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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
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 
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 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC (  1 ), and in particular 
Articles 58 and 131 thereof,  
Whereas:  
(1) Regulation (EC) No 1907/2006 provides that substances 
meeting the criteria for classification as carcinogenic 
(category 1 or 2), mutagenic (category 1 or 2) and 
toxic for reproduction (category 1 or 2) in accordance 
with Council Directive 67/548/EEC of 27 June 1967 on 
the approximation of the laws, regulations and adminis ­
trative provisions relating to the classification, packaging 
and labelling of dangerous substances (  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.  
(2) Pursuant to Article 58(4) of Regulation (EC) No 
1272/2008 of the European Parliament and of the 
Council of 16 December 2008 on classification, 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 
1907/2006 shall refer to the classification criteria laid 
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 
1907/2006 should be made in accordance with that 
provision.  
(3) 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) is very 
persistent and very bioaccumulative in accordance with 
the criteria for inclusion in Annex XIV to Regulation (EC) 
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.  
(4) 4,4’-Diaminodiphenylmethane (MDA) meets the criteria 
for classification as carcinogenic (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 
Article 57(a) of that Regulation. It has been identified 
and included in the candidate list in accordance with 
Article 59 of that Regulation.  
(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 
Article 57(d) and (e) respectively and set out in Annex 
XIII to that Regulation. They have been identified and 
included in the candidate list in accordance with 
Article 59 of that Regulation.EN L 44/2 Official Journal of the European Union 18.2.2011  
( 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.(6) Hexabromocyclododecane (HBCDD) and the diaste ­
reoisomers alpha-, beta- and gamma-hexabromocyclo ­
dodecane are persistent, bioaccumulative and toxic in 
accordance with the criteria for inclusion in Annex XIV 
to Regulation (EC) No 1907/2006 pursuant to 
Article 57(d) and set out in Annex XIII to that Regu ­
lation. They have been identified and included in the 
candidate list in accordance with Article 59 of that Regu ­
lation.  
(7) Bis(2-ethylhexyl) phthalate (DEHP) meets the criteria for 
classification 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 
Article 57(c) of that Regulation. It has been identified 
and included in the candidate list in accordance with 
Article 59 of that Regulation.  
(8) Benzyl butyl phthalate (BBP) meets the criteria for clas ­
sification 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 
Article 57(c) of that Regulation. It has been identified 
and included in the candidate list in accordance with 
Article 59 of that Regulation.  
(9) Dibutyl phthalate (DBP) meets the criteria for classifi ­
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 
Article 57(c) of that Regulation. It has been identified 
and included in the candidate list in accordance with 
Article 59 of that Regulation.  
(10) The abovementioned substances have been prioritised for 
inclusion in Annex XIV to Regulation (EC) No 
1907/2006 by the European Chemicals Agency in its 
recommendation of 1 June 2009 (  1 ) in accordance with 
Article 58 of that Regulation.  
(11) In December 2009, SCCPs were included as a persistent 
organic pollutant under the 1998 Protocol on Persistent 
Organic Pollutants to the 1979 Convention on Long- 
Range Transboundary Air Pollution. The inclusion of 
SCCPs in this Protocol has triggered additional obli ­
gations for the European Union under Regulation (EC) 
No 850/2004 of the European Parliament and of the 
Council of 29 April 2004 on persistent organic 
pollutants and amending Directive 79/117/EEC (  2 ) that 
could have an impact on the inclusion at this stage of 
SCCPs in Annex XIV to Regulation (EC) No 1907/2006.  (12) For each substance listed in Annex XIV to Regulation 
(EC) No 1907/2006, where the applicant wishes to 
continue to use the substance or place the substance 
on the market, it is appropriate to set a date by which 
applications must be received by the European Chemicals 
Agency, in accordance with Article 58(1)(c)(ii) of that 
Regulation.  
(13) For each substance listed in Annex XIV to Regulation 
(EC) No 1907/2006 it is appropriate to set a date 
from which the use and placing on the market is 
prohibited, in accordance with Article 58(1)(c)(i) of that 
Regulation.  
(14) The European Chemicals Agency recommendation of 
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 
application for the authorisation, taking into account 
the information available on the different substances 
and specifically the information received during the 
public consultation carried out in accordance with 
Article 58(4) of Regulation (EC) No 1907/2006. 
Factors such as the number of actors in the supply 
chain, their homogeneity or heterogeneity, the existence 
of ongoing substitution efforts and information on 
potential alternatives and the expected complexity of 
the preparation of the analysis of alternatives should be 
taken into account.  
(15) In accordance with Article 58(1)(c)(ii) of Regulation (EC) 
No 1907/2006, the latest application date is to be set at 
least 18 months before the sunset date.  
(16) Article 58(1)(e) in conjunction with Article 58(2) of 
Regulation (EC) No 1907/2006 provides for the possi ­
bility of exemptions of uses or categories of uses in cases 
where there is specific Community legislation imposing 
minimum requirements relating to the protection of 
human health or the environment that ensures proper 
control of the risks.  
(17) DEHP, BBP, and DBP are used in the immediate 
packaging of medicinal products. Aspects of safety of 
the immediate packaging of medicines are covered by 
Directive 2001/82/EC of the European Parliament and 
of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal 
products (  3 ) and Directive 2001/83/EC of the European 
Parliament and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for 
human use (  4 ). That legislation of the Union provides for 
a framework to properly control risks of such immediateEN 18.2.2011 Official Journal of the European Union L 44/3  
( 1 ) http://echa.europa.eu/chem_data/authorisation_pr ocess/annex_xiv_ 
rec_en.asp  
( 2 ) OJ L 158, 30.4.2004, p. 7.  ( 3 ) OJ L 311, 28.11.2001, p. 1.  
( 4 ) OJ L 311, 28.11.2001, p. 67.packaging materials by imposing requirements on the 
quality, stability, and safety of the immediate packaging 
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 
(EC) No 1907/2006.  
(18) In accordance with Article 60(2) of Regulation (EC) No 
1907/2006, the Commission should not consider, when 
granting authorisations, the human health risks 
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 
Member States relating to active implantable medical 
devices (  1 ), Council Directive 93/42/EEC of 14 June 
1993 concerning medical devices (  2 ), or Directive 
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 ­
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 
medical device regulated under those Directives. It 
follows that an application for an authorisation should 
not be required for a substance used in medical devices 
regulated under Directives 90/385/EEC, 93/42/EEC, or 
98/79/EC if such a substance has been identified in 
Annex XIV to Regulation (EC) No 1907/2006 for 
human health concerns only. Therefore, an assessment 
as to whether the conditions for an exemption pursuant to Article 58(2) of Regulation (EC) No 
1907/2006 apply is not necessary.  
(19) On the basis of the information currently available it is 
not appropriate to set exemptions for product and 
process orientated research and development.  
(20) On the basis of the information currently available it is 
not appropriate to set review periods for certain uses.  
(21) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee estab ­
lished pursuant to Article 133 of Regulation (EC) 
No 1907/2006,  
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 
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 BARROSOEN L 44/4 Official Journal of the European Union 18.2.2011  
( 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.ANNEX  
In Annex XIV to Regulation (EC) No 1907/2006 the following table is inserted:  
‘Entry 
Nr Substance  Intrinsic 
property(ies) 
referred to in 
Article 57  Transitional arrangements  
Exempted (categories of) 
uses  Review 
periods Latest application 
date (  1 ) Sunset date (  2 ) 
1. 5-tert-butyl-2,4,6- 
trinitro-m-xylene 
(Musk xylene ) 
EC No: 201-329-4 
CAS No: 81-15-2  vPvB  21 January 2013  21 July 2014  —  —  
2. 4,4’-Diaminodiphe ­
nylmethane  
(MDA)  
EC No: 202-974-4 
CAS No: 101-77-9  Carcinogenic 
(category 1B)  21 January 2013  21 July 2014  —  —  
3. Hexabromocyclodo ­
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  PBT  21 January 2014  21 July 2015  —  —  
4. Bis(2-ethylhexyl) 
phthalate 
(DEHP ) 
EC No: 204-211-0 
CAS No: 117-81-7  Toxic for 
reproduction 
(category 1B)  21 July 2013  21 January 2015  Uses in the immediate 
packaging of medicinal 
products covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC.  
5. Benzyl butyl phthalate 
(BBP ) 
EC No: 201-622-7 
CAS No: 85-68-7  Toxic for 
reproduction 
(category 1B)  21 July 2013  21 January 2015  Uses in the immediate 
packaging of medicinal 
products covered under 
Regulation (EC) No 
726/2004, Directive 
2001/82/EC, and/or 
Directive 2001/83/EC.EN 18.2.2011 Official Journal of the European Union L 44/5Entry 
Nr Substance  Intrinsic 
property(ies) 
referred to in 
Article 57  Transitional arrangements  
Exempted (categories of) 
uses  Review 
periods Latest application 
date (  1 ) Sunset date (  2 ) 
6. Dibutyl phthalate 
(DBP ) 
EC No: 201-557-4 
CAS No: 84-74-2  Toxic for 
reproduction 
(category 1B)  21 July 2013  21 January 2015  Uses in the immediate 
packaging of medicinal 
products covered under 
Regulation (EC) No 
726/2004, Directive 
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.’EN L 44/6 Official Journal of the European Union 18.2.2011