EN    EN  
 EUROPEAN COMMISSION   
Brussels, XXX  
D016833/01  
[…](2011) XXX draft  
  
COMMISSION REGULATION (EU) No …/..  
of XXX  
amending, for the purposes of its adaptation to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the European Parliament an d of the Council on 
classification, labelling and packaging 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 European Parliament and of the Council on 
classification, labelling and packaging of substan ces 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 cla ssification, 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 p rovisions 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 classification s and to include new harmonis ed classifications.  
(2) The Committee for Risk Assessment of the E uropean 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 
                                                
1 OJ L 353, 31.12.2008, p. 1.  
2 OJ 196, 16.8.1967, p. 1 .   
EN 3   EN packaging o f substances and mixtures to the new classifications  and to sell their 
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 subs tances 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 wi th 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 wi th 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, s uppliers 
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 June 
2013.  
(5) The measures provided for in this Regulation are in accordance with the opinion of th e 
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 t o 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 corr esponding 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 . 
                                                
3 OJ L 136, 29.5.2007, p. 3.    
EN 4   EN Article 2  
1. This Regulation shall enter into f orce on the twentieth day following that of its 
publication in the Official Journal of the European Union . 
2. Article 1 shall apply from 1 December  2013.   
3. 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, […]  
 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 
statemen t 
Code(s)  Specific Conc. Limits,  
M-factors  Notes  
           
"009-016-00-2 
 trisodium hexafluoroaluminate [1]  
trisodium hexafluoroaluminate (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%  
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)  
H 317 
H400  
H410  GHS07  
GHS08  
GHS09  
Wng  
 H351  
H302  
H373 (heart)  
H317  
H410   
 
 M = 1    
EN 6   EN  
613-175-00-9 epoxiconazole  (ISO);  
(2RS,3SR) -3-(2-chlorophenyl) -2-(4-
fluorophenyl) -[(1H -1,2,4 -triazol -1-
yl)methyl]oxirane  406-850-2 133855 -98-8 Carc. 2  
Repr. 1B  
Aquatic Chronic 2  H351  
H360Df  
H411  GHS08 
GHS09  
Dgr H351  
H360Df  
H411     
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 I I 
Class ification  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 Ch ronic 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 
testes) GHS08  
Wng  H361f  
(causing 
atrophy of the 
testes)    
602-109-00-74 Hexabromo cyclododecane [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 avermecti n B1a and 
avermectin B1b) (ISO)  [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  
Aquatic Chroni c 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  H360F  
H372  
H302      
EN 9   EN 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-dimethy lphenyl) -N-(1H-
pyrazol -1-ylmethyl)acetamide  266-583-0 67129 -08-2 Skin Sens. 1 B 
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 Identificati on EC No  CAS No  Classification  Labelling  Concentration Limits  Notes  
        
"009-016-00-2 
 trisodium hexafluoroaluminate [1]  
trisodium hexafluoroaluminate (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;  R51-53 T; N  
R: 20 -48/23/25 -51/53  
S: (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; R40  
Xi; R36/37  
 F; Xn ; Xi 
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: 0,2 5 %  C < 2,5 %   
613-175-00-9 epoxiconazole  (ISO);  
(2RS,3SR) -3-(2-chlorophenyl) -2-(4-fluorophenyl) -
[(1H -1,2,4 -triazol -1-yl)methyl]oxirane  406-850-2 133855 -98-8 Carc. Cat. 3; R40  
Repr. Cat.2;  R61 
Repr. Cat. 3; R62  
N; R51 -53 T; N 
R: 40 -61-62-51/53  
S: 45 -53-61    
EN 11   EN 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 L imits  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    
EN 12   EN 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.    
602-109-00-74 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 -64 
S: 36/37 -53   
606-143-00-0 abamectin (combination of avermectin B1a and 
avermectin B1b) (ISO) [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; 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     
EN 13   EN 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% "