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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^note, and in particular Article 74(1) and Article 132 thereof,Whereas:

(1)Increasing the sustainability of the financing model of the European Chemicals Agency (‘the Agency’) is one of the objectives envisaged under the Chemicals Strategy for Sustainability^note, considering in particular the reduced and unpredictable fee income following the last registration deadline in 2018 under Regulation (EC) No 1907/2006 of the European Parliament and of the Council and the planned reassignment of scientific and technical work to Union agencies. This Regulation, amending Commission Regulation (EC) No 340/2008^note, with regard to the fees and charges under Regulation (EC) No 1907/2006 and procedures related to same, is one of a series of measures to contribute to increasing the financial sustainability of the Agency.

(2)According to Article 22(1) of Regulation (EC) No 340/2008, the fees and charges provided for in that Regulation should be reviewed annually by reference to the inflation rate as measured by means of the European Index of Consumer Prices as published by Eurostat pursuant to Council Regulation (EC) No 2494/95^note, repealed and replaced by Regulation (EU) 2016/792 of the European Parliament and of the Council^note.

(3)Following the review conducted by the Commission, standard fees and charges should be adjusted in accordance with the average annual inflation rates for 2021, 2022 and 2023, as published by Eurostat to reflect the cumulative inflation rate of 19,5 %. To safeguard the competitiveness of small and medium-sized enterprises (‘SMEs’) and in line with the objectives of the Commission’s Political Guidelines 2024-2029^note and Commission’s SME Relief Package^note, this inflation adjustment will not apply to fees and charges payable by SMEs to the Agency.

(4)The adjustment of fees and charges should be fixed at such a level that the revenue derived from those fees and charges, 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 by the Agency.

(5)The Management Board of the Agency should, within the powers conferred to it by Regulation (EC) No 1907/2006, continue monitoring the efforts pursued by the Agency for efficiency gains to achieve the best relationship between resources employed and results achieved. The Commission should have regard to the opinion of the Management Board when next reviewing the Agency’s fees and charges according to Article 22(1) of Regulation (EC) No 340/2008.

(6)According to Article 13 of Regulation (EC) No 340/2008, registrants or applicants self-declare their company size, on the basis of the Commission Recommendation 2003/361/EC^note, at the time of dossier submissions. Following this, the Agency carries out an ex post verification of the correctness of these declarations. This system was initially required to be able to cope with the magnitude of the registrations under the regulatory deadlines under Regulation (EC) No 1907/2006. However, experience has shown that the ex post verification is work intensive, often requiring multiple interactions with registrants or applicants, in particular where the company’s status has changed since the initial self-declaration, and therefore requires verification by means of multi-annual batches. Moreover, in cases where the size of a registrant or applicant is larger than that which was self-declared, a top-up fee and an administrative charge is applied in line with the Agency’s Management Board decision^note and Regulation (EC) No 340/2008. The correctness of the fee payments and the effectiveness and timeliness of the SME verification process have also been brought to the Commission’s attention by the European Court of Auditors, the European Parliament^note and the Council^note.

(7)Given that the magnitude of submissions has declined since the last registration deadline in 2018 and in order to improve the efficiency of the SME verification process and to establish a level-playing field, it is appropriate to request the application for recognition of the SME status and supporting documents in advance of the corresponding submission. The Agency should thus conduct an ex ante SME verification. The Agency should decide on applications for the recognition of the SME status without delay and should decide at the latest within two months from receipt of all relevant documentation. Accordingly, an application for recognition of the SME status should be submitted without delay and at the latest two months before a submission for which a fee reduction is claimed, so that the Agency has sufficient time to make a decision on the applicant’s SME status before the actual submission.

(8)In view of the appeal deadline under Article 92(2) of Regulation (EC) No 1907/2006 and the impact that the timely payment of the appeal fee has on the admissibility of such an appeal, for the purpose of a reduced appeal fee, the appellant should submit a self-declaration and supporting documents on its SME status, together with the submission of the appeal.

(9)The verification of SME status might use resources from the Agency that would not be covered by the SME fee or charge paid with the subsequent submission, therefore, the Agency should have the possibility to introduce an administrative charge to be paid by companies applying for SME status reflecting the workload associated with the verification. The administrative charge should not be levied where the subsequent decision of the Agency on the SME status recognises the SME status of the applicant.

(10)In order to enhance legal certainty and reduce the administrative burden associated with the submission of an SME claim and verification of such claim, the Agency’s decision on SME status should remain valid for three years and, during this period, it should apply to all submissions made to the Agency in accordance with relevant Union law requiring SME status verification, not only to submissions under Regulation (EC) No 1907/2006. This means that any other submissions under Regulation (EC) No 1907/2006 or other Union law, triggering a fee or charge during this three-year period by the same company should be covered by the Agency’s existing decision on SME status, without the need to reapply for SME status recognition. To ease the burden on SMEs, the first re-application for recognition of SME status after the Agency’s first decision on the SME status may be done by a self-declaration on the company size if it is submitted two months before the end of the three-year validity period and if the SME status has not changed. If the status has not changed then no new information is required to be submitted.

(11)Stakeholders and the Agency require sufficient time to take the appropriate measures to comply with the changes to the SME verification process of this Regulation. The application of the amendments to Article 13 of Regulation (EC) No 340/2008 concerning the SME verification process should therefore be deferred by 15 months from entry into force of this Regulation.

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

(13)This Regulation should not apply to valid submissions that are pending on the date of entry into force of this Regulation.

(14)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 10, the following paragraph 2a is inserted:‘2a.A natural or legal person shall be entitled to pay a reduced appeal fee if the latest decision issued by the Agency to that person in accordance with Article 13(4) of this Regulation concluded that the person in question is entitled to such a reduction and if the validity period of that decision has not yet expired. In that case, the natural or legal person shall provide the Agency with the decision on the recognition of the SME status when submitting the appeal.If a decision on recognition of SME status is still pending at the time of the submission of the appeal, Article 13(7) shall apply mutatis mutandis.If no such decision was previously issued by the Agency or is pending, or if the validity period of the decision has expired, the person concerned shall, when submitting the appeal, provide a self-declaration on the company size and the supporting evidence referred to in Article 13(1b) of this Regulation that it is entitled to the reduction.’;

(2)Article 13 is amended as follows:

(a)the title of the article is replaced by:‘Recognition of SME status, reductions and fee waiver’;

(b)paragraph 1 is replaced by the following:‘1.A natural or legal person that claims to be entitled to a reduced fee or charge in accordance with Articles 3 to 9 shall apply to the Agency for recognition of SME status at least two months before the submission giving rise to the payment of the fee.A natural or legal person that claims to be entitled to a reduced fee or charge shall submit to the Agency the relevant documentation proving entitlement to such reduction by virtue of the status of SME in accordance with Recommendation 2003/361/EC.’;

(c)the following paragraphs 1a and 1b are inserted:‘1a.The verification of the SME status by the Agency may be subject to an administrative charge.The level of that administrative charge shall be determined by the Management Board of the Agency, based on a proposal by the Executive Director of the Agency, reflecting the workload associated with the verification of the SME status under this Article. An administrative charge shall not be levied where the subsequent decision of the Agency on the SME status recognises the SME status of the applicant. The decision of the Management Board on the level of the administrative charge shall be published.1b.The Agency shall publish a list of the relevant documentation to be submitted in accordance with paragraph 1.’;

(d)paragraphs 3 and 4 are replaced by:‘3.The Agency may request, at any time, additional evidence that the conditions for a reduction of the fees or charges or for a fee waiver apply. The Agency shall reject the application if the evidence requested is not provided within the deadline set by the Agency in such a request.Where any document submitted to the Agency is not in one of the official languages of the Union, it shall be accompanied by a certified translation into any one of the official languages.4.Upon receipt of all the relevant documentation the Agency shall within two months, decide whether the SME status can be recognised. The timeline may be longer if mutually agreed between the Agency and the company.A decision on recognition of SME status shall be valid for three years for all submissions made after such decision to the Agency in accordance with the relevant Union law requiring such submissions. The first re-application for recognition of SME status after the Agency’s first decision on the SME status may be done by a self-declaration on the company size if it is submitted two months before the end of the three-year validity period and if the SME status has not changed.’;

(e)the following paragraphs 5, 6 and 7 are inserted:‘5.If the Agency decides not to recognise the SME status applied for, the applicant is not entitled to any claim to a reduced fee or charge in accordance with Articles 3 to 10.6.A natural or legal person claiming a reduced fee or charge in accordance with Articles 3 to 9 when making a submission to the Agency in accordance with Regulation (EC) No 1907/2006 shall provide the Agency decision on the recognition of SME status together with the submission.7.Where, in exceptional circumstances, the Agency is unable to adopt a decision on the SME status within two months after receipt of all relevant documentation, a submission made thereafter by the applicant for SME status giving rise to the payment of a fee or charge referred to under paragraph 1 shall benefit temporarily from the reduced fee or charge claimed. Such reduced fee or charge shall be conditionally granted until a decision on the SME status has been adopted. If the subsequent decision does not recognise the SME status, the Agency shall levy the balance of the full fee or charge and may levy an administrative charge.Paragraphs 5, 6 and 7 of Articles 3 to 5 and paragraphs 3, 4 and 5 of Article 7 shall apply mutatis mutandis.For fees payable in accordance with Articles 6, 8 and 9, the balance of the full fee or charge shall be paid within 14 calendar days from the date of reception of the Agency’s decision not to recognise the SME status.’;

(3)Annexes I to VIII to Regulation (EC) No 340/2008 are replaced by Annexes I to VIII to this Regulation.

Article 2 #

This Regulation shall not apply to valid submissions pending on the date of entry into force of this Regulation.

Article 3 #

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.However, Article 1(1) and (2) shall apply from 5 February 2027.

Annex I

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

Table 1
	Individual submission	Joint submission
Fee for substances in the range of 1 to 10 tonnes	EUR 2078	EUR 1558
Fee for substances in the range 10 to 100 tonnes	EUR 5585	EUR 4190
Fee for substances in the range 100 to 1000 tonnes	EUR 14939	EUR 11204
Fee for substances above 1000 tonnes	EUR 40270	EUR 30202

Table 2
	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 1131	EUR 848	EUR 609	EUR 457	EUR 87	EUR 65
Fee for substances in the range 10 to 100 tonnes	EUR 3038	EUR 2279	EUR 1636	EUR 1227	EUR 234	EUR 175
Fee for substances in the range 100 to 1000 tonnes	EUR 8126	EUR 6094	EUR 4375	EUR 3282	EUR 625	EUR 469
Fee for substances above 1000 tonnes	EUR 21904	EUR 16428	EUR 11795	EUR 8846	EUR 1685	EUR 1264

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
	Individual submission	Joint submission
Fee	EUR 2078	EUR 1558

Table 2
	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 1131	EUR 848	EUR 609	EUR 457	EUR 87	EUR 65

III

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

Table 1
	Individual submission	Joint submission
From 1-10 tonnes range to 10-100 tonnes range	EUR 3507	EUR 2630
From 1-10 tonnes range to 100-1 000 tonnes range	EUR 12861	EUR 9645
From 1-10 tonnes range to over 1000 tonnes range	EUR 38192	EUR 28644
From 10-100 tonnes range to 100-1 000 tonnes range	EUR 9353	EUR 7015
From 10-100 tonnes range to over 1000 tonnes range	EUR 34685	EUR 26013
From 100-1 000 tonnes range to over 1000 tonnes range	EUR 25332	EUR 18998

Table 2
	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 1908	EUR 1431	EUR 1027	EUR 770	EUR 147	EUR 110
From 1-10 tonnes range to 100-1 000 tonnes range	EUR 6995	EUR 5246	EUR 3767	EUR 2825	EUR 538	EUR 404
From 1-10 tonnes range to over 1000 tonnes range	EUR 20774	EUR 15580	EUR 11186	EUR 8389	EUR 1598	EUR 1198
From 10-100 tonnes range to 100-1 000 tonnes range	EUR 5087	EUR 3816	EUR 2739	EUR 2055	EUR 391	EUR 294
From 10-100 tonnes range to over 1000 tonnes range	EUR 18866	EUR 14150	EUR 10159	EUR 7619	EUR 1451	EUR 1088
From 100-1 000 tonnes range to over 1000 tonnes range	EUR 13779	EUR 10334	EUR 7419	EUR 5564	EUR 1060	EUR 795

Table 3
Type of update
Change in identity of the registrant involving a change in legal personality	EUR 1949
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 5846	EUR 4384
Relevant tonnage band	EUR 1949	EUR 1461
A study summary or a robust study summary	EUR 5846	EUR 4384
Information in the safety data sheet	EUR 3897	EUR 2923
Trade name of the substance	EUR 1949	EUR 1461
IUPAC name for non-phase-in substances referred to in Article 119(1), point (a), of Regulation (EC) No 1907/2006	EUR 1949	EUR 1461
IUPAC name for substances referred to in Article 119(1), point (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 1949	EUR 1461

Table 4
Type of update	Medium enterprise	Small enterprise	Micro enterprise
Change in identity of the registrant involving a change in legal personality	EUR 1060	EUR 571	EUR 82
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 3180	EUR 2385	EUR 1712	EUR 1284	EUR 245	EUR 183
Relevant tonnage band	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
A study summary or a robust study summary	EUR 3180	EUR 2385	EUR 1712	EUR 1284	EUR 245	EUR 183
Information in the safety data sheet	EUR 2120	EUR 1590	EUR 1141	EUR 856	EUR 163	EUR 122
Trade name of the substance	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
IUPAC name for non-phase-in substances referred to in Article 119(1), point (a), of Regulation (EC) No 1907/2006	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
IUPAC name for substances referred to in Article 119(1), point (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 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61

Annex IV

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

Table 1
Item for which confidentiality is requested	Individual submission	Joint submission
Degree of purity and/or identity of impurities or additives	EUR 5846	EUR 4384
Relevant tonnage band	EUR 1949	EUR 1461
A study summary or a robust study summary	EUR 5846	EUR 4384
Information in the safety data sheet	EUR 3897	EUR 2923
Trade name of the substance	EUR 1949	EUR 1461
IUPAC name for non-phase-in substances referred to in Article 119(1), point (a), of Regulation (EC) No 1907/2006	EUR 1949	EUR 1461
IUPAC name for substances referred to in Article 119(1), point (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 1949	EUR 1461

Table 2
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 3180	EUR 2385	EUR 1712	EUR 1284	EUR 245	EUR 183
Relevant tonnage band	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
A study summary or a robust study summary	EUR 3180	EUR 2385	EUR 1712	EUR 1284	EUR 245	EUR 183
Information in the safety data sheet	EUR 2120	EUR 1590	EUR 1141	EUR 856	EUR 163	EUR 122
Trade name of the substance	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
IUPAC name for non-phase-in substances referred to in Article 119(1), point (a), of Regulation (EC) No 1907/2006	EUR 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61
IUPAC name for substances referred to in Article 119(1), point (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 1060	EUR 795	EUR 571	EUR 428	EUR 82	EUR 61

Annex V

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

Table 1
Standard fee	EUR 650
Reduced fee for medium enterprise	EUR 353
Reduced fee for small enterprise	EUR 190
Reduced fee for micro enterprise	EUR 27

Table 2
Standard charge	EUR 1299
Reduced charge for medium enterprise	EUR 707
Reduced charge for small enterprise	EUR 380
Reduced charge for micro enterprise	EUR 54

Annex VI

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

Table 1
Base fee	EUR 64650
Additional fee per substance	EUR 12930
Additional fee per use	EUR 58185

Table 2
Base fee	EUR 40575
Additional fee per substance	EUR 8115
Additional fee per use	EUR 36518

Table 3
Base fee	EUR 24345
Additional fee per substance	EUR 4869
Additional fee per use	EUR 21911

Table 4
Base fee	EUR 5410
Additional fee per substance	EUR 1082
Additional fee per use	EUR 4869

2. Fees for applications for an authorisation for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in Article 8(2), fifth subparagraph

Table 1Standard feesBase fee | EUR 32325Additional fee per substance | EUR 6465Additional fee per use | EUR 29092

Table 2Reduced fees for medium enterprisesBase fee | EUR 20287Additional fee per substance | EUR 4057Additional fee per use | EUR 18259

Table 3Reduced fees for small enterprisesBase fee | EUR 12172Additional fee per substance | EUR 2434Additional fee per use | EUR 10955

Table 4Reduced fees for micro enterprisesBase fee | EUR 2705Additional fee per substance | EUR 541Additional fee per use | EUR 2434

VII

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

Table 1
Base charge	EUR 64650
Additional charge per substance	EUR 12930
Additional charge per use	EUR 58185

Table 2
Base charge	EUR 40575
Additional charge per substance	EUR 8115
Additional charge per use	EUR 36518

Table 3
Base charge	EUR 24345
Additional charge per substance	EUR 4869
Additional charge per use	EUR 21911

Table 4
Base charge	EUR 5410
Additional charge per substance	EUR 1082
Additional charge per use	EUR 4869

2. Charges for the review of an authorisation granted for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in Article 9(2), fifth subparagraph

Table 1Standard chargesBase charge | EUR 32325Additional charge per substance | EUR 6465Additional charge per use | EUR 29092

Table 2Reduced charges for medium enterprisesBase charge | EUR 20287Additional charge per substance | EUR 4057Additional charge per use | EUR 18259

Table 3Reduced charges for small enterprisesBase charge | EUR 12172Additional charge per substance | EUR 2434Additional charge per use | EUR 10955

Table 4Reduced charges for micro enterprisesBase charge | EUR 2705Additional charge per substance | EUR 541Additional charge per use | EUR 2434

VIII

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

Table 1
Appeal against decision taken under	Fee
Article 9 or 20 of Regulation (EC) No 1907/2006	EUR 2858
Article 27 or 30 of Regulation (EC) No 1907/2006	EUR 5716
Article 51 of Regulation (EC) No 1907/2006	EUR 8574

Table 2
Appeal against decision taken under	Fee
Article 9 or 20 of Regulation (EC) No 1907/2006	EUR 1794
Article 27 or 30 of Regulation (EC) No 1907/2006	EUR 3587
Article 51 of Regulation (EC) No 1907/2006	EUR 5381