EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
Commission Regulation .../...  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
as regards the use in cosmetic products of certain substances classified as carcinogenic, 
mutagenic or toxic for reproduction and correcting that Regulation  
   
EN 1  EN ANNEX  I 
 
Annexes II and III to Regulation (EC) No 1223/2009 are amended as follows:  
(1) in Annex II, t he following entries  are added : 
 
Reference 
number  Substance ide ntification  
 
Chemical name/INN  CAS number  EC n umber  
a b c d 
ʻ[OP: please 
insert the next  
consecutive  
number ] Tetrafluoroethylene  116-14-3 204-126-9 
 [OP: please 
insert  the next 
consecutive 
number ] 6,6'-di-tert-butyl -2,2'-methylenedi -p-cresol;[DBMC]  119-47-1 204-327-1 
[OP: please insert  
the next 
consecutive 
number ] (5-chloro -2-methoxy -4-methyl -3-pyridyl)(4,5,6 -trimethoxy -o-
tolyl)methanone; pyriofenone  688046 -61-9 692-456-8 
 [OP: please 
insert  the next 
consecutive 
number ] (RS)-1-{1-ethyl -4-[4-mesyl -3-(2-methoxyethoxy) -o-toluoyl]pyrazol -5-
yloxy}ethyl methyl carbonate; tolpyralate  1101132 -67-5 701-225-3 
[OP: please insert  
the next Azamethiphos (ISO); S-[(6-chloro -2-oxooxazolo[4,5 -b]pyridin -3(2H)-
yl)methyl] O,O-dimethyl thiophosphate  35575 -96-3 252-626-0  
EN 2  EN consecutive 
number ] 
 [OP: please 
insert  the next 
consecutive 
number ] 3-methylpyrazole  1453 -58-3 215-925-7 
 [OP: please 
insert  the next 
consecutive 
number ] N-methoxy -N-[1-methyl -2-(2,4,6 -trichlorophenyl) -ethyl] -3-
(difluoromethyl) -1-methylpyrazole -4-carboxamide; pydiflumetofen  1228284 -64-7 817-852-1  
 [OP: please 
insert  the next 
consecutive 
number ] N-{2-[[1,1' -bi(cyclopropyl)] -2-yl]phenyl} -3-(difluoromethyl) -1-methyl -
1H-pyrazole -4-carboxamide; sedaxane  874967 -67-6 688-331-2  
 [OP: please 
insert  the next 
consecutive 
number ] 4-methylpentan -2-one; isobutyl methyl ketone  (MIBK)  108-10-1 203-550-1 
 [OP: please 
insert  the next 
consecutive 
number ] Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl) -3-(3,4-
dimethoxyphenyl)acryloyl )morpholine  110488 -70-5 404-200-2 
 [OP: please 
insert  the next 
consecutive 
number ] Imazamox (ISO); ( RS)-2-(4-isopropyl -4-methyl -5-oxo-2-imidazolin -2-
yl)-5-methoxymethylnicotinic acid  114311 -32-9 601-305-7  
 [OP: please 
insert  the next 
consecutive Thiamethoxam (ISO); 3 -(2-chloro -thiazol -5-ylmethyl) -5-
methyl[1,3,5]oxadiazinan -4-ylidene -N-nitroamine  153719 -23-4 428-650-4  
EN 3  EN number ] 
[OP: please insert  
the next 
consecutive 
number ] Triticonazole (ISO); ( RS)-(E)-5-(4-chlorobenzylidene) -2,2-dimethyl -1-
(1H-1,2,4 -triazol -1-methyl)cyclopentanol  138182 -18-0 - 
[OP: please insert  
the next 
consecutive 
number ] Desmedipham (ISO); ethyl 3 -phenylcarbamoyloxyphenylcarbamate  13684 -56-5 237-198-5’; 
 
(2) in Annex III , the following entry is added :  
 
Reference 
number  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 
ʻ[OP: 
please 
insert  the 
next 
consecuti
ve 
number ] Methyl 2 -
hydroxybenzoate Methyl 
Salicylate  
 119-36-8 204-317-7 (a) Leave -on skin 
products  (except face 
makeup , spray/aerosol 
body lotion , 
spray/aerosol deodorant  
and hydroalcoholic -
based fragrances)  and (a) 0,06 %  
 
 
 
 
 
  
Not to be 
used in 
preparations 
for children 
under 6 years 
of age. ʼ.   
EN 4  EN leave on hair products  
(except  spray /aerosol 
products )  
 
(b) Face makeup 
(except lip  products , 
eye makeup and 
makeup remover)  
 
(c) Eye makeup and 
makeup remover  
 
(d) Leave -on hair 
products 
(spray /aerosol ) 
 
(e) Deodorant  
spray/aerosol  
 
(f) Body lotion  
spray/aerosol  
 
(g) Rinse -off skin  
products (except hand 
wash) and rinse -off hair 
products  
 
(h) Hand wash  
 
(i) Hydroalcoholic - 
 
 
 
(b) 0,05 %  
 
 
 
 
(c) 0,002 %  
 
 
(d) 0,009 %  
 
 
 
(e) 0,003 %  
 
 
(f) 0,04 %  
 
 
(g) 0,06 %  
 
 
 
 
(h) 0,6 %  
 
(i) 0,6 %   
EN 5  EN based fragrances  
 
(j) Lip products  
 
(k) Toothpaste  
 
(l) Mouthwash 
intended for  children 
aged 6 –10 years  
 
(m) Mouthwash 
intended for children 
above 10 years of age 
and adults  
 
(n) Mouth spray   
 
(j) 0,03 %  
 
(k) 2,52 %  
 
(l) 0,1 %  
 
 
 
(m) 0,6 %  
 
 
 
 
(n) 0,65 %  
 
 
   
EN 6  EN ANNEX II  
 
Annexes II and V to Regulation (EC) No 1223/2009 are corrected as follows:  
(1) in Annex II , entry 1669 is deleted ; 
(2) in Annex V , entry 51 is replaced by the following:  
Refere nce 
numbe r Substance identification  Conditions  Wording of 
conditions 
of use and 
warnings  Chemical 
name/INN  Name of 
Common 
Ingredients 
Glossary  CAS 
number  EC number  Product type, B ody parts  Maximum 
concentration in 
ready for use 
preparation  Other  
a b c d e f g h i 
‘51 Sodium N -
(hydroxymethyl )gl
ycinate   Sodium 
Hydroxym
ethylglycin
ate 70161 -
44-3 274-357-8  0,5 %  Not to be used 
if it cannot be 
shown that the 
maximum 
theoretical 
concentration 
of releasable 
formaldehyde, 
irrespective of 
the source, i n 
the mixture as 
placed on the   
EN 7  EN market is ≥ 0,1 
% w/w’ .