EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Regulation (EU) .../...  
amending Annexes III and VI to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council  
 
   
EN 1  EN ANNEX   
Regulation (EC) No 1223/2009 is amended as follows:  
(1) In Annex III , the following entries  are added:  
* From … [OP please insert the date = first day of the month following 6 months after the date of entry into force of this Regulatio n] non -oxidative 
hair dye products containing that substance and not complying with the restrictions shall not be placed on the Uni on market. From … [OP please insert Refer
ence 
numb
er 
 Substance identification  Restrictions  Wordings 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 use 
preparation  Other  
a b c d e f g h i 
‘OP: 
please 
insert 
the 
next 
conse
cutive 
numb
er 2,6-Di-Tert-Butyl -4-
Methylphenol*  Butylated 
Hydroxytoluene  128-37-0 204-881-4 a) Mouthwash  
b) Toothpaste  
c) Other leave -on and 
rinse -off products  a) 0,001 %  
b) 0,1 %  
c) 0,8 %    
OP: 
please 
insert 
the 
next 
conse
cutive 
numb
er 1H-Indene -1,3(2H) -
dione, 2 -(2-
quinolinyl) -, 
sulfonated, sodium 
salts (CI 47005) *,** Acid Yellow 3  8004 -92-0 305-897-5 Non-oxidative hair dye 
products  0,5 %     
EN 2  EN the date = first day of the month following 12 months after the date of entry into force of this Regulation] non -oxidative hair dye products containing 
that substance and not complying with the restrictions shall not be made available on the Union market.  
** For use as a colorant, see Annex IV, entry No. 82.’. 
 
(2) Annex VI is amended as follows:  
(a) entry 3 is replaced by the following : 
Refer
ence 
numb
er 
 Substance identification  Conditions  Wordings 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 use 
preparation  Other  
a b c d e f g h i 
‘3  Benzoic acid, 2 - 
hydroxy -, 3,3,5 - 
trimethylcyclohexyl 
ester/Homosalate*  Homosalate  118-56-9 204-260-8 Face products  with the 
exception of propellent 
spray products  7,34 % 
    
* From … [OP please insert the date = first day of the month following 24 months after the date of entry into force of this Regulation] cosmetic 
products containing that substance and not complying with the conditions shall not be placed on the Union market. From … [OP please insert the date 
= first day of the month following 30 months after the date of entry into force of this Regulation] cosmetic products containing that substance and not 
complying with the conditions shall not be made available on the Union market. ’;  
 
(b) the following entr ies are added:  
Refer
ence 
numb
er 
 Substance identification  Conditions  Wordings 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 use 
preparation  Other   
EN 3  EN a b c d e f g h i 
‘OP: 
please 
insert 
the 
next 
conse
cutive 
numb
er 1,1'-(1,4-
piperazinediyl)bis[1 -
[2-[4-(diethylamino) -
2-
hydroxybenzoyl]phen
yl]-methanone  Bis-
(Diethylaminohy
d-roxybenzoyl 
Benzoyl) 
Piperazine  
 919803 -
06-8 485-100-6  10 % *    
OP: 
please 
insert 
the 
next 
conse
cutive 
numb
er 1,1'-(1,4-
piperazinediyl)bis[1 -
[2-[4-(diethylamino) -
2-
hydroxybenzoyl]phen
yl]-methanone  Bis-
(Diethylaminohy
d-roxybenzoyl 
Benzoyl) 
Piperazine 
(nano)  919803 -
06-8 485-100-6  10 % *  
 
 Only nanomaterials 
having the following 
characteristics are 
allowed:  
- Purity ≥ 97 %  
- Median particle size 
D50 (50 % of the 
number below this 
diameter): ≥ 50 nm of 
number size 
distribution.’  
 
Not to be used in 
applications that may 
lead to exposure of the 
end user’s lungs by 
inhalation.    
 
* In case of combined use of Bis -(Diethylaminohyd -roxybenzoyl Benzoyl) Piperazine and Bis -(Diethylaminohyd -roxybenzoyl Benzoyl) Piperazine 
(nano), the sum shall not exceed 10 %.’.