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Document 32012R0618

    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

    OJ L 179, 11/07/2012, p. 3–10 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵This document has been published in a special edition(s) (HR)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg/2012/618/oj

    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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