Information about http://www.buyusa.gov/europeanunion/reachfeesregulation.pdf

L 107/6 EN Official Journal of…

Tags: 16 april, 18 december, accordance with article, authorisation, commission of the european communities, council directive, ec, european chemicals, european parliament, european union, legal personality, official journal of the european union, parliament, regard, registrant, relevance, restriction, tonnage, treaty establishing the european community,
Pages: 20
Language: english
Created: Wed Apr 16 20:45:58 2008
Display cached document
Page 1
image
Page 2
image
Page 3
image
Page 4
image
Page 5
image
Page 6
image
Page 7
image
Page 8
image
Page 9
image
Page 10
image
Page 11
image
Page 12
image
Page 13
image
Page 14
image
Page 15
image
Page 16
image
Page 17
image
Page 18
image
Page 19
image
Page 20
image
L 107/6               EN                           Official Journal of the European Union                                      17.4.2008


                                           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,                              (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.
Having regard to the Treaty establishing the European
Community,
                                                                         (6)    A fee should be levied for updates to the registration. In
Having regard to Regulation (EC) No 1907/2006 of the                            particular, a fee should be paid for updates of the
European Parliament and of the Council of 18 December                           tonnage range, for changes in the identity of the
2006 concerning the Registration, Evaluation, Authorisation                     registrant involving a change in legal personality, and
and Restriction of Chemicals (REACH), establishing a                            for certain changes in the status of the information
European Chemicals Agency, amending Directive 1999/45/EC                        contained in the registration.
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               (7)    A fee should be levied for the notification of information
Article 74(1) and Article 132 thereof,                                          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
Whereas:
                                                                                PPORD exemption.

(1)    The structure and amounts of the fees and charges
       collected by the European Chemicals Agency, hereinafter           (8)    A fee should be levied for the submission of an appli-
       the `Agency', as well as the rules for payment should be                 cation for an authorisation. The fee should consist of a
       established.                                                             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.
(2)    The structure and amount of the fees should take                         A charge should also be levied for the submission of a
       account of the work required by Regulation (EC) No                       review report.
       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                  (9)    Reduced fees and charges should apply in the case of
       revenue pursuant to Article 96(1) of Regulation (EC)                     certain joint submissions. Reduced fees and charges
       No 1907/2006 is sufficient to cover the cost of the                      should also apply to micro, small and medium-sized
       services delivered. The fees for registration should also                enterprises (SMEs) within the meaning of Commission
       take into account the work that may be done pursuant                     Recommendation 2003/361/EC of 6 May 2003
       to Title VI of Regulation (EC) No 1907/2006.                             concerning the definition of micro, small and medium-
                                                                                sized enterprises (2).

(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 regis-           (10)   In case of an only representative, the assessment of
       trations covered by Article 74(2) of Regulation (EC) No                  whether the reduction for SMEs applies should be done
       1907/2006.                                                               by reference to the headcount, turnover and balance
                                                                                sheet information of the non-Community manufacturer,
                                                                                formulator of a preparation, or producer of an article
(4)    Specific fees should be levied in the case of registrations              that is represented by that only representative in
       of isolated intermediates submitted under Article 17(2),                 connection with that transaction, including relevant
       Article 18(2) or (3) or Article 19 of Regulation (EC) No                 information from linked and partner companies of the
       1907/2006.                                                               non-Community manufacturer, formulator of a
                                                                                preparation, or producer of an article, in accordance
                                                                                with Recommendation 2003/361/EC.
(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).                              (2) OJ L 124, 20.5.2003, p. 36.
17.4.2008            EN                          Official Journal of the European Union                                          L 107/7


(11)   Reductions provided for in this Regulation should apply                should be fixed taking into account the deadline
       on the basis of a declaration of the entity that claims to             provided for in Article 9(5) of Regulation (EC) No
       be entitled to the reduction. The submission of false                  1907/2006. However, a second reasonable deadline
       information should be discouraged by the imposition                    should be set by the Agency for payments that are not
       of an administrative charge by the Agency and a                        made before expiry of the first deadline.
       dissuasive fine by the Member States, if appropriate.

                                                                       (17)   Fees and charges provided for under this Regulation
                                                                              should be adapted to take account of inflation and for
(12)   A fee should be levied       for any appeal lodged in
                                                                              that purpose the European Index of Consumer Prices
       accordance with Article     92 of Regulation (EC) No
                                                                              published by Eurostat pursuant to Council Regulation
       1907/2006. The amount       of the fee should take into
                                                                              (EC) No 2494/95 of 23 October 1995 concerning
       account the complexity of   the work involved.
                                                                              harmonised indices of consumer prices (2) should be
                                                                              used.

(13)   Fees and charges should be levied in euro only.
                                                                       (18)   The measures provided for in this Regulation are in
                                                                              accordance with the opinion of the Committee estab-
                                                                              lished under Article 133 of Regulation (EC) No
(14)   A proportion of the fees and charges collected by the                  1907/2006,
       Agency should be transferred to the competent authori-
       ties of the Member States to compensate them for the
       work of the rapporteurs of the committees of the Agency         HAS ADOPTED THIS REGULATION:
       and, as appropriate, for other tasks provided for in Regu-
       lation (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                                       CHAPTER I
       by the Management Board of the Agency following a
                                                                                    SUBJECT MATTER AND DEFINITIONS
       favourable opinion from the Commission.
                                                                                                    Article 1
                                                                                                Subject matter
(15)   In fixing the amounts to be transferred to the competent        This Regulation lays down the amounts, and rules for payment,
       authorities of the Member States and in fixing any              of the fees and charges levied by the European Chemicals
       necessary remuneration in respect of any other agreed           Agency, hereinafter the `Agency', as provided for in Regulation
       work done for the Agency, the Management Board of               (EC) No 1907/2006.
       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                                       Article 2
       the general budget of the European Communities (1). It                                     Definitions
       should also ensure that the Agency continues to have
       available sufficient financial resources to undertake its       For the purposes of this Regulation:
       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.                               1. `SME' means a micro, small or medium-sized enterprise
                                                                          within the meaning of Recommendation 2003/361/EC;


(16)   Deadlines for the payment of fees and charges levied            2. `medium enterprise' means a medium-sized enterprise within
       under this Regulation should be fixed taking due                   the meaning of Recommendation 2003/361/EC;
       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       3. `small enterprise' means a small enterprise within the
       an update should be fixed taking into account the                  meaning of Recommendation 2003/361/EC;
       deadlines during which the Agency must perform the
       completeness check. Likewise, the first deadline for
       payment of fees in connection with notifications for an         4. `micro enterprise' means a micro enterprise within the
       exemption from the obligation to register for product              meaning of Recommendation 2003/361/EC.
       and process orientated research and development
                                                                       (2) OJ L 257, 27.10.1995, p. 1. Regulation as amended by Regulation
(1) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regu-         (EC) No 1882/2003 of the European Parliament and of the Council
    lation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9).                 (OJ L 284, 31.10.2003, p. 1).
L 107/8               EN                            Official Journal of the European Union                                       17.4.2008


                            CHAPTER II                                    made before expiry of the second deadline, the registration shall
                                                                          be rejected.
                      FEES AND CHARGES

                              Article 3
Fees for registrations submitted under Articles 6, 7 or 11                7.     Where the registration has been rejected due to the failure
             of Regulation (EC) No 1907/2006                              of the registrant to submit missing information or due to his
                                                                          failure to pay the fee before expiry of the deadlines, the fees
1.   The Agency shall levy a fee, as provided for in paragraphs           paid in relation to that registration shall not be refunded or
2, 3 and 4 of this Article, for any registration of a substance           otherwise credited to the registrant.
under Article 6, 7 or 11 of Regulation (EC) No 1907/2006.


                                                                                                      Article 4
However, no fee shall be levied for the registration of a
substance in a quantity of between 1 and 10 tonnes where                  Fees for registrations submitted under Article 17(2),
the submission of the registration contains all the information           Article 18(2) or (3) or Article 19 of Regulation (EC) No
required in Annex VII to Regulation (EC) No 1907/2006, as                                         1907/2006
provided for in Article 74(2) of that Regulation.
                                                                          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),
2.    Where the submission for registration of a substance in             Article 18(2) or (3) or Article 19 of Regulation (EC) No
the range of 1 to 10 tonnes does not contain all the infor-               1907/2006.
mation 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.
                                                                          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
The Agency shall levy a fee for any registration of a substance           contains all the information required in Annex VII to Regu-
in a quantity of 10 tonnes or more, as set out in Annex I.                lation (EC) No 1907/2006 as provided for in Article 74(2) of
                                                                          that Regulation.

3.   In the case of a joint submission the Agency shall levy a
reduced fee on each registrant, as set out in Annex I.                    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
However, if a registrant submits separately part of the relevant          (EC) No 1907/2006. In the case of registrations of intermediate
information referred to in Article 10(a)(iv), (vi), (vii) and (ix) of     substances that require the information specified in Article 10
Regulation (EC) No 1907/2006, the Agency shall levy a fee for             of Regulation (EC) No 1907/2006, the fees set out in Article 3
an individual submission on that registrant, as set out in Annex          of this Regulation shall apply.
I to this Regulation.

                                                                          2.    Where the submission for registration of an on-site or
4.   Where the registrant is an SME, the Agency shall levy a              transported isolated intermediate in the range of 1 to 10
reduced fee, as set out in Table 2 of Annex I.                            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.

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.                                             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, 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                 3.   In the case of a joint submission the Agency shall levy a
Article 23 of Regulation (EC) No 1907/2006 shall be paid                  reduced fee on each registrant, as set out in Annex II.
within 30 days from the date on which the invoice is notified
to the registrant by the Agency.
                                                                          However, if a registrant submits separately part of the relevant
                                                                          information referred to in Article 17(2)(c) and (d), or
6.    Where the payment is not made before expiry of the                  Article 18(2)(c) and (d) of Regulation (EC) No 1907/2006, the
deadline provided for in paragraph 5, the Agency shall set a              Agency shall levy a fee for an individual submission on that
second deadline for the payment. Where the payment is not                 registrant, as set out in Annex II to this Regulation.
17.4.2008            EN                          Official Journal of the European Union                                           L 107/9


4.   Where the registrant is an SME, the Agency shall levy a           (g) a change in the classification and labelling of the substance;
reduced fee, as set out in Table 2 of Annex II.

                                                                       (h) a change in the chemical safety report;
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.
                                                                       (i) a change in the guidance on safe use;

However, invoices linked to a registration of a pre-registered
substance that is submitted to the Agency during the two               (j) a notification that a test listed in Annex IX or X to Regu-
months that precede the relevant registration deadline of                  lation (EC) No 1907/2006 must be developed;
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.
                                                                       (k) a request for previously confidential information to be
                                                                           accessible.
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              2.    The Agency shall levy a fee for updates of the tonnage
made before the expiry of the second deadline, the registration        range, as set out in Tables 1 and 2 of Annex III.
shall be rejected.

                                                                       For other updates, the Agency shall levy a fee, as set out in
7.     Where the registration has been rejected due to the failure     Tables 3 and 4 of Annex III.
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.                                  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.
                            Article 5
Fees for updates of a registration under Article 22 of                 However, if part of the relevant information referred to in
            Regulation (EC) No 1907/2006                               Article 10(a)(iv), (vi), (vii) and (ix), Article 17(2)(c) and (d), or
1.    The Agency shall levy a fee, as provided for in paragraphs       Article 18(2)(c) and (d) of Regulation (EC) No 1907/2006 is
2, 3 and 4 of this Article, for updates of a registration under        submitted separately, the Agency shall levy a fee for an indi-
Article 22 of Regulation (EC) No 1907/2006.                            vidual submission, as set out in Annex III to this Regulation.


However, the Agency shall not levy a fee for the following             4.   Where the registrant is an SME, the Agency shall levy a
updates of a registration:                                             reduced fee, as set out in Annex III.


(a) a change from a higher to a lower tonnage range;
                                                                       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.
(b) a change from a lower to a higher tonnage range if the
    registrant has previously paid the fee for that higher tonnage
    range;
                                                                       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
(c) a change in the status of the registrant or his identity,          the registrant by the Agency.
    provided that it does not involve a change in legal
    personality;
                                                                       6.    Where the payment is not made before expiry of the
                                                                       deadline provided for in paragraph 5, the Agency shall set a
(d) a change in the composition of the substance;                      second deadline for the payment.


(e) information on new uses including uses advised against;            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
(f) information on new risks of the substance;                         1907/2006, the update shall be rejected.
L 107/10             EN                           Official Journal of the European Union                                      17.4.2008


Where the payment is not made before expiry of the second               exemption from the general obligation to register for PPORD
deadline, in the case of other updates, the update shall be             under Article 9 of Regulation (EC) No 1907/2006.
rejected after the Agency has given formal warning to the
registrant.
                                                                        Where the request is made by an SME, the Agency shall levy a
                                                                        reduced charge as set out in Table 2 of Annex V.
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                3.     Fees due under paragraph 1 shall be paid within seven
otherwise credited to the registrant.                                   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.
                             Article 6
Fees for requests under Article 10(a)(xi) of Regulation (EC)
                                                                        Charges due under paragraph 2 shall be paid within 30 calendar
                      No 1907/2006
                                                                        days from the date on which the invoice is notified by the
1.    The Agency shall levy a fee, as provided for in paragraphs        Agency to the manufacturer, importer, or producer of articles
2, 3 and 4 of this Article, for any request under Article 10(a)(xi)     requesting an extension.
of Regulation (EC) No 1907/2006.

                                                                        4.    Where the payment is not made before expiry of the
2.   The Agency shall levy a fee per item for which a request is        deadline provided for in paragraph 3, the Agency shall set a
made, as set out in Annex IV.                                           second deadline for the payment.


In the case of a request concerning study summaries or robust
                                                                        Where the payment is not made before expiry of the second
study summaries, the Agency shall levy a fee for each study
                                                                        deadline, the notification or the request for an extension shall
summary or robust study summary for which the request is
                                                                        be rejected.
made.


3.   In the case of a request that refers to a joint submission,        5.    Where a notification or the request for an extension has
the Agency shall levy a reduced fee on each registrant, as set out      been rejected due to the failure of the registrant to submit
in Annex IV.                                                            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
4.    Where the request is made by an SME, the Agency shall
                                                                        person making the notification or the request.
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                                    Article 8
by the Agency shall be considered to be the date of receipt of          Fees for applications under Article 62 of Regulation (EC)
the request.                                                                                  No 1907/2006
                                                                        1.   The Agency shall levy a fee, as provided for in paragraphs
                             Article 7                                  2 and 3 of this Article, for any application for an authorisation
                                                                        of a substance under Article 62 of Regulation (EC) No
Fees and charges for notifications under Article 9 of                   1907/2006.
            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                 2.    The Agency shall levy a base fee for any application for an
exemption from the general obligation to register for product           authorisation of a substance, as set out in Annex VI. The base
and process orientated research and development, hereinafter            fee shall cover the application for an authorisation for one
`PPORD', under Article 9 of Regulation (EC) No 1907/2006.               substance, one use, and one applicant.


Where the notification is made by an SME, the Agency shall              The Agency shall levy an additional fee, as set out in Annex VI
levy a reduced fee as set out in Table 1 of Annex V.                    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
2.  The Agency shall levy a charge, as set out in Table 2 of            1907/2006 and that is covered by the application, and for
Annex V to this Regulation, for any request to extend an                each additional applicant that is party to the application.
17.4.2008           EN                          Official Journal of the European Union                                      L 107/11


For the purposes of this paragraph, each exposure scenario shall      small enterprise, the Agency shall levy a reduced base charge
be considered a different use.                                        and reduced additional charges, as set out in Table 3 of Annex
                                                                      VII.

3.    Where the application is submitted by a medium
enterprise or by two or more SMEs only, of which the largest          Where the application is submitted by one or more micro
enterprise is a medium enterprise, the Agency shall levy a            enterprises only, the Agency shall levy a reduced base charge
reduced base fee and reduced additional fees, as set out in           and reduced additional charges as set out in Table 4 of Annex
Table 2 of Annex VI.                                                  VII.


Where the application is submitted by a small enterprise or by
two or more SMEs only, of which the largest enterprise is a           4.    The date on which the charge levied for submission of the
small enterprise, the Agency shall levy a reduced base fee and        review report is received by the Agency shall be considered to
reduced additional fees, as set out in Table 3 of Annex VI.           be the date of receipt of the submission.



Where the application is submitted by one or more micro                                          Article 10
enterprises only, the Agency shall levy a reduced base fee and
reduced additional fees, as set out in Table 4 of Annex VI.           Fees for appeals against a decision of the Agency under
                                                                             Article 92 of Regulation (EC) No 1907/2006
                                                                      1.    The Agency shall levy a fee, as set out in Annex VIII to
4.   The date on which the fee levied for the application for an      this Regulation, for any submission of an appeal against a
authorisation is received by the Agency shall be considered to        decision of the Agency under Article 92 of Regulation (EC)
be the date of receipt of the application.                            No 1907/2006.


                           Article 9                                  2.    Where the appeal is submitted by an SME, the Agency
Charges for reviews of authorisations under Article 61 of             shall levy a reduced fee, as set out in Table 2 of Annex VIII.
             Regulation (EC) No 1907/2006
1.    The Agency shall levy a charge, as provided for in para-
graphs 2 and 3 of this Article, for any submission of a review        3.  If the appeal is considered inadmissible by the Board of
report under Article 61 of Regulation (EC) No 1907/2006.              Appeal, the fee shall not be refunded.


2.    The Agency shall levy a base charge for submission of any       4.   The Agency shall refund the fee levied in accordance with
review report, as set out in Annex VII. The base charge shall         paragraph 1 of this Article if the Executive Director of the
cover the submission of a review report for one substance, one        Agency rectifies a decision in accordance with Article 93(1) of
use, and one applicant.                                               Regulation (EC) No 1907/2006, or if the appeal is decided in
                                                                      favour of the appellant.

The Agency shall levy an additional charge, as set out in Annex
VII to this Regulation, for each additional use, for each addi-       5.   An appeal shall not be considered to be received by the
tional substance that meets the definition of a group of              Board of Appeal until the relevant fee has been received by the
substances as defined in Section 1(5) of Annex XI to Regulation       Agency.
(EC) No 1907/2006 and that is covered by the review report,
and for each additional entity covered by the review report.

                                                                                                 Article 11
For the purposes of this paragraph, each exposure scenario shall                              Other charges
be considered a different use.
                                                                      1.    A charge may be levied for administrative and technical
                                                                      services provided by the Agency at the request of a party which
3.    Where the application is submitted by a medium                  are not covered by another fee or charge provided for in this
enterprise or by two or more SMEs only, of which the largest          Regulation. The level of the charge shall take into account the
enterprise is a medium enterprise, the Agency shall levy a            workload involved.
reduced base charge and reduced additional charges, as set
out in Table 2 of Annex VII.
                                                                      However, charges shall not be levied for the assistance provided
                                                                      by its Helpdesk and for the support to Member States as
Where the application is submitted by a small enterprise or by        provided for in Article 77(2)(h) and (i) of Regulation (EC) No
two or more SMEs only, of which the largest enterprise is a           1907/2006.
L 107/12             EN                           Official Journal of the European Union                                       17.4.2008


The Executive Director of the Agency may decide not to levy a           4.     Where a natural or legal person that claims to be entitled
charge on international organisations or countries that request         to a reduction or a fee waiver cannot demonstrate that it is
assistance from the Agency.                                             entitled to such a reduction or waiver, the Agency shall levy the
                                                                        full fee or charge as well as an administrative charge.

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.                                              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
3.    Where the payment is not made before expiry of the                an administrative charge.
deadline provided for in paragraph 2, the Agency shall set a
second deadline for the payment.

                                                                        Paragraphs 2, 3 and 5 of Article 11 shall apply mutatis mutandis.
Where the payment is not made before expiry of the second
deadline, the Agency shall reject the request.
                                                                                                   CHAPTER III
4.    In the absence of contractual agreement to the contrary,                PAYMENT OF REMUNERATION BY THE AGENCY
the charges for technical services shall be paid before the service
is provided.                                                                                        Article 14
                                                                                    Transfers of funds to Member States

5.    A classification of the services and charges shall be drawn       1.   A proportion of the fees and charges collected under this
up by the Management Board of the Agency and adopted after              Regulation shall be transferred to the competent authorities of
a favourable opinion by the Commission.                                 the Member States in the following cases:



                            Article 12                                  (a) where the competent authority of the Member State notifies
                     Only representatives                                   to the Agency the conclusion of an evaluation procedure for
                                                                            a substance in accordance with Article 46(4) of Regulation
In the case of an only representative referred to in Article 8 of           (EC) No 1907/2006;
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             (b) where the competent authority has appointed a member of
producer of an article that is represented by that only represen-           the Committee for Risk Assessment who acts as rapporteur
tative in connection with the transaction concerned, including              in the context of an authorisation procedure, including in
relevant information from linked and partner companies of the               the context of a review;
non-Community manufacturer, formulator of a preparation, or
producer of an article, in accordance with Recommendation
2003/361/EC.
                                                                        (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 au-
                            Article 13                                      thorisation procedure, including in the context of a review;
                  Reductions and fee waiver
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           (d) where the competent authority of the Member State has
Agency thereof at the time of the submission of the registration,           appointed a member of the Committee for Risk Assessment
update of registration, request, notification, application, review          who acts as rapporteur in the context of a restrictions
report or appeal giving rise to the payment of the fee.                     procedure;


2.    A natural or legal person that claims to be entitled to the       (e) where the competent authority of the Member State has
fee waiver under Article 74(2) of Regulation (EC) No                        appointed a member of the Committee for Socioeconomic
1907/2006 shall inform the Agency thereof at the time of                    Analysis who acts as rapporteur in the context of a
the submission of the registration.                                         restrictions procedure;


3.    The Agency may request, at any time, evidence that the
conditions for a reduction of fees or charges or for a fee waiver       (f) where appropriate, for other tasks performed by the
apply.                                                                      competent authorities at the request of the Agency.
17.4.2008            EN                           Official Journal of the European Union                                         L 107/13


When the Committees referred to in this paragraph decide to             2.    Payments shall be made only after the Agency has issued
appoint a co-rapporteur, the transfer shall be divided between          an invoice, with the exception of payments due under
the rapporteur and the co-rapporteur.                                   Article 10.


2.     The amounts for each of the tasks identified under
paragraph 1 of this Article and the maximum proportion of               3.   Payments shall be made by means of a transfer to the
the fees and charges to be transferred to the competent au-             bank account of the Agency.
thorities of the Member States as well as any arrangements
necessary for the transfer, shall be set by the Management
Board of the Agency following a favourable opinion from the                                          Article 17
Commission. In fixing the amounts to be transferred, the
Management Board of the Agency shall comply with the prin-                                 Identification of the payment
ciples of economy, efficiency and effectiveness as defined in           1.    Every payment must indicate in the reference field the
Article 27 of Regulation (EC, Euratom) No 1605/2002. It                 invoice number, with the exception of payments due under
shall also ensure that the Agency continues to have available           Article 10.
sufficient financial resources 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, and it shall take into account           Payments due under Article 10 shall indicate in the reference
the workload for the competent authorities of the Member                field the identity of the appellant(s) and, if available, the number
States.                                                                 of the decision that is being appealed.


3.     Transfers provided for in paragraph 1 shall be made only
after the relevant report has been made available to the Agency.        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
However, the Management Board of the Agency may decide to               receive a notification of the purpose of the payment before
authorise pre-financing or interim payments in accordance with          expiry of that deadline, the payment shall be considered
Article 81(1) of Regulation (EC, Euratom) No 1605/2002.                 invalid and the amount concerned shall be refunded to the
                                                                        payer.

4.    The transfers of funds provided for in points (b) to (e) of
paragraph 1 are intended to compensate competent authorities                                         Article 18
of a Member State for the work of the rapporteur or co-
rapporteur and for any related scientific and technical support                                  Date of payment
and shall be without prejudice to the obligation of Member
                                                                        1.   The date on which the full amount of the payment is
States not to give instructions incompatible with the inde-
                                                                        deposited in a bank account held by the Agency shall be
pendence of the Agency.
                                                                        considered to be the date on which the payment has been
                                                                        made.
                            Article 15
                      Other remuneration
                                                                        2.    The payment shall be considered to have been made in
In fixing the amounts of the payments made to remunerate                time where sufficient documentary evidence is produced to
experts or co-opted members of the committees for work                  show that the payer ordered the transfer to the bank account
done for the Agency in accordance with Article 87(3) of Regu-           indicated on the invoice before expiry of the relevant deadline.
lation (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,           A confirmation of the transfer order issued by a financial insti-
Euratom) No 1605/2002. It shall also ensure that the Agency             tution shall be regarded as sufficient evidence. However, where
has sufficient financial resources available to undertake its tasks     the transfer requires the use of the SWIFT electronic bank
as defined in Regulation (EC) No 1907/2006, having regard to            payment method, the acknowledgement of provision of the
its existing budgetary appropriations and pluriannual estimates         transfer order shall take the form of a copy of the SWIFT
of income, including a Community subsidy.                               report, stamped and signed by a duly authorised official of a
                                                                        financial institution.

                           CHAPTER IV

                           PAYMENTS                                                                  Article 19

                            Article 16                                                         Insufficient payment

                       Mode of 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
1.   The fees and charges shall be paid in euro.                        paid in due time.
L 107/14            EN                          Official Journal of the European Union                                      17.4.2008


2.    When an invoice relates to a group of transactions, the         following financial year in accordance with Article 96(5) of
Agency may attribute any under-payment to any of the relevant         Regulation (EC) No 1907/2006, include a specific provisional
transactions. The criteria for the attribution of payments shall      estimate of income from fees and charges which is separate
be laid down by the Management Board of the Agency.                   from income from any subsidy from the Community.


                           Article 20                                                              Article 22
             Refund of amounts paid in excess                                                      Review
1.   The arrangements for the refund to the payer of amounts          1.    The fees and charges provided for in this Regulation shall
paid in excess of a fee or a charge shall be fixed by the             be reviewed annually by reference to the inflation rate as
Executive Director of the Agency and published on the                 measured by means of the European Index of Consumer
website of the Agency.                                                Prices as published by Eurostat pursuant to Regulation (EC)
                                                                      No 2494/95. A first review shall be carried out by 1 June 2009.
However, where an amount paid in excess is under EUR 100
and the party concerned has not expressly requested a refund,         2.     The Commission shall also keep this Regulation under
the amount paid in excess shall not be refunded.                      continual review in the light of significant information
                                                                      becoming available in relation to the underlying assumptions
                                                                      for anticipated income and expenditure of the Agency. At the
2.    It shall not be possible to count any amounts paid in           latest, by 1 January 2013, the Commission shall review this
excess towards future payments to the Agency.                         Regulation with a view to amend it, if appropriate, taking
                                                                      into account in particular the costs of the Agency and the
                                                                      related costs of the services provided by the competent au-
                          CHAPTER V                                   thorities of the Member States.
                     FINAL PROVISIONS
                           Article 21                                                              Article 23
                     Provisional estimate                                                     Entry into force
The Management Board of the Agency shall, when producing an           This Regulation shall enter into force on the third day following
estimate of the overall expenditure and income for the                its publication in the Official Journal of the European Union.


                    This Regulation shall be binding in its entirety and directly applicable in all Member States.


                    Done at Brussels, 16 April 2008.


                                                                              For the Commission
                                                                              Günter VERHEUGEN
                                                                                 Vice-President
17.4.2008           EN                             Official Journal of the European Union                                                          L 107/15


                                                                     ANNEX I


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

                                                                      Table 1
                                                                   Standard fees
                                                                                                                                           (EUR)

                                                                                          Individual submission          Joint submission

            Fee for substances in the range of 1 to 10 tonnes                                    1 600                           1 200

            Fee for substances in the range 10 to 100 tonnes                                     4 300                           3 225

            Fee for substances in the range 100 to 1 000 tonnes                                 11 500                           8 625

            Fee for substances above 1 000 tonnes                                               31 000                          23 250



                                                                      Table 2
                                                             Reduced fees for SMEs
                                                                                                                                           (EUR)

                                                      Medium         Medium          Small          Small            Micro            Micro
                                                     enterprise     enterprise     enterprise     enterprise       enterprise       enterprise
                                                     (Individual      (Joint      (Individual       (Joint         (Individual        (Joint
                                                    submission)    submission)   submission)     submission)      submission)      submission)

            Fee for substances in the range of 1       1 120            840            640           480              160                120
            to 10 tonnes

            Fee for substances in the range 10         3 010          2 258          1 720         1 290              430                323
            to 100 tonnes

            Fee for substances in the range 100        8 050          6 038          4 600         3 450            1 150                863
            to 1 000 tonnes

            Fee for substances above 1 000           21 700         16 275         12 400          9 300            3 100            2 325
            tonnes
L 107/16          EN                            Official Journal of the European Union                                                               17.4.2008


                                                                    ANNEX II


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

                                                                      Table 1
                                                                   Standard fees
                                                                                                                                             (EUR)

                                                                          Individual submission                       Joint submission

           Fee                                                                       1 600                                    1 200



                                                                      Table 2
                                                           Reduced fees for SMEs
                                                                                                                                             (EUR)

                                 Medium
                                                   Medium           Small enterprise                         Micro enterprise
                                enterprise                                              Small enterprise                         Micro enterprise
                                                  enterprise
                                                                       (Individual                              (Individual
                                (Individual                                             (Joint submission)                      (Joint submission)
                                              (Joint submission)      submission)                              submission)
                               submission)

           Fee                   1 120              840                  640                  480                 160                  120
17.4.2008           EN                             Official Journal of the European Union                                                            L 107/17


                                                                      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
                                                                                                                                             (EUR)

                                                                                           Individual submission           Joint submission

            From 1-10 tonnes range to 10-100 tonnes range                                           2 700                          2 025

            From 1-10 tonnes range to 100-1 000 tonnes range                                        9 900                          7 425

            From 1-10 tonnes range to over 1 000 tonnes range                                      29 400                         22 050

            From 10-100 tonnes range to 100-1 000 tonnes range                                      7 200                          5 400

            From 10-100 tonnes range to over 1 000 tonnes range                                    26 700                         20 025

            From 100-1 000 tonnes range to over 1 000 tonnes range                                 19 500                         14 625



                                                                        Table 2
                                       Reduced fees for SMEs for the update of the tonnage range
                                                                                                                                             (EUR)

                                                        Medium        Medium          Small            Small           Micro            Micro
                                                       enterprise    enterprise     enterprise       enterprise      enterprise       enterprise
                                                       (Individual      (Joint      (Individual        (Joint        (Individual        (Joint
                                                      submission)    submission)   submission)      submission)     submission)      submission)

            From 1-10 tonnes range to 10-100             1 890          1 418         1 080               810            270               203
            tonnes range

            From 1-10 tonnes range to 100-               6 930          5 198         3 960           2 970              990               743
            1 000 tonnes range

            From 1-10 tonnes range to over             20 580         15 435        11 760            8 820             2 940          2 205
            1 000 tonnes range

            From 10-100 tonnes range to 100-             5 040          3 780         2 880           2 160              720               540
            1 000 tonnes range

            From 10-100 tonnes range to over           18 690         14 018        10 680            8 010             2 670          2 003
            1 000 tonnes range

            From 100-1 000 tonnes range to             13 650         10 238          7 800           5 850             1 950          1 463
            over 1 000 tonnes range



                                                                        Table 3
                                                                Fees for other updates
                                                                                                                                             (EUR)

                                     Type of update

            Change in identity of the registrant involving a change in legal                                    1 500
            personality

                                     Type of update                                  Individual submission                Joint submission

            Change in the access granted to information in the submission                         1 500                            1 125
            (per item)
L 107/18           EN                              Official Journal of the European Union                                                           17.4.2008


                                                                     Table 4
                                                  Reduced fees for SMEs for other Updates
                                                                                                                                            (EUR)

                        Type of update                 Medium enterprise             Small enterprise                 Micro enterprise

           Change in identity of the registrant              1 050                            600                              150
           involving a change in legal
           personality

                                                     Medium        Medium          Small              Small         Micro              Micro
                                                    enterprise    enterprise     enterprise         enterprise    enterprise         enterprise
                        Type of update
                                                    (Individual      (Joint      (Individual       (Joint         (Individual       (Joint
                                                   submission)    submission)   submission)     submission)      submission)     submission)

           Change in the access granted to           1 050           788           600                450           150                113
           information in the submission (per
           item)
17.4.2008           EN                                 Official Journal of the European Union                                                          L 107/19


                                                                            ANNEX IV


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

                                                                             Table 1
                                                                       Standard fees
                                                                                                                                               (EUR)

                              Item for which confidentiality is requested                      Individual submission          Joint submission

            Degree of purity and/or identity of impurities or additives                               4 500                           3 375

            Relevant tonnage band                                                                     1 500                           1 125

            A study summary or a robust study summary                                                 4 500                           3 375

            Information in the safety data sheet                                                      3 000                           2 250

            Trade name of the substance                                                               1 500                           1 125

            IUPAC name for non-phase in substances that are dangerous                                 1 500