欧盟Eurlex法规详细信息

EURLEX ID:32013R0348

OJ编号:OJ L 108, 18.4.2013, p. 1-5

中文标题:委员会条例(EU) No 348/2013,修订欧洲议会和理事会条例(EC) No 1907/2006的附件XIV,该条例关于化学品注册、评估、授权和限制(REACH)?(1)

原文标题:Commission Regulation (EU) No 348/2013 of 17 April 2013 amending Annex XIV 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

分类:15.20.30_健康与安全保护

文件类型:二级立法 Regulation|条例

生效日期:2013-04-21

废止日期:2058-12-31

法规全文:查看欧盟官方文件

EN
18.4.2013 Official
Journal
of
the
European
Union L
108/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 348/2013
of 17 April 2013
amending Annex XIV 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,
(3) Chromium
trioxide
meets
the
criteria
for
classification
as
carcinogenic (category 1A) and mutagenic (category 1B)
in accordance with Regulation (EC) No 1272/2008 and
Having regard to the Treaty on the Functioning of the European
therefore meets the criteria for inclusion in Annex XIV to
Union,
Regulation (EC) No 1907/2006 set out in Article 57(a)
and (b) of that Regulation.
Having regard to Regulation (EC) No 1907/2006 of the
European Parliament and of the Council of 18 December
2006 concerning the Registration, Evaluation, Authorisation
(4) Acids
generated
from
chromium
trioxide
and
their
and Restriction of Chemicals (REACH), establishing a
oligomers meet the criteria for classification as carci
European Chemicals Agency, amending Directive 1999/45/EC
nogenic (category 1B) in accordance with Regulation
and repealing Council Regulation (EEC) No 793/93 and
(EC) No 1272/2008 and therefore meet the criteria for
Commission Regulation (EC) No 1488/94 as well as Council
inclusion in Annex XIV to Regulation (EC) No
Directive 76/769/EEC and Commission Directives 91/155/EEC,
1907/2006 set out in Article 57(a) of that Regulation.
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
Articles 58 and 131 thereof,
Whereas:
(5) Sodium
dichromate
meets
the
criteria
for
classification
as

carcinogenic (category 1B), mutagenic (category 1B) and
toxic for reproduction (category 1B) in accordance with
Regulation (EC) No 1272/2008 and therefore meets the
(1) Regulation
(EC)
No
1907/2006
provides
that
substances
criteria for inclusion in Annex XIV to Regulation (EC) No
meeting the criteria for classification as carcinogenic
1907/2006 set out in Article 57(a), (b) and (c) of that
(category 1A or 1B), mutagenic (category 1A or 1B)
Regulation.
and toxic for reproduction (category 1A or 1B) in
accordance with Regulation (EC) No 1272/2008 of the
European Parliament and the Council of 16 December
2008 on classification, labelling and packaging of
substances and mixtures
( 2 ), substances that are
(6) Potassium
dichromate
meets
the
criteria
for
classification
persistent, bioaccumulative and toxic, substances that
as carcinogenic (category 1B), mutagenic (category 1B)
are very persistent and very bioaccumulative, and
and toxic for reproduction (category 1B) in accordance
substances for which there is scientific evidence of
with Regulation (EC) No 1272/2008 and therefore meets
probable serious effects to human health or the
the criteria for inclusion in Annex XIV to Regulation (EC)
environment giving rise to an equivalent level of
No 1907/2006 set out in Article 57(a), (b) and (c) of that
concern may be subject to authorisation.
Regulation.
(2) Trichloroethylene
meets
the
criteria
for
classification
as
carcinogenic (category 1B) in accordance with Regulation
(7) Ammonium
dichromate
meets
the
criteria
for
classifi
(EC) No 1272/2008 and therefore meets the criteria for
cation as carcinogenic (category 1B), mutagenic
inclusion in Annex XIV to Regulation (EC) No
(category 1B) and toxic for reproduction (category 1B)
1907/2006 set out in Article 57(a) of that Regulation.
in accordance with Regulation (EC) No 1272/2008 and
therefore meets the criteria for inclusion in Annex XIV to
( 1 ) OJ L 396, 30.12.2006, p. 1.
Regulation (EC) No 1907/2006 set out in Article 57(a),
( 2 ) OJ L 353, 31.12.2008, p. 1.
(b) and (c) of that Regulation.

L 108/2
EN
Official Journal of the European Union
18.4.2013
(8) Potassium
chromate
meets
the
criteria
for
classification
as
Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006 for
carcinogenic (category 1B) and mutagenic (category 1B)
each of the substances listed in the Annex to this Regu
in accordance with Regulation (EC) No 1272/2008 and
lation. Those dates have been identified on the basis of
therefore meets the criteria for inclusion in Annex XIV to
the estimated time that would be required to prepare an
Regulation (EC) No 1907/2006 set out in Article 57(a)
application for the authorisation, taking into account the
and (b) of that Regulation.
information available on the different substances and the
information received during the public consultation
carried out in accordance with Article 58(4) of Regu
lation (EC) No 1907/2006. The Agency’s capacity to
(9) Sodium
chromate
meets
the
criteria
for
classification
as
carcinogenic (category 1B), mutagenic (category 1B) and
handle applications in the time provided for in the Regu
toxic for reproduction (category 1B) in accordance with
lation (EC) No 1907/2006 has also been taken into
Regulation (EC) No 1272/2008 and therefore meets the
account.
criteria for inclusion in Annex XIV to Regulation (EC) No
1907/2006 set out in Article 57(a), (b) and (c) of that
Regulation.
(14) Concerning
the
seven
chromium
compounds,
the
Agency
proposed the latest application date to be set at 21
months after entry into force of this Regulation.
However, based on a discussion with Member States, a
(10) Those
substances
have
been
identified
and
included
in
broader appreciation of the significance of the specific
the candidate list in accordance with Article 59 of Regu
structure of the relevant markets and the related supply
lation (EC) No 1907/2006. They have furthermore been
chains leads to the conclusion that the latest application
prioritised for inclusion in Annex XIV to Regulation (EC)
date should be set at 35 months after entry into force of
No 1907/2006 by the European Chemicals Agency
this Regulation.
(hereinafter ‘the Agency’) in its recommendation of
20 December 2011 ( 1 ) in accordance with Article 58
of that Regulation. It is therefore appropriate to include
(15) For each of the substances listed in the Annex to this
the substances in that Annex.
Regulation the sunset date referred to in Article 58(1)(c)(i)
of Regulation (EC) No 1907/2006 should be 18 months
after the latest application date referred to in
(11) The
cobalt
compounds
cobalt(II)
sulphate,
cobalt
dich
Article 58(1)(c)(ii) of that Regulation.
loride, cobalt(II) dinitrate, cobalt(II) carbonate and
cobalt(II) diacetate meet the criteria for classification as
carcinogenic (category 1B) and toxic for reproduction
(16) It is appropriate to specify the dates referred to in points
(category 1B) in accordance with Regulation (EC) No
(i) and (ii) of Article 58(1)(c) of Regulation (EC) No
1272/2008 and therefore meet the criteria for inclusion
1907/2006 in Annex XIV to that Regulation.
in Annex XIV to Regulation (EC) No 1907/2006 set out
in Article 57(a) and (c) of that Regulation. They have
been identified and included in the candidate list in
(17) Article 58(1)(e) in conjunction with Article 58(2) of
accordance with Article 59 of Regulation (EC) No
Regulation (EC) No 1907/2006 provides for the possi
1907/2006.
bility of exemptions of uses or categories of uses in cases
where there is specific Union legislation imposing
minimum requirements relating to the protection of
(12) Those
cobalt
compounds
have
also
been
prioritised
for
human health or the environment that ensures proper
inclusion in Annex XIV to Regulation (EC) No
control of the risks. In accordance with the information
1907/2006 by the recommendation of the Agency of
currently available it is not appropriate to set exemptions
20 December 2011 in accordance with Article 58 of
based on those provisions.
that Regulation. However the Commission considers
that at least one of the uses of those substances (i.e.
surface treatment) poses a risk to human health that is
(18) On the basis of the information currently available it is
not adequately controlled and needs to be addressed.
not appropriate to set exemptions for product and
Therefore, in accordance with Article 69(1) of Regulation
process orientated research and development.
(EC) No 1907/2006, the Commission should ask the
Agency to prepare a dossier in accordance with the
requirements of Annex XV to that Regulation. It is
(19) On the basis of the information currently available it is
therefore appropriate to postpone the decision on the
not appropriate to set review periods for certain uses.
inclusion of any of these substances in Annex XIV
until after the process laid down in Articles 69 to 73
of that Regulation is concluded.
(20) Regulation
(EC) No 1907/2006 should therefore be
amended accordingly.
(13) The
Agency’s
recommendation
of
20
December
2011
has identified the latest application dates referred to in
(21) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Committee estab
( 1 ) http://echa.europa.eu/documents/10162/13640/3rd_a_xiv_
lished under Article 133 of Regulation (EC) No
recommendation_20dec2011_en.pdf
1907/2006,

EN
18.4.2013 Official
Journal
of
the
European
Union L
108/3
HAS ADOPTED THIS REGULATION:
Article 1
Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the third day following that 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, 17 April 2013.
For the Commission
The President
José Manuel BARROSO

L 108/4
ANNEX
In the table in Annex XIV to Regulation (EC) No 1907/2006 the following entries are added:
Transitional arrangements
Entry
Exempted (categories
No
Substance
Intrinsic property(ies) referred to
in Article 57
of) uses
Review periods
Latest application date (1 ) Sunset
date
(2 )
EN

‘15. Trichloroethylene
Carcinogenic
21 October 2014 21
April
2016


(category 1B)
EC No: 201-167-4
CAS No: 79-01-6
16. Chromium
trioxide
Carcinogenic
21 March 2016 21
September
2017


(category 1A)
EC No: 215-607-8
Mutagenic
Off
CAS No: 1333-82-0
(category 1B)
icial
Jour
nal
17. Acids
generated
from
chromium
trioxide
and
their
Carcinogenic
21 March 2016 21
September
2017


oligomers
(category 1B)
of
the
Group containing:
European
Chromic acid
EC No: 231-801-5
CAS No: 7738-94-5
Union
Dichromic acid
EC No: 236-881-5
CAS No: 13530-68-2
Oligomers of chromic acid and dichromic acid
EC No: not yet assigned
CAS No: not yet assigned
18. Sodium
dichromate
Carcinogenic
21 March 2016 21
September
2017


(category 1B)
EC No: 234-190-3
Mutagenic
CAS No: 7789-12-0
(category 1B)
18.4.2013
10588-01-9
Toxic for reproduction
(category 1B)

18.4.2013 Off
Transitional arrangements
Entry
Exempted (categories
No
Substance
Intrinsic property(ies) referred to
in Article 57
of) uses
Review periods
Latest application date (1 ) Sunset
date
(2 )
19. Potassium
dichromate
Carcinogenic
21 March 2016 21
September
2017


(category 1B)
EC No: 231-906-6
Mutagenic
CAS No: 7778-50-9
(category 1B)
EN

Toxic for reproduction
(category 1B)
20. Ammonium
dichromate
Carcinogenic
21 March 2016 21
September
2017
(category 1B)
EC No: 232-143-1
Mutagenic
CAS No: 7789-09-5
(category 1B)
Toxic for reproduction
icial
(category 1B)
Jour
nal
21. Potassium
chromate
Carcinogenic
21 March 2016 21
September
2017
(category 1B)
of
EC No: 232-140-5
the
Mutagenic
CAS No: 7789-00-6
(category 1B)
European
22. Sodium
chromate
Carcinogenic
21 March 2016 21
September
2017’
Union
(category 1B)
EC No: 231-889-5
Mutagenic
CAS No: 7775-11-3
(category 1B)
Toxic for reproduction
(category 1B)
(1 ) Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006.
(2 ) Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.
L
108/5

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