Commission Regulation (EU) No 895/2014 of 14 August 2014 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)  Text with EEA relevance
Date: 2014-08-14
Institutions: European Commission
Subjects: carcinogenic substance, health control, health risk, market approval, product safety, reproductive health, toxic substance




L_2014244EN.01000601.xml










19.8.2014   


EN


Official Journal of the European Union


L 244/6








            COMMISSION REGULATION (EU) No 895/2014
of 14 August 2014
         
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning 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)


Formaldehyde, oligomeric reaction products with aniline (technical MDA) meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and the Council (2) 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.












(2)


Arsenic acid 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.












(3)


Bis(2-methoxyethyl) ether (diglyme) 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.












(4)


1,2-dichloroethane (EDC) 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.












(5)


2,2′-dichloro-4,4′-methylenedianiline (MOCA) 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.












(6)


Dichromium tris(chromate) 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.












(7)


Strontium chromate 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.












(8)


Potassium hydroxyoctaoxodizincatedichromate 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.












(9)


Pentazinc chromate octahydroxide 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.












(10)


Those substances have been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006. They have furthermore been prioritised for inclusion in Annex XIV to Regulation (EC) No 1907/2006 by the European Chemicals Agency (hereinafter ‘the Agency’) in its recommendation of 17 January 2013 (3) in accordance with Article 58 of that Regulation. It is therefore appropriate to include those substances in that Annex.












(11)


N,N-Dimethylacetamide (DMAC) 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 also been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 and prioritised for inclusion in Annex XIV to that Regulation by the Agency's recommendation of 17 January 2013 in accordance with Article 58 of that Regulation. DMAC has similar intrinsic properties to those of N-Methyl-2-pyrrolidone (NMP) and both substances may be considered as potential alternatives for some of their major uses. Currently the chemical substance NMP is the subject of a restriction procedure in accordance with Article 69 of Regulation (EC) No 1907/2006.In view of the similarities of the two substances, both regarding their intrinsic properties and their industrial applications, and in order to ensure that a consistent regulatory approach is warranted, the Commission considers it appropriate to postpone the decision on the inclusion of DMAC in Annex XIV.












(12)


It is appropriate to specify the latest application dates and the sunset dates referred to in points (i) and (ii) of Article 58(1)(c) of Regulation (EC) No 1907/2006 in Annex XIV to that Regulation.












(13)


The Agency's recommendation of 17 January 2013 has identified the dates referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006, by which applications must be received if the applicant wishes to continue to use a substance or place it on the market for certain uses, for each of the substances listed in the Annex to this Regulation. Those dates have been identified 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 Regulation (EC) No 1907/2006 has also been taken into account, as provided in Article 58(3) of that Regulation.












(14)


Concerning dichromium tris(chromate), strontium chromate, potassium hydroxyoctaoxodizincatedichromate and pentazinc chromate octahydroxide, which are all chromium (VI) compounds, the Agency proposed the latest application date to be set at 24 months after entry into force of this Regulation. However, the Commission considers that the latest application date should be set at 35 months after entry into force of this Regulation in order to follow the approach used for the seven chromium VI compounds already listed in entries 16 to 22 of Annex XIV to Regulation (EC) No 1907/2006.












(15)


For each of the substances listed in the Annex to this Regulation the date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006 should be set at 18 months after the date referred to in Article 58(1)(c)(ii) of that Regulation.












(16)


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 specific Union legislation imposes minimum requirements relating to the protection of human health or the environment ensuring proper control of the risks. In accordance with the information currently available it is not appropriate to set exemptions based on those provisions.












(17)


On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development.












(18)


On the basis of the information currently available it is not appropriate to set review periods for certain uses.












(19)


Regulation (EC) No 1907/2006 should therefore be amended accordingly.












(20)


The measures provided for in this Regulation are in accordance with the opinion of the Committee established under 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 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, 14 August 2014.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 396, 30.12.2006, p. 1.

(2)  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 (OJ L 353, 31.12.2008, p. 1).

(3)  http://echa.europa.eu/documents/10162/13640/4th_a_xiv_recommendation_17jan2013_en.pdf




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 date (*1)



Sunset date (*2)





‘23.


Formaldehyde, oligomeric reaction products with aniline (technical MDA)
EC No: 500-036-1
CAS No: 25214-70-4


Carcinogenic
(category 1B)


22 February 2016


22 August 2017


—


—




24.


Arsenic acid
EC No: 231-901-9
CAS No: 7778-39-4


Carcinogenic
(category 1A)


22 February 2016


22 August 2017


—


—




25.


Bis(2-methoxyethyl) ether (diglyme)
EC No: 203-924-4
CAS No: 111-96-6


Toxic for reproduction
(category 1B)


22 February 2016


22 August 2017


—


—




26.


1,2-dichloroethane (EDC)
EC No: 203-458-1
CAS No: 107-06-2


Carcinogenic
(category 1B)


22 May 2016


22 November 2017


—


—




27.


2,2′-dichloro-4,4′-methylenedianiline (MOCA)
EC No: 202-918-9
CAS No: 101-14-4


Carcinogenic
(category 1B)


22 May 2016


22 November 2017


—


—




28.


Dichromium tris(chromate)
EC No: 246-356-2
CAS No: 24613-89-6


Carcinogenic
(category 1B)


22 July 2017


22 January 2019


—


—




29.


Strontium chromate
EC No: 232-142-6
CAS No: 7789-06-2


Carcinogenic
(category 1B)


22 July 2017


22 January 2019


—


—




30.


Potassium hydroxyoctaoxodizincatedichromate
EC No: 234-329-8
CAS No: 11103-86-9


Carcinogenic
(category 1A)


22 July 2017


22 January 2019


—


—




31.


Pentazinc chromate octahydroxide
EC No: 256-418-0
CAS No: 49663-84-5


Carcinogenic
(category 1A)


22 July 2017


22 January 2019


—


—’







(*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.