http://www.legislation.gov.uk/id/eur/2012/618

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 1907/20061, 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 substances2. 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/EC3.

(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:
1. (a)
  The entries corresponding to the entries set out in Annex I are replaced by the entries set out in that Annex;
2. (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:
1. (a)
  The entries corresponding to the entries set out in Annex III are replaced by the entries set out in that Annex;
2. (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

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"

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’

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"

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%’