Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013 amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)  Text with EEA relevance
Date: 2013-03-20
Institutions: European Commission
Subjects: European Chemicals Agency, access to information, market approval, payment




L_2013079EN.01000701.xml










21.3.2013   


EN


Official Journal of the European Union


L 79/7








            COMMISSION IMPLEMENTING REGULATION (EU) No 254/2013
of 20 March 2013
         
amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 74(1) and Article 132 thereof,

Whereas:







(1)


From the review of Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (2), conducted pursuant to Article 22(2) of that Regulation, it results that that Regulation should be amended in various respects.












(2)


For reasons of legal certainty, it is appropriate to clarify the consequences of late payments to the Agency. The Agency should not refund fees or charges paid before the rejection of the submission concerned. However, fees or charges paid after such rejection should be refunded as undue payments.












(3)


With respect to updates of a registration concerning confidentiality claims, it is appropriate that fees should be applied consistently regardless of when the request is made. With respect to updates of a registration other than tonnage band updates, it is appropriate to provide for the possibility for the registrant to request an extension of the second deadline for payment of the corresponding fee in order to give additional time to the registrant to make the payment.












(4)


For reasons of legal certainty, it is also appropriate to clarify the existing provisions on reduced fees for confidentiality claims in joint submissions or by lead registrants.












(5)


With respect to fees for applications under Article 62 of Regulation (EC) No 1907/2006 and charges for reviews of authorisations under Article 61 of that Regulation, each exposure scenario should no longer automatically be considered as one use since the number of additional uses applied for in an authorisation application or authorisation review report may not necessarily be identical to the number of exposure scenarios included in those submissions.












(6)


It should also be clarified that the Agency should issue one invoice covering the base fee or charge and all additional fees or charges, including in cases of joint authorisation applications and joint review reports.












(7)


The Agency may request evidence that the conditions for a reduction of fees or charges or for a fee waiver apply. In order to be able to verify that those conditions are met, it is necessary to require the submission of such evidence in one of the official languages of the Union or, if it is available only in another language, with a certified translation into one of the official languages of the Union.












(8)


It is also appropriate, following the review of the fees and charges, in line with Article 22(1) of Regulation (EC) No 340/2008, in the light of the applicable average annual inflation rate of 3,1 % for April 2012 published by Eurostat, to adapt the standard fees and charges in line with that rate.












(9)


The existing reduced fees and charges applicable to micro, small and medium-sized enterprises (SMEs) should be further reduced in order to minimise the regulatory burden and the numerous practical challenges faced by SMEs in complying with REACH obligations, in particular with the registration obligation, as identified in the Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions in accordance with Article 117(4) of REACH and Article 46(2) of CLP, and a review of certain elements of REACH in line with Articles 75(2), 138(2), 138(3) and 138(6) of REACH (3).












(10)


In order to rebalance the distribution of fees and charges across various company size classes, the standard fees and charges should be further increased by 4 % in the registration area and by 3,5 % in the authorisation area taking into account, on the one hand, the costs of the Agency and the related costs of the services provided by the competent authorities of the Member States, and, on the other hand, the further reduction of fees and charges for SMEs and the number of SMEs involved.












(11)


The overall adjustment of fees and charges is fixed at such a level that the revenue derived from them when combined with other sources of the Agency's revenue pursuant to Article 96(1) of Regulation (EC) No 1907/2006 is sufficient to cover the cost of the services delivered.












(12)


Regulation (EC) No 340/2008 should therefore be amended accordingly.












(13)


For reasons of legal certainty, this Regulation should not apply to valid submissions which are pending on the date of entry into force of this Regulation.












(14)


Given that the phase-in substances referred to in Article 23(2) of Regulation (EC) No 1907/2006 must be registered by 31 May 2013, this Regulation should enter into force as a matter of urgency.












(15)


The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,





HAS ADOPTED THIS REGULATION:



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






(1)


In Article 3, paragraph 7 is replaced by the following:

‘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:

‘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:

‘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:

‘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:

‘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:

‘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
            





(1)  
            OJ L 396, 30.12.2006, p. 1.

(2)  
            OJ L 107, 17.4.2008, p. 6.

(3)  COM(2013) 49 final, SWD(2013) 25 final




ANNEX



‘ANNEX I

Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006


Table 1


Standard fees








 


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 








Table 2


Reduced fees for SMEs












 


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

Fees for registrations submitted under Article 17(2), Article 18(2) and (3) or Article 19 of Regulation (EC) No 1907/2006


Table 1


Standard fees








 


Individual submission


Joint submission




Fee


EUR 1 714 


EUR 1 285 








Table 2


Reduced fees for SMEs












 


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

Fees for the update of registrations under Article 22 of Regulation (EC) No 1907/2006


Table 1


Standard fees for the update of the tonnage range








 


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 








Table 2


Reduced fees for SMEs for the update of the tonnage range












 


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 








Table 3


Fees for other updates









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 








Table 4


Reduced fees for SMEs for other updates













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

Fees for requests under point (xi) of Article 10(a) of Regulation (EC) No 1907/2006


Table 1


Standard fees








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 








Table 2


Reduced fees for SMEs












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

Fees and charges for PPORD notifications under Article 9 of Regulation (EC) No 1907/2006


Table 1


Fees for PPORD notifications







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 








Table 2


Charges for the extension of a PPORD exemption







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

Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006


Table 1


Standard fees







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 








Table 2


Reduced fees for medium enterprises







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 








Table 3


Reduced fees for small enterprises







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 








Table 4


Reduced fees for micro enterprises







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

Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006


Table 1


Standard charges







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 








Table 2


Reduced charges for medium enterprises







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 








Table 3


Reduced charges for small enterprises







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 








Table 4


Reduced charges for micro enterprises







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

Fees for appeals under Article 92 of Regulation (EC) NO 1907/2006


Table 1


Standard fees







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 








Table 2


Reduced fees for SMEs







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 





’