Na Podlagi Sedmega Odstavka 21
(UL RS 5/15; p.342)
ANNEX 2
Fees in accordance with Article 74 of Regulation (EC) 1107/2009
I.Costs associated with inclusion and renewal of inclusion of an active substance onto the list of approved active substances when the Republic of Slovenia act asa rapporteur Member State(when the Republic of Slovenia act as co-rapporteur MS the costs amount to 30% of the value).
1. Inclusion of an active substance onto the list of approved active substances in accordance with Articles 7, 8, 9, 10, 11 and 38 of Regulation (EC) 1107/2009 / EURchecking the completeness of dossier / 3,000.00
assessment of equivalence / 5,000.00
assessment of physical-chemical properties and analytical methods / 8,810.00
assessment of toxicological studies and metabolism studies / 18,810.00
assessment of residues in or on food and feed / 10,810.00
assessment of fate and behaviour in the environment / 18,810.00
assessment of ecotoxicological studies / 18,810.00
assessment of efficacy data / 10,810.00
elaboration of a draft assessment report / 3,000.00
TOTAL / 97,860.00
2. Renewal of inclusion of an active substance in the list of approved active substances in accordance with Articles 15, 16, 17 and 38 of Regulation (EC) 1107/2009[1] / EUR
checking the completeness of dossier / 3,000.00
assessment of equivalence / 5,000.00
assessment of physical-chemical properties and analytical methods / 8,810.00
assessment of toxicological studies and metabolism studies / 18,810.00
assessment of residues in or on food and feed / 10,810.00
assessment of fate and behaviour in the environment / 18,810.00
assessment of ecotoxicological studies / 18,810.00
assessment of efficacy data / 10,810.00
elaboration of a draft assessment report / 3,000.00
TOTAL / 97,860.00
II.Costs associated with the authorisation of PPPs in zones when the Republic of Slovenia act as a zonal rapporteur Member State
1. Authorisation, renewal and amendment of the authorisations of PPPs with one active substance[2]and 4in accordance with Articles 28, 29, 30, 33, 34, 35, 36, 37 and 43 of Regulation (EC) 1107/2009 / EURchecking the completeness of dossier / 2,744.00
assessment of physical-chemical properties and analytical methods / 2,000.00
assessment of toxicological studies and metabolism studies / 3,160.00
assessment of residues in or on food and feed / 2,439.00
assessment of fate and behaviour in the environment / 2,439.00
assessment of ecotoxicological studies / 2,996.00
assessment of efficacy data[3] / 2,439.00
elaboration of draft assessment report / 2,000.00
adjustment of the draft label with instructions for use / 300.00
TOTAL / 20,517.00
2. Checking the compliance of the dossier with the requirements of Article 59 of Regulation (EC) 1107/2009 concerning data protection / EUR
checking the compliance of the dossier / 3,000.00
comparison of every individual study / 300.00
III.Costs associated with authorisationsand renewal of authorisations in the case of Slovenia being a Member State concerned; with mutual recognition of authorisations of PPPs and amendment of authorisations in the Republic of Slovenia
1. Authorisations and renewal of authorisations when Slovenia is a MS concerned in accordance with Articles 28, 29, 30, 33, 34, 35, 36, 37 and 43; mutual recognition of authorisations in accordance with Articles 40, 41 and 42 of Regulation (EC) 1107/20092 / EURchecking the completeness of dossier / 300.00
assessment of physical-chemical properties and analytical methods / 300.00
assessment of toxicological studies and metabolism studies / 450.00
assessment of residues in or on food and feed / 250.00
assessment of fate and behaviour in the environment / 450.00
assessment of ecotoxicological studies / 600.00
assessment of efficacy data / 600.00
adjustment of the draft label / 300.00
TOTAL / 3,250.00
2. Amendment of authorisations of PPPs in accordance with Articles 44 and 45 of Regulation (EC) 1107/2009[4][i]and 2 / EUR
checking the completeness of dossier / 300.00
assessment of physical-chemical properties and analytical methods / 300.00
assessment of toxicological studies and metabolism studies / 450.00
assessment of residues in or on food and feed / 350.00
assessment of fate and behaviour in the environment / 450.00
assessment of ecotoxicological studies / 600.00
assessment of efficacy data / 500.00
adjustment of the draft label / 300.00
TOTAL / 3,250.00
3. Mutual recognition of authorisations of PPPs of low risk in accordance with Articles 40, 41, 42 and 47 of Regulation (EC) 1107/2009 / EUR
checking of the completeness and suitability of the documentation and evaluations / 700.00
adjustment of the draft label / 300.00
TOTAL / 1,000.00
IV.Costs associated with comparative assessment of PPPs containing a candidate for substitution
Costs associated with the comparative assessment of PPPs containing a candidate for substitution in accordance with Article 50 of Regulation (EC) 1107/2009 / EURcomparative assessment (costs up to 3,000.00 € depending on the volume of work) / 3,000.00
V. Costs associated with extension of authorisation of PPPs for minor uses
1. Extension of authorisation of PPPs for minor uses in accordance with Article 51 of Regulation (EC) 1107/2009[5] / EURchecking the completeness of dossier / 100.00
assessment of toxicological studies and metabolism studies / 150.00
assessment of residues in or on food and feed / 250.00
assessment of fate and behaviour in the environment / 100.00
assessment of ecotoxicological studies / 100.00
adjustment of the draft label / 100.00
TOTAL / 800.00
VI.Costs associated with PPP permits
1. Parallel trade permit in accordance with Article 52 of Regulation (EC) 1107/2009 / EURexamination of application and identity assessment / 200.00
2. Permit for emergency situations in accordance with Article 53 of Regulation (EC) 1107/2009 / EUR
examination of application and risk assessment to human health and the environment / 700.00
3. Permit for research and development in accordance with Article 54 of Regulation (EC) 1107/2009 / EUR
examination of application / 100.00
VII. Costs associated with procedures for establishment of maximum pesticide residue levels if they are not included into evaluation procedures of active substances
Costs associated with procedures for establishment of maximum pesticide residue levels if they are not included into evaluation procedures of active substances; in accordance with Article 4 of Regulation (EC) 1107/2009 / EURchecking the completeness of dossier / 300.00
assessment of residues for substances not approved in EU / 5,000.00
assessment of residues for new GAPs / 2,439.00
the proposal for MRL for a commodity and consumer risk assessment / 1,000.00
TOTAL / 8,739.00
1
[1]The costs associated with the renewal of inclusion of active substance may be, considering the lover volume of work, reduced by maximum 30% of the basic price.
[2]The costs associated with the authorisation of PPPs with two or more active substances may be, considering the larger volume of work, increased proportionally; however, they must not exceed 50% of the basic price.
[3] The costs associated with authorisation s of PPPs with five or more uses may be increased proportionally considering larger volume of work; however, they must not exceed 50% of the basic price
[4]In the case of amendment of authorisations of PPPs a fee shall be paid only for the procedures essential to the required amendment of the authorisation of the PPP.
[5] In the case of extended authorisations of PPPs for minor uses, fee shall be paid only for the procedures essential to the required extension of the authorisation of the PPP.