EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
Commission Regulation (EU) .../...  
amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the 
European Parliament and of the Council on cosmetic products    
EN 1  EN ANNEX I 
 
(1) Annex II  to Regulation (EC) No 1223/2009 is amended as follows:  
The following entries are added:  
 
 
Reference 
number  Substance identification  
 
Chemical name/INN  CAS number  EC n umber  
a b c d 
 x Phosmet (ISO);  S-[(1,3 -dioxo -1,3-dihydro -2H- isoindol -2-
yl)methyl] -O,O-dimethyl phosphorodithioate;  
O,O-dimethyl -S-phthalimidomethyl phosphorodithioate  732-11-6 211-987-4 
 x Potassium permanganate  
 7722 -64-7 231-760-3 
 x Acetaldehyde; ethanal  75-07-0 200-836-8 
 x 2-Benzyl -2-dimethylamino -4′- morpholinobutyrophenone  119313 -12-1 404-360-3 
 x Quizalofop -p-tefuryl (ISO);  
(+/–) tetrahydrofurfuryl ( R)-2-[4-(6- chloroquinoxalin -2- 
yloxy)phenyloxy]propionate  200509 -41-7 414-200-4 
 x Propiconazole (ISO); (2RS,4RS;2RS,4SR) -1-{[2-(2,4- 
dichlorophenyl) -4-propyl -1,3- dioxolan -2-yl]methyl} -1H- 
1,2,4 -triazole  60207 -90-1 262-104-4 
 x Pinoxaden (ISO); 8-(2,6-diethyl -4-methylphenyl) -7-oxo-
1,2,4,5 -tetrahydro -7H-pyrazolo[1,2 -d][1,4,5]oxadiazepin -9-yl 
2,2-dimethylpropanoate  243973 -20-8 635-361-9  
EN 2  EN  x Tetramethrin (ISO);  
(1,3-dioxo -1,3,4,5,6,7 -hexahydro -2H-isoindol -2-yl)methyl 2,2-
dimethyl -3-(2-methylprop -1-en-1-yl)cyclopropanecarboxylate  7696 -12-0 231-711-6 
 x (1,3,4,5,6,7 -Hexahydro -1,3-dioxo -2H-isoindol -2-yl)methyl 
(1R-trans) -2,2-dimethyl -3-(2- methylprop -1-
enyl)cyclopropanecarboxylate  1166 -46-7 214-619-0 
 x Spirodiclofen (ISO);  
3-(2,4-dichlorophenyl) -2-oxo- 1-oxaspiro[4.5]dec -3-en-4-yl 
2,2-dimethylbutyrate  148477 -71-8 604-636-5 
 x Reaction mass of 1 -[2-(2-aminobutoxy)ethoxy]but -2-ylamine 
and 1 -({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but -2-
ylamine   
897393 -42-9 447-920-2 
 x 1-Vinylimidazole  1072 -63-5 214-012-0 
 x Amisulbrom (ISO)3 -(3-bromo -6-fluoro -2-methylindol -1-
ylsulfonyl) -N,N-dimethyl -1H-1,2,4 -triazole -1-sulfonamide  348635 -87-0 672-776-4” 
 
   
EN 3  EN  
(2) Annex V to Regulation (EC) No 1223/2009 is amended as follows:  
Entry 3 is replaced by the following:  
 
 
Reference 
number  Substance Identification  Conditions  Word
ing of 
condi
tions 
of use 
and 
warni
ngs 
Chemical 
name/INN  Name of Common 
Ingredients Glossary  CAS number  EC number  Product type, 
Body parts  Maximum 
concentration 
in ready for 
use 
preparation  Other   
a b c d e f g h i 
'3 Salicylic acid (1) 
and its salts  
 Salicylic acid  
 
 
 
 
 69-72-7 
 
 
 
 
 200-712-3  
 
 
 
 
  0,5 % (acid)  
 
 
 
 
 Not to be 
used in 
products for 
children 
under 3 years 
of age  
Not to be 
used in oral Not 
to be 
used 
for 
childr
en 
under 
3 
years  
EN 4  EN  
 
 
 
 
 
 
Calcium salicylate, 
magnesium 
salicylate, MEA - 
salicylate, sodium 
salicylate, potassium 
salicylate, TEA - 
salicylate   
 
 
 
 
 
 
824-35-1, 
18917 -89-0, 
59866 - 70-5, 
54-21-7, 578 -
36-9, 2174 -16-
5  
 
 
 
 
 
 
212-525-4, 
242-669-3, 
261-963-2, 
200-198-0, 
209-421-6, 
218-531-3  
 
 
 
 
 
 
0,5 % (acid)  
 products 
except for 
lipsticks  
Not to be 
used in 
applications 
that may lead 
to exposure 
of the end -
user's lungs 
by inhalation  
 
 
 
 
Not to be 
used in 
products for 
children 
under 3 years 
of age , except 
for shampoos  
 of age  
 
 
 
 
 
 
 
 
Not 
to be 
used 
for 
childr
en 
under 
3 
years 
of age 
(2) 
(1) For use s other than preservative, see Annex III, No 98  
(2) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin   
EN 5  EN ANNEX II 
 
(1) Annex II  to Regulation (EC) No 1223/2009 is corrected as follows:  
 (a) entry  395 is replaced by the following:   
 
 
Reference 
number  Substance identification  
 
Chemical name/INN  CAS 
number  EC n umber  
“395  Hydroxy -8-quinoline and its sulphate 
bis(8 -hydroxy quinoli nium) sulphate , 
except for the uses of the  sulphate 
provided for in entry 51 of Annex III   
148-24-3 
134-31-6 205-711-1 
205-137-1” 
 
(b) entry 1386 is deleted.  
(c ) entry 1396 is replaced by the following:  
 
Reference 
number  Substance identification  
 
Chemical name/INN  CAS number  EC n umber  
a b c d 
"1396   Borates, tetraborates, octaborates and boric 
acid salts and esters, including:  
Disodium octaborate  anhydrous [1]  
Disodium octaborate tetrahydrate [2]  
2-Aminoethanol, monoester with boric acid 
[3]  
 
12008 -41-2 [1]  
12280 -03-4 [2]  
10377 -81-8 [3]  
  
 
234-541-0 [1]  
234-541-0 [2] 
233-829-3 [3]  
  
EN 6  EN 2-Hydroxypropyl ammonium dihydrogen 
orthoborate [4]  
Potassium borate, boric acid potassium salt 
[5] 
Trioctyldodecyl borate [6]  
Zinc borate [7]  
Sodium borate, disodium tetraborate 
anhydrous; boric acid, sodium salt [8]  
Tetraboron disodium heptaoxide, hydrate [9]  
Orthoboric acid, sodium salt [10]  
Disodium tetraborate decahydrate; borax 
decahydrate [11]  
Disodium tetraborate pentahydrate; borax 
pentahydrate [12]  
  
68003 -13-4 [4]  
 
12712 -38-8 [5]  
 
- [6] 
1332 -07-6 [7]  
1330 -43-4 [8]  
 
12267 -73-1 [9]  
 
13840 -56-7 [10]  
1303 -96-4 [11]  
 
12179 -04-3 [12]   
268-109-8 [4]  
 
603-184-6 [5]  
 
- [6] 
215-566-6 [7]  
215-540-4 [8]  
 
235-541-3 [9]  
 
237-560-2 [10]  
215-540-4 [11]  
 
215-540-4 [12] ” 
 
(d) the following entries are added:  
 
Reference 
number  Substance identification  
 
Chemical name/INN  CAS number  EC n umber  
a b c d 
“x Pirimicarb (ISO); 2-(dimethylamino) -5,6-
dimethylpyrimidin -4-yl dimethylcarbamate  23103 -98-2 245-430-1 
x 1,2-Dichloropropane; propylene dichloride
  78-87-5 201-152-2 
x Phenol, dodecyl -, branched [1]  
Phenol, 2 -dodecyl -, branched [2]  
Phenol, 3 -dodecyl -, branched [3]  121158 -58-5 [1]  
1801269 -80-6 [2] 
1801269 -77-1 [3]  310-154-3 [1]  
- [2] 
- [3]  
EN 7  EN Phenol, 4-dodecyl -, branched [4]  
Phenol, (tetrapropenyl) derivatives [5]  210555 -94-5 [4]  
 74499 -35-7 [5]  
 640-104-9 [4] 
 616-100-8 [5] 
x Coumatetralyl (ISO); 4 - hydroxy -3-(1,2,3,4 -
tetrahydro -1-naphthyl) coumarin  5836 -29-3 227-424-0 
x Difenacoum (ISO); 3 -(3- biphenyl -4-yl-
1,2,3,4 - tetrahydro -1-naphthyl) - 4-
hydroxycoumarin  56073 -07-5 259-978-4 
x Brodifacoum (ISO); 4-hydroxy -3-(3-(4′-
bromo -4-biphenylyl) -1,2,3,4 -tetrahydro -1-
naphthyl)coumarin  56073 -10-0 259-980-5 
x Flocoumafen (ISO); reaction mass of: cis -4- 
hydroxy -3-(1,2,3,4 -tetrahydro -3-(4-(4-
trifluoromethylbenzyloxy)phenyl) -1-
naphthyl)coumarin and trans -4-hydroxy -3-
(1,2,3,4 -tetrahydro -3-(4-(4-
trifluoromethylbenzyloxy)phenyl) -1-
naphthyl)coumarin  90035 -08-8 421-960-0 
x Acetochlor (ISO); 2 - chloro -N-
(ethoxymethyl) -N-(2-ethyl -6- 
methylphenyl)acetamide  34256 -82-1 251-899-3 
x e-Glass microfibres of representative 
composition  - - 
x Glass microfibres of representative 
composition  - - 
x Bromadiolone (ISO); 3 - [3-(4′-
bromobiphenyl - 4-yl)-3-hydroxy -1-
phenylpropyl] -4-hydroxy - 2H-chromen -2-
one 28772 -56-7 249-205-9  
EN 8  EN x Difethialone (ISO); 3-[3-(4′-bromobiphenyl -
4-yl)-1,2,3,4 -tetrahydronaphthalen -1-yl]- 4-
hydroxy -2H-1-benzothiopyran -2-one 104653 -34-1 600-594-7 
x Perfluorononan -1-oic acid [1]  
and its sodium [2]  
and ammonium [3] salts  375-95-1 [1]  
21049 -39-8 [2]  
4149 -60-4 [3]  206-801-3 [1]  
- [2] 
- [3] 
x Dicyclohexyl phthalate  84-61-7 201-545-9 
x 3,7-Dimethylocta -2,6- dienenitrile  5146 -66-7 225-918-0 
x Bupirimate (ISO); 5 -butyl -2-ethylamino -6- 
methylpyrimidin -4-yl dimethylsulfamate  41483 -43-6 255-391-2 
x Triflumizole (ISO); (1 E)-N-[4-chloro -2-
(trifluoromethyl)phenyl] -1- (1H-imidazol -1-
yl)-2- propoxyethanimine  68694 -11-1 604-708-8 
x tert-Butyl hydroperoxide  75-91-2 200-915-7” 
 
   
EN 9  EN (2) Annex III  to Regulation (EC) No 1223/2009  is corrected as follows:  
(a) entry 9 is replaced by the following:  
Ref 
No. Substance identification  Restrictions  Wording of 
conditions of use and 
warnings  
Chemical 
name/  
INN Name of Common 
Ingredients 
Glossary  CAS 
number  EC 
number  Product type, 
body parts  Maximum 
concentration in 
ready for use 
preparation  Other   
a b c d e f g h i 
'9 Methylpheny
lenediamines, 
their N - 
substituted 
derivatives 
and their salts 
(1), with the 
exception of 
the substance 
listed under 
reference 
number s 9 a 
and 9  b of 
this Annex 
and the 
substances 
listed under 
reference 
numbers 364,    Hair dye 
substance in 
oxidative hair 
dye products   (a) General 
use 
 
 
 
 
 
 
 
 
 
 
 
 (a) To be printed on 
the label:   
The mixing ratio.  
‘Hair colourants 
can cause severe 
allergic reactions.  
Read and follow 
instructions.  
This product is not 
intended for use on 
persons under the 
age of 16.  
Temporary “black 
henna” tattoos may 
increase your risk of 
allergy.  
 
EN 10  EN 1310, 1313 
and 1507 of 
Annex II   
 
 
 
 
 
(b) 
Professional 
use 
 For (a) and 
(b): After 
mixing under 
oxidative 
conditions 
the 
maximum 
concentratio
n applied to 
hair must not 
exceed 5 % 
calculated as 
free base   Do not colour your 
hair if: — you have 
a rash on your face 
or sensitive, irritated 
and damaged  scalp, 
— you have ever 
experienced any 
reaction after 
colouring your hair, 
— you have 
experienced a 
reaction to a 
temporary “black 
henna” tattoo in the 
past. 
Contains 
phenylenediamines 
(toluenediamines).  
 Do not use to dye 
eyelashes or 
eyebrows.’  
 
(b) To be printed on 
the label:  
The mixing ratio.  
‘For professional 
use only Hair 
colourants can 
cause severe  
EN 11  EN allergic reactions.  
Read and follow 
instructions.  
This product is not 
intended for use on 
persons under the 
age of 16.  
Temporary “black 
henna” tattoos m ay 
increase your risk of 
allergy.  
Do not colour your 
hair if: — you have 
a rash on your face 
or sensitive, irritated 
and damaged scalp,  
— you have ever 
experienced any 
reaction after 
colouring your hair,  
 — you have 
experienced a 
reaction to a 
temporary “b lack 
henna” tattoo in the 
past. 
Contains 
phenylenediamines 
(toluenediamines).   
EN 12  EN Wear suitable 
gloves.’ ; 
 
 
(b) entry 98 is replaced by the following:  
“98 2-hydroxy -
benzoic acid  
(9 ) salicylic acid  69-72-7 200-712-
3 (a) Rinse -off 
hair products  
(b) Other 
products 
except body 
lotion, eye 
shadow, 
mascara, 
eyeliner, 
lipstick, roll 
on deodorant  
  (a) 3,0 %  
 
 (b) 2,0 %  
 
 
 
 Not to be used 
in preparations 
for children 
under 3 years 
of age  
Not to be used 
in applications 
that may lead 
to exposure of 
the end -user's 
lungs by 
inhalation  
Not to be used 
in oral  
products  
For purposes 
other than 
inhibiting the 
development 
of micro -
organisms in 
the product. Not to be used for 
children under 3 
years of age ”   
EN 13  EN This purpose 
has to be 
apparent from 
the 
presentation of 
the product  
(9) For use as preservative see Annex  V, entry No 3  
(c) the following entry is added:  
Referen
ce 
number  Substance identification  Restrictions  Wording of conditions of use 
and warnings  
Chemical name/INN  Name of 
Common 
Ingredients 
Glossary  CAS 
numbe
r EC 
numbe
r Product type, 
body parts  Maximum 
concentrati
on in ready 
for use 
preparation  Other  
a b c d e f g h i 
'51 bis(8-
hydroxyquinoli nium ) 
sulphate  oxyquinoli
ne 
sulphate  134-
31-6 
 205-
137-1 Stabilizer 
for 
hydrogen 
peroxide in 
rinse -off 
hair 
products  
Stabilizer 
for 
hydrogen 
peroxide in 
leave -on (0,3 % as 
base)  
 
 
 (0,03 % 
as base) ” 
    
EN 14  EN hair 
products  
 