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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
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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%’

 


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