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  Text with EEA relevance
Date: 2012-07-10
Institutions: European Commission
Subjects: carcinogenic substance, classification, labelling, marketing standard, packaging, toxic substance








L_2012179EN.01000301.xml










11.7.2012   


EN


Official Journal of the European Union


L 179/3








            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
(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 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 (1), and in particular Article 37(5) thereof,

Whereas:







(1)


Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains two lists of harmonised classification and labelling of hazardous substances. Table 3.1 lists the harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to Regulation (EC) No 1272/2008. Table 3.2 lists the harmonised classification and labelling of hazardous substances based on the criteria set out in Annex VI to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2). Those two lists need to be amended to include updated classifications for substances already subject to those harmonised classifications and to include new harmonised classifications.












(2)


The Committee for Risk Assessment of the European Chemicals Agency (ECHA) has issued opinions on proposals for harmonised classification and labelling of substances which had been submitted to ECHA pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on those opinions, as well as on the comments received from the parties concerned, it is appropriate to amend Annex VI to Regulation (EC) No 1272/2008 in order to harmonise the classification and labelling of certain substances.












(3)


The harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, should not apply immediately, as a certain period of time will be necessary to allow operators to adapt the labelling and packaging of substances and mixtures to the new classifications and to sell existing stocks. In addition, a certain period of time will be necessary to allow operators to comply with the registration obligations resulting from the new harmonised classifications for substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1A and 1B (Table 3.1) and categories 1 and 2 (Table 3.2), or as very toxic to aquatic organisms which may cause long term effects in the aquatic environment, in particular with those set out in Article 23 of 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 (3).












(4)


In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, and of adapting the labelling and packaging accordingly on a voluntary basis before 1 December 2013.












(5)


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
Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended as follows:






(1)


Table 3.1 is amended as follows:






(a)


The entries corresponding to the entries set out in Annex I are replaced by the entries set out in that Annex;










(b)


The entries set out in Annex II are inserted in accordance with the order of the entries set out in Table 3.1.














(2)


Table 3.2 is amended as follows:






(a)


The entries corresponding to the entries set out in Annex III are replaced by the entries set out in that Annex;










(b)


The entries set out in Annex IV are inserted in accordance with the order of the entries set out in Table 3.2.










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.
Article 1 shall apply from 1 December 2013.
The harmonised classifications set out in Part 3 of Annex VI to Regulation (EC) No 1272/2008, as amended by this Regulation, may be applied before 1 December 2013.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 July 2012.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 353, 31.12.2008, p. 1.

(2)  
            OJ 196, 16.8.1967, p. 1.

(3)  
            OJ L 136, 29.5.2007, p. 3.




ANNEX I
















Index No


International Chemical Identification


EC No


CAS No


Classification


Labelling


Specific Conc. Limits, M-factors


Notes




Hazard Class and Category Code(s)


Hazard Statement Code(s)


Pictogram, Signal Word Code(s)


Hazard statement Code(s)


Suppl. Hazard statement Code(s)




"009-016-00-2


trisodium hexafluoroaluminate [1]


237-410-6 [1]


13775-53-6 [1]


STOT RE 1
Acute Tox. 4
Aquatic Chronic 2


H372
H332
H411


GHS07
GHS08
GHS09
Dgr


H372
H332
H411


 


 


 




trisodium hexafluoroaluminate (cryolite) [2]


239-148-8 [2]


15096-52-3 [2]




603-012-00-X


2-ethoxyethanol;
ethylene glycol monoethyl ether


203-804-1


110-80-5


Flam. Liq. 3
Repr. 1B
Acute Tox. 3
Acute Tox. 4


H226
H360FD
H331
H302


GHS02
GHS08
GHS06
Dgr


H226
H360FD
H331
H302


 


 


 




603-025-00-0


tetrahydrofuran


203-726-8


109-99-9


Flam. Liq. 2
Carc. 2
Eye Irrit. 2
STOT SE 3


H225
H351
H319
H335


GHS02
GHS07
GHS08
Dgr


H225
H351
H319
H335


EUH019


STOT SE 3;
H335: C ≥ 25 %
Eye Irrit.2;
H319: C ≥ 25 %


 




613-016-00-3


fuberidazole (ISO);
2-(2-furyl)-1H-benzimidazole


223-404-0


3878-19-1


Carc. 2
Acute Tox. 4
STOT RE 2
Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1


H351
H302
H373 (heart)
H317
H400
H410


GHS07
GHS08
GHS09
Wng


H351
H302
H373 (heart)
H317
H410


 


M = 1


 




617-001-00-2


di-tert-butyl peroxide


203-733-6


110-05-4


Org. Perox. E
Flam. Liq. 2
Muta. 2


H242
H225
H341


GHS02
GHS08
Dgr


H242
H225
H341"


 


 


 










ANNEX II
















Index No


International Chemical Identification


EC No


CAS No


Classification


Labelling


Specific Conc. Limits, M-factors


Notes




Hazard Class and Category Code(s)


Hazard Statement Code(s)


Pictogram, Signal Word Code(s)


Hazard statement Code(s)


Suppl. Hazard statement Code(s)




‘015-199-00-X


tris[2-chloro-1-chloromethyl)ethyl] phosphate


237-159-2


13674-87-8


Carc. 2


H351


GSH08
Wng


H351


 


 


 




015-200-00-3


indium phosphide


244-959-5


22398-80-7


Carc. 1B
Repr. 2
STOT RE 1


H350
H361f
H372 (lungs)


GHS08
Dgr


H350
H361f
H372 (lungs)


 


STOT RE 1;
H372: C ≥0,1 %
Carc 1B;
H350: C ≥0,01 %
STOT RE 2;
H373: 0,01 % ≤ C < 0,1 %


 




015-201-00-9


trixylyl phosphate


246-677-8


25155-23-1


Repr. 1B


H360F


GHS08
Dgr


H360F


 


 


 




015-202-00-4


tris(nonylphenyl) phosphite


247-759-6


26523-78-4


Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1


H317
H400
H410


GHS07
GHS09
Wng


H317
H410


 


 


 




015-203-00-X


diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide


278-355-8


75980-60-8


Repr. 2


H361f (causing atrophy of the testes)


GHS08
Wng


H361f (causing atrophy of the testes)


 


 


 




602-109-00-4


Hexabromocyclododecane [1]


247-148-4 [1]


25637-99-4[1]


Repr. 2
Lact.


H361
H362


GHS08
Wng


H361
H362


 


 


 




1,2,5,6,9,10-hexabromocyclododecane [2]


221-695-9[2]


3194-55-6[2]




606-143-00-0


abamectin (combination of avermectin B1a and avermectin B1b) (ISO) [1]


_ [1]


71751-41-2 [1]


Repr. 2
Acute Tox. 2
Acute Tox. 1
STOT RE 1
Aquatic Acute 1
Aquatic Chronic 1


H361d
H300
H330
H372 (nervous system)
H400
H410


GHS06
GHS08
GHS09
Dgr


H361d
H300
H330
H372 (nervous system)
H410


 


STOT RE 1;
H372: C ≥ 5 %
STOT RE 2;
H373: 0,5 % ≤C<5 %
M = 10 000 


 




avermectin B1a (purity ≥80 %); [2]


265-610-3 [2]


65195-55-3 [2]




606-144-00-6


acequinocyl (ISO);
3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl acetate


—


57960-19-7


Skin Sens. 1
STOT SE 1
STOT RE 2
Aquatic Acute 1
Aquatic Chronic 1


H317
H370 (lung)
(inhalation)
H373 (blood system)
H400
H410


GHS07
GHS08
GHS09
Dgr


H317
H370 (lung)
(inhalation)
H373 (blood system)
H410


 


M = 1 000 


 




607-698-00-1


4-tert-butylbenzoic acid


202-696-3


98-73-7


Repr. 1B
STOT RE 1
Acute Tox. 4


H360F
H372
H302


GHS07
GHS08
Dgr


H360F
H372
H302


 


 


 




612-281-00-2


leucomalachite green;
N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline


204-961-9


129-73-7


Carc. 2
Muta. 2


H351
H341


GHS08
Wng


H351
H341


 


 


 




616-205-00-9


Metazachlor (ISO);
2-chloro-N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)acetamide


266-583-0


67129-08-2


Skin Sens. 1B
Carc. 2
Aquatic Acute 1
Aquatic Chronic 1


H317
H351
H400
H410


GHS07
GHS08
GHS09
Wng


H317
H351
H410


 


M = 100
M = 100’


 










ANNEX III













Index No


International Chemical Identification


EC No


CAS No


Classification


Labelling


Concentration Limits


Notes




"009-016-00-2


trisodium hexafluoroaluminate [1]


237-410-6 [1]


13775-53-6 [1]


Xn; R20
T; R48/23/25
N; R51-53


T; N
R: 20-48/23/25-51/53
S: (1/2-)22-37-45-61


 


 




trisodium hexafluoroaluminate (cryolite) [2]


239-148-8 [2]


15096-52-3 [2]




603-012-00-X


2-ethoxyethanol;
ethylene glycol monoethyl ether


203-804-1


110-80-5


R10
Repr. Cat. 2; R60-61
Xn; R20/22


T
R: 60-61-10-20/22
S: 53-45


 


E




603-025-00-0


tetrahydrofuran


203-726-8


109-99-9


F; R11-19
Carc. Cat. 3; R40
Xi; R36/37


F; Xn
R: 11-19-40-36/37
S: (2-)(13-)16-29-33-36-37(-46)


Xi; R36/37: C ≥ 25 %


 




613-016-00-3


fuberidazole (ISO);
2-(2-furyl)-1H-benzimidazole


223-404-0


3878-19-1


Carc. Cat. 3; R40
Xn; R48/22
Xn; R22
Xi; R43
N; R50-53


Xn; N
R: 40-48/22-22-43-50/53
S: (2)-22-36/37-60-61


N; R50-53: C ≥ 25 %
N; R51-53: 2,5 % ≤ C < 25 %
R52-53: 0,25 % ≤ C < 2,5 %


 




617-001-00-2


di-tert-butyl peroxide


203-733-6


110-05-4


O; R7
F; R11
Muta. Cat. 3, R68


O; F; Xn
R: 7-11-68
S: (2-)3/7-14-16-23-36/37/39"


 


 










ANNEX IV













Index No


International Chemical Identification


EC No


CAS No


Classification


Labelling


Concentration Limits


Notes




‘015-199-00-X


tris[2-chloro-1-chloromethyl)ethyl] phosphate


237-159-2


13674-87-8


Carc. Cat. 3; R40


Xn
R: 40
S: (2-)36/37


 


 




015-200-00-3


indium phosphide


244-959-5


22398-80-7


Carc. Cat. 2; R45
Repr. Cat. 3; R62
T; R48/23


T
R: 45–48/23–62
S: 45- 53


T; R48/23: C ≥0,1%
Carc Cat 2; R45: C ≥0,01%
Xn; R48/20: 0,01%≤ C < 0,1%


E




015-201-00-9


trixylyl phosphate


246-677-8


25155-23-1


Repr. Cat. 2; R60


T
R: 60
S: 53-45


 


 




015-202-00-4


tris(nonylphenyl) phosphite


247-759-6


26523-78-4


Xi; R43
N; R50-53


Xi; N
R: 43-50/53
S: 24-37-60-61


 


 




015-203-00-X


diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide


278-355-8


75980-60-8


Repr. Cat. 3; R62


Xn
R: 62
S: (2)-22-36/37.


 


 




602-109-00-4


Hexabromocyclododecane [1]


247-148-4 [1]


25637-99-4[1]


Repr. Cat. 3; R63 R64


Xn
R: 63-64
S: 36/37-53


 


 




1,2,5,6,9,10-hexabromocyclododecane [2]


221-695-9[2]


3194-55-6[2]




606-143-00-0


abamectin (combination of avermectin B1a and avermectin B1b) (ISO) [1]


_ [1]


71751-41-2 [1]


Repr. Cat. 3; R63
T+; R26/28
T; R48/23/25
N; R50-53


T+; N
R: 63-26/28-48/23/25-50/53
S: 28-36/37-45-60-61


T; R48/23: C ≥ 5%
Xn; R48/20: 0,5% ≤ C <5%
N; R50-53: C ≥ 0,0025%
N; R51-53: 0,00025% ≤ C <0,0025%
R52-53: 0,000025% ≤ C<0,00025%


 




avermectin B1a (purity ≥80%); [2]


265-610-3 [2]


65195-55-3 [2]




606-144-00-6


acequinocyl (ISO);
3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl acetate


—


57960-19-7


T; R39/23
Xi; R43
N; R50-53


T; N
R: 39/23-43-50/53,
S: (2-)24-37-38-60-61


N; R50-53: C ≥ 0,025%
N; R51-53: 0,0025% ≤ C < 0,025%
R52-53: 0,00025% ≤ C < 0,0025%


 




607-698-00-1


4-tert-butylbenzoic acid


202-696-3


98-73-7


Repr. Cat. 2; R60
T; R48/23/24/25
Xn; R22


T
R: 60-22-48/23/24/25
S: 53-45


 


E




612-281-00-2


leucomalachite green
N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline


204-961-9


129-73-7


Carc. Cat. 3; R40
Muta. Cat. 3; R68


Xn
R: 40-68
S: (2-)36/37


 


 




616-205-00-9


Metazachlor (ISO);
2-chloro-N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)acetamide


266-583-0


67129-08-2


R43
Carc. Cat. 3; R40
N; R50-53


Xn; N
R: 40-43-50/53
S: (2-)36-37-60-61


N; R50-53: C ≥ 0,25%
N; R51-53: 0,025% ≤ C < 0,25%
R52-53: 0,0025% ≤ C < 0,025%’