欧盟Eurlex法规详细信息

EURLEX ID:32013R0254

OJ编号:OJ L 79, 21.3.2013, p. 7-18

中文标题:委员会实施条例(EU) No 254/2013,修订条例(EC) No 340/2008,该条依据有关化学品注册、评估、授权和限制(REACH)的欧洲议会和理事会条例(EC) No 1907/2006向欧洲化学品机构收费(1)

原文标题:Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013 amending Regulation (EC) No 340/2008 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) (1)

分类:13.30.18_危险物质

文件类型:二级立法 Regulation|条例

生效日期:2013-03-22

废止日期:2058-12-31

法规全文:查看欧盟官方文件

EN
21.3.2013 Official
Journal
of
the
European
Union
L
79/7
COMMISSION IMPLEMENTING REGULATION (EU) No 254/2013
of 20 March 2013
amending Regulation (EC) No 340/2008 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 EUROPEAN COMMISSION,
(5) With
respect
to
fees
for
applications
under
Article
62
of
Regulation (EC) No 1907/2006 and charges for reviews
of authorisations under Article 61 of that Regulation,
Having regard to the Treaty on the Functioning of the European
each exposure scenario should no longer automatically
Union,
be considered as one use since the number of additional
uses applied for in an authorisation application or auth
Having regard to Regulation (EC) No 1907/2006 of the
orisation review report may not necessarily be identical
European Parliament and of the Council of 18 December
to the number of exposure scenarios included in those
2006 concerning the Registration, Evaluation, Authorisation
submissions.
and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/EC
and repealing Council Regulation (EEC) No 793/93 and
(6)
It should also be clarified that the Agency should issue
Commission Regulation (EC) No 1488/94 as well as Council
one invoice covering the base fee or charge and all
Directive 76/769/EEC and Commission Directives 91/155/EEC,
additional fees or charges, including in cases of joint
93/67/EEC, 93/105/EC and 2000/21/EC (
authorisation applications and joint review reports.

1 ), and in particular

Article 74(1) and Article 132 thereof,
(7) The
Agency
may
request
evidence
that
the
conditions
for
Whereas:
a reduction of fees or charges or for a fee waiver apply.
In order to be able to verify that those conditions are
met, it is necessary to require the submission of such
(1) From
the
review
of
Commission
Regulation
(EC)
No
340/2008 of 16 April 2008 on the fees and charges
evidence in one of the official languages of the Union
payable to the European Chemicals Agency pursuant to
or, if it is available only in another language, with a
Regulation (EC) No 1907/2006 of the European
certified translation into one of the official languages of
Parliament and of the Council on the Registration, Evalu
the Union.
ation, Authorisation and Restriction of Chemicals
(REACH) ( 2 ), conducted pursuant to Article 22(2) of
that Regulation, it results that that Regulation should
(8)
It is also appropriate, following the review of the fees and
be amended in various respects.
charges, in line with Article 22(1) of Regulation (EC) No
340/2008, in the light of the applicable average annual
inflation rate of 3,1 % for April 2012 published by
(2) For
reasons
of
legal
certainty,
it
is
appropriate
to
clarify
Eurostat, to adapt the standard fees and charges in line
the consequences of late payments to the Agency. The
with that rate.
Agency should not refund fees or charges paid before the
rejection of the submission concerned. However, fees or
charges paid after such rejection should be refunded as
(9) The
existing
reduced
fees
and
charges
applicable
to
undue payments.
micro, small and medium-sized enterprises (SMEs)
should be further reduced in order to minimise the regu
latory burden and the numerous practical challenges
(3) With
respect
to
updates
of
a
registration
concerning
faced by SMEs in complying with REACH obligations,
confidentiality claims, it is appropriate that fees should
in particular with the registration obligation, as identified
be applied consistently regardless of when the request is
in the Report from the Commission to the European
made. With respect to updates of a registration other
Parliament, the Council, the European Economic and
than tonnage band updates, it is appropriate to provide
Social Committee and the Committee of the Regions in
for the possibility for the registrant to request an
accordance with Article 117(4) of REACH and
extension of the second deadline for payment of the
Article 46(2) of CLP, and a review of certain elements
corresponding fee in order to give additional time to
of REACH in line with Articles 75(2), 138(2), 138(3) and
the registrant to make the payment.
138(6) of REACH ( 3 ).
(4)
For reasons of legal certainty, it is also appropriate to
clarify the existing provisions on reduced fees for
(10) In
order
to
rebalance
the
distribution
of
fees
and
charges
confidentiality claims in joint submissions or by lead
across various company size classes, the standard fees
registrants.
and charges should be further increased by 4 % in the
registration area and by 3,5 % in the authorisation area
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 2 ) OJ L 107, 17.4.2008, p. 6.
( 3 ) COM(2013) 49 final, SWD(2013) 25 final

L 79/8
EN
Official Journal of the European Union
21.3.2013
taking into account, on the one hand, the costs of the
In the case of an update concerning study summaries
Agency and the related costs of the services provided by
or robust study summaries, the Agency shall levy a fee
the competent authorities of the Member States, and, on
for each study summary or robust study summary for
the other hand, the further reduction of fees and charges
which the update is made.’
for SMEs and the number of SMEs involved.
(b) In paragraph 6, the third subparagraph is replaced by
(11) The
overall
adjustment
of
fees
and
charges
is
fixed
at
the following:
such a level 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
‘Where the payment is not made before the expiry of
1907/2006 is sufficient to cover the cost of the
the second deadline, in the case of other updates, the
services delivered.
Agency shall reject the update. Where the applicant so
requests, the Agency shall extend the second deadline
provided that the request for extension has been
(12) Regulation (EC) No 340/2008 should therefore be
amended accordingly.
submitted before the expiry of the second deadline.

Where the payment is not made before the expiry of
the extended deadline, the Agency shall reject the
(13) For
reasons
of
legal
certainty,
this
Regulation
should
not
update’.
apply to valid submissions which are pending on the
date of entry into force of this Regulation.
(c) Paragraph 7 is replaced by the following:
(14) Given that the phase-in substances referred to in
Article 23(2) of Regulation (EC) No 1907/2006 must
‘7. Where
the
update
has
been
rejected
due
to
the
be registered by 31 May 2013, this Regulation should
failure of the registrant to submit missing information
enter into force as a matter of urgency.
or due to his failure to pay the fee before expiry of the
deadlines, the fees paid in relation to that update
(15) The
measures
provided
for
in
this
Regulation
are
in
before its rejection shall not be refunded or
accordance with the opinion of the Committee estab
otherwise credited to the registrant.’
lished under Article 133 of Regulation (EC) No
1907/2006,
(4) In Article 6, paragraph 3 is replaced by the following:
HAS ADOPTED THIS REGULATION:
‘3. In
the
case
of
a
request
that
refers
to
a
joint
submission, the Agency shall levy a reduced fee, as set
Article 1
out in Annex IV. In the case of a request by the lead
Regulation (EC) No 340/2008 is amended as follows:
registrant, the Agency shall levy a reduced fee to the
lead registrant only, as set out in Annex IV.’
(1) In Article 3, paragraph 7 is replaced by the following:
(5) In Article 7, paragraph 5 is replaced by the following:
‘7. Where
the
registration
has
been
rejected
due
to
the
failure of the registrant to submit missing information or
‘5. Where
a
notification
or
the
request
for
an
extension
due to his failure to pay the fee before expiry of the
has been rejected due to the failure of the manufacturer,
deadlines, the fees paid in relation to that registration
importer, or producer of articles to submit missing
before its rejection shall not be refunded or otherwise
information or due to his failure to pay the fee or
credited to the registrant.’
charges before expiry of the deadlines, the fees or
charges paid in relation to that notification or that
(2) In Article 4, paragraph 7 is replaced by the following:
request for an extension before their respective rejection
shall not be refunded or otherwise credited to the person
‘7. Where
the
registration
has
been
rejected
due
to
the
making the notification or the request.’
failure of the registrant to submit missing information or
due to his failure to pay the fee before expiry of the
(6) In Article 8, the third subparagraph of paragraph 2 is
deadlines, the fees paid in relation to that registration
replaced by the following:
before its rejection shall not be refunded or otherwise
credited to the registrant.’
‘The Agency shall issue one invoice covering the base fee
(3) Article
5
is
amended
as
follows:
and any applicable additional fees, including in the case of
a joint authorisation application.’
(a) In paragraph 2, the following subparagraphs are
inserted after the second subparagraph:
(7) In Article 9, the third subparagraph of paragraph 2 is
replaced by the following:
‘For change in the access granted to information in the
registration, the Agency shall levy a fee per item for
‘The Agency shall issue one invoice covering the base
which an update is made, as set out in Tables 3 and 4
charge and any applicable additional charges, including
of Annex III.
in the case of a joint review report.’

EN
21.3.2013 Official
Journal
of
the
European
Union
L
79/9
(8) In Article 13(3), the following subparagraph is inserted
taking into account in particular the costs of the Agency
after the first subparagraph:
and the related costs of the services provided by the
competent authorities of the Member States.’
‘Where the evidence to be submitted to the Agency is not
in one of the official languages of the Union, it shall be
(10) Annexes I to VIII to Regulation (EC) No 340/2008 are
accompanied with a certified translation into any of those
replaced by the text set out in the Annex to this Regu
official languages.’
lation.
(9) In Article 22, paragraph 2 is replaced by the following:
Article 2
This Regulation shall not apply to valid submissions pending on
‘2. The
Commission
shall
also
keep
this
Regulation 22 March 2013.
under continual review in the light of significant
information becoming available in relation to underlying
Article 3
assumptions for anticipated income and expenditure of the
Agency. By 31 January 2015, the Commission shall review
This Regulation shall enter into force on the day following that
this Regulation with a view to amend it, if appropriate,
of 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, 20 March 2013.
For the Commission
The President
José Manuel BARROSO

L 79/10
EN
Official Journal of the European Union
21.3.2013
ANNEX
‘ANNEX I
Fees for registrations submitted under Articles 6, 7 or 11 of Regulation (EC) No 1907/2006
Table 1
Standard fees
Individual submission Joint
submission
Fee for substances in the range of 1 to 10 tonnes EUR
1
714 EUR
1
285
Fee for substances in the range 10 to 100 tonnes EUR
4
605 EUR
3
454
Fee for substances in the range 100 to 1 000 tonnes EUR
12
317 EUR
9
237
Fee for substances above 1 000 tonnes EUR
33
201 EUR
24
901
Table 2
Reduced fees for SMEs
Medium
Medium
Small enterprise
Small
Micro
Micro
enterprise
enterprise
enterprise
enterprise
enterprise
(Individual
(Joint
(Individual
(Joint
(Individual
(Joint
submission)
submission)
submission)
submission)
submission)
submission)
Fee for substances in the range EUR 1 114 EUR
835 EUR
600 EUR
450 EUR
86 EUR
64
of 1 to 10 tonnes
Fee for substances in the range EUR 2 993 EUR
2
245 EUR
1
612 EUR
1
209 EUR
230 EUR
173
10 to 100 tonnes
Fee for substances in the range EUR 8 006 EUR
6
004 EUR
4
311 EUR
3
233 EUR
616 EUR
462
100 to 1 000 tonnes
Fee for substances above 1 000 EUR 21 581 EUR
16
185 EUR
11
620 EUR
8
715 EUR
1
660 EUR
1
245
tonnes

EN
21.3.2013 Official
Journal
of
the
European
Union L
79/11
ANNEX II
Fees for registrations submitted under Article 17(2), Article 18(2) and (3) or Article 19 of Regulation (EC) No
1907/2006
Table 1
Standard fees
Individual submission Joint
submission
Fee EUR
1
714 EUR
1
285
Table 2
Reduced fees for SMEs
Medium
Medium
Small enterprise Small enterprise Micro enterprise Micro enterprise
enterprise
enterprise
(Individual
(Joint
(Individual
(Joint
(Individual
(Joint
submission)
submission)
submission)
submission)
submission)
submission)
Fee EUR
1
114 EUR
835 EUR
600 EUR
450 EUR
86 EUR
64

L 79/12
EN
Official Journal of the European Union
21.3.2013
ANNEX III
Fees for the update of registrations under Article 22 of Regulation (EC) No 1907/2006
Table 1
Standard fees for the update of the tonnage range
Individual submission Joint
submission
From 1-10 tonnes range to 10-100 tonnes range EUR
2
892 EUR
2
169
From 1-10 tonnes range to 100-1 000 tonnes range EUR
10
603 EUR
7
952
From 1-10 tonnes range to over 1 000 tonnes range EUR
31
487 EUR
23
616
From 10-100 tonnes range to 100-1 000 tonnes range EUR
7
711 EUR
5
783
From 10-100 tonnes range to over 1 000 tonnes range EUR
28
596 EUR
21
447
From 100-1 000 tonnes range to over 1 000 tonnes range EUR
20
885 EUR
15
663
Table 2
Reduced fees for SMEs for the update of the tonnage range
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
EUR 1 880 EUR
1
410 EUR
1
012 EUR
759 EUR
145 EUR
108
10-100 tonnes range
From 1-10 tonnes range to
EUR 6 892 EUR
5
169 EUR
3
711 EUR
2
783 EUR
530 EUR
398
100-1 000 tonnes range
From 1-10 tonnes range to
EUR 20 467 EUR
15
350 EUR
11
021 EUR
8
265 EUR
1
574 EUR
1
181
over 1 000 tonnes range
From 10-100 tonnes range to
EUR 5 012 EUR
3
759 EUR
2
699 EUR
2
024 EUR
386 EUR
289
100-1 000 tonnes range
From 10-100 tonnes range to EUR 18 587 EUR
13
940 EUR
10
008 EUR
7
506 EUR
1
430 EUR
1
072
over 1 000 tonnes range
From 100-1 000 tonnes range EUR 13 575 EUR
10
181 EUR
7
310 EUR
5
482 EUR
1
044 EUR
783
to over 1 000 tonnes range
Table 3
Fees for other updates
Type of update
Change in identity of the EUR 1 607
registrant involving a change
in legal personality
Type of update
Individual
submission
Joint submission
Change in the access granted Degree of purity and/or identity of impurities or EUR 4 820 EUR
3
615
to information in the additives
submission:
Relevant tonnage band EUR
1
607 EUR
1
205

EN
21.3.2013 Official
Journal
of
the
European
Union L
79/13
Type of update
Individual
submission
Joint submission
A study summary or a robust study summary EUR
4
820 EUR
3
615
Information in the safety data sheet EUR
3
213 EUR
2
410
Trade name of the substance EUR
1
607 EUR
1
205
IUPAC name for non-phase-in substances referred to in EUR 1 607 EUR
1
205
Article 119(1)(a) of Regulation (EC) No 1907/2006
IUPAC name for substances referred to in EUR 1 607 EUR
1
205
Article 119(1)(a) of Regulation (EC) No 1907/2006
used as intermediates, in scientific research and devel
opment or in product and process orientated research
and development
Table 4
Reduced fees for SMEs for other updates
Type of update Medium
enterprise Small
enterprise Micro
enterprise
Change in identity of the registrant
EUR 1 044 EUR
562 EUR
80
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 Degree of purity
EUR 3 133 EUR
2
350 EUR
1
687 EUR 1
265 EUR
241 EUR
181
access granted and/or identity of
to information impurities or
in the
additives
submission:
Relevant tonnage
EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
band
A study summary or EUR 3 133 EUR
2
350 EUR
1
687 EUR 1
265 EUR
241 EUR
181
a robust study
summary
Information in the
EUR 2 088 EUR
1
566 EUR
1
125 EUR
843 EUR
161 EUR
120
safety data sheet
Trade name of the
EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
substance
IUPAC name for non- EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
phase-in substances
referred to in
Article 119(1)(a) of
Regulation (EC) No
1907/2006
IUPAC name for
EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
substances referred to
in Article 119(1)(a) of
Regulation (EC) No
1907/2006 used as
intermediates, in
scientific research and
development or in
product and process
orientated research
and development

L 79/14
EN
Official Journal of the European Union
21.3.2013
ANNEX IV
Fees for requests under point (xi) of Article 10(a) of Regulation (EC) No 1907/2006
Table 1
Standard fees
Item for which confidentiality is requested Individual
submission Joint
submission
Degree of purity and/or identity of impurities or
EUR 4 820 EUR
3
615
additives
Relevant tonnage band EUR
1
607 EUR
1
205
A study summary or a robust study summary EUR
4
820 EUR
3
615
Information in the safety data sheet EUR
3
213 EUR
2
410
Trade name of the substance EUR
1
607 EUR
1
205
IUPAC name for non-phase-in substances referred to in
EUR 1 607 EUR
1
205
Article 119(1)(a) of Regulation (EC) No 1907/2006
IUPAC name for substances referred to in
EUR 1 607 EUR
1
205
Article 119(1)(a) of Regulation (EC) No 1907/2006
used as intermediates, in scientific research and devel
opment or in product and process orientated research
and development
Table 2
Reduced fees for SMEs
Medium
Medium
Small
Small
Micro
Micro
Item for which confidentiality is
enterprise
enterprise
enterprise
enterprise
enterprise
enterprise
requested
(Individual
(Joint
(Individual
(Joint
(Individual
(Joint
submission)
submission)
submission)
submission)
submission)
submission)
Degree of purity and/or identity of EUR 3 133 EUR
2
350 EUR
1
687 EUR
1
265 EUR
241 EUR
181
impurities or additives
Relevant tonnage band EUR
1
044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
A study summary or a robust study EUR 3 133 EUR
2
350 EUR
1
687 EUR
1
265 EUR
241 EUR
181
summary
Information in the safety data sheet EUR
2
088 EUR
1
566 EUR
1
125 EUR
843 EUR
161 EUR
120
Trade name of the substance EUR
1
044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
IUPAC name for non-phase-in
EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
substances referred to in
Article 119(1)(a) of Regulation (EC)
No 1907/2006
IUPAC name for substances referred EUR 1 044 EUR
783 EUR
562 EUR
422 EUR
80 EUR
60
to in Article 119(1)(a) of Regulation
(EC) No 1907/2006 used as inter
mediates, in scientific research and
development or in product and
process orientated research and
development

EN
21.3.2013 Official
Journal
of
the
European
Union L
79/15
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 EUR
536
Reduced fee for medium enterprise EUR
348
Reduced fee for small enterprise EUR
187
Reduced fee for micro enterprise EUR
27
Table 2
Charges for the extension of a PPORD exemption
Standard charge EUR
1
071
Reduced charge for medium enterprise EUR
696
Reduced charge for small enterprise EUR
375
Reduced charge for micro enterprise EUR
54

L 79/16
EN
Official Journal of the European Union
21.3.2013
ANNEX VI
Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006
Table 1
Standard fees
Base fee EUR
53
300
Additional fee per substance EUR
10
660
Additional fee per use EUR
10
660
Additional fee per applicant Additional
applicant
is
not
an
SME:
EUR
39
975
Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Table 2
Reduced fees for medium enterprises
Base fee EUR
39
975
Additional fee per substance EUR
7
995
Additional fee per use EUR
7
995
Additional fee per applicant Additional
applicant
is
a
medium
enterprise:
EUR
29
981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Table 3
Reduced fees for small enterprises
Base fee EUR
23
985
Additional fee per substance EUR
4
797
Additional fee per use EUR
4
797
Additional fee per applicant Additional
applicant
is
a
small
enterprise:
EUR
17
989
Additional applicant is a micro enterprise: EUR 3 998
Table 4
Reduced fees for micro enterprises
Base fee EUR
5
330
Additional fee per substance EUR
1
066
Additional fee per use EUR
1
066
Additional fee per applicant Additional
applicant:
EUR
3
998

EN
21.3.2013 Official
Journal
of
the
European
Union L
79/17
ANNEX VII
Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006
Table 1
Standard charges
Base charge EUR
53
300
Additional charge per use EUR
10
660
Additional charge per substance EUR
10
660
Additional charge per applicant Additional
applicant
is
not
an
SME:
EUR
39
975
Additional applicant is a medium enterprise: EUR 29 981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Table 2
Reduced charges for medium enterprises
Base charge EUR
39
975
Additional charge per use EUR
7
995
Additional charge per substance EUR
7
995
Additional charge per applicant Additional
applicant
is
a
medium
enterprise:
EUR
29
981
Additional applicant is a small enterprise: EUR 17 989
Additional applicant is a micro enterprise: EUR 3 998
Table 3
Reduced charges for small enterprises
Base charge EUR
23
985
Additional charge per use EUR
4
797
Additional charge per substance EUR
4
797
Additional charge per applicant Additional
applicant
is
a
small
enterprise:
EUR
17
989
Additional applicant is a micro enterprise: EUR 3 998
Table 4
Reduced charges for micro enterprises
Base charge EUR
5
330
Additional charge per use EUR
1
066
Additional charge per substance EUR
1
066
Additional charge per applicant Additional
applicant
is
a
micro
enterprise:
EUR
3
998

L 79/18
EN
Official Journal of the European Union
21.3.2013
ANNEX VIII
Fees for appeals under Article 92 of Regulation (EC) NO 1907/2006
Table 1
Standard fees
Appeal against decision taken under: Fee
Article 9 or 20 of Regulation (EC) No 1907/2006 EUR
2
356
Article 27 or 30 of Regulation (EC) No 1907/2006 EUR
4
712
Article 51 of Regulation (EC) No 1907/2006 EUR
7
069
Table 2
Reduced fees for SMEs
Appeal against decision taken under: Fee
Article 9 or 20 of Regulation (EC) No 1907/2006 EUR
1
767
Article 27 or 30 of Regulation (EC) No 1907/2006 EUR
3
534
Article 51 of Regulation (EC) No 1907/2006 EUR
5
301’

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