Address https://gelex.eu/eli/EU/regulation/2013/254@2013-03-20/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3
3. ANNEX
4. ANNEX
5. ANNEX I Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006 Table 1 Table 2 Standard fees Reduced fees for SMEs
6. 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 Table 2 Standard fees Reduced fees for SMEs
7. ANNEX III Fees for the update of registrations under Article 22 of Regulation (EC) No 1907/2006 Table 1 Table 2 Table 3 Table 4 Standard fees for the update of the tonnage range Reduced fees for SMEs for the update of the tonnage range Fees for other updates Reduced fees for SMEs for other updates
8. ANNEX IV Fees for requests under point (xi) of Article 10(a) of Regulation (EC) No 1907/2006 Table 1 Table 2 Standard fees Reduced fees for SMEs
9. ANNEX V Fees and charges for PPORD notifications under Article 9 of Regulation (EC) No 1907/2006 Table 1 Table 2 Fees for PPORD notifications Charges for the extension of a PPORD exemption
10. ANNEX VI Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006 Table 1 Table 2 Table 3 Table 4 Standard fees Reduced fees for medium enterprises Reduced fees for small enterprises Reduced fees for micro enterprises
11. ANNEX VII Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006 Table 1 Table 2 Table 3 Table 4 Standard charges Reduced charges for medium enterprises Reduced charges for small enterprises Reduced charges for micro enterprises
12. ANNEX VIII Fees for appeals under Article 92 of Regulation (EC) NO 1907/2006 Table 1 Table 2 Standard fees Reduced fees for SMEs

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, 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), 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.

(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

ANNEX

ANNEX

ANNEX I Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006 Table 1 Table 2 Standard fees Reduced fees for SMEs

Individual submission Joint submission Fee for substances in the range of 1 to 10 tonnes EUR 1714 EUR 1285 Fee for substances in the range 10 to 100 tonnes EUR 4605 EUR 3454 Fee for substances in the range 100 to 1000 tonnes EUR 12317 EUR 9237 Fee for substances above 1000 tonnes EUR 33201 EUR 24901 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 1114 EUR 835 EUR 600 EUR 450 EUR 86 EUR 64 Fee for substances in the range 10 to 100 tonnes EUR 2993 EUR 2245 EUR 1612 EUR 1209 EUR 230 EUR 173 Fee for substances in the range 100 to 1000 tonnes EUR 8006 EUR 6004 EUR 4311 EUR 3233 EUR 616 EUR 462 Fee for substances above 1000 tonnes EUR 21581 EUR 16185 EUR 11620 EUR 8715 EUR 1660 EUR 1245

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 Table 2 Standard fees Reduced fees for SMEs

Individual submission Joint submission Fee EUR 1714 EUR 1285 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 1114 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 Table 2 Table 3 Table 4 Standard fees for the update of the tonnage range Reduced fees for SMEs for the update of the tonnage range Fees for other updates Reduced fees for SMEs for other updates

Individual submission Joint submission From 1-10 tonnes range to 10-100 tonnes range EUR 2892 EUR 2169 From 1-10 tonnes range to 100-1000 tonnes range EUR 10603 EUR 7952 From 1-10 tonnes range to over 1000 tonnes range EUR 31487 EUR 23616 From 10-100 tonnes range to 100-1000 tonnes range EUR 7711 EUR 5783 From 10-100 tonnes range to over 1000 tonnes range EUR 28596 EUR 21447 From 100-1000 tonnes range to over 1000 tonnes range EUR 20885 EUR 15663 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 1880 EUR 1410 EUR 1012 EUR 759 EUR 145 EUR 108 From 1-10 tonnes range to 100-1000 tonnes range EUR 6892 EUR 5169 EUR 3711 EUR 2783 EUR 530 EUR 398 From 1-10 tonnes range to over 1000 tonnes range EUR 20467 EUR 15350 EUR 11021 EUR 8265 EUR 1574 EUR 1181 From 10-100 tonnes range to 100-1000 tonnes range EUR 5012 EUR 3759 EUR 2699 EUR 2024 EUR 386 EUR 289 From 10-100 tonnes range to over 1000 tonnes range EUR 18587 EUR 13940 EUR 10008 EUR 7506 EUR 1430 EUR 1072 From 100-1000 tonnes range to over 1000 tonnes range EUR 13575 EUR 10181 EUR 7310 EUR 5482 EUR 1044 EUR 783 Type of update Change in identity of the registrant involving a change in legal personality EUR 1607 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 4820 EUR 3615 Relevant tonnage band EUR 1607 EUR 1205 A study summary or a robust study summary EUR 4820 EUR 3615 Information in the safety data sheet EUR 3213 EUR 2410 Trade name of the substance EUR 1607 EUR 1205 IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1607 EUR 1205 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 1607 EUR 1205 Type of update Medium enterprise Small enterprise Micro enterprise Change in identity of the registrant involving a change in legal personality EUR 1044 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 3133 EUR 2350 EUR 1687 EUR 1265 EUR 241 EUR 181 Relevant tonnage band EUR 1044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60 A study summary or a robust study summary EUR 3133 EUR 2350 EUR 1687 EUR 1265 EUR 241 EUR 181 Information in the safety data sheet EUR 2088 EUR 1566 EUR 1125 EUR 843 EUR 161 EUR 120 Trade name of the substance EUR 1044 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 1044 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 1044 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 Table 2 Standard fees Reduced fees for SMEs

Item for which confidentiality is requested Individual submission Joint submission Degree of purity and/or identity of impurities or additives EUR 4820 EUR 3615 Relevant tonnage band EUR 1607 EUR 1205 A study summary or a robust study summary EUR 4820 EUR 3615 Information in the safety data sheet EUR 3213 EUR 2410 Trade name of the substance EUR 1607 EUR 1205 IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 EUR 1607 EUR 1205 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 1607 EUR 1205 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 3133 EUR 2350 EUR 1687 EUR 1265 EUR 241 EUR 181 Relevant tonnage band EUR 1044 EUR 783 EUR 562 EUR 422 EUR 80 EUR 60 A study summary or a robust study summary EUR 3133 EUR 2350 EUR 1687 EUR 1265 EUR 241 EUR 181 Information in the safety data sheet EUR 2088 EUR 1566 EUR 1125 EUR 843 EUR 161 EUR 120 Trade name of the substance EUR 1044 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 1044 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 1044 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 Table 2 Fees for PPORD notifications Charges for the extension of a PPORD exemption

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 1071 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 Table 2 Table 3 Table 4 Standard fees Reduced fees for medium enterprises Reduced fees for small enterprises Reduced fees for micro enterprises

Base fee EUR 53300 Additional fee per substance EUR 10660 Additional fee per use EUR 10660 Additional fee per applicant Additional applicant is not an SME: EUR 39975 Additional applicant is a medium enterprise: EUR 29981 Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base fee EUR 39975 Additional fee per substance EUR 7995 Additional fee per use EUR 7995 Additional fee per applicant Additional applicant is a medium enterprise: EUR 29981 Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base fee EUR 23985 Additional fee per substance EUR 4797 Additional fee per use EUR 4797 Additional fee per applicant Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base fee EUR 5330 Additional fee per substance EUR 1066 Additional fee per use EUR 1066 Additional fee per applicant Additional applicant: EUR 3998

ANNEX VII Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006 Table 1 Table 2 Table 3 Table 4 Standard charges Reduced charges for medium enterprises Reduced charges for small enterprises Reduced charges for micro enterprises

Base charge EUR 53300 Additional charge per use EUR 10660 Additional charge per substance EUR 10660 Additional charge per applicant Additional applicant is not an SME: EUR 39975 Additional applicant is a medium enterprise: EUR 29981 Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base charge EUR 39975 Additional charge per use EUR 7995 Additional charge per substance EUR 7995 Additional charge per applicant Additional applicant is a medium enterprise: EUR 29981 Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base charge EUR 23985 Additional charge per use EUR 4797 Additional charge per substance EUR 4797 Additional charge per applicant Additional applicant is a small enterprise: EUR 17989 Additional applicant is a micro enterprise: EUR 3998 Base charge EUR 5330 Additional charge per use EUR 1066 Additional charge per substance EUR 1066 Additional charge per applicant Additional applicant is a micro enterprise: EUR 3998

ANNEX VIII Fees for appeals under Article 92 of Regulation (EC) NO 1907/2006 Table 1 Table 2 Standard fees Reduced fees for SMEs

Appeal against decision taken under: Fee Article 9 or 20 of Regulation (EC) No 1907/2006 EUR 2356 Article 27 or 30 of Regulation (EC) No 1907/2006 EUR 4712 Article 51 of Regulation (EC) No 1907/2006 EUR 7069 Appeal against decision taken under: Fee Article 9 or 20 of Regulation (EC) No 1907/2006 EUR 1767 Article 27 or 30 of Regulation (EC) No 1907/2006 EUR 3534 Article 51 of Regulation (EC) No 1907/2006 EUR 5301

Versions

1. 2013-03-20

Cited by

• Commission Implementing Regulation (EU) No 211/2014 of 27 February 2014 correcting the Slovak language version of Commission 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) Regulation · Grade B

  In the Slovak language version, an error occurring three times in Table 4 of Annex III to Commission Regulation (EC) No 340/2008, as amended by Implementing Regulation (EU) No 254/2013, should be corrected. The other language versions are not affected.