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)
Date: 2008-04-16
Institutions: European Commission
Subjects: European Chemicals Agency, chemical product, dangerous substance, market approval, tax system

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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
the Council on the Registration, Evaluation,
1907/2006 of

the European Parliament and of

Authorisation and Restriction of Chemicals (REACH)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

of Chemicals

the
Having regard to Regulation (EC) No 1907/2006 of
European Parliament and of
the Council of 18 December
2006 concerning the Registration, Evaluation, Authorisation
and Restriction
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,

establishing

(REACH),

Whereas:

the fees and charges
The structure and amounts of
collected by the European Chemicals Agency, hereinafter
the ‘Agency’, as well as the rules for payment should be
established.

the fees

The structure and amount of
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.

(5)

(6)

(7)

(8)

(9)

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.

A fee should be levied for updates to the registration. In
the
particular, a fee should be paid for updates of
tonnage range,
the
in the identity of
registrant involving a change in legal personality, and
for certain changes in the status of
the information
contained in the registration.

for changes

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.

A fee should be levied for the submission of an appli-
cation 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.

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
2003/361/EC of
concerning the definition of micro, small and medium-
sized enterprises (2).

6 May

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-
trations covered by Article 74(2) of Regulation (EC) No
1907/2006.

(10)

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.

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
in
connection with that
including relevant
information from linked and partner companies of the
non-Community manufacturer,
a
preparation, or producer of an article,
in accordance
with Recommendation 2003/361/EC.

represented by that only representative
transaction,

formulator

of

is

(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.

(1)

(2)

(3)

(4)

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(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.

fixed taking into account

the deadline
should be
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.

(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 authori-
ties 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 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
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
sound
the Agency should observe the principle of
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 (1). It
should also ensure that the Agency continues to have
available sufficient financial resources to undertake its
tasks, having
and pluriannual
estimated budgetary appropriations and it should take
into account the workload involved for the competent
authorities of the Member States.

to existing

regard

(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
research and development
and process orientated

(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 (2) should be
used.

(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
1907/2006,

HAS ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER AND DEFINITIONS

Article 1

Subject matter

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

Article 2

Definitions

For the purposes of this Regulation:

1.

‘SME’ means a micro, small or medium-sized enterprise
within the meaning of Recommendation 2003/361/EC;

2.

‘medium enterprise’ means a medium-sized enterprise within
the meaning of Recommendation 2003/361/EC;

3.

‘small enterprise’ means a small enterprise within the
meaning of Recommendation 2003/361/EC;

4.

‘micro enterprise’ means a micro enterprise within the
meaning of Recommendation 2003/361/EC.

(1) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regu-

lation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9).

(2) 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).

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CHAPTER II

FEES AND CHARGES

Article 3

made before expiry of the second deadline, the registration shall
be rejected.

Fees 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.

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.

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 infor-
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.

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.

In the case of a joint submission the Agency shall levy a

3.
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.

invoices linked to a registration of a pre-registered
However,
is submitted to the Agency during the two
substance that
months
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.

that precede the relevant

Article 4

for

registrations

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

under Article

isolated

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 Regu-
lation (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
the information required in
tonnes does not contain all
the Agency
Annex VII
shall levy a fee, as set out in Annex II to this Regulation.

to Regulation (EC) No 1907/2006,

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.

In the case of a joint submission the Agency shall levy a

3.
reduced fee on each registrant, as set out in Annex II.

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

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.

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4. Where the registrant is an SME, the Agency shall levy a
reduced fee, as set out in Table 2 of Annex II.

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

Fees due under paragraphs 1 to 4 shall be paid within 14
5.
calendar days from the date on which the invoice is notified to
the registrant by the Agency.

(h) a change in the chemical safety report;

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

invoices linked to a registration of a pre-registered
However,
is submitted to the Agency during the two
substance that
months
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.

that precede the relevant

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.

Article 5

Fees 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.

(j) a notification that a test listed in Annex IX or X to Regu-

lation (EC) No 1907/2006 must be developed;

(k) a request
accessible.

for previously confidential

information to be

The Agency shall levy a fee for updates of the tonnage

2.
range, as set out in Tables 1 and 2 of Annex III.

For other updates, the Agency shall
Tables 3 and 4 of Annex III.

levy a fee, as set out in

In the case of an update to a joint submission the Agency
levy a reduced fee on each registrant submitting the

3.
shall
update, as set out in Annex III.

if part of

the relevant

However,
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 indi-
vidual submission, as set out in Annex III to this Regulation.

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

4. Where the registrant is an SME, the Agency shall levy a
reduced fee, as set out in Annex III.

(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,
involve a change in legal

it does not

provided that
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;

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.

Fees due under paragraphs 1 to 4 shall be paid within 14
5.
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.

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Where the payment is not made before expiry of the second
deadline,
the update shall be
rejected after the Agency has given formal warning to the
registrant.

in the case of other updates,

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.

Article 6

Fees 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.

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.

Fees due under paragraph 1 shall be paid within seven
3.
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.

The Agency shall levy a fee per item for which a request is

2.
made, as set out in Annex IV.

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.

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.

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

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. 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 fees or charges
for an
paid in relation to that notification or that request
extension shall not be refunded or otherwise credited to the
person making the notification or the request.

the deadlines,

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 7

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

levy a fee, as set out in Table 1 of
1.
The Agency shall
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.
Annex V to this Regulation,

The Agency shall levy a charge, as set out in Table 2 of
to extend an

for any request

Article 8

Fees 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, 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.

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For the purposes of this paragraph, each exposure scenario shall
be considered a different use.

small enterprise, the Agency shall levy a reduced base charge
and reduced additional charges, as set out in Table 3 of Annex
VII.

the

application is

submitted by a medium
3. Where
enterprise or by two or more SMEs only, of which the largest
enterprise is a medium enterprise,
levy a
reduced base fee and reduced additional
fees, as set out in
Table 2 of Annex VI.

the Agency shall

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.

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.

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.

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.

The date on which the fee levied for the application for an
4.
authorisation is received by the Agency shall be considered to
be the date of receipt of the application.

Article 9

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

The Agency shall levy a charge, as provided for in para-
1.
graphs 2 and 3 of this Article, for any submission of a review
report under Article 61 of Regulation (EC) No 1907/2006.

Article 10

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
for any submission of an appeal against a
this Regulation,
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.

If the appeal is considered inadmissible by the Board of

3.
Appeal, the fee shall not be refunded.

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.

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.

The Agency shall levy an additional charge, as set out in Annex
VII to this Regulation, for each additional use, for each addi-
substance that meets the definition of a group of
tional
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.

the

application is

3. Where
submitted by a medium
enterprise or by two or more SMEs only, of which the largest
enterprise is a medium enterprise,
levy a
reduced base charge and reduced additional charges, as set
out in Table 2 of Annex VII.

the Agency shall

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.

Article 11

Other 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.

Where the application is submitted by a small enterprise or by
two or more SMEs only, of which the largest enterprise is a

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.

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

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.

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.

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

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

CHAPTER III

PAYMENT OF REMUNERATION BY THE AGENCY

Article 14

Transfers of funds to Member States

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.

1.
A proportion of the fees and charges collected under this
Regulation shall be transferred to the competent authorities of
the Member States in the following cases:

Article 12

Only representatives

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

Article 13

Reductions and fee waiver

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

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

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

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.

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

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.

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

(f) where appropriate,

for other
competent authorities at the request of the Agency.

tasks performed by the

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Official Journal of the European Union

L 107/13

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

Payments shall be made only after the Agency has issued
exception of payments due under

2.
an invoice, with the
Article 10.

The amounts for each of

In fixing the amounts to be transferred,

2.
the tasks identified under
paragraph 1 of this Article and the maximum proportion of
the fees and charges to be transferred to the competent au-
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
Commission.
the
Management Board of the Agency shall comply with the prin-
ciples of economy, efficiency and effectiveness as defined in
It
Article 27 of Regulation (EC, Euratom) No 1605/2002.
shall also ensure that the Agency continues to have available
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
the workload for the competent authorities of
the Member
States.

3.
Transfers provided for in paragraph 1 shall be made only
after the relevant report has been made available to the Agency.

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

The transfers of funds provided for in points (b) to (e) of
4.
paragraph 1 are intended to compensate competent authorities
of a Member State for the work of
the rapporteur or co-
rapporteur and for any related scientific and technical support
and shall be without prejudice to the obligation of Member
States not
to give instructions incompatible with the inde-
pendence of the Agency.

Article 15

Other remuneration

the Management Board of

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

CHAPTER IV

PAYMENTS

Article 16

Mode of payment

1.

The fees and charges shall be paid in euro.

Payments shall be made by means of a transfer to the

3.
bank account of the Agency.

Article 17

Identification of the payment

Every payment must indicate in the reference field the
1.
invoice number, with the exception of payments due under
Article 10.

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

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
shall be considered
invalid and the amount concerned shall be refunded to the
payer.

that deadline,

the payment

Article 18

Date of payment

The date on which the full amount of the payment is
1.
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 insti-
tution shall be regarded as sufficient evidence. However, where
the transfer requires the use of
the SWIFT electronic bank
payment method,
the acknowledgement of provision of the
transfer order shall take the form of a copy of the SWIFT
report, stamped and signed by a duly authorised official of a
financial institution.

Article 19

Insufficient payment

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.

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Official Journal of the European Union

17.4.2008

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 Management Board of the Agency.

following financial year in accordance with Article 96(5) of
Regulation (EC) No 1907/2006, include a specific provisional
estimate of income from fees and charges which is separate
from income from any subsidy from the Community.

Article 20

Refund of amounts paid in excess

Article 22

Review

The arrangements for the refund to the payer of amounts
1.
paid in excess of a fee or a charge shall be fixed by the
Executive Director of
the Agency and published on the
website of the Agency.

The fees and charges provided for in this Regulation shall
1.
be reviewed annually by reference to the inflation rate as
measured by means of
the European Index of Consumer
Prices as published by Eurostat pursuant to 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,
the amount paid in excess shall not be refunded.

It shall not be possible to count any amounts paid in

2.
excess towards future payments to the Agency.

CHAPTER V

FINAL PROVISIONS

Article 21

Provisional estimate

light of

significant

review in the

The Commission shall also keep this Regulation under
2.
continual
information
becoming available in relation to the underlying assumptions
for anticipated income and expenditure of the Agency. At the
latest, by 1 January 2013, the Commission shall review this
Regulation with a view to amend it,
taking
into account in particular the costs of the Agency and the
related costs of the services provided by the competent au-
thorities of the Member States.

if appropriate,

Article 23

Entry into force

The Management Board of the Agency shall, when producing an
the
estimate of

the overall expenditure and income for

This Regulation shall enter into force on the third day following
its publication in the Official Journal of the European Union.

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

Done at Brussels, 16 April 2008.

For the Commission

Günter VERHEUGEN
Vice-President

17.4.2008

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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

Fee for substances in the range of 1 to 10 tonnes

Fee for substances in the range 10 to 100 tonnes

Fee for substances in the range 100 to 1 000 tonnes

Fee for substances above 1 000 tonnes

Individual submission

Joint submission

(EUR)

1 600

4 300

11 500

31 000

1 200

3 225

8 625

23 250

Table 2

Reduced fees for SMEs

(EUR)

Medium
enterprise

Medium
enterprise

Small
enterprise

Small
enterprise

Micro
enterprise

Micro
enterprise

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

1 120

840

640

480

160

120

3 010

2 258

1 720

1 290

430

323

8 050

6 038

4 600

3 450

1 150

863

Fee for substances in the range of 1
to 10 tonnes

Fee for substances in the range 10
to 100 tonnes

Fee for substances in the range 100
to 1 000 tonnes

for

Fee
tonnes

substances

above 1 000

21 700

16 275

12 400

9 300

3 100

2 325

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

Fee

1 600

1 200

Individual submission

Joint submission

Table 2

Reduced fees for SMEs

(EUR)

(EUR)

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

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

From 1-10 tonnes range to 10-100 tonnes range

From 1-10 tonnes range to 100-1 000 tonnes range

From 1-10 tonnes range to over 1 000 tonnes range

From 10-100 tonnes range to 100-1 000 tonnes range

From 10-100 tonnes range to over 1 000 tonnes range

From 100-1 000 tonnes range to over 1 000 tonnes range

Individual submission

Joint submission

(EUR)

2 700

9 900

29 400

7 200

26 700

19 500

2 025

7 425

22 050

5 400

20 025

14 625

Table 2

Reduced fees for SMEs for the update of the tonnage range

(EUR)

Medium
enterprise

Medium
enterprise

Small
enterprise

Small
enterprise

Micro
enterprise

Micro
enterprise

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

1 890

1 418

1 080

810

6 930

5 198

3 960

2 970

270

990

203

743

20 580

15 435

11 760

8 820

2 940

2 205

5 040

3 780

2 880

2 160

720

540

18 690

14 018

10 680

8 010

2 670

2 003

13 650

10 238

7 800

5 850

1 950

1 463

From 1-10 tonnes range to 10-100
tonnes range

From 1-10 tonnes range to 100-
1 000 tonnes range

From 1-10 tonnes range to over
1 000 tonnes range

From 10-100 tonnes range to 100-
1 000 tonnes range

From 10-100 tonnes range to over
1 000 tonnes range

From 100-1 000 tonnes range to
over 1 000 tonnes range

Table 3

Fees for other updates

Type of update

(EUR)

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

1 500

Type of update

Individual submission

Joint submission

Change in the access granted to information in the submission
(per item)

1 500

1 125

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Official Journal of the European Union

17.4.2008

Table 4

Reduced fees for SMEs for other Updates

Type of update

Medium enterprise

Small enterprise

Micro enterprise

(EUR)

Change in identity of the registrant
involving
legal
personality

change

in

a

1 050

600

150

Type of update

Change in the access granted to
information in the submission (per
item)

Medium
enterprise

Medium
enterprise

Small
enterprise

Small
enterprise

Micro
enterprise

Micro
enterprise

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

1 050

788

600

450

150

113

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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

Item for which confidentiality is requested

Individual submission

Joint submission

(EUR)

Degree of purity and/or identity of impurities or additives

Relevant tonnage band

A study summary or a robust study summary

Information in the safety data sheet

Trade name of the substance

IUPAC name for non-phase in substances that are dangerous

IUPAC name for dangerous substances used as intermediates,
in
scientific research and development or product process oriented
research and development

4 500

1 500

4 500

3 000

1 500

1 500

1 500

3 375

1 125

3 375

2 250

1 125

1 125

1 125

Table 2

Reduced fees for SMEs

(EUR)

Item for which confidentiality is
requested

Medium
enterprise

Medium
enterprise

Small
enterprise

Small
enterprise

Micro
enterprise

Micro
enterprise

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

(Individual
submission)

(Joint
submission)

Degree of purity and/or identity of
impurities or additives

3 150

2 363

1 800

1 350

450

338

Relevant tonnage band

1 050

788

600

450

A study summary or a robust study
summary

3 150

2 363

1 800

1 350

Information in the safety data sheet

2 100

1 575

1 200

Trade name of the substance

1 050

IUPAC name
substances that are dangerous

for non-phase

in

1 050

788

788

600

600

900

450

450

150

450

300

150

150

113

338

225

113

113

for

name

IUPAC
dangerous
substances used as intermediates, in
scientific research and development
or
oriented
research and development

product

process

1 050

788

600

450

150

113

L 107/20

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Official Journal of the European Union

17.4.2008

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

Reduced fee for medium enterprise

Reduced fee for small enterprise

Reduced fee for micro enterprise

Table 2

Charges for the extension of a PPORD exemption

Standard charge

Reduced charge for medium enterprise

Reduced charge for small enterprise

Reduced charge for micro enterprise

(EUR)

(EUR)

500

350

200

50

1 000

700

400

100

17.4.2008

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Official Journal of the European Union

L 107/21

ANNEX VI

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

Base fee

Additional fee per substance

Additional fee per use

Additional fee per applicant

Base fee

Additional fee per substance

Additional fee per use

Additional fee per applicant

Base fee

Additional fee per substance

Additional fee per use

Additional fee per applicant

Table 1

Standard fees

EUR 50 000

EUR 10 000

EUR 10 000

Additional applicant is not an SME:
EUR 37 500

Additional applicant is a medium enterprise:
EUR 30 000

Additional applicant is a small enterprise:
EUR 18 750

Additional applicant is a micro enterprise:
EUR 5 625

Table 2

Reduced fees for medium enterprises

EUR 40 000

EUR 8 000

EUR 8 000

Additional applicant is a Medium enterprise:
EUR 30 000

Additional applicant is a Small enterprise:
EUR 18 750

Additional applicant is a Micro enterprise:
EUR 5 625

Table 3

Reduced fees for small enterprises

EUR 25 000

EUR 5 000

EUR 5 000

Additional applicant is a small enterprise:
EUR 18 750

Additional applicant is a micro enterprise:
EUR 5 625

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Official Journal of the European Union

17.4.2008

Table 4

Reduced Fees for micro enterprises

Base fee

Additional fee per substance

Additional fee per use

EUR 7 500

EUR 1 500

EUR 1 500

Additional fee per applicant

Additional applicant: EUR 5 625

17.4.2008

EN

Official Journal of the European Union

L 107/23

ANNEX VII

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

Base charge

Additional charge per use

Additional charge per substance

Additional charge per applicant

Table 1

Standard charges

EUR 50 000

EUR 10 000

EUR 10 000

Additional applicant is not an SME:
EUR 37 500

Additional applicant is a Medium enterprise:
EUR 30 000

Additional applicant is a Small enterprise:
EUR 18 750

Additional applicant is a Micro enterprise:
EUR 5 625

Base charge

Additional charge per use

Additional charge per substance

Additional charge per applicant

Table 2

Reduced charges for medium enterprises

EUR 40 000

EUR 8 000

EUR 8 000

Additional applicant is a medium enterprise:
EUR 30 000

Additional applicant is a small enterprise:
EUR 18 750

Additional applicant is a micro enterprise:
EUR 5 625

Base charge

Additional charge per use

Additional charge per substance

Additional charge per applicant

Table 3

Reduced charges for small enterprises

EUR 25 000

EUR 5 000

EUR 5 000

Additional applicant is a small enterprise:
EUR 18 750

Additional applicant is a micro enterprise:
EUR 5 625

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Official Journal of the European Union

17.4.2008

Table 4

Reduced charges for micro enterprises

Base charge

Additional charge per use

Additional charge per substance

Additional charge per applicant

EUR 7 500

EUR 1 500

EUR 1 500

Additional applicant is a Micro enterprise:
EUR 5 625

17.4.2008

EN

Official Journal of the European Union

L 107/25

ANNEX VIII

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

Table 1

Standard fees

Appeal against decision taken under:

Article 9 or 20 of Regulation (EC) No 1907/2006

Article 27 or 30 of Regulation (EC) No 1907/2006

Article 51 of Regulation (EC) No 1907/2006

Table 2

Reduced fees for SMEs

Appeal against decision taken under:

Article 9 or 20 of Regulation (EC) No 1907/2006

Article 27 or 30 of Regulation (EC) No 1907/2006

Article 51 of Regulation (EC) No 1907/2006

(EUR)

(EUR)

Fee

2 200

4 400

6 600

Fee

1 800

3 600

5 400