http://www.legislation.gov.uk/eur/2008/340/chapter/II/adoptedCommission 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)Commission Regulation (EC) No 340/2008Commission 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)2020-12-13King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0340texttext/xmlen CHAPTER II FEES AND CHARGES Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006 Article 3 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. 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. 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 shall not be refunded or otherwise credited to the registrant. Fees for registrations submitted under Article 17(2), Article 18(2) or (3) or Article 19 of Regulation (EC) No 1907/2006 Article 4 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. 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. 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 shall not be refunded or otherwise credited to the registrant. Fees for updates of a registration under Article 22 of Regulation (EC) No 1907/2006 Article 5 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. 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 expiry of the second deadline, in the case of other updates, the update shall be rejected after the Agency has given formal warning to the registrant. 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 shall not be refunded or otherwise credited to the registrant. Fees for requests under Article 10(a)(xi) of Regulation (EC) No 1907/2006 Article 6 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 on each registrant, 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. Fees and charges for notifications under Article 9 of Regulation (EC) No 1907/2006 Article 7 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 registrant 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 shall not be refunded or otherwise credited to the person making the notification or the request. Fees for applications under Article 62 of Regulation (EC) No 1907/2006 Article 8 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, one use, and one applicant. The Agency shall levy an additional fee, as set out in Annex VI to this Regulation, for each additional use, for each additional substance that meets the definition of a group of substances as defined in Section 1(5) of Annex XI to Regulation (EC) No 1907/2006 and that is covered by the application, and for each additional applicant that is party to the application. For the purposes of this paragraph, each exposure scenario shall be considered a different use. 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. Charges for reviews of authorisations under Article 61 of Regulation (EC) No 1907/2006 Article 9 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, one use, and one applicant. The Agency shall levy an additional charge, as set out in Annex VII to this Regulation, for each additional use, for each additional substance that meets the definition of a group of substances as defined in Section 1(5) of Annex XI to Regulation (EC) No 1907/2006 and that is covered by the review report, and for each additional entity covered by the review report. For the purposes of this paragraph, each exposure scenario shall be considered a different use. 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. Fees for appeals against a decision of the Agency under Article 92 of Regulation (EC) No 1907/2006 Article 10 1 The Agency shall levy a fee, as set out in Annex VIII to this Regulation, for any submission of an appeal against a decision of the Agency under Article 92 of Regulation (EC) No 1907/2006. 2 Where the appeal is submitted by an SME, the Agency shall levy a reduced fee, as set out in Table 2 of Annex VIII. 3 If the appeal is considered inadmissible by the Board of Appeal, the fee shall not be refunded. 4 The Agency shall refund the fee levied in accordance with paragraph 1 of this Article if the Executive Director of the Agency rectifies a decision in accordance with Article 93(1) of Regulation (EC) No 1907/2006, or if the appeal is decided in favour of the appellant. 5 An appeal shall not be considered to be received by the Board of Appeal until the relevant fee has been received by the Agency. Other charges Article 11 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 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. 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 Management Board of the Agency and adopted after a favourable opinion by the Commission. Only representatives Article 12 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. Reductions and fee waiver Article 13 1 A natural or legal person that claims to be entitled to a reduced fee or charge under Articles 3 to 10 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. 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.