
Article 1 
Regulation (EC) No 340/2008 is amended as follows:

((1)) In Article 3, paragraph 7 is replaced by the following:
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7. Where the registration has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that registration before its rejection shall not be refunded or otherwise credited to the registrant.'
((2)) In Article 4, paragraph 7 is replaced by the following:
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7. Where the registration has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that registration before its rejection shall not be refunded or otherwise credited to the registrant.'
((3)) Article 5 is amended as follows:

((a)) In paragraph 2, the following subparagraphs are inserted after the second subparagraph:
'For change in the access granted to information in the registration, the Agency shall levy a fee per item for which an update is made, as set out in Tables 3 and 4 of Annex III.In the case of an update concerning study summaries or robust study summaries, the Agency shall levy a fee for each study summary or robust study summary for which the update is made.'
((b)) In paragraph 6, the third subparagraph is replaced by the following:
'Where the payment is not made before the expiry of the second deadline, in the case of other updates, the Agency shall reject the update. Where the applicant so requests, the Agency shall extend the second deadline provided that the request for extension has been submitted before the expiry of the second deadline. Where the payment is not made before the expiry of the extended deadline, the Agency shall reject the update'.
((c)) Paragraph 7 is replaced by the following:
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7. Where the update has been rejected due to the failure of the registrant to submit missing information or due to his failure to pay the fee before expiry of the deadlines, the fees paid in relation to that update before its rejection shall not be refunded or otherwise credited to the registrant.'
((4)) In Article 6, paragraph 3 is replaced by the following:
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3. In the case of a request that refers to a joint submission, the Agency shall levy a reduced fee, as set out in Annex IV. In the case of a request by the lead registrant, the Agency shall levy a reduced fee to the lead registrant only, as set out in Annex IV.'
((5)) In Article 7, paragraph 5 is replaced by the following:
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5. Where a notification or the request for an extension has been rejected due to the failure of the manufacturer, importer, or producer of articles to submit missing information or due to his failure to pay the fee or charges before expiry of the deadlines, the fees or charges paid in relation to that notification or that request for an extension before their respective rejection shall not be refunded or otherwise credited to the person making the notification or the request.'
((6)) In Article 8, the third subparagraph of paragraph 2 is replaced by the following:
'The Agency shall issue one invoice covering the base fee and any applicable additional fees, including in the case of a joint authorisation application.'
((7)) In Article 9, the third subparagraph of paragraph 2 is replaced by the following:
'The Agency shall issue one invoice covering the base charge and any applicable additional charges, including in the case of a joint review report.'
((8)) In Article 13(3), the following subparagraph is inserted after the first subparagraph:
'Where the evidence to be submitted to the Agency is not in one of the official languages of the Union, it shall be accompanied with a certified translation into any of those official languages.'
((9)) In Article 22, paragraph 2 is replaced by the following:
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2. The Commission shall also keep this Regulation under continual review in the light of significant information becoming available in relation to underlying assumptions for anticipated income and expenditure of the Agency. By 31 January 2015, the Commission shall review this Regulation with a view to amend it, if appropriate, taking into account in particular the costs of the Agency and the related costs of the services provided by the competent authorities of the Member States.'
((10)) Annexes I to VIII to Regulation (EC) No 340/2008 are replaced by the text set out in the Annex to this Regulation.
Article 2 
This Regulation shall not apply to valid submissions pending on 22 March 2013.
Article 3 
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 20 March 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX


ANNEX I 
 Individual submission Joint submission
Fee for substances in the range of 1 to 10 tonnes EUR 1 714 EUR 1 285
Fee for substances in the range 10 to 100 tonnes EUR 4 605 EUR 3 454
Fee for substances in the range 100 to 1 000 tonnes EUR 12 317 EUR 9 237
Fee for substances above 1 000 tonnes EUR 33 201 EUR 24 901
 Medium enterprise(Individual submission) Medium enterprise(Joint submission) Small enterprise(Individual submission) Small enterprise(Joint submission) Micro enterprise(Individual submission) Micro enterprise(Joint submission)
Fee for substances in the range of 1 to 10 tonnes EUR 1 114 EUR 835 EUR 600 EUR 450 EUR 86 EUR 64
Fee for substances in the range 10 to 100 tonnes EUR 2 993 EUR 2 245 EUR 1 612 EUR 1 209 EUR 230 EUR 173
Fee for substances in the range 100 to 1 000 tonnes EUR 8 006 EUR 6 004 EUR 4 311 EUR 3 233 EUR 616 EUR 462
Fee for substances above 1 000 tonnes EUR 21 581 EUR 16 185 EUR 11 620 EUR 8 715 EUR 1 660 EUR 1 245
ANNEX II 
 Individual submission Joint submission
Fee EUR 1 714 EUR 1 285
 Medium enterprise(Individual submission) Medium enterprise(Joint submission) Small enterprise(Individual submission) Small enterprise(Joint submission) Micro enterprise(Individual submission) Micro enterprise(Joint submission)
Fee EUR 1 114 EUR 835 EUR 600 EUR 450 EUR 86 EUR 64
ANNEX III 
 Individual submission Joint submission
From 1-10 tonnes range to 10-100 tonnes range EUR 2 892 EUR 2 169
From 1-10 tonnes range to 100-1 000 tonnes range EUR 10 603 EUR 7 952
From 1-10 tonnes range to over 1 000 tonnes range EUR 31 487 EUR 23 616
From 10-100 tonnes range to 100-1 000 tonnes range EUR 7 711 EUR 5 783
From 10-100 tonnes range to over 1 000 tonnes range EUR 28 596 EUR 21 447
From 100-1 000 tonnes range to over 1 000 tonnes range EUR 20 885 EUR 15 663
 Medium enterprise(Individual submission) Medium enterprise(Joint submission) Small enterprise(Individual submission) Small enterprise(Joint submission) Micro enterprise(Individual submission) Micro enterprise(Joint submission)
From 1-10 tonnes range to 10-100 tonnes range EUR 1 880 EUR 1 410 EUR 1 012 EUR 759 EUR 145 EUR 108
From 1-10 tonnes range to 100-1 000 tonnes range EUR 6 892 EUR 5 169 EUR 3 711 EUR 2 783 EUR 530 EUR 398
From 1-10 tonnes range to over 1 000 tonnes range EUR 20 467 EUR 15 350 EUR 11 021 EUR 8 265 EUR 1 574 EUR 1 181
From 10-100 tonnes range to 100-1 000 tonnes range EUR 5 012 EUR 3 759 EUR 2 699 EUR 2 024 EUR 386 EUR 289
From 10-100 tonnes range to over 1 000 tonnes range EUR 18 587 EUR 13 940 EUR 10 008 EUR 7 506 EUR 1 430 EUR 1 072
From 100-1 000 tonnes range to over 1 000 tonnes range EUR 13 575 EUR 10 181 EUR 7 310 EUR 5 482 EUR 1 044 EUR 783
Type of update
Change in identity of the registrant involving a change in legal personality EUR 1 607
Type of update Individual submission Joint submission
Change in the access granted to information in the submission: Degree of purity and/or identity of impurities or additives EUR 4 820 EUR 3 615
Relevant tonnage band EUR 1 607 EUR 1 205
A study summary or a robust study summary EUR 4 820 EUR 3 615
Information in the safety data sheet EUR 3 213 EUR 2 410
Trade name of the substance EUR 1 607 EUR 1 205
IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1 607 EUR 1 205
IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development EUR 1 607 EUR 1 205
Type of update Medium enterprise Small enterprise Micro enterprise
Change in identity of the registrant involving a change in legal personality EUR 1 044 EUR 562 EUR 80
Type of update Medium enterprise(Individual submission) Medium enterprise(Joint submission) Small enterprise(Individual submission) Small enterprise(Joint submission) Micro enterprise(Individual submission) Micro enterprise(Joint submission)
Change in the access granted to information in the submission: Degree of purity and/or identity of impurities or additives EUR 3 133 EUR 2 350 EUR 1 687 EUR 1 265 EUR 241 EUR 181
Relevant tonnage band EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
A study summary or a robust study summary EUR 3 133 EUR 2 350 EUR 1 687 EUR 1 265 EUR 241 EUR 181
Information in the safety data sheet EUR 2 088 EUR 1 566 EUR 1 125 EUR 843 EUR 161 EUR 120
Trade name of the substance EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
ANNEX IV 
Item for which confidentiality is requested Individual submission Joint submission
Degree of purity and/or identity of impurities or additives EUR 4 820 EUR 3 615
Relevant tonnage band EUR 1 607 EUR 1 205
A study summary or a robust study summary EUR 4 820 EUR 3 615
Information in the safety data sheet EUR 3 213 EUR 2 410
Trade name of the substance EUR 1 607 EUR 1 205
IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1 607 EUR 1 205
IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development EUR 1 607 EUR 1 205
Item for which confidentiality is requested Medium enterprise(Individual submission) Medium enterprise(Joint submission) Small enterprise(Individual submission) Small enterprise(Joint submission) Micro enterprise(Individual submission) Micro enterprise(Joint submission)
Degree of purity and/or identity of impurities or additives EUR 3 133 EUR 2 350 EUR 1 687 EUR 1 265 EUR 241 EUR 181
Relevant tonnage band EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
A study summary or a robust study summary EUR 3 133 EUR 2 350 EUR 1 687 EUR 1 265 EUR 241 EUR 181
Information in the safety data sheet EUR 2 088 EUR 1 566 EUR 1 125 EUR 843 EUR 161 EUR 120
Trade name of the substance EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
IUPAC name for substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 used as intermediates, in scientific research and development or in product and process orientated research and development EUR 1 044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60
ANNEX V 
Standard fee EUR 536
Reduced fee for medium enterprise EUR 348
Reduced fee for small enterprise EUR 187
Reduced fee for micro enterprise EUR 27
Standard charge EUR 1 071
Reduced charge for medium enterprise EUR 696
Reduced charge for small enterprise EUR 375
Reduced charge for micro enterprise EUR 54
ANNEX VI 
Base fee EUR 53 300
Additional fee per substance EUR 10 660
Additional fee per use EUR 10 660
Additional fee per applicant Additional applicant is not an SME: EUR 39 975
Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base fee EUR 39 975
Additional fee per substance EUR 7 995
Additional fee per use EUR 7 995
Additional fee per applicant Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base fee EUR 23 985
Additional fee per substance EUR 4 797
Additional fee per use EUR 4 797
Additional fee per applicant Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base fee EUR 5 330
Additional fee per substance EUR 1 066
Additional fee per use EUR 1 066
Additional fee per applicant Additional applicant: EUR 3 998
ANNEX VII 
Base charge EUR 53 300
Additional charge per use EUR 10 660
Additional charge per substance EUR 10 660
Additional charge per applicant Additional applicant is not an SME: EUR 39 975
Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base charge EUR 39 975
Additional charge per use EUR 7 995
Additional charge per substance EUR 7 995
Additional charge per applicant Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base charge EUR 23 985
Additional charge per use EUR 4 797
Additional charge per substance EUR 4 797
Additional charge per applicant Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Base charge EUR 5 330
Additional charge per use EUR 1 066
Additional charge per substance EUR 1 066
Additional charge per applicant Additional applicant is a micro enterprise: EUR 3 998
ANNEX VIII 
Appeal against decision taken under: Fee
Article 9 or 20 of Regulation (EC) No 1907/2006 EUR 2 356
Article 27 or 30 of Regulation (EC) No 1907/2006 EUR 4 712
Article 51 of Regulation (EC) No 1907/2006 EUR 7 069
Appeal against decision taken under: Fee
Article 9 or 20 of Regulation (EC) No 1907/2006 EUR 1 767
Article 27 or 30 of Regulation (EC) No 1907/2006 EUR 3 534
Article 51 of Regulation (EC) No 1907/2006 EUR 5 301
