Paragraph 1 Fees for application and evaluation of a plant protection product for authorisationF1

Application for authorisation under Regulation 1107/2009 not involving evaluation of technical information or data.

Application for authorisation under Regulation 1107/2009 involving no technical consideration.

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

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“Standard technical stream applications” are all applications other than F8items 1-4, 10 and 11.

The co-ordination of applications for new products or a change to an existing product.

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.

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.

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

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.

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.

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.

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.

Pre-submission meetings may be held at the request of the applicant prior to the submission of an application F9....

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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.