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)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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)The structure and amounts of the fees and charges collected by the European Chemicals Agency, hereinafter the ‘Agency’, as well as the rules for payment should be established.
(2)The structure and amount of the fees should take account of the work required by Regulation (EC) No 1907/2006 to be carried out by the Agency and the competent authorities and should be fixed at such a level as to ensure 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. The fees for registration should also take into account the work that may be done pursuant to Title VI of Regulation (EC) No 1907/2006.
(3)A fee should be set for the registration of substances which should depend on the tonnage range of those substances. However, no fee should be levied for registrations covered by Article 74(2) of Regulation (EC) No 1907/2006.
(4)Specific fees should be levied in the case of registrations of isolated intermediates submitted under Article 17(2), Article 18(2) or (3) or Article 19 of Regulation (EC) No 1907/2006.
(5)Requests made in accordance with Article 10(a)(xi) of Regulation (EC) No 1907/2006 should also give rise to the payment of a fee.
(6)A fee should be levied for updates to the registration. In particular, a fee should be paid for updates of the tonnage range, for changes in the identity of the registrant involving a change in legal personality, and for certain changes in the status of the information contained in the registration.
(7)A fee should be levied for the notification of information concerning product and process oriented research and development (PPORD) in accordance with Article 9 of Regulation (EC) No 1907/2006. A charge should be levied also for any request for an extension of a PPORD exemption.
(8)A fee should be levied for the submission of an application for an authorisation. The fee should consist of a base fee that should cover one substance, one use, and one applicant, and additional fees for any additional substance, use, or applicant covered by the application. A charge should also be levied for the submission of a review report.
(9)Reduced fees and charges should apply in the case of certain joint submissions. Reduced fees and charges should also apply to micro, small and medium-sized enterprises (SMEs) within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises(2).
(10)In case of an only representative, the assessment of whether the reduction for SMEs applies should be done 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 that transaction, 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.
(11)Reductions provided for in this Regulation should apply on the basis of a declaration of the entity that claims to be entitled to the reduction. The submission of false information should be discouraged by the imposition of an administrative charge by the Agency and a dissuasive fine by the Member States, if appropriate.
(12)A fee should be levied for any appeal lodged in accordance with Article 92 of Regulation (EC) No 1907/2006. The amount of the fee should take into account the complexity of the work involved.
(13)Fees and charges should be levied in euro only.
(14)A proportion of the fees and charges collected by the Agency should be transferred to the competent authorities of the Member States to compensate them for the work of the rapporteurs of the committees of the Agency and, as appropriate, for other tasks provided for in Regulation (EC) No 1907/2006. The maximum proportion of the fees and charges to be transferred to the competent authorities of the Member States should be determined by the Management Board of the Agency following a favourable opinion from the Commission.
(15)In fixing the amounts to be transferred to the competent authorities of the Member States and in fixing any necessary remuneration in respect of any other agreed work done for the Agency, the Management Board of the Agency should observe the principle of sound financial management as defined in Article 27 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities(3). It should also ensure that the Agency continues to have available sufficient financial resources to undertake its tasks, having regard to existing and pluriannual estimated budgetary appropriations and it should take into account the workload involved for the competent authorities of the Member States.
(16)Deadlines for the payment of fees and charges levied under this Regulation should be fixed taking due account of the deadlines of the procedures provided for in Regulation (EC) No 1907/2006. In particular, the first deadline for payment of the fee in connection with the submission of a registration dossier or the submission of an update should be fixed taking into account the deadlines during which the Agency must perform the completeness check. Likewise, the first deadline for payment of fees in connection with notifications for an exemption from the obligation to register for product and process orientated research and development should be fixed taking into account the deadline provided for in Article 9(5) of Regulation (EC) No 1907/2006. However, a second reasonable deadline should be set by the Agency for payments that are not made before expiry of the first deadline.
(17)Fees and charges provided for under this Regulation should be adapted to take account of inflation and for that purpose the European Index of Consumer Prices published by Eurostat pursuant to Council Regulation (EC) No 2494/95 of 23 October 1995 concerning harmonised indices of consumer prices(4) should be used.
(18)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:
CHAPTER ISUBJECT MATTER AND DEFINITIONS
Article 1Subject matter
This Regulation lays down the amounts, and rules for payment, of the fees and charges levied by the Agency, within the meaning of Regulation (EC) No 1907/2006.
Article 2Definitions
For the purposes of this Regulation:
‘SME’ means a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC;
‘medium enterprise’ means a medium-sized enterprise within the meaning of Recommendation 2003/361/EC;
‘small enterprise’ means a small enterprise within the meaning of Recommendation 2003/361/EC;
‘micro enterprise’ means a micro enterprise within the meaning of Recommendation 2003/361/EC.
In the application of Recommendation 2003/361/EC for the purposes of this Regulation, the Annex to that Recommendation has effect with the following modifications:
(a)in Article 2(1)—
(i)the reference to EUR 50 million has effect as a reference to £43.650 million;
(ii)the reference to EUR 43 million has effect as a reference to £37.539 million;
(b)in Article 2(2) the reference to EUR 10 million has effect as a reference to £8.730 million;
(c)in Article 2(3) the reference to EUR 2 million has effect as a reference to £1.746 million;
(d)in Article 3(2)—
(i)in point (a), the reference to EUR 1,250,000 has effect as a reference to £1,091,250;
(ii)in point (d), the reference to EUR 10 million has effect as a reference to £8.730 million.
CHAPTER IIFEES AND CHARGES
Article 3Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as provided for in paragraphs 2, 3 and 4 of this Article, for any registration of a substance under Article 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.
2.Where the submission for registration of a substance in the range of 1 to 10 tonnes does not contain all the information required in Annex VII to Regulation (EC) No 1907/2006, the Agency shall levy a fee, as set out in Annex I to this 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.
3.In the case of a joint submission the Agency shall levy a reduced fee on each registrant, 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.
4.Where the registrant is an SME, the Agency shall levy a reduced fee, as set out in Table 2 of Annex I.
5.Fees due under paragraphs 1 to 4 shall be paid within 14 calendar days from the date on which the invoice is notified to the registrant by the Agency.
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6.Where the payment is not made before expiry of the deadline provided for in paragraph 5, the Agency shall set a second deadline for the payment. Where the payment is not made before expiry of the second deadline, the registration shall be rejected.
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 4Fees for registrations submitted under Article 17(2), Article 18(2) or (3) or Article 19 of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as provided for in paragraphs 2, 3 and 4 of this Article, for any registration of an on-site or transported isolated intermediate 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.
2.Where the submission for registration of an on-site or transported isolated intermediate in the range of 1 to 10 tonnes does not contain all the information required in Annex VII to Regulation (EC) No 1907/2006, the Agency shall levy a fee, as set out in Annex II to this Regulation.
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.
3.In the case of a joint submission the Agency shall levy a reduced fee on each registrant, 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.
4.Where the registrant is an SME, the Agency shall levy a reduced fee, as set out in Table 2 of Annex II.
5.Fees due under paragraphs 1 to 4 shall be paid within 14 calendar days from the date on which the invoice is notified to the registrant by the Agency.
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6.Where the payment is not made before the expiry of the deadline provided for in paragraph 5, the Agency shall set a second deadline for the payment. Where the payment is not made before the expiry of the second deadline, the registration shall be rejected.
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 5Fees for updates of a registration under Article 22 of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as provided for in paragraphs 2, 3 and 4 of this Article, 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.
2.The Agency shall levy a fee for updates of the tonnage range, as set out in Tables 1 and 2 of Annex III.
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.
3.In the case of an update to a joint submission the Agency shall levy a reduced fee on each registrant submitting the update, as set out in Annex III.
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.
4.Where the registrant is an SME, the Agency shall levy a reduced fee, as set out in Annex III.
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.
5.Fees due under paragraphs 1 to 4 shall be paid within 14 calendar days from the date on which the invoice is notified to the registrant by the Agency.
6.Where the payment is not made before expiry of the deadline provided for in paragraph 5, the Agency shall set a second deadline for the payment.
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.
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.
Article 6Fees for requests under Article 10(a)(xi) of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as provided for in paragraphs 2, 3 and 4 of this Article, for any request under Article 10(a)(xi) of Regulation (EC) No 1907/2006.
2.The Agency shall levy a fee per item for which a request is made, as set out in Annex IV.
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.
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.
4.Where the request is made by an SME, the Agency shall levy a reduced fee, as set out in Table 2 of Annex IV.
5.The date on which the fee levied for a request is received by the Agency shall be considered to be the date of receipt of the request.
Article 7Fees and charges for notifications under Article 9 of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as set out in Table 1 of Annex V to this Regulation, for any notification for an exemption from the general obligation to register for product and process orientated research and development, hereinafter ‘PPORD’, 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.
2.The Agency shall levy a charge, as set out in Table 2 of Annex V to this Regulation, for any request to extend an exemption from the general obligation to register for PPORD under Article 9 of Regulation (EC) No 1907/2006.
Where the request is made by an SME, the Agency shall levy a reduced charge as set out in Table 2 of Annex V.
3.Fees due under paragraph 1 shall be paid within seven calendar days from the date on which the invoice is notified by the Agency to the manufacturer, importer, or producer of articles making the notification.
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.
4.Where the payment is not made before expiry of the deadline provided for in paragraph 3, the Agency shall set a second deadline for the payment.
Where the payment is not made before expiry of the second deadline, the notification or the request for an extension shall be rejected.
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.
Article 8Fees for applications under Article 62 of Regulation (EC) No 1907/2006
1.The Agency shall levy a fee, as provided for in paragraphs 2 and 3 of this Article, for any application for an authorisation of a substance under Article 62 of Regulation (EC) No 1907/2006.
2.The Agency shall levy a base fee for any application for an authorisation of a substance, as set out in Annex VI. The base fee shall cover the application for an authorisation for one substance and one use.
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 issue one invoice covering the base fee and any applicable additional fees.
3.Where the application is submitted by a medium enterprise or by two or more SMEs only, of which the largest enterprise is a medium enterprise, the Agency shall levy a reduced base fee and reduced additional fees, as set out in Table 2 of Annex VI.
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.
4.The date on which the fee levied for the application for an authorisation is received by the Agency shall be considered to be the date of receipt of the application.
Article 9Charges for reviews of authorisations under Article 61 of Regulation (EC) No 1907/2006
1.The Agency shall levy a charge, as provided for in paragraphs 2 and 3 of this Article, for any submission of a review report under Article 61 of Regulation (EC) No 1907/2006.
2.The Agency shall levy a base charge for submission of any review report, as set out in Annex VII. The base charge shall cover the submission of a review report for one substance and one use.
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 issue one invoice covering the base charge and any applicable additional charges.
3.Where the application is submitted by a medium enterprise or by two or more SMEs only, of which the largest enterprise is a medium enterprise, the Agency shall levy a reduced base charge and reduced additional charges, as set out in Table 2 of Annex VII.
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.
4.The date on which the charge levied for submission of the review report is received by the Agency shall be considered to be the date of receipt of the submission.
Article 10Fees for appeals against a decision of the Agency under Article 92 of Regulation (EC) No 1907/2006
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Article 11Other charges
1.A charge may be levied for administrative and technical services provided by the Agency at the request of a party which are not covered by another fee or charge provided for in this Regulation. The level of the charge shall take into account the workload involved.
However, charges shall not be levied for the assistance provided by its Helpdesk ....
The ... Agency may decide not to levy a charge on international organisations or countries that request assistance from the Agency.
2.The charges for administrative services shall be paid within 30 calendar days from the date on which the invoice is notified by the Agency.
3.Where the payment is not made before expiry of the deadline provided for in paragraph 2, the Agency shall set a second deadline for the payment.
Where the payment is not made before expiry of the second deadline, the Agency shall reject the request.
4.In the absence of contractual agreement to the contrary, the charges for technical services shall be paid before the service is provided.
5.A classification of the services and charges shall be drawn up by ... the Agency and adopted after a favourable opinion by the Secretary of State .
The function of the Secretary of State under this paragraph is subject to the consent requirement in Article 4A of Regulation (EC) No 1907/2006.
Article 12Only 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-Great British 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-Great British manufacturer, formulator of a preparation, or producer of an article, in accordance with Recommendation 2003/361/EC.
Article 13Reductions and fee waiver
1.A natural or legal person that claims to be entitled to a reduced fee or charge under Articles 3 to 9 shall inform the Agency thereof at the time of the submission of the registration, update of registration, request, notification, application, review report or appeal giving rise to the payment of the fee.
2.A natural or legal person that claims to be entitled to the fee waiver under Article 74(2) of Regulation (EC) No 1907/2006 shall inform the Agency thereof at the time of the submission of the registration.
3.The Agency may request, at any time, evidence that the conditions for a reduction of fees or charges or for a fee waiver apply.
Where the evidence to be submitted to the Agency is not in English, it shall be accompanied with a certified translation into English.
4.Where a natural or legal person that claims to be entitled to a reduction or a fee waiver cannot demonstrate that it is entitled to such a reduction or waiver, the Agency shall levy the full fee or charge as well as an administrative charge.
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 IIIPAYMENT OF REMUNERATION BY THE AGENCY
Article 14Transfers of funds to Member States
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Article 15Other remuneration
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CHAPTER IVPAYMENTS
Article 16Mode of payment
1.The fees and charges shall be paid in sterling .
2.Payments shall be made only after the Agency has issued an invoice ....
3.Payments shall be made by means of a transfer to the bank account of the Agency.
Article 17Identification of the payment
1.Every payment must indicate in the reference field the submission number assigned by the Agency under Article 20 of Regulation (EC) No 1907/2006.
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2.If the purpose of the payment cannot be established, the Agency shall set a deadline by which the payer must notify it in writing of the purpose of the payment. If the Agency does not receive a notification of the purpose of the payment before expiry of that deadline, the payment shall be considered invalid and the amount concerned shall be refunded to the payer.
Article 18Date of payment
1.The date on which the full amount of the payment is deposited in a bank account held by the Agency shall be considered to be the date on which the payment has been made.
2.The payment shall be considered to have been made in time where sufficient documentary evidence is produced to show that the payer ordered the transfer to the bank account indicated on the invoice before expiry of the relevant deadline.
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 19Insufficient payment
1.A deadline for payment shall be considered to have been observed only if the full amount of the fee or charge has been paid in due time.
2.When an invoice relates to a group of transactions, the Agency may attribute any under-payment to any of the relevant transactions. The criteria for the attribution of payments shall be laid down by ... the Agency.
Article 20Refund of amounts paid in excess
1.The arrangements for the refund to the payer of amounts paid in excess of a fee or a charge shall be fixed by ... the Agency and published on the website of the Agency.
However, where an amount paid in excess is under £87 and the party concerned has not expressly requested a refund, the amount paid in excess shall not be refunded.
2.It shall not be possible to count any amounts paid in excess towards future payments to the Agency.
CHAPTER VFINAL PROVISIONS
Article 21Provisional estimate
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Article 22Amendment of fees and charges
1.The Secretary of State may, by regulations, amend this Regulation so as to alter the fees and charges provided for in it if the Secretary of State considers that the alterations are appropriate having regard to—
(a)the change in the relevant prices index, and
(b)the costs of the Agency (taking one year with another).
2.Regulations under this Article are to be made by statutory instrument.
A statutory instrument containing regulations under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.
The Secretary of State must consult the other appropriate authorities before making regulations under this Article.
3.In this Article—
(a)“appropriate authority” has the same meaning as in Article 3 of Regulation (EC) No 1907/2006;
(b)“relevant prices index” means—
(i)the all items consumer prices index published by the Statistics Board, or
(ii)if that index ceases to be available, such other similar general index of prices which the Secretary of State considers appropriate to use for the purposes of this Article.
Article 23Entry into force
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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
Table 1
Standard fees
| Individual submission | Joint submission | |
|---|---|---|
| Fee for substances in the range of 1 to 10 tonnes | £1,518 | £1,138 |
| Fee for substances in the range 10 to 100 tonnes | £4,080 | £3,061 |
| Fee for substances in the range 100 to 1 000 tonnes | £10,913 | £8,185 |
| Fee for substances above 1 000 tonnes | £29,419 | £22,064 |
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 | £987 | £740 | £532 | £399 | £76 | £57 |
| Fee for substances in the range 10 to 100 tonnes | £2,652 | £1,990 | £1,428 | £1,071 | £204 | £153 |
| Fee for substances in the range 100 to 1 000 tonnes | £7,094 | £5,320 | £3,819 | £2,865 | £546 | £409 |
| Fee for substances above 1 000 tonnes | £19,122 | £14,342 | £10,297 | £7,723 | £1,471 | £1,103 |
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 | £1,518 | £1,138 |
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 | £987 | £740 | £532 | £399 | £76 | £57 |
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 | £2,562 | £1,921 |
| From 1-10 tonnes range to 100- 1 000 tonnes range | £9,395 | £7,046 |
| From 1-10 tonnes range to over 1 000 tonnes range | £27,901 | £20,926 |
| From 10-100 tonnes range to 100- 1 000 tonnes range | £6,833 | £5,125 |
| From 10-100 tonnes range to over 1 000 tonnes range | £25,339 | £19,003 |
| From 100- 1 000 tonnes range to over 1 000 tonnes range | £18,506 | £13,879 |
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 | £1,666 | £1,249 | £897 | £672 | £128 | £96 |
| From 1-10 tonnes range to 100- 1 000 tonnes range | £6,107 | £4,580 | £3,289 | £2,466 | £470 | £353 |
| From 1-10 tonnes range to over 1 000 tonnes range | £18,136 | £13,601 | £9,765 | £7,324 | £1,395 | £1,046 |
| From 10-100 tonnes range to 100- 1 000 tonnes range | £4,441 | £3,331 | £2,391 | £1,794 | £341 | £257 |
| From 10-100 tonnes range to over 1 000 tonnes range | £16,470 | £12,353 | £8,869 | £6,651 | £1,267 | £950 |
| From 100- 1 000 tonnes range to over 1 000 tonnes range | £12,029 | £9,022 | £6,477 | £4,857 | £925 | £694 |
Table 3
Fees for other updates
| Type of update | |||
|---|---|---|---|
| Change in identity of the registrant involving a change in legal personality | £1,424 | ||
| 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 | £4,271 | £3,203 |
| Relevant tonnage band | £1,424 | £1,068 | |
| A study summary or a robust study summary | £4,271 | £3,203 | |
| Information in the safety data sheet | £2,847 | £2,135 | |
| Trade name of the substance | £1,424 | £1,068 | |
| IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 | £1,424 | £1,068 | |
| 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 | £1,424 | £1,068 | |
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 | £925 | £498 | £72 | ||||
| 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 | £2,776 | £2,082 | £1,495 | £1,121 | £214 | £160 |
| Relevant tonnage band | £925 | £694 | £498 | £374 | £72 | £53 | |
| A study summary or a robust study summary | £2,776 | £2,082 | £1,495 | £1,121 | £214 | £160 | |
| Information in the safety data sheet | £1,851 | £1,388 | £996 | £747 | £142 | £107 | |
| Trade name of the substance | £925 | £694 | £498 | £374 | £72 | £53 | |
| IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 | £925 | £694 | £498 | £374 | £72 | £53 | |
| 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 | £925 | £694 | £498 | £374 | £72 | £53 | |
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 | £4,271 | £3,203 |
| Relevant tonnage band | £1,424 | £1,068 |
| A study summary or a robust study summary | £4,271 | £3,203 |
| Information in the safety data sheet | £2,847 | £2,135 |
| Trade name of the substance | £1,424 | £1,068 |
| IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 | £1,424 | £1,068 |
| 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 | £1,424 | £1,068 |
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 | £2,776 | £2,082 | £1,495 | £1,121 | £214 | £160 |
| Relevant tonnage band | £925 | £694 | £498 | £374 | £72 | £53 |
| A study summary or a robust study summary | £2,776 | £2,082 | £1,495 | £1,121 | £214 | £160 |
| Information in the safety data sheet | £1,851 | £1,388 | £996 | £747 | £142 | £107 |
| Trade name of the substance | £925 | £694 | £498 | £374 | £72 | £53 |
| IUPAC name for non-phase-in substances referred to in Article 119(1)(a) of Regulation (EC) No 1907/2006 | £925 | £694 | £498 | £374 | £72 | £53 |
| 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 | £925 | £694 | £498 | £374 | £72 | £53 |
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 | £475 |
| Reduced fee for medium enterprise | £308 |
| Reduced fee for small enterprise | £166 |
| Reduced fee for micro enterprise | £24 |
Table 2
Charges for the extension of a PPORD exemption
| Standard charge | £949 |
| Reduced charge for medium enterprise | £617 |
| Reduced charge for small enterprise | £332 |
| Reduced charge for micro enterprise | £47 |
ANNEX VI Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006
Table 1
Standard fees
| Base fee | £47,229 |
|---|---|
| Additional fee per substance | £9,446 |
| Additional fee per use | £42,506 |
Table 2
Reduced fees for medium enterprises
| Base fee | £35,422 |
|---|---|
| Additional fee per substance | £7,084 |
| Additional fee per use | £31,880 |
Table 3
Reduced fees for small enterprises
| Base fee | £21,253 |
|---|---|
| Additional fee per substance | £4,251 |
| Additional fee per use | £19,128 |
Table 4
Reduced fees for micro enterprises
| Base fee | £4,723 |
|---|---|
| Additional fee per substance | £945 |
| Additional fee per use | £4,251 |
ANNEX VII Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006
Table 1
Standard charges
| Base charge | £47,229 |
|---|---|
| Additional charge per substance | £9,446 |
| Additional charge per use | £42,506 |
Table 2
Reduced charges for medium enterprises
| Base charge | £35,422 |
|---|---|
| Additional charge per substance | £7,084 |
| Additional charge per use | £31,880 |
Table 3
Reduced charges for small enterprises
| Base charge | £21,253 |
|---|---|
| Additional charge per substance | £4,251 |
| Additional charge per use | £19,128 |
Table 4
Reduced charges for micro enterprises
| Base charge | £4,723 |
|---|---|
| Additional charge per substance | £945 |
| Additional charge per use | £4,251 |
ANNEX VIII Fees for appeals under Article 92 of Regulation (EC) NO 1907/2006
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007, p. 3. Regulation as amended by Council Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1).
OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9).
OJ L 257, 27.10.1995, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007, p. 3. Regulation as amended by Council Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1).
OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9).
OJ L 257, 27.10.1995, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).