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) (Text with EEA relevance)

CHAPTER I

SUBJECT MATTER AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down the amounts, and rules for payment, of the fees and charges levied by the European Chemicals Agency, hereinafter the ‘Agency’, as provided for in Regulation (EC) No 1907/2006.

Article 2

Definitions

For the purposes of this Regulation:

CHAPTER II

FEES AND CHARGES

Article 3

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

However, no fee shall be levied for the registration of a substance in a quantity of between 1 and 10 tonnes where the submission of the registration contains all the information required in Annex VII to Regulation (EC) No 1907/2006, as provided for in Article 74(2) of that Regulation.

The Agency shall levy a fee for any registration of a substance in a quantity of 10 tonnes or more, as set out in Annex I.

However, if a registrant submits separately part of the relevant information referred to in Article 10(a)(iv), (vi), (vii) and (ix) of Regulation (EC) No 1907/2006, the Agency shall levy a fee for an individual submission on that registrant, as set out in Annex I to this Regulation.

However, invoices linked to a registration of a pre-registered substance that is submitted to the Agency during the two months that precede the relevant registration deadline of Article 23 of Regulation (EC) No 1907/2006 shall be paid within 30 days from the date on which the invoice is notified to the registrant by the Agency.

Article 4

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

However, no fee shall be levied for the registration of an on-site or transported isolated intermediate in a quantity of between 1 and 10 tonnes where the submission of the registration contains all the information required in Annex VII to Regulation (EC) No 1907/2006 as provided for in Article 74(2) of that Regulation.

The fees under this Article shall only apply to registrations of on-site or transported isolated intermediates submitted under Article 17(2), Article 18(2) or (3) or Article 19 of Regulation (EC) No 1907/2006. In the case of registrations of intermediate substances that require the information specified in Article 10 of Regulation (EC) No 1907/2006, the fees set out in Article 3 of this Regulation shall apply.

The Agency shall levy a fee for any registration of an on-site or transported isolated intermediate in a quantity of 10 tonnes or more, as set out in Annex II.

However, if a registrant submits separately part of the relevant information referred to in Article 17(2)(c) and (d), or Article 18(2)(c) and (d) of Regulation (EC) No 1907/2006, the Agency shall levy a fee for an individual submission on that registrant, as set out in Annex II to this Regulation.

However, invoices linked to a registration of a pre-registered substance that is submitted to the Agency during the two months that precede the relevant registration deadline of Article 23 of Regulation (EC) No 1907/2006 shall be paid within 30 days from the date on which the invoice is notified to the registrant by the Agency.

Article 5

Fees for updates of a registration under Article 22 of Regulation (EC) No 1907/2006

However, the Agency shall not levy a fee for the following updates of a registration:

(a) a change from a higher to a lower tonnage range;

(b) a change from a lower to a higher tonnage range if the registrant has previously paid the fee for that higher tonnage range;

(c) a change in the status of the registrant or his identity, provided that it does not involve a change in legal personality;

(d) a change in the composition of the substance;

(e) information on new uses including uses advised against;

(f) information on new risks of the substance;

(g) a change in the classification and labelling of the substance;

(h) a change in the chemical safety report;

(i) a change in the guidance on safe use;

(j) a notification that a test listed in Annex IX or X to Regulation (EC) No 1907/2006 must be developed;

(k) a request for previously confidential information to be accessible.

For other updates, the Agency shall levy a fee, as set out in Tables 3 and 4 of Annex III.

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.

However, if part of the relevant information referred to in Article 10(a)(iv), (vi), (vii) and (ix), Article 17(2)(c) and (d), or Article 18(2)(c) and (d) of Regulation (EC) No 1907/2006 is submitted separately, the Agency shall levy a fee for an individual submission, as set out in Annex III to this Regulation.

However, in cases of updates involving a change in the identity of the registrant, the SME reduction shall apply only if the new entity is an SME.

Where the payment is not made before expiry of the second deadline, in the case of updates of the tonnage range submitted in accordance with Article 22(1)(c) of Regulation (EC) No 1907/2006, the update shall be rejected.

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.

Article 6

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

In the case of a request concerning study summaries or robust study summaries, the Agency shall levy a fee for each study summary or robust study summary for which the request is made.

Article 7

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

Where the notification is made by an SME, the Agency shall levy a reduced fee as set out in Table 1 of Annex V.

Where the request is made by an SME, the Agency shall levy a reduced charge as set out in Table 2 of Annex V.

Charges due under paragraph 2 shall be paid within 30 calendar days from the date on which the invoice is notified by the Agency to the manufacturer, importer, or producer of articles requesting an extension.

Where the payment is not made before expiry of the second deadline, the notification or the request for an extension shall be rejected.

Article 8

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

The Agency shall levy an additional fee, as set out in Annex VI to this Regulation, for each additional use and for each additional substance that meets the definition of a group of substances as defined in point 1.5 of Annex XI to Regulation (EC) No 1907/2006 and that is covered by the application. No additional fee shall be levied where more than one applicant is party to the application for an authorisation.

Where the applicants that are party to a joint application for an authorisation are of different sizes, the highest fee applicable to any of those applicants shall be levied for that application.

Where a joint application for an authorisation is submitted, the applicants shall make every effort to share the fee in a fair, transparent and non-discriminatory manner, in particular with regard to SMEs.

The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Commission Implementing Regulation (EU) 2021/876 (¹) and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation.

The Agency shall issue one invoice covering the base fee and any applicable additional fees.

Where the application is submitted by a small enterprise or by two or more SMEs only, of which the largest enterprise is a small enterprise, the Agency shall levy a reduced base fee and reduced additional fees, as set out in Table 3 of Annex VI.

Where the application is submitted by one or more micro enterprises only, the Agency shall levy a reduced base fee and reduced additional fees, as set out in Table 4 of Annex VI.

Article 9

Charges for reviews of authorisations under Article 61 of Regulation (EC) No 1907/2006

The Agency shall levy an additional charge, as set out in Annex VII to this Regulation, for each additional use and for each additional substance that meets the definition of a group of substances as defined in point 1.5 of Annex XI to Regulation (EC) No 1907/2006 and that is covered by the review report. No additional charge shall be levied where there is more than one party to a review report.

Where the entities that are party to the submission of a joint review report are of different sizes, the highest charge applicable to any of those applicants shall be levied to that submission.

Where a joint review report is submitted, the holders of the authorisation shall make every effort to share the charge in a fair, transparent and non-discriminatory manner, in particular with regard to SMEs.

The Agency shall levy a reduced charge as set out in point 2 of Annex VII to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Implementing Regulation (EU) 2021/876 and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation

The Agency shall issue one invoice covering the base charge and any applicable additional charges.

Where the application is submitted by a small enterprise or by two or more SMEs only, of which the largest enterprise is a small enterprise, the Agency shall levy a reduced base charge and reduced additional charges, as set out in Table 3 of Annex VII.

Where the application is submitted by one or more micro enterprises only, the Agency shall levy a reduced base charge and reduced additional charges as set out in Table 4 of Annex VII.

Article 10

Fees for appeals against a decision of the Agency under Article 92 of Regulation (EC) No 1907/2006

Article 11

Other charges

However, charges shall not be levied for the assistance provided by its Helpdesk and for the support to Member States as provided for in Article 77(2)(h) and (i) of Regulation (EC) No 1907/2006.

The Executive Director of the Agency may decide not to levy a charge on international organisations or countries that request assistance from the Agency.

Where the payment is not made before expiry of the second deadline, the Agency shall reject the request.

Article 12

Only representatives

In the case of an only representative referred to in Article 8 of Regulation (EC) No 1907/2006, the assessment of whether the reduction for SMEs applies shall be determined by reference to the headcount, turnover and balance sheet information of the non-Community manufacturer, formulator of a preparation, or producer of an article that is represented by that only representative in connection with the transaction concerned, including relevant information from linked and partner companies of the non-Community manufacturer, formulator of a preparation, or producer of an article, in accordance with Recommendation 2003/361/EC.

Article 13

Reductions and fee waiver

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.

Where a natural or legal person that has claimed to be entitled to a reduction has already paid a reduced fee or charge, but cannot demonstrate that it is entitled to such a reduction, the Agency shall levy the balance of the full fee or charge as well as an administrative charge.

Paragraphs 2, 3 and 5 of Article 11 shall apply mutatis mutandis.

CHAPTER III

PAYMENT OF REMUNERATION BY THE AGENCY

Article 14

Transfers of funds to Member States

A proportion of the fees and charges collected under this Regulation shall be transferred to the competent authorities of the Member States in the following cases:

(a) where the competent authority of the Member State notifies to the Agency the conclusion of an evaluation procedure for a substance in accordance with Article 46(4) of Regulation (EC) No 1907/2006;

(b) where the competent authority has appointed a member of the Committee for Risk Assessment who acts as rapporteur in the context of an authorisation procedure, including in the context of a review;

(c) where the competent authority of the Member State has appointed a member of the Committee for Socioeconomic Analysis who acts as rapporteur in the context of an authorisation procedure, including in the context of a review;

(d) where the competent authority of the Member State has appointed a member of the Committee for Risk Assessment who acts as rapporteur in the context of a restrictions procedure;

(e) where the competent authority of the Member State has appointed a member of the Committee for Socioeconomic Analysis who acts as rapporteur in the context of a restrictions procedure;

(f) where appropriate, for other tasks performed by the competent authorities at the request of the Agency.

When the Committees referred to in this paragraph decide to appoint a co-rapporteur, the transfer shall be divided between the rapporteur and the co-rapporteur.

However, the Management Board of the Agency may decide to authorise pre-financing or interim payments in accordance with Article 81(1) of Regulation (EC, Euratom) No 1605/2002.

Article 15

Other remuneration

In fixing the amounts of the payments made to remunerate experts or co-opted members of the committees for work done for the Agency in accordance with Article 87(3) of Regulation (EC) No 1907/2006, the Management Board of the Agency shall take into account the workload involved and it shall comply with the principles of economy, efficiency and effectiveness as defined in Article 27 of the Regulation (EC, Euratom) No 1605/2002. It shall also ensure that the Agency has sufficient financial resources available to undertake its tasks as defined in Regulation (EC) No 1907/2006, having regard to its existing budgetary appropriations and pluriannual estimates of income, including a Community subsidy.

CHAPTER IV

PAYMENTS

Article 16

Mode of payment

Article 17

Identification of the payment

Payments due under Article 10 shall indicate in the reference field the identity of the appellant(s) and, if available, the number of the decision that is being appealed.

Article 18

Date of payment

A confirmation of the transfer order issued by a financial institution shall be regarded as sufficient evidence. However, where the transfer requires the use of the SWIFT electronic bank payment method, the acknowledgement of provision of the transfer order shall take the form of a copy of the SWIFT report, stamped and signed by a duly authorised official of a financial institution.

Article 19

Insufficient payment

Article 20

Refund of amounts paid in excess

However, where an amount paid in excess is under EUR 100 and the party concerned has not expressly requested a refund, the amount paid in excess shall not be refunded.

CHAPTER V

FINAL PROVISIONS

Article 21

Provisional estimate

The Management Board of the Agency shall, when producing an estimate of the overall expenditure and income for the following financial year in accordance with Article 96(5) of Regulation (EC) No 1907/2006, include a specific provisional estimate of income from fees and charges which is separate from income from any subsidy from the Community.

Article 22

Review

Article 23

Entry into force

This Regulation shall enter into force on the third day following 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.

ANNEX I

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

	Individual submission	Joint submission
Fee for substances in the range of 1 to 10 tonnes	EUR 2 078	EUR 1 558
Fee for substances in the range 10 to 100 tonnes	EUR 5 585	EUR 4 190
Fee for substances in the range 100 to 1 000 tonnes	EUR 14 939	EUR 11 204
Fee for substances above 1 000 tonnes	EUR 40 270	EUR 30 202
	Medium enterprise (Individual submission)	Medium enterprise (Joint submission)
---	---	---
Fee for substances in the range of 1 to 10 tonnes	EUR 1 131	EUR 848
Fee for substances in the range 10 to 100 tonnes	EUR 3 038	EUR 2 279
Fee for substances in the range 100 to 1 000 tonnes	EUR 8 126	EUR 6 094
Fee for substances above 1 000 tonnes	EUR 21 904	EUR 16 428

ANNEX II

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