EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending, for the purposes of its adaptation  to technical and scientific progress, 
Regulation (EC) No 1272/20 08 of the European Parliame nt and of the Council on 
classification, labelling and packagi ng of substances and mixtures 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending, for the purposes of its adaptation  to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the Europe an Parliament and of the Council on 
classification, labelling and packagi ng 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, labe lling and packaging of substances and 
mixtures, amending and repealing Directiv es 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006
1, and in particular Ar ticle 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 subs tances based on the criteria set out in 
Parts 2 to 5 of Annex I to Regulati on (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 ad ministrative provisions relating to the 
classification, packaging and la belling of danger ous substances
2. Those two lists need 
to be amended to include updated classifica tions 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 cl assification and label ling 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 classificat ion 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, shoul d not apply immediately, as a certain 
period of time will be necessary to allo w operators to adapt the labelling and 
                                                 
1 OJ L 353, 31.12.2008, p. 1.  
2 OJ 196, 16.8.1967, p. 1.   
EN 3   EN packaging of substances and mixtures to the new classifications and to sell their 
stocks. In addition, a certain period of tim e will be necessary to allow operators to 
comply with the registra tion obligations resulting from the new harmonised 
classifications for substances classified as carcinogenic, muta genic 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 a nd of the Council of 18 December 2006 
concerning the Registration, Evaluation, Aut horisation and Restriction of Chemicals 
(REACH), establishing a European Ch emicals Agency, amending Directive 
1999/45/EC and repealing Council Regula tion (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 transition al provisions of Regulati on (EC) No 1272/2008 which allow 
the application of the new pr ovisions at an earlie r stage on a voluntar y basis, suppliers 
should have the possibility of applying the ha rmonised 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 June 
2013. 
(5) The measures provided for in this Regulati on 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 entrie s set out in Annex I are replaced by the 
entries set out in that Annex; 
(b) The entries set out in Annex II are inse rted 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 in serted in accordance w ith the order of the 
entries set out in Table 3.2. 
                                                 
3 OJ L 136, 29.5.2007, p. 3.   
EN 4   EN Article 2 
1. This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of the European Union . 
2. Article 1 shall apply from 1 June 2013.  
3. The harmonised classifications set out in Pa rt 3 of Annex VI to  Regulation (EC) No 
1272/2008, as amended by this Regulation, ma y be applied before 1 June 2013.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX I  
Classification Labelling Index No International Chemical  
Identification EC No CAS No 
Hazard Class and 
Category Code(s) Hazard  
Statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) Specific Conc. Limits,  
M-factors Notes 
           
"009-016-00-2 
 trisodium hexafluoroaluminate [1] 
trisodium hexafluoroalu minate (cryolite) [2] 237-410-6 [1] 
239-148-8 [2]
 13775-53-6 [1] 
15096-52-3 [2]
 STOT RE 1  
Acute Tox. 4 
Aquatic Chronic 2 H372 
H332 
H411 GHS07 
GHS08 
GHS09  Dgr  
 H372 
H332 
H411    
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%   
EN 6   EN 613-016-00-3 fuberidazole (ISO);  
2-(2-furyl)-1 H-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    
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"    
  
EN 7   EN ANNEX II  
Classification Labelling Index No International Chemical  
Identification EC No CAS No 
Hazard Class and 
Category Code(s) Hazard  
Statement 
Code(s) Pictogram, 
Signal 
Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) Specific Conc. Limits,  
M-factors Notes 
           
"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     
EN 8   EN 015-203-00-X diphenyl(2,4,6-trimethylbenzoyl)phosphine 
oxide 278-355-8 75980-60-8 Repr. 2 H361f 
(causing atrophy of the 
testis) GHS08 
Wng H361f 
(causing atrophy of the 
testis)    
602-109-00-74 He xabromocyclododecane [1]  
1,2,5,6,9,10- hexabromocyclododecane [2] 
 247-148-4 [1] 
221-695-9[2] 
 25637-99-
4[1] 
3194-55-6[2]
 Repr. 2 
Lact. H361  
H362 GHS08 
Wng 
 
 H361  
H362    
606-143-00-0 abamectin (combination of avermectin B1a and 
avermectin B1b) [1]
avermectin B1a (purity ≥80%); [2] 
 _ [1] 
 
265-610-3 [2] 71751-41-2 
[1] 
 
65195-55-3 
[2] 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 
  
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 H317 
H370 
(lung) (inhalation) 
H373 
(blood system) 
 
H400 
H410 GHS07 
GHS08 
GHS09 Dgr H317 
H370 
(lung) (inhalation) 
H373 
(blood system)H410   
 
  
 
   
EN 9   EN Aquatic Chronic 1  
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 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; 
2-chloro-N-(2,6-dimethylphenyl)-N-(1H-
pyrazol-1-ylmethyl)acetamide 266-583-0 67129-08-2 Skin Sens. 1 
Carc. 2 Aquatic Acute 1 
Aquatic Chronic 1 H317 
H351 H400 
H410 GHS07 
GHS08 GHS09 
Wng H317 
H351 H410 
   
 M = 100 
M = 100"  
  
EN 10   EN ANNEX III  
Index No International Chemical name EC No CAS No  Classification Labelling Concentration Limits Notes 
        
"009-016-00-2 
 trisodium hexafluoroaluminate [1] 
trisodium hexafluoroalu minate (cryolite) [2] 237-410-6 [1] 
239-148-8 [2]
 13775-53-6 [1] 
15096-52-3 [2]
 Xn; R20 
T; R48/23/25 N; R 51-53 T; N
R: 20-48/23/25-51/53S: (1/2-)22-37-45-61   
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; R40Xi; 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)-1 H-benzimidazole 
 223-404-0 3878-19-1 Carc. Cat. 3; R40
Xn; R48/22
Xn; R22
Xi; R43N; 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; R11Muta. Cat. 3, R68 O; F; Xn 
R: 7-11-68S: (2-)3/7-14-16-23-
36/37/39    
EN 11   EN  
ANNEX IV  
Index No International Chemical name EC No CAS No  Classification Labelling Concentration Limits Notes 
        
"015-199-00-X tris[2-chloro-1-chloromethyl)ethyl] phos phate  237-159-2 13674-87-8 Carc. Cat. 3; R40 Xn 
R: 40S: (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: 
0,01%≤ C < 0,1% 
Xn; R48/20: 0,01% ≤ C < 
0,1% Note 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.    
EN 12   EN 602-109-00-74 Hexabromocyclododecane [1] 
1,2,5,6,9,10- hexabromocyclododecane [2] 
 247-148-4 [1] 
221-695-9[2] 
 25637-99-4[1] 
3194-55-6[2] 
 Repr. Cat 3; R63 
R64 Xn 
R: 63-64S: 36/37-53   
606-143-00-0 abamectin (combination of avermectin B1a and 
avermectin B1b) [1]
avermectin B1a (purity ≥80%); [2] 
 _ [1] 
 
265-610-3 [2] 71751-41-2 [1] 
 
65195-55-3 [2] 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%  
606-144-00-6 acequinocyl (ISO); 
3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl 
acetate 
 _ 57960-19-7 T; R39/23
Xi; R43N; 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   
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    
EN 13   EN 616-205-00-9 Metazachlor; 
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%"