- Latest available (Revised)
- Original (As adopted by EU)
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)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
This version of this Regulation was derived from EUR-Lex on IP completion day (31 December 2020 11:00 p.m.). It has not been amended by the UK since then. Find out more about legislation originating from the EU as published on legislation.gov.uk.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
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:
Regulation (EC) No 340/2008 is amended as follows:
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.’
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.’
Article 5 is amended as follows:
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.’
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’.
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.’
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.’
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.’
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.’
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.’
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.’
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.’
Annexes I to VIII to Regulation (EC) No 340/2008 are replaced by the text set out in the Annex to this Regulation.
This Regulation shall not apply to valid submissions pending on 22 March 2013.
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
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 |
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 |
Standard fees
Individual submission | Joint submission | |
---|---|---|
Fee | EUR 1 714 | EUR 1 285 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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” |
COM(2013) 49 final, SWD(2013) 25 final
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: