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

In accordance with section 56(1) of the Finance Act 1973 the Treasury consents to the making of these Regulations.

Title and commencement

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.

Interpretation

2

• (1) In these Regulations—

• “authorisation holder” means the holder of a valid authorisation or permit for a plant protection product—issued in accordance with Regulation 1107/2009, ordeemed 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;

• “Great Britain competent authorities” means—in relation to England, the Secretary of State;in relation to Wales, the Welsh Ministers;in relation to Scotland, the Scottish Ministers;

• ...

• “import tolerance” has , 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;

• “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;

• “the MRL Regulation” means—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;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 Northern Ireland by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement

• “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;

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

• “Regulation 1107/2009” means—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;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 Northern Ireland by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement;

• “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;

• “United Kingdom competent authorities” means—in relation to England, the Secretary of State;in relation to Wales, the Welsh Ministers;in relation to Scotland, the Scottish Ministers;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.

Functions of the Member State

3

• (1) The functions ... referred to in Article 74(1) of Regulation 1107/2009 are to be performed by the Northern Ireland competent authority.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fees

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;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

and such fees are payable in accordance with paragraphs 1 and 3 respectively of Schedule 1.

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

• (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[^f00010] or the Plant Protection Products (Fees) Regulations (Northern Ireland) 2004[^f00011] in relation to that work.

• (4) Fees are payable by the applicant, on invoice, to the relevant competent authority.

• (5) The 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 the relevant competent authority as a civil debt.

Charge in relation to Regulation 1107/2009 and the MRL Regulation

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[^f00012].

Charge in relation to the Directive

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 under the Plant Protection Products (Sustainable Use) Regulations 2012 .

Liability to pay the charge

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 under regulations 4(1), 4(1A) or 4(1B) and Schedule 1, ... regulation 4(2) and Schedule 2 or 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.

Calculation of charge

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

Revocation

9

The following regulations are revoked—

• (a) The Fees for Assessment of Active Substances (Third Stage Review) Regulations 2005[^f00013];

• (b) The Fees for Assessment of Active Substances (Fourth Stage Review) Regulations 2005[^f00014]; and

• (c) The Plant Protection Products (Fees) Regulations 2007.

SCHEDULE 1 — Fees

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

1

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

Item	Chargeable item	Chargeable item	Chargeable item	Chargeable item	Chargeable item	Fee(£)
1	Administrative research and development application⁽¹⁾	Administrative research and development application⁽¹⁾	Administrative research and development application⁽¹⁾	Administrative research and development application⁽¹⁾	Administrative research and development application⁽¹⁾	52
2	Extension of use application including administration, co-ordination and technical consideration	Extension of use application including administration, co-ordination and technical consideration	Extension of use application including administration, co-ordination and technical consideration	Extension of use application including administration, co-ordination and technical consideration	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	Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further	Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further	Preliminary consideration of application type listed in items 4, 5, 7,12 or 13 to determine whether the application can proceed further	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)... for a new product or change to an existing product—	Administrative application(2)... for a new product or change to an existing product—	Administrative application(2)... for a new product or change to an existing product—	Administrative application(2)... for a new product or change to an existing product—	Administrative application(2)... for a new product or change to an existing product—
4a			one product	one product	one product	156
4b		each additional product⁽⁴⁾	each additional product⁽⁴⁾	each additional product⁽⁴⁾	each additional product⁽⁴⁾	52
5	. . .	. . .	. . .	. . .	. . .
5a					. . .	. . .
5b					. . .	. . .
6	Evaluation of a label in any application	Evaluation of a label in any application	Evaluation of a label in any application	Evaluation of a label in any application	Evaluation of a label in any application	208
7	Co-ordination of standard technical stream applications ⁽⁷⁾⁽⁸⁾	Co-ordination of standard technical stream applications ⁽⁷⁾⁽⁸⁾	Co-ordination of standard technical stream applications ⁽⁷⁾⁽⁸⁾	Co-ordination of standard technical stream applications ⁽⁷⁾⁽⁸⁾	Co-ordination of standard technical stream applications ⁽⁷⁾⁽⁸⁾	1,872
8	Evaluation of simple reasoned cases in each of the following specialist areas—	Evaluation of simple reasoned cases in each of the following specialist areas—	Evaluation of simple reasoned cases in each of the following specialist areas—	Evaluation of simple reasoned cases in each of the following specialist areas—	Evaluation of simple reasoned cases in each of the following specialist areas—
8a				chemistry⁽⁹⁾	chemistry⁽⁹⁾	416
8b				toxicology(10)	toxicology(10)	416
8c				operator exposure(11)	operator exposure(11)	416
8d				residues and consumer exposure(12)	residues and consumer exposure(12)	416
8e				fate and behaviour in the environment(13)	fate and behaviour in the environment(13)	416
8f				ecotoxicology(14)	ecotoxicology(14)	416
8g				efficacy(15)	efficacy(15)	416
9	Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—	Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—	Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—	Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—	Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas—
9a				chemistry⁽⁹⁾	chemistry⁽⁹⁾	780
9b				toxicology(10)	toxicology(10)	780
9c				operator exposure(11)	operator exposure(11)	780
9d				residues and consumer exposure(12)	residues and consumer exposure(12)	780
9e				fate and behaviour in the environment(13)	fate and behaviour in the environment(13)	1,872
9f				ecotoxicology(14)	ecotoxicology(14)	1,872
9g				efficacy(15)	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	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	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	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	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 to discuss potential product applications (16)	Pre-submission meetings to discuss potential product applications (16)	Pre-submission meetings to discuss potential product applications (16)	Pre-submission meetings to discuss potential product applications (16)	Pre-submission meetings to discuss potential product applications (16)	5,200
12	. . .	. . .	. . .	. . .	. . .
	. . .	. . .	. . .	. . .	. . .	. . .
	. . .	. . .	. . .	. . .	. . .	. . .
13	Commenting on draft study protocols(18)	Commenting on draft study protocols(18)	Commenting on draft study protocols(18)	Commenting on draft study protocols(18)	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.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) “Standard technical stream applications” are all applications other than items 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 ....

• (17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Fees for application and evaluation of an active substance, safener or synergist

2

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

Item	Application	Application	Application	Application	Application	Application	Fee(£)
	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone	Where an active substance, safener , synergist or basic substance is neither a biocontrol agent nor a pheromone
1		Preliminary evaluation⁽¹⁾ of the admissibility of an application	Preliminary evaluation⁽¹⁾ of the admissibility of an application	Preliminary evaluation⁽¹⁾ of the admissibility of an application	Preliminary evaluation⁽¹⁾ of the admissibility of an application	Preliminary evaluation⁽¹⁾ of the admissibility of an application	5,200
2		. . .	. . .	. . .	. . .	. . .	. . .
3		Co-ordination of scientific advice and public consultation and finalising the draft assessment report	Co-ordination of scientific advice and public consultation and finalising the draft assessment report	Co-ordination of scientific advice and public consultation and finalising the draft assessment report	Co-ordination of scientific advice and public consultation and finalising the draft assessment report	Co-ordination of scientific advice and public consultation and finalising the draft assessment report	36,400
4		Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	114,400
5		Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:
				Band 1	Band 1	Band 1	7,800
				Band 2	Band 2	Band 2	15,600
				Band 3	Band 3	Band 3	31,200
				Band 4	Band 4	Band 4	52,000
				Band 5	Band 5	Band 5	72,800
				Band 6	Band 6	Band 6	93,600
				Band 7	Band 7	Band 7	114,400
	Where an active substance is a biocontrol agent	Where an active substance is a biocontrol agent	Where an active substance is a biocontrol agent	Where an active substance is a biocontrol agent	Where an active substance is a biocontrol agent	Where an active substance is a biocontrol agent
6			Evaluation of a full data package ⁽³⁾	Evaluation of a full data package ⁽³⁾	Evaluation of a full data package ⁽³⁾	Evaluation of a full data package ⁽³⁾	23,400
7			Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	7,800
8			Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:	Evaluation of a partial data package⁽⁴⁾:
					Band 1	Band 1	5,720
					Band 2	Band 2	11,700
					Band 3	Band 3	17,680
					Band 4	Band 4	23,400
	Where an active substance is a pheromone	Where an active substance is a pheromone	Where an active substance is a pheromone	Where an active substance is a pheromone	Where an active substance is a pheromone	Where an active substance is a pheromone
9		Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	Evaluation of a full data package⁽³⁾	13,520
10		Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	Co-ordination of scientific advice and public consultation, and finalising the draft assessment report	7,800
11		Evaluation of a partial data package:⁽⁴⁾	Evaluation of a partial data package:⁽⁴⁾	Evaluation of a partial data package:⁽⁴⁾	Evaluation of a partial data package:⁽⁴⁾	Evaluation of a partial data package:⁽⁴⁾
		Band 1	Band 1	Band 1	Band 1	Band 1	3,380
		Band 2	Band 2	Band 2	Band 2	Band 2	6,760
		Band 3	Band 3	Band 3	Band 3	Band 3	10,140
		Band 4	Band 4	Band 4	Band 4	Band 4	13,520
	For all evaluations	For all evaluations	For all evaluations	For all evaluations	For all evaluations
12	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic substance, biocontrol agent or pheromone	Meeting before the submission of an application in support of a new active substance, safener, synergist, basic 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.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) In 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. In 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 or 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;

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) 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;

• (e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

• (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.

Fees for official recognition of a test facility or organisation

3

The fees for the official recognition of a test facility or organisation by 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 substances

4

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

SCHEDULE 2 — Import tolerance fees and standalone MRL application fees

Fees for product-related applications are in accordance with the following table.

Item	Category	Fee(£)
1	Full Human health description⁽¹⁾	16,224
2	Metabolism and residues evaluation⁽²⁾	6,760
3	Residues evaluation⁽³⁾	2,028

Signed

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 — 2011-08-20

We consent

James Duddridge — Angela Watkinson — Two of the Lords Commissioners of Her Majesty’s Treasury — 2011-08-25

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

1These Regulations provide the charging regime in relation to—aRegulation (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”);bRegulation (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”); andcDirective 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”).

2Regulation 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.

3These 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—awork 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, andbapplications for import tolerances under Article 7 of the MRL Regulation.

4These 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.

5These Regulations revoke and replace—aThe Fees for Assessment of Active Substances (Third Stage Review) Regulation 2005 (S.I. 2005/117);bThe Fees for Assessment of Active Substances (Fourth Stage Review) Regulation 2005 (S.I. 2005/1811); andcthe Plant Protection Products (Fees) Regulations 2007(S.I. 2007/295).

6A 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/).

7The new fees compared with those fixed by or determined under the previous fee-charging provisions are as follows:Type of FeePrevious Fee (£)New Fee (£)Percentage Increase/DecreaseSchedule 11. Product related applications1Administrative research and development application30.0050.0066.67%2Extension of use application including administration, co-ordination and technical consideration1,495.001,495.000.00%Extension of use application from 1 April 20121,495.001,700.0013.71%3Preliminary consideration of application type listed in item 4, 5, 7, 12 or 13, to determine whether the application can proceed further150.00 (electronic)or175.00 (other)220.0046.67%or25.71%4Administrative application for a new product or change to an existing product,(a)One product120.00150.0025.00%(b)Each additional product40.0050.0025.00%5Parallel trade application;(a)Co-ordination of application for new product or change to existing product involving parallel trade710.00700.00-1.41%(b)Parallel trade verification200.00200.000.00%6Evaluation of a label in any application.300.00200.00-33.33%7Coordination of standard technical stream application1,100.00 (technical)or1,800.00 (data evaluation)1,800.0045.45%or0.00%8Evaluation of simple reasoned cases in each of the following specialist areas:(a)Chemistry250.00400.0060.00%(b)Toxicology250.00400.0060.00%(c)Operator exposure250.00400.0060.00%(d)Residues/consumer exposure250.00400.0060.00%(e)Fate and behaviour in the environment250.00400.0060.00%(f)Ecotoxicology250.00400.0060.00%(g)Efficacy250.00400.0060.00%9Evaluation of data, modelling and detailed scientific cases in each of the following specialist areas:(a)Chemistry425.00750.0076.47%(b)Toxicology500.00750.0050.00%(c)Operator exposure750.00750.000.00%(d)Residues/consumer exposure1,000.00750.00-25.00%(e)Fate and behaviour in the environment1,000.001,800.0080.00%(f)Ecotoxicology1,000.001,800.0080.00%(g)Efficacy1,500.001,800.0020.00%Crop Safety (£500) and Effectiveness (£1000) previously charged separately10Withdrawal 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 done100.00100.000.00%11Pre-submission meetings for lead zone re-registration and new product applications0.005,000.00New item12Zonal surcharges for lead zonal re-registration and new product applications. This fee is in addition to these described in 7 to 9 aboveZonal surcharge 10.007,500.00New itemZonal surcharge 20.0015,000.00New item13Commenting on draft study protocols0.00400.00New item2. Active substances related applicationsWhere an active substance, safener or synergist is neither a biocontrol agent nor a pheromone1Preliminary evaluation of an application’s admissibility5,000.005,000.000.00%2Processing an application for provisional authorisation35,000.0035,000.000.00%3Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur member state35,000.0035,000.000.00%4Evaluation of a full data package105,000.00110,00.004.76%5Evaluation of a partial data package:Band 17,500.00New itemBand 215,000.0015,000.000.00%Band 330,000.0030,000.000.00%Band 440,000.0050,000.0025.00%Band 560,000.0070,000.0016.67%Band 680,000.0090,000.0012.50%Band 7105,000.00110,000.004.76%Where an active substance is a biocontrol agent6Evaluation of a full data package22,500.0022,500.000.00%7Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur member State7,500.007,500.000.00%8Evaluation of a partial data package:Band 15,500.005,500.000.00%Band 211,250.0011,250.000.00%Band 317,000.0017,000.000.00%Band 422,500.0022,500.000.00%Where an active substance is a pheromone9Evaluation of a fill data package13,000.0013,000.000.00%10Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is a rapporteur or co-rapporteur member State.7,500.007,500.000.00%11Evaluation of a partial data package:Band 13,250.003,250.000.00%Band 26,500.006,500.000.00%Band 39,750.009,750.000.00%Band 413,000.0013,000.000.00%For all evaluations12Meeting before the submission of an application in support of new active substance, safener or synergist, biocontrol and pheromone applications0.005,000.00New item3. Fees for official recognition of a test facility or organisationInitial official recognition of the test facility1,500.002,000.0033.33%Renewal of an official recognition1,500.002,000.0033.33%Each re-inspection1,125.001,500.0033.33%4. Basic substance applications1Assistance with a full data package0.00110,000.00New item2Assistance with a partial data package:Band 10.007,500.00New itemBand 20.0015,000.00New itemBand 30.0030,000.00New itemBand 40.0050,000.00New itemBand 50.0070,000.00New itemBand 60.0090,000.00New itemBand 70.00110,000.00New itemSchedule 2Import tolerance fee1Full human health evaluation15,600.0015,600.000.00%2Metabolism and residues evaluation6,500.006,500.000.00%3Residues evaluation1,950.001,950.000.00%

Footnotes

[^f00001]: 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).

[^f00002]: S.I. 1972/1811.

[^f00003]: S.I. 1999/2027.

[^f00004]: S.I. 2008/301.

[^f00005]: 1973 c. 51.

[^f00010]: S.I. 2007/295.

[^f00011]: S.R.(NI) 2004 No 372.

[^f00012]: 1985 c.48.

[^f00013]: S.I. 2005/117.

[^f00014]: S.I. 2005/1811.

Notes

• (1) This category is mainly for plant protection products not currently authorised in any Member State. In certain cases, it may also include plant protection products still being reviewed if toxicological endpoints have not yet been agreed at a European level.

• (2) This category is for plant protection products where toxicological endpoints have already been agreed at a European level, but the residue definition has only been established for crop groups unrelated to the intended use or imported produce.

• (3) This category is for plant protection products where relevant toxicological endpoints and residue definition have already been agreed at European level.

Editorial notes

[^key-40e3c080511dc5c65967741068930626]: 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)

[^key-3fa728799aa84e27edbba0aac0c7db50]: Sch. 2 substituted (6.4.2016) by The Plant Protection Products (Fees and Charges) (Amendment) Regulations 2016 (S.I. 2016/254), regs. 1, 2(3)

[^key-e77c3f5166bca017f6d2b6ec3b44cd30]: Reg. 8(3A)-(3C) inserted (1.3.2019) by The Pesticides and Fertilisers (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/306), regs. 1(3), 7(3)(b)

[^key-a07f2949b6e02a1c63e211017a046809]: Words in reg. 8(3) substituted (1.3.2019) by The Pesticides and Fertilisers (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/306), regs. 1(3), 7(3)(a)

[^key-61e8a1c8f2199549fce8b2306f2a8466]: Words in reg. 2(1) substituted (1.3.2019) by The Pesticides and Fertilisers (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/306), regs. 1(3), 7(2) (with reg. 8)

[^key-1585cf85fc7f544d9d6b294afc980c16]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(2A) (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. 5(2))

[^key-d5d656bca7074e9b8a56d82488bbb680]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(2B) (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. 5(2))

[^key-22c6bbcdf4c0b2e1f34a783daa3158c4]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(3) (as substituted 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. 5(3)

[^key-0b49115c767fd88876de320cb372361e]: Words in reg. 2(1) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(3A) (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. 5(4))

[^key-ea2084a2fb98c820fce40bb5a7f0df63]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, reg. 1(2), Sch. 1 para. 8(4) (as amended 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. 5(5)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d98f5db5d59f7ad934206f830d4e5bb8]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(4A) (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. 5(6))

[^key-8f8ee68cba702ed4dded9a0c43c0aac5]: Words in reg. 2(1) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 8(4B) (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. 5(6))

[^key-33eb3c3923d397a8cb31e21687cc095d]: Words in reg. 2(1) inserted (31.12.2020) by S.I. 2019/720, reg. 1(2), Sch. 1 para. 8(5) (as amended 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. 5(7)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-acc8778b7a15d1719e3f47382f5710c4]: Words in reg. 2(1) 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. 8(2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-14854830192a7dda66d0903e71346584]: Reg. 3 heading substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 9(a) (as substituted 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. 6)

[^key-7ec714a67123530ff9d76eb3a0a24558]: Words in reg. 3(1) omitted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 9(b)(i) (as substituted 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. 6)

[^key-9caa29f0d9ac09cc42d26b81a5faee33]: Words in reg. 3(1) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 9(b)(ii) (as substituted 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. 6)

[^key-c1937d7c9095bb1d6bfb484cc7ce324d]: Reg. 3(2) omitted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 9(c) (as substituted 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. 6)

[^key-4012849de0d5b124c75a63397ee097d7]: Reg. 4(1)(b) omitted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(a)(i) (as substituted 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. 7)

[^key-8a068c8c84d14d8277fbba8a0ec7012c]: Words in reg. 4(1) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(a)(ii) (as substituted 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. 7)

[^key-d196d0bd5d42d6dc976d0d6111ee15b7]: Reg. 4(1A)(1B) inserted by S.I. 2019/720, Sch. 1 para. 10(b) (as substituted 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. 7)

[^key-6a09a8db8ff6da7f7fdb578b9b95f449]: Words in reg. 4(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(c)(i) (as substituted 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. 7)

[^key-3f2d2a8782820463bc5cc0280e4eed9c]: Words in reg. 4(2) inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(c)(ii) (as substituted 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. 7)

[^key-5bc31d004481204438f2edba4a36464c]: Reg. 4(2A) inserted by S.I. 2019/720, Sch. 1 para. 10(d) (as substituted 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. 7)

[^key-208765025ff402d26ce3a29e85dd699c]: Words in reg. 4(4) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(e) (as substituted 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. 7)

[^key-250f3e79c00e73dabe865e653cd1cdac]: Words in reg. 4(5) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(f) (as substituted 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. 7)

[^key-c904725c1debdeae2c3179809822614f]: Words in reg. 4(7) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 10(g) (as substituted 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. 7)

[^key-e9230b36c3207d2246a6db98092a02fc]: Reg. 6 heading substituted (31.12.2020) by 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. 11(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4c0f8971603de8244e79d00bd1347647]: Words in reg. 6 substituted (31.12.2020) by 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. 11(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3baa6b86f1074042973ce3f784e8c000]: Word in reg. 7(2) 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. 12(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5ae6a8b2a5a41c30c09a6c1b872342ee]: Words in reg. 7(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 12(aa) (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. 8)

[^key-f410745d6f02513a761f9225e04fca83]: Words in reg. 7(2) inserted (31.12.2020) by 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. 12(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b6f45f2984ed4bf79b73aba78bc59d3f]: Words in reg. 8(6) substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 13 (as substituted 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. 9)

[^key-bd347985c99a97592a779194b4b9ea73]: Words 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))

[^key-5a5385240a41e8b84b6be80a8e776acd]: Word 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)

[^key-2e54b199033f261b26e5c57bad7a9364]: Sch. 1 para. 1 Table Item 5-5b 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)(ii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-67c7c2364a01ff85977d2fe6eb34cf50]: Words in Sch. 1 para. 1 Table Item 11 substituted (31.12.2020) by 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)(iii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7ef926f5bc771298b7cda3bc35555b1f]: Words in Sch. 1 para. 1 Table Item 12 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)(iv) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-866171aee9739cd450a49251d162b0d1]: Sch. 1 para. 1 Notes 3, 5, 6 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)(c)(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)

[^key-517b6fb760e8cdbde0125d6781682e55]: Words in Sch. 1 para. 1 Note 7 substituted (31.12.2020) by 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)(c)(ii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-34765baaeee87451a9b967b0518acb8c]: Words in Sch. 1 para. 1 Note 16 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)(c)(iii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cc1d44ecc59b2b591eeb3c5492db766f]: Sch. 1 para. 1 Note 17 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)(c)(iv) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9080d3594e0ce7c5c15b6bc5b4323d08]: Words in Sch. 1 para. 1 Note 18 substituted (31.12.2020) by 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)(c)(v) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 10(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_9fa09936-c6a6-49b7-a9ce-adbee7144a0c]: Sch. 1 para. 1A inserted (31.12.2020) by S.I. 2019/720, Sch. 01 para. 014(02A) (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(3))

[^key-5c5408670dc3749309ddedb2983636e4]: Words in Sch. 1 para. 2 heading substituted (31.12.2020) by 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(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d866907334e288fec83d063c4456ed0d]: Words in Sch. 1 para. 2 inserted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 14(3)(b)(i) (as substituted 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(4))

[^key-429c57007e3abaf61bc0135d20c225f3]: Words in Sch. 1 para. 2 substituted (31.12.2020) by S.I. 2019/720, Sch. 1 para. 14(3)(b)(ii) (as substituted 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(4))

[^key-25d85a53748e5d080d08643c7ed5d3b1]: Words in Sch. 1 para. 2 Table heading substituted (31.12.2020) by 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(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f1ba22baaa874d71f95f9d43e5522271]: Sch. 1 para. 2 Table Item 2 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(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)