The Plant Protection Products (Fees) Regulations 2003

Made: 10th March 2003

Laid before Parliament: 11th March 2003

Coming into force: 1st April 2003

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Title, commencement, extent and interpretation

1

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Fees in connection with applications under the Plant Protection Products Regulations 1995

2

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Transitional provisions

3

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Revocation of previous Regulations

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SCHEDULE — Table of amounts payable for types of examination undertaken

A

B

C

Signed

Whitty — Parliamentary Under-Secretary, — Department for Environment, Food and Rural Affairs — 2003-03-10

Explanatory note

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Footnotes

[^f00001]: S.I. 1972/1811.

[^f00002]: 1972 c. 68.

[^f00003]: OJ No. L230, 19.8.91 p.1 (as read with corrigenda published in OJ No. L170, 25.6.92, p.40).

[^f00004]: The final amending instrument listed is Commission Directive 2002/81/EC (OJ No. L276, 12.10.02, p.28)

[^f00005]: S.I. 1995/887 as amended by S.I. 1997/7, 1997/2499, 1999/3430, and as regards England and Wales, by S.I. 2002/2874. As regards Scotland S.I. 1995/887 has also been amended by S.S.I. 2001/161, 2001/454, 2002/117, 2002/279 and 2002/537 and, as provided for in regulation 25A, arrangements have been entered into for functions to be exercised as regards Scotland, and for fees to be collected, by the Secretary of State.

[^f00006]: S.I. 2001/2477 as amended by S.I. 2001/3898 and 2002/2733.

[^f00007]: S.I. 2002/2733.

[^f00008]: S.I. 2001/3898.

[^f00009]: S.I. 1986/1510 as amended by S.I. 1990/2487, S.I. 1994/3142 and S.I. 1997/188.

A

B

C

Notes (numbered)

1

Approval/extension applications comprise all cases not covered by item B or item C.

2

A Preliminary examination is the initial examination needed (in relation to applications other than Administrative Experimental applications and Off-label applications) in order to notify an applicant whether his application can proceed further.

3

An Administrative Experimental application is an application which would be an Experimental application but for the fact that it does not call for examination of data or of technical information.

4

An Administrative application is—

• (a) an application (other than an Administrative Experimental application) to make a change to an existing approval of a type which does not call for examination of data, label checking or detailed examination of technical information, or

• (b) an application by a prospective importer for approval of a product to be imported for personal use.

5

A Fast application is an application under regulation 5 (standard approvals), a subsequent application under regulation 7 (provisional approvals), or an application for a modification of either such approval under regulation 13(7)(b), of the 1995 Regulations of a type which calls for technical consideration or label checking, but not significant data examination. A subsequent application is an application under regulation 7 where there is already an approval for a product containing the active substance covered by the application and the applicant has access to data relating to the active substance covered by the approval in question.

6

A Parallel Import application is an application by a prospective importer for approval of a product to be imported for commercial use where the approval applied for relates to a product which is materially identical to a product identified in the application and already approved in the UK under the Control of Pesticides Regulations 1986 or the 1995 Regulations.

7

A Mutual Recognition application is an application under regulation 11 (mutual recognition of approvals), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations.

8

An Experimental application is an application under regulation 9 (approvals for research and development), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations which is not a Departmental application but which requires examination of data or technical information.

9

An Off-label application is an application for extension of an approved use under regulation 10, or for modification of such an extension under regulation 13(7)(b), of the 1995 Regulations of a type which calls for examination of data or detailed examination of technical information but is not a Departmental application.

10

A Normal application is—

• (a) an application under regulation 8 (emergency approvals), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations, or

• (b) an application under regulation 5 (standard approvals), a subsequent application (as described in Note 5) under regulation 7 (provisional approvals), or an application for modification of either such approval under regulation 13(7)(b), of the 1995 Regulations of a type which calls for significant data examination,

that is not a Departmental application.

11

A Departmental application is an application under regulation 5, 8, 9 or 10 or a subsequent application (as described in Note 5) under regulation 7, of the 1995 Regulations of a type which calls for evaluation of data supplied by the applicant and referred to Government Departments other than the relevant authority.

12

A routine additional matter is a product or use change covered in the same application as a different product or different use change that calls for no additional examination.

13

Further examination is an examination in any case where the application is of a type which calls for examination by an expert on a matter covered by item A(4).

14

Product/active chemistry data are data to enable assessment of the technical specification of the active substance and the physico-chemical properties of the product.

15

Crop safety data are data supplied to show that the product does not adversely affect the treated crops, following crops or treated produce. The check is a minor one if only one aspect of crop safety is required to be addressed and it is required to confirm a finding deduced from other data, and otherwise it is a major one.

16

Parallel import verification is verification that a product to be imported is materially identical with a product approved under regulation 5 (standard approvals) or under regulation 7 (provisional approvals) of the 1995 Regulations.

17

This applies where a reasoned case for technical or scientific justification for an approval or a change to the conditions of an approval is provided instead of data for consideration of matters covered by item A (4) (a) (v).

18

Toxicology data are data used to assess the mammalian metabolism and toxicology of the active substance in the product and to determine the types of hazard to which the product can give rise.

19

Operator exposure additionally covers exposure of other persons resulting from the product use.

20

Residues/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.

21

Fate and behaviour in the environment covers the potential environmental exposure from product use, including the identity and quantity of active substance, metabolites, degradation products and reaction products which may be available in the soil, water or air and are of toxicological or environmental significance.

22

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.

23

Effectiveness data are data (other than crop safety data) supplied to show that a product consistently controls the target pest.

24

Annex I application cases cover applications under regulation 4 (applications concerning active substances) or 7 (provisional approvals) of the 1995 Regulations with the exception of a subsequent application (as described in Note 5).

25

A full data package comprises the total dossier called for by Annex II, Annex III, or both, to the 1991 Directive, and percentages of it are based on the value of expert time called for in assessing a resubmitted application.

26

A resubmitted application is one where a previous application for approval has been unsuccessful, and a new application is made in an attempt to address all the concerns raised from that earlier application.

27

Annex III to the 1991 Directive requires that the tests and analyses of the efficacy data be conducted only by officially recognised testing facilities or organisations which are found to satisfy the requirements of the Directive following evaluation of their application and inspection of their facilities.

Notes (lettered)

A

If an application which falls entirely within this description could also fall within a description of another description of application, the fee payable remains the fee for this description of application.

B

If the application is withdrawn after preliminary examination but before further activity in relation to the item starts, a fee of £100 is payable for processing the withdrawal.

C

For any examination in a Departmental application in addition to the item fee, an additional fee £1,475 for each such matter is charged.

D

Where further information is submitted in response to requests made by the Commission pursuant to Article 6 (4) of the 1991 Directive and the further information is required to be examined and evaluated in order to determine whether an active substance can be added to Annex I to that Directive, then an additional fee under item B (3), based on the size of the data package contained within that information, will become payable as if submission of that information were a resubmitted application.

E

If the application is withdrawn after preliminary examination but before processing and evaluation, the fee in respect of the item is £5,000.

F

The fee is payable where a person responsible for applying to another Member State for evaluation of a new active substance for inclusion in Annex I to the 1991 Directive requests the relevant authority to assist the other Member State with evaluation and scientific review.

Editorial notes

[^key-23fe6b57829c0f368d85930ad09ebeb5]: Regulations revoked (1.3.2007) by The Plant Protection Products (Fees) Regulations 2007 (S.I. 2007/295), regs. 1, 4(b)

3A

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