(a)

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;

(b)

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;]

[F9“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;]

[F10“United Kingdom competent authorities” means—

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales, the Welsh Ministers;

(c)

in relation to Scotland, the Scottish Ministers;

(d)

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.

Textual Amendments

[F11Functions in Article 74(1) of Regulation 1107/2009: Northern Ireland]U.K.

3.—(1) The functions F12... referred to in Article 74(1) of Regulation 1107/2009 are to be performed by the [F13Northern Ireland competent authority].

F14(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

FeesU.K.

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;

F15(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)official recognition of a test facility or organisation,

and such fees are payable in accordance with [F16paragraphs 1 and 3 respectively of] Schedule 1.

[F17(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 [F18Great Britain] competent authority may charge fees for applications for import tolerances [F19and standalone MRL applications] under Article 7 of the MRL Regulation and such fees are payable in accordance with Schedule 2.

[F20(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 [F21the relevant] competent authority.

(5) [F22The 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 [F23the relevant] competent authority as a civil debt.

Textual Amendments

Charge in relation to Regulation 1107/2009 and the MRL RegulationU.K.

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).

[F24Charge for work under the Plant Protection Products (Sustainable Use) Regulations 2012]U.K.

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 [F25under the Plant Protection Products (Sustainable Use) Regulations 2012 ].

Textual Amendments

Liability to pay the chargeU.K.

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 [F26under regulations 4(1), 4(1A) or 4(1B)] and Schedule 1, F27... regulation 4(2) and Schedule 2 [F28or 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.

Textual Amendments

Calculation of chargeU.K.

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. [F29Except where paragraphs (3A) to (3C) apply, the] percentage must be calculated by applying the following formula—

A/B x 100% = the percentage

where—

A

=

the total costs incurred in the liability period, and

B

=

the total annual turnover.

[F30(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).]

[F30(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.]

[F30(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—

[F31“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—

(a)

regulations 4(1), 4(1A) or 4(1B) and Schedule 1,

(b)

regulation 4(2) and Schedule 2, or

(c)

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 1st October and 30th September the following year, the latter date being in the calendar year in which the liability period starts by—

(a)

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

(b)

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.

Textual Amendments

RevocationU.K.

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)

[F32SCHEDULE 1U.K.Fees

Textual Amendments

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

1.  Fees for product-related applications [F33to 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)F34... for a new product or change to an existing product—
4aone product156
4beach additional product(4)52
5F35. . .
5aF35. . .F35. . .
5bF35. . .F35. . .
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 [F36to discuss potential product applications] (16)5,200
12F37. . .
F37. . .F37. . .
F37. . .F37. . .
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.

F38(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

F38(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F38(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) “Standard technical stream applications” are all applications other than [F39items 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 F40....

F41(17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(18) The fee is equivalent to a specialist case fee and relates to requests from applicants for [F42a 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

[F431A.  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 [F44, synergist or basic substance] U.K.

2.  The fees [F45chargeable by a Great Britain competent authority] for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener [F46, synergist or basic substance], are in accordance with the following table.

ItemApplicationFee(£)
Where an active substance, safener [F47, synergist or basic substance] is neither a biocontrol agent nor a pheromone
1Preliminary evaluation(1) of the admissibility of an application5,200
2F48. . .F48. . .
3 [F49Co-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 [F50Co-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 [F50Co-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, [F51basic 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.

F52(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) [F53In 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. [F54In 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 [F55or 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;

F56(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)[F57 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;

F58(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)[F59in 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)[F59in relation to active substances, safeners or synergists,] additional studies submitted to support an adverse data review.

[F60(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.]

[F61The 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 [F62by 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.

F634.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Regulation 4(2)

[F64SCHEDULE 2U.K.Import tolerance [F65fees and standalone MRL application fees]

Textual Amendments

[F66Fees for import tolerances ]U.K.

[F671.]  [F68Fees chargeable by a Great Britain competent authority for import tolerances] are in accordance with the following table.

ItemCategoryFee(£)
[F69A1 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) [F70This 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 [F71active substances] where toxicological endpoints have already been agreed [F72and 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 [F73active substances] where relevant toxicological endpoints and residue definition have already been agreed [F74and accepted in respect of the part of Great Britain to which the application relates].

[F75Fees for multiple import tolerances for the same active substance are calculated on a modular basis with a charge applied for each crop.]]

Textual Amendments

[F76Fees 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)

[F77SCHEDULE 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.]

EXPLANATORY NOTE

(This note is not part of the Regulations)

1.  These Regulations provide the charging regime in relation to—U.K.

(a)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 and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ No L309, 24.11.2009, p.1) (“Regulation 1107/2009”);

(b)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 (OJ No L70, 16.3.2005, p.1) (“the MRL Regulation”); and

(c)Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ No L 4, 6. 1. 96, p.16) (“the Directive”).

2.  Regulation 1107/2009 replaces the existing scheme for approval under Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ No L230, 19.8.1991, p.1), and lays down rules for the approval of active substances and the authorisation of plant protection products.U.K.

3.  These Regulations set fees, chargeable by the Secretary of State, the Scottish Ministers and the Department of Agriculture and Rural Development in Northern Ireland (“the United Kingdom competent authorities”) for—U.K.

(a)work carried out within the scope of Regulation 1107/2009 which relates to evaluating applications for the authorisation of plant protection products, the approval of active substances, safeners, synergists and basic substances and official recognition of a test facility or organisation, and

(b)applications for import tolerances under Article 7 of the MRL Regulation.

4.  These Regulations also provide for an annual charge to be paid by authorisation holders for costs incurred by or on behalf of the United Kingdom competent authorities associated with any work carried out within the scope of Regulation 1107/2009 and work arising from the obligations under the MRL Regulation (other than for work charged under section 18(2)(b) or (c) of the Food and Environment Protection Act 1985) and, after 26th November 2011, work pursuant to obligations within the scope of the Directive. These Regulations also set out the consequences of failure to pay fees or charges.U.K.

5.  These Regulations revoke and replace—U.K.

(a)The Fees for Assessment of Active Substances (Third Stage Review) Regulation 2005 (S.I. 2005/117);

(b)The Fees for Assessment of Active Substances (Fourth Stage Review) Regulation 2005 (S.I. 2005/1811); and

(c)the Plant Protection Products (Fees) Regulations 2007(S.I. 2007/295).

6.  A full regulatory impact assessment of the effect that this instrument will have on the costs to business and the voluntary sector has also been prepared. A copy of this document has been placed in the library of each House of Parliament and is available on DEFRA’s website (www.defra.gov.uk). A copy of the regulatory impact assessment is also annexed to the Explanatory Memorandum to the Plant Protection Products Regulations 2011 and to these Regulations and is available alongside the instruments on the legislation website (http://www.legislation.gov.uk/).U.K.

7.  The new fees compared with those fixed by or determined under the previous fee-charging provisions are as follows:U.K.

Type of FeePrevious Fee (£)New Fee (£)Percentage Increase/Decrease
Schedule 1
1. Product related applications

1.— U.K.

Administrative research and development application

30.00

50.00

66.67%

2.— U.K.

Extension of use application including administration, co-ordination and technical consideration

1,495.00

1,495.00

0.00%

Extension of use application from 1 April 2012

1,495.00

1,700.00

13.71%

3.— U.K.

Preliminary consideration of application type listed in item 4, 5, 7, 12 or 13, to determine whether the application can proceed further

150.00 (electronic)

or

175.00 (other)

220.00

46.67%

or

25.71%

4.— U.K.

Administrative application for a new product or change to an existing product,

(a)

One product

120.00

150.00

25.00%

(b)

Each additional product

40.00

50.00

25.00%

5.— U.K.

Parallel trade application;

(a)

Co-ordination of application for new product or change to existing product involving parallel trade

710.00

700.00

-1.41%

(b)

Parallel trade verification

200.00

200.00

0.00%

6.— U.K.

Evaluation of a label in any application.

300.00

200.00

-33.33%

7.— U.K.

Coordination of standard technical stream application

1,100.00 (technical)

or

1,800.00 (data evaluation)

1,800.00

45.45%

or

0.00%

8.— U.K.

Evaluation of simple reasoned cases in each of the following specialist areas:

(a)

Chemistry

250.00

400.00

60.00%

(b)

Toxicology

250.00

400.00

60.00%

(c)

Operator exposure

250.00

400.00

60.00%

(d)

Residues/consumer exposure

250.00

400.00

60.00%

(e)

Fate and behaviour in the environment

250.00

400.00

60.00%

(f)

Ecotoxicology

250.00

400.00

60.00%

(g)

Efficacy

250.00

400.00

60.00%

9.— U.K.

Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas:

(a)

Chemistry

425.00

750.00

76.47%

(b)

Toxicology

500.00

750.00

50.00%

(c)

Operator exposure

750.00

750.00

0.00%

(d)

Residues/consumer exposure

1,000.00

750.00

-25.00%

(e)

Fate and behaviour in the environment

1,000.00

1,800.00

80.00%

(f)

Ecotoxicology

1,000.00

1,800.00

80.00%

(g)

Efficacy

1,500.00

1,800.00

20.00%

Crop Safety (£500) and Effectiveness (£1000) previously charged separately

10.— U.K.

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

100.00

100.00

0.00%

11.— U.K.

Pre-submission meetings for lead zone re-registration and new product applications

0.00

5,000.00

New item

12.— U.K.

Zonal surcharges for lead zonal re-registration and new product applications. This fee is in addition to these described in 7 to 9 above

Zonal surcharge 1

0.00

7,500.00

New item

Zonal surcharge 2

0.00

15,000.00

New item

13.— U.K.

Commenting on draft study protocols

0.00

400.00

New item

2. Active substances related applications
Where an active substance, safener or synergist is neither a biocontrol agent nor a pheromone

1.— U.K.

Preliminary evaluation of an application’s admissibility

5,000.00

5,000.00

0.00%

2.— U.K.

Processing an application for provisional authorisation

35,000.00

35,000.00

0.00%

3.— U.K.

Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur member state

35,000.00

35,000.00

0.00%

4.— U.K.

Evaluation of a full data package

105,000.00

110,00.00

4.76%

5.— U.K.

Evaluation of a partial data package:

Band 1

7,500.00

New item

Band 2

15,000.00

15,000.00

0.00%

Band 3

30,000.00

30,000.00

0.00%

Band 4

40,000.00

50,000.00

25.00%

Band 5

60,000.00

70,000.00

16.67%

Band 6

80,000.00

90,000.00

12.50%

Band 7

105,000.00

110,000.00

4.76%

Where an active substance is a biocontrol agent

6.— U.K.

Evaluation of a full data package

22,500.00

22,500.00

0.00%

7.— U.K.

Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur member State

7,500.00

7,500.00

0.00%

8.— U.K.

Evaluation of a partial data package:

Band 1

5,500.00

5,500.00

0.00%

Band 2

11,250.00

11,250.00

0.00%

Band 3

17,000.00

17,000.00

0.00%

Band 4

22,500.00

22,500.00

0.00%

Where an active substance is a pheromone

9.— U.K.

Evaluation of a fill data package

13,000.00

13,000.00

0.00%

10.— U.K.

Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is a rapporteur or co-rapporteur member State.

7,500.00

7,500.00

0.00%

11.— U.K.

Evaluation of a partial data package:

Band 1

3,250.00

3,250.00

0.00%

Band 2

6,500.00

6,500.00

0.00%

Band 3

9,750.00

9,750.00

0.00%

Band 4

13,000.00

13,000.00

0.00%

For all evaluations

12.— U.K.

Meeting before the submission of an application in support of new active substance, safener or synergist, biocontrol and pheromone applications

0.00

5,000.00

New item

3. Fees for official recognition of a test facility or organisation

Initial official recognition of the test facility

1,500.00

2,000.00

33.33%

Renewal of an official recognition

1,500.00

2,000.00

33.33%

Each re-inspection

1,125.00

1,500.00

33.33%

4. Basic substance applications

1.— U.K.

Assistance with a full data package

0.00

110,000.00

New item

2.— U.K.

Assistance with a partial data package:

Band 1

0.00

7,500.00

New item

Band 2

0.00

15,000.00

New item

Band 3

0.00

30,000.00

New item

Band 4

0.00

50,000.00

New item

Band 5

0.00

70,000.00

New item

Band 6

0.00

90,000.00

New item

Band 7

0.00

110,000.00

New item

Schedule 2
Import tolerance fee

1.— U.K.

Full human health evaluation

15,600.00

15,600.00

0.00%

2.— U.K.

Metabolism and residues evaluation

6,500.00

6,500.00

0.00%

3.— U.K.

Residues evaluation

1,950.00

1,950.00

0.00%

(1)

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).