http://www.legislation.gov.uk/id/uksi/2011/2132

F1SCHEDULE 1Fees

Regulation 4(1)

Annotations:

Amendments (Textual)

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)

Fees for application and evaluation of a plant protection product for authorisation1

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.

F73

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

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

F75

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F76

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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....

F1017

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.

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.

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 F13, synergist or basic substance2

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.

Item	Application					Fee(£)
	Where an active substance, safener F16, 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		F17. . .				F17. . .
3		F18Co-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			F19Co-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		F19Co-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, F20basic 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.

F212

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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;

F25c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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;

F27e

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.

F29h

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.

Fees for official recognition of a test facility or organisation3

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⁾.

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 substancesF324

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