HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 44/2
EN
Official Journal of the European Union
18.2.2011
REGULATIONS
COMMISSION REGULATION (EU) No 143/2011
of 17 February 2011
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,
labelling and packaging of substances and mixtures,
amending and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC) No
1907/2006 ( 3 ), as from 1 December 2010
Article 57(a), (b) and (c) of Regulation (EC) No
Having regard to the Treaty on the Functioning of the European
1907/2006 shall refer to the classification criteria laid
Union,
down respectively in Sections 3.6, 3.5 and 3.7 of
Annex I to Regulation (EC) No 1272/2008. Therefore,
references in this Regulation to the classification criteria
referred to in Article 57 of Regulation (EC) No
Having regard to Regulation (EC) No 1907/2006 of the
1907/2006 should be made in accordance with that
European Parliament and of the Council of 18 December
provision.
2006 concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH), establishing 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
(3) 5-tert-butyl-2,4,6-trinitro-m-xylene
(musk
xylene)
is
very
Directive 76/769/EEC and Commission Directives 91/155/EEC,
persistent and very bioaccumulative in accordance with
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
the criteria for inclusion in Annex XIV to Regulation (EC)
Articles 58 and 131 thereof,
No 1907/2006 pursuant to Article 57(e) and set out in
Annex XIII to that Regulation. It has been identified and
included in the candidate list in accordance with
Article 59 of that Regulation.
Whereas:
(1) Regulation
(EC)
No
1907/2006
provides
that
substances (4) 4,4’-Diaminodiphenylmethane
(MDA)
meets
the
criteria
meeting the criteria for classification as carcinogenic
for classification as carcinogenic (category 1B) in
(category 1 or 2), mutagenic (category 1 or 2) and
accordance with Regulation (EC) No 1272/2008 and
toxic for reproduction (category 1 or 2) in accordance
therefore meets the criteria for inclusion in Annex XIV
with Council Directive 67/548/EEC of 27 June 1967 on
to Regulation (EC) No 1907/2006 pursuant to
the approximation of the laws, regulations and adminis
Article 57(a) of that Regulation. It has been identified
trative provisions relating to the classification, packaging
and included in the candidate list in accordance with
and labelling of dangerous substances (
Article 59 of that Regulation.

2 ), substances that
are persistent, bioaccumulative and toxic, substances that
are very persistent and very bioaccumulative, and/or
substances for which there is scientific evidence of
probable serious effects to human health and
environment giving rise to an equivalent level of
concern may be subject to authorisation.
(5) Alkanes,
C10-13,
chloro
(Short
Chain
Chlorinated
Paraffins – SCCPs) are persistent, bioaccumulative and
toxic, and very persistent and very bioaccumulative in
accordance with the criteria for inclusion in Annex XIV
to Regulation (EC) No 1907/2006 pursuant to
(2) Pursuant
to
Article
58(4)
of
Regulation
(EC)
No
Article 57(d) and (e) respectively and set out in Annex
1272/2008 of the European Parliament and of the
XIII to that Regulation. They have been identified and
Council of 16 December 2008 on classification,
included in the candidate list in accordance with
Article 59 of that Regulation.
( 1 ) OJ L 396, 30.12.2006, p. 1.
( 2 ) OJ 196, 16.8.1967, p. 1.
( 3 ) OJ L 353, 31.12.2008, p. 1.

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EN
18.2.2011 Official
Journal
of
the
European
Union
L
44/3
(6) Hexabromocyclododecane
(HBCDD)
and
the
diaste
(12) For
each
substance
listed
in
Annex
XIV
to
Regulation
reoisomers alpha-, beta- and gamma-hexabromocyclo
(EC) No 1907/2006, where the applicant wishes to
dodecane are persistent, bioaccumulative and toxic in
continue to use the substance or place the substance
accordance with the criteria for inclusion in Annex XIV
on the market, it is appropriate to set a date by which
to Regulation (EC) No 1907/2006 pursuant to
applications must be received by the European Chemicals
Article 57(d) and set out in Annex XIII to that Regu
Agency, in accordance with Article 58(1)(c)(ii) of that
lation. They have been identified and included in the
Regulation.
candidate list in accordance with Article 59 of that Regu
lation.
(13) For
each
substance
listed
in
Annex
XIV
to
Regulation
(EC) No 1907/2006 it is appropriate to set a date
(7) Bis(2-ethylhexyl)
phthalate
(DEHP)
meets
the
criteria
for
from which the use and placing on the market is
classification as toxic for reproduction (category 1B) in
prohibited, in accordance with Article 58(1)(c)(i) of that
accordance with Regulation (EC) No 1272/2008 and
Regulation.
therefore meets the criteria for inclusion in Annex XIV
to Regulation (EC) No 1907/2006 pursuant to
Article 57(c) of that Regulation. It has been identified
and included in the candidate list in accordance with
(14) The
European
Chemicals
Agency
recommendation
of
Article 59 of that Regulation.
1 June 2009 has identified different latest application
dates for the substances listed in the Annex to this Regu
lation. These dates should be set on the basis of the
estimated time that would be required to prepare an
(8) Benzyl
butyl
phthalate
(BBP)
meets
the
criteria
for
clas
application for the authorisation, taking into account
sification as toxic for reproduction (category 1B) in
the information available on the different substances
accordance with Regulation (EC) No 1272/2008 and
and specifically the information received during the
therefore meets the criteria for inclusion in Annex XIV
public consultation carried out in accordance with
to Regulation (EC) No 1907/2006 pursuant to
Article 58(4) of Regulation (EC) No 1907/2006.
Article 57(c) of that Regulation. It has been identified
Factors such as the number of actors in the supply
and included in the candidate list in accordance with
chain, their homogeneity or heterogeneity, the existence
Article 59 of that Regulation.
of ongoing substitution efforts and information on
potential alternatives and the expected complexity of
the preparation of the analysis of alternatives should be
(9) Dibutyl
phthalate
(DBP)
meets
the
criteria
for
classifi
taken into account.
cation as toxic for reproduction (category 1B) in
accordance with Regulation (EC) No 1272/2008 and
therefore meets the criteria for inclusion in Annex XIV
to Regulation (EC) No 1907/2006 pursuant to
(15) In
accordance
with
Article
58(1)(c)(ii)
of
Regulation
(EC)
Article 57(c) of that Regulation. It has been identified
No 1907/2006, the latest application date is to be set at
and included in the candidate list in accordance with
least 18 months before the sunset date.
Article 59 of that Regulation.
(16) Article 58(1)(e) in conjunction with Article 58(2) of
(10) The
abovementioned
substances
have
been
prioritised
for
Regulation (EC) No 1907/2006 provides for the possi
inclusion in Annex XIV to Regulation (EC) No
bility of exemptions of uses or categories of uses in cases
1907/2006 by the European Chemicals Agency in its
where there is specific Community legislation imposing
recommendation of 1 June 2009 (
minimum requirements relating to the protection of

1 ) in accordance with
Article 58 of that Regulation.
human health or the environment that ensures proper
control of the risks.
(11) In
December
2009,
SCCPs
were
included
as
a
persistent
organic pollutant under the 1998 Protocol on Persistent
(17) DEHP, BBP, and DBP are used in the immediate
Organic Pollutants to the 1979 Convention on Long-
packaging of medicinal products. Aspects of safety of
Range Transboundary Air Pollution. The inclusion of
the immediate packaging of medicines are covered by
SCCPs in this Protocol has triggered additional obli
Directive 2001/82/EC of the European Parliament and
gations for the European Union under Regulation (EC)
of the Council of 6 November 2001 on the
No 850/2004 of the European Parliament and of the
Community code relating to veterinary medicinal
Council of 29 April 2004 on persistent organic
products ( 3 ) and Directive 2001/83/EC of the European
pollutants and amending Directive 79/117/EEC ( 2 ) that
Parliament and of the Council of 6 November 2001 on
could have an impact on the inclusion at this stage of
the Community code relating to medicinal products for
SCCPs in Annex XIV to Regulation (EC) No 1907/2006.
human use ( 4 ). That legislation of the Union provides for
a framework to properly control risks of such immediate
( 1 ) http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_
rec_en.asp
( 3 ) OJ L 311, 28.11.2001, p. 1.
( 2 ) OJ L 158, 30.4.2004, p. 7.
( 4 ) OJ L 311, 28.11.2001, p. 67.

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Official Journal of the European Union
18.2.2011
packaging materials by imposing requirements on the
pursuant to Article 58(2) of Regulation (EC) No
quality, stability, and safety of the immediate packaging
1907/2006 apply is not necessary.
materials. It is therefore appropriate to exempt the use of
DEHP, BBP, and DBP in the immediate packaging of
medicinal products from authorisation under Regulation
(19) On the basis of the information currently available it is
(EC) No 1907/2006.
not appropriate to set exemptions for product and
process orientated research and development.
(18) In
accordance
with
Article
60(2)
of
Regulation
(EC)
No
1907/2006, the Commission should not consider, when
(20) On the basis of the information currently available it is
granting authorisations, the human health risks
not appropriate to set review periods for certain uses.
associated with the use of substances in medical
devices regulated by Council Directive 90/385/EEC of
20 June 1990 on the approximation of the laws of the
(21) The
measures
provided
for
in
this
Regulation
are
in
Member States relating to active implantable medical
accordance with the opinion of the Committee estab
devices ( 1 ), Council Directive 93/42/EEC of 14 June
lished pursuant to Article 133 of Regulation (EC)
1993 concerning medical devices
( 2 ), or Directive
No 1907/2006,
98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic
medical devices ( 3 ). In addition, Article 62(6) of Regu
HAS ADOPTED THIS REGULATION:
lation (EC) No 1907/2006 provides that applications
for authorisation should not include the risks to
human health arising from the use of a substance in a
Article 1
medical device regulated under those Directives. It
follows that an application for an authorisation should
Annex XIV to Regulation (EC) No 1907/2006 is amended in
not be required for a substance used in medical devices
accordance with the Annex to this Regulation.
regulated under Directives 90/385/EEC, 93/42/EEC, or
98/79/EC if such a substance has been identified in
Article 2
Annex XIV to Regulation (EC) No 1907/2006 for
human health concerns only. Therefore, an assessment
This Regulation shall enter into force on the third day following
as to whether the conditions for an exemption
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 February 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 189, 20.7.1990, p. 17.
( 2 ) OJ L 169, 12.7.1993, p. 1.
( 3 ) OJ L 331, 7.12.1998, p. 1.

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EN
18.2.2011 Official
Journal
of
the
European
Union
L
44/5
ANNEX
In Annex XIV to Regulation (EC) No 1907/2006 the following table is inserted:
Intrinsic
Transitional arrangements
‘Entry
property(ies)
Exempted (categories of) Review
Nr
Substance
referred to in
Latest application
uses
periods
Article 57
date ( 1 )
Sunset date ( 2 )
1. 5-tert-butyl-2,4,6-
vPvB 21
January
2013 21
July
2014
—
—
trinitro-m-xylene
(Musk xylene)
EC No: 201-329-4
CAS No: 81-15-2
2. 4,4’-Diaminodiphe
Carcinogenic
21 January 2013 21
July
2014
—
—
nylmethane
(category 1B)
(MDA)
EC No: 202-974-4
CAS No: 101-77-9
3. Hexabromocyclodo
PBT 21
January
2014 21
July
2015
—
—
decane
(HBCDD)
EC No: 221-695-9,
247-148-4,
CAS No: 3194-55-6
25637-99-4
alpha-hexabromocyclo
dodecane
CAS No: 134237-50-6,
beta-hexabromocyclo
dodecane
CAS No: 134237-51-7
gamma-hexabromocy-
clododecane
CAS No: 134237-52-8
4. Bis(2-ethylhexyl)
Toxic for
21 July 2013 21
January
2015 Uses in the immediate
phthalate
reproduction
packaging of medicinal
products covered under
(DEHP)
(category 1B)
Regulation (EC) No
EC No: 204-211-0
726/2004, Directive
2001/82/EC, and/or
CAS No: 117-81-7
Directive 2001/83/EC.
5. Benzyl
butyl
phthalate Toxic for
21 July 2013 21
January
2015 Uses in the immediate
reproduction
packaging of medicinal
(BBP)
products covered under
(category 1B)
EC No: 201-622-7
Regulation (EC) No
726/2004, Directive
CAS No: 85-68-7
2001/82/EC, and/or
Directive 2001/83/EC.

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L 44/6
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Official Journal of the European Union
18.2.2011
Intrinsic
Transitional arrangements
Entry
property(ies)
Exempted (categories of) Review
Nr
Substance
referred to in
Latest application
uses
periods
Article 57
date ( 1 )
Sunset date ( 2 )
6. Dibutyl
phthalate
Toxic for
21 July 2013 21
January
2015 Uses in the immediate
reproduction
packaging of medicinal
(DBP)
products covered under
(category 1B)
EC No: 201-557-4
Regulation (EC) No
726/2004, Directive
CAS No: 84-74-2
2001/82/EC, and/or
Directive 2001/83/EC.
( 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.’

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