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)

In forceVersion 2012-07-10from 2012-07-31

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Contents

Preamble
1. Article 1
2. Article 2
ANNEX
ANNEX I
ANNEX II
ANNEX III
ANNEX IV

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, 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. 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.

(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

ANNEX

ANNEX I

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 = 10000 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 = 1000 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%

Versions

2012-07-10

Cited by

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) Regulation · Grade B
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.
Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) Regulation · Grade B
The substance Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, with the INCI name Trimethylbenzoyl diphenylphosphine oxide (TPO), is currently not included in the Annexes to Regulation (EC) No 1223/2009. TPO has been classified as a CMR substance of category 2 by Commission Regulation (EU) No 618/2012. The classification became applicable on 1 December 2013. On 27 March 2014, the SCCS issued a scientific opinion which concluded that TPO is safe when used as a nail modelling product in a concentration of up to 5,0 % but that it is however a moderate skin sensitizer. Considering the skin sensiti