The Plant Protection Products (Fees and Charges) Regulations 2011

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[F1Fees for application and evaluation of a plant protection product for authorisationU.K.

This section has no associated Explanatory Memorandum

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.

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)F3... for a new product or change to an existing product—
4a			one product			156
4b		each additional product⁽⁴⁾				52
5	F4. . .
5a					F4. . .	F4. . .
5b					F4. . .	F4. . .
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 [F5to discuss potential product applications] ⁽¹⁶⁾					5,200
12	F6. . .
	F6. . .					F6. . .
	F6. . .					F6. . .
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.

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

F1Sch. 1 substituted (6.4.2016) by The Plant Protection Products (Fees and Charges) (Amendment) Regulations 2016 (S.I. 2016/254), regs. 1, 2(2)

F2Words in Sch. 1 para. 1 inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 14(2)(a) (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 1 para. 10(2)(b))

F3Word in Sch. 1 para. 1 Table Item 4 omitted (31.12.2020) by virtue of 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. 14(2)(b)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)