
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, 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 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 1Acute Tox. 4Aquatic Chronic 2 H372H332H411 GHS07GHS08GHS09Dgr H372H332H411   
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. 3Repr. 1BAcute Tox. 3Acute Tox. 4 H226H360FDH331H302 GHS02GHS08GHS06Dgr H226H360FDH331H302   
603-025-00-0 tetrahydrofuran 203-726-8 109-99-9 Flam. Liq. 2Carc. 2Eye Irrit. 2STOT SE 3 H225H351H319H335 GHS02GHS07GHS08Dgr H225H351H319H335 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. 2Acute Tox. 4STOT RE 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 H351H302H373 (heart)H317H400H410 GHS07GHS08GHS09Wng H351H302H373 (heart)H317H410  M = 1 
617-001-00-2 di-tert-butyl peroxide 203-733-6 110-05-4 Org. Perox. EFlam. Liq. 2Muta. 2 H242H225H341 GHS02GHS08Dgr H242H225H341"   

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 GSH08Wng H351   
015-200-00-3 indium phosphide 244-959-5 22398-80-7 Carc. 1BRepr. 2STOT RE 1 H350H361fH372 (lungs) GHS08Dgr H350H361fH372 (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 GHS08Dgr H360F   
015-202-00-4 tris(nonylphenyl) phosphite 247-759-6 26523-78-4 Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 H317H400H410 GHS07GHS09Wng H317H410   
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) GHS08Wng H361f (causing atrophy of the testes)   
602-109-00-4 Hexabromocyclododecane [1] 247-148-4 [1] 25637-99-4[1] Repr. 2Lact. H361H362 GHS08Wng H361H362   
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. 2Acute Tox. 2Acute Tox. 1STOT RE 1Aquatic Acute 1Aquatic Chronic 1 H361dH300H330H372 (nervous system)H400H410 GHS06GHS08GHS09Dgr H361dH300H330H372 (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. 1STOT SE 1STOT RE 2Aquatic Acute 1Aquatic Chronic 1 H317H370 (lung)(inhalation)H373 (blood system)H400H410 GHS07GHS08GHS09Dgr H317H370 (lung)(inhalation)H373 (blood system)H410  M = 1 000 
607-698-00-1 4-tert-butylbenzoic acid 202-696-3 98-73-7 Repr. 1BSTOT RE 1Acute Tox. 4 H360FH372H302 GHS07GHS08Dgr H360FH372H302   
612-281-00-2 leucomalachite green;N,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 204-961-9 129-73-7 Carc. 2Muta. 2 H351H341 GHS08Wng H351H341   
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. 1BCarc. 2Aquatic Acute 1Aquatic Chronic 1 H317H351H400H410 GHS07GHS08GHS09Wng H317H351H410  M = 100M = 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; R20T; R48/23/25N; R51-53 T; NR: 20-48/23/25-51/53S: (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 R10Repr. Cat. 2; R60-61Xn; R20/22 TR: 60-61-10-20/22S: 53-45  E
603-025-00-0 tetrahydrofuran 203-726-8 109-99-9 F; R11-19Carc. Cat. 3; R40Xi; R36/37 F; XnR: 11-19-40-36/37S: (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; R40Xn; R48/22Xn; R22Xi; R43N; R50-53 Xn; NR: 40-48/22-22-43-50/53S: (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; R7F; R11Muta. Cat. 3, R68 O; F; XnR: 7-11-68S: (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 XnR: 40S: (2-)36/37  
015-200-00-3 indium phosphide 244-959-5 22398-80-7 Carc. Cat. 2; R45Repr. Cat. 3; R62T; R48/23 TR: 45–48/23–62S: 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 TR: 60S: 53-45  
015-202-00-4 tris(nonylphenyl) phosphite 247-759-6 26523-78-4 Xi; R43N; R50-53 Xi; NR: 43-50/53S: 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 XnR: 62S: (2)-22-36/37.  
602-109-00-4 Hexabromocyclododecane [1] 247-148-4 [1] 25637-99-4[1] Repr. Cat. 3; R63 R64 XnR: 63-64S: 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; R63T+; R26/28T; R48/23/25N; R50-53 T+; NR: 63-26/28-48/23/25-50/53S: 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; R39/23Xi; R43N; R50-53 T; NR: 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; R60T; R48/23/24/25Xn; R22 TR: 60-22-48/23/24/25S: 53-45  E
612-281-00-2 leucomalachite greenN,N,N',N'-tetramethyl-4,4'-benzylidenedianiline 204-961-9 129-73-7 Carc. Cat. 3; R40Muta. Cat. 3; R68 XnR: 40-68S: (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 R43Carc. Cat. 3; R40N; R50-53 Xn; NR: 40-43-50/53S: (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%’ 
