Commission Regulation (EU) No 317/2014 of 27 March 2014 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances)  Text with EEA relevance
Date: 2014-03-27
Institutions: European Commission
Subjects: carcinogenic substance, chemical product, health control, health risk, market approval, toxic substance








L_2014093EN.01002401.xml










28.3.2014   


EN


Official Journal of the European Union


L 93/24








            COMMISSION REGULATION (EU) No 317/2014
of 27 March 2014
         
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances)
(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 Article 68(2) thereof,

Whereas:







(1)


Annex XVII to Regulation (EC) No 1907/2006, in its entries 28 to 30, prohibits the sale to the general public of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B or of mixtures containing them in concentration above specified concentration limits. The substances concerned are listed in Appendices 1 to 6 to Annex XVII.












(2)


Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) was amended by Commission Regulations (EU) No 618/2012 (3) and (EU) No 944/2013 (4) for the purposes of its adaptation to technical and scientific progress, in order to update or include a number of new harmonised classifications of CMR substances.












(3)


Regulation (EU) No 618/2012 establishes a new harmonised classification for the following substances: indium phosphide has been classified as carcinogenic 1B, trixylyl phosphate and 4-tert-butylbenzoic acid have been classified as reproductive toxicant 1B.












(4)


Regulation (EU) No 944/2013 establishes a new harmonised classification for the following substances: [pitch, coal tar, high-temp.] has been classified as carcinogenic 1A; gallium arsenide has been classified as carcinogenic 1B; [pitch, coal tar, high-temp.] has been classified as mutagenic 1B; [pitch, coal tar, high-temp.], epoxiconazole (ISO), nitrobenzene, dihexyl phthalate, N-ethyl-2-pyrrolidone, ammoniumpentadecafluorooctanoate, perfluorooctanoic acid and 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate have been classified as reproductive toxicant 1B.












(5)


As operators may apply the harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008 at an earlier date, they should be able to apply the provisions of this Regulation earlier, on a voluntary basis.












(6)


Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006 should be amended accordingly.












(7)


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 XVII to Regulation (EC) No 1907/2006 is amended in accordance with Annexes I, II and III to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex I to this Regulation shall apply from 1 April 2014.
Annex II to this Regulation shall apply from 1 January 2015.
Annex III to this Regulation shall apply from 1 April 2016.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 March 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 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 (OJ L 353, 31.12.2008, p. 1).

(3)  Commission Regulation (EU) No 618/2012 of 10 July 2012 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 179, 11.7.2012, p. 3).

(4)  Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 261, 3.10.2013, p. 5).




ANNEX I
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:






(1)


In Appendix 2, the following entry is inserted in the table in accordance with the order of the entries set out therein:









‘indium phosphide


015-200-00-3


244-959-5


22398-80-7’


 














(2)


In Appendix 6, the following entries are inserted in the table in accordance with the order of the entries set out therein:









‘trixylyl phosphate


015-201-00-9


246-677-8


25155-23-1


 




4-tert-butylbenzoic acid


607-698-00-1


202-696-3


98-73-7’


 













ANNEX II
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:






(1)


In Appendix 2, the following entry is inserted in the table in accordance with the order of the entries set out therein:









‘gallium arsenide


031-001-00-4


215-114-8


1303-00-0’


 














(2)


In Appendix 6, the following entries are inserted in the table in accordance with the order of the entries set out therein:









‘epoxiconazole (ISO);
(2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane


613-175-00-9


406-850-2


133855-98-8


 




nitrobenzene


609-003-00-7


202-716-0


98-95-3


 




dihexyl phthalate


607-702-00-1


201-559-5


84-75-3


 




N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one


616-208-00-5


220-250-6


2687-91-4


 




ammoniumpentadecafluorooctanoate


607-703-00-7


223-320-4


3825-26-1


 




perfluorooctanoic acid


607-704-00-2


206-397-9


335-67-1


 




2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate


050-027-00-7


239-622-4


15571-58-1’


 













ANNEX III
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:






(1)


In Appendix 1, the following entry is inserted in the table in accordance with the order of the entries set out therein:









‘pitch, coal tar, high-temp.;
(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)


648-055-00-5


266-028-2


65996-93-2’


 














(2)


In Appendix 2, the following entry is deleted:









‘pitch, coal tar, high-temp.;
(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)


648-055-00-5


266-028-2


65996-93-2’


 














(3)


In Appendix 4, the following entry is inserted in the table in accordance with the order of the entries set out therein:









‘pitch, coal tar, high-temp.;
(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)


648-055-00-5


266-028-2


65996-93-2’


 














(4)


In Appendix 6, the following entry is inserted in the table in accordance with the order of the entries set out therein:









‘pitch, coal tar, high-temp.;
(The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.)


648-055-00-5


266-028-2


65996-93-2’