Commission Regulation (EU) No 125/2012
of 14 February 2012
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,
Whereas:
Diisobutyl phthalate (DIBP) 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 set out in Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Diarsenic trioxide meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Diarsenic pentaoxide meets the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Lead chromate meets the criteria for classification as carcinogenic (category 1B) and toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) and (c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Lead sulfochromate yellow (C.I. Pigment Yellow 34) meets the criteria for classification as carcinogenic (category 1B) and toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) and (c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) meets the criteria for classification as carcinogenic (category 1B) and toxic for reproduction (category 1A) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) and (c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Tris (2-chloroethyl) phosphate (TCEP) 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 set out in Article 57(c) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
2,4-Dinitrotoluene (2,4 DNT) 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 set out in Article 57(a) of that Regulation. It has been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
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.
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.
The European Chemicals Agency recommendation of 17 December 2010 has identified different latest application dates for the substances listed in the Annex to this Regulation. 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 the information received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006. The Agency’s capacity to handle applications in the time provided for in the Regulation (EC) No 1907/2006 should also be taken into account.
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.
Diisobutyl phthalate is an alternative substance to dibutyl phthalate which is already included in Annex XIV to Regulation (EC) No 1907/2006. In order to avoid potential substitution between these two substances, the latest application date for diisobutyl phthalate should be set as close as possible to the latest application date set out for dibutyl phthalate.
Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where there is specific EU legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of the risks. In accordance with the information currently available it is not appropriate to set exemptions based on those provisions.
On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development.
On the basis of the information currently available it is not appropriate to set review periods for certain uses.
The measures provided for in this Regulation are in accordance with the opinion of the Committee established 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, 14 February 2012.
For the Commission
The President
José Manuel Barroso
ANNEX
In the table in Annex XIV to Regulation (EC) No 1907/2006 the following entries are added:
Entry Nr
Substance
Intrinsic property(ies) referred to in Article 57
Transitional arrangements
Exempted (categories of) uses
Review periods
Latest application date4 Sunset date5‘7.
Diisobutyl phthalate (DIBP)
EC No: 201-553-2
CAS No: 84-69-5
Toxic for reproduction
(category 1B)
21 August 2013
21 February 2015
—
—
8.
Diarsenic trioxide
EC No: 215-481-4
CAS No: 1327-53-3
Carcinogenic
(category 1A)
21 November 2013
21 May 2015
—
—
9.
Diarsenic pentaoxide
EC No: 215-116-9
CAS No: 1303-28-2
Carcinogenic
(category 1A)
21 November 2013
21 May 2015
—
—
10.
Lead chromate
EC No: 231-846-0
CAS No: 7758-97-6
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
21 November 2013
21 May 2015
—
—
11.
Lead sulfochromate yellow
(C.I. Pigment Yellow 34)
EC No: 215-693-7
CAS No: 1344-37-2
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
21 November 2013
21 May 2015
—
—’
12.
Lead chromate molybdate sulphate red
(C.I. Pigment Red 104)
EC No: 235-759-9
CAS No: 12656-85-8
Carcinogenic
(category 1B)
Toxic for reproduction
(category 1A)
21 November 2013
21 May 2015
13.
Tris (2-chloroethyl) phosphate
(TCEP)
EC No: 204-118-5
CAS No: 115-96-8
Toxic for reproduction
(category 1B)
21 February 2014
21 August 2015
14.
2,4-Dinitrotoluene (2,4-DNT)
EC No: 204-450-0
CAS No: 121-14-2
Carcinogenic
(category 1B)
21 February 2014
21 August 2015