The Plant Protection Products (Fees) Regulations 2007

Inclusion in Annex I to Council Directive 91/414/EEC, or the first approval in the United Kingdom for a product with a new active substance

4.—(1) The fee for inclusion in Annex I to Council Directive 91/414/EEC (concerning the placing of plant protection products on the market(1)), or the first approval in the United Kingdom for a product containing a new active substance, is in accordance with the following table.

(2) In this paragraph, “new active substance” means an active substance not previously used in a product approved in the United Kingdom.

Applications to include a substance in Annex I to Council Directive 91/414/EEC, or the first approval in the United Kingdom of a product containing a new active substance ⁽¹⁾

Item	Application	Fee(£)
Notes
(1) Application under regulation 4 or 7 of the 2005 Regulations excepting a subsequent application (i.e. an application under regulation 7 for approval of a product containing an active substance where there is already an approval for a product containing that active substance and the applicant has access to the data relating to the active substance in the approved product).
(2) The initial evaluation carried out in order to notify the applicant whether his application can proceed further.
(3) A full data package comprises the complete dossier called for by Annex II and Annex III to Council Directive 91/414/EEC to support one major representative use of one product. 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 then these studies will be treated as an additional partial data package. See also note (4).
(4) The size of a partial data package is expressed as a percentage of a full data package. The percentage is estimated on the basis of the amount of time required to evaluate the data and to conduct the necessary risk assessments. The following are partial data packages— (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) resubmissions i.e. where the previous application for approval or inclusion in Annex 1 to Directive 91/414/EEC has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission; (d) data to support the extension of the inclusion of an active substance in Annex 1 to Directive 91/414/EEC once the initial inclusion period of 10 years has expired or to change the conditions of Annex I inclusion during the inclusion period; (e) data to support the evaluation of an active substance under the EC Regulation expected to replace Directive 91/414/EEC once the initial period of inclusion in Annex 1 of Directive 91/414/EEC has expired i.e. with no full dossier, just additional data to fill new guidance, regulations and scientific advances; (f) joint evaluation where the Pesticides Safety Directorate will evaluate part of a core dossier and the remainder of the dossier is evaluated by the competent authorities of one or more other member States.
	Where an active substance is neither a biocontrol agent nor a pheromone
1	Preliminary evaluation(2) of an application	5,000
2	Processing an application for provisional approval	35,000
3	Processing an application for the inclusion of an active substance in Annex I to Directive 91/414	35,000
4	Evaluation of a full data package(3)	105,000
5	Evaluation of a partial data package(4): percentage of data provided—
5a	<5%	15,000
5b	≥5% and <10 %	30,000
5c	≥10% and <25%	40,000
5d	≥25% and <50%	60,000
5e	≥50% and <75%	80,000
5f	≥75%	105,000
	Where an active substance is a biocontrol agent
6	Evaluation of a full data package and processing an application for provisional approval(3)	22,500
7	Processing an application for the inclusion of an active substance in Annex I	7,500
8	Evaluation of a partial data package: percentage of data provided(4)
8a	<25%	5,500
8b	≥25% and <50%	11,250
8c	≥50% and <75%	17,000
8d	≥75%	22,500
	Where an active substance is a pheromone
9	Evaluation of a full data package and processing an application for provisional approval (3)	13,000
10	Processing an application for the inclusion of an active substance in Annex I	7,500
11	Evaluation of a partial data package: percentage of data provided (4)
11a	<25%	3,250
11b	≥25% and <50%	6,500
11c	≥50% and <75%	9,750
11d	≥75%	13,000

(1)

OJ No. L230, 19.8.1991, p. 1 as last amended by Commission Directive No. 2006/136/EC, OJ No. L349, 12.12.2006, p. 42.