EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) …/… of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
as regards the use of the nanomaterials Styrene/Acrylates copolymer, Sodium 
Styrene/Acrylates copolymer, Copper, Colloidal Copper, Hydroxyapatite, Gold, 
Colloidal Gold, Gol d Thioethylamino Hyaluronic Acid, Acetyl heptapeptide -9 Colloidal 
gold, Platinum, Colloidal Platinum, Acetyl tetrapeptide -17 Colloidal Platinum and 
Colloidal Silver in cosmetics products     
       
   
EN 1  EN ANNEX  
 
Annexes II and III are amended as follows:  
(1) in Annex II, the following entr ies are  added:  
 
Reference 
number  Substance identification  
 
Chemical name/INN  CAS number  EC n umber  
a b c d 
‘X [OP: please 
replace with the 
next consecutive 
number ]  Styrene/Acrylates copolymer (nano)  [INCI] * 
Sodium Styrene/Acrylates copolymer (nano)  [INCI] * 9010 -92-8 927-710-1 
X [OP: please 
replace with the 
next consecutive 
number ]  Copper (nano)  [INCI] *, Colloidal Copper (nano)  [INCI] * 7440 -50-8 231-159-6 
X [OP: please 
replace with the 
next consecutive 
number ]  Colloidal silver (nano) [INCI] * 7440 -22-4 231-131-3  
X [OP: please 
replace with  the 
next consecutive 
number ]  Gold (nano)  [INCI] *, Colloidal Gold (nano)  [INCI]  [1]* 
Gold Thioet hylamino Hyaluronic Acid (nano) [INCI] [2]* 
Acetyl heptapeptide -9 Colloidal gold (nano ) [INCI] [3]* 7440 -57-5 [1]  
1360157 -34-1 [2]  
- [3] 231-165-9 [1] 
- [2] 
- [3] 
X [OP: please 
replace with the 
next consecutive 
number ]  Platinum (nano)  [INCI] *, Colloidal Platinum (nano)  [INCI]  [1]* 
Acetyl tetrapeptide -17 Colloidal Platinum (nano)  [INCI]  [2]* 7440 -06-4 [1] 
- [2] 231-116-1 [1] 
- [2]  
EN 2  EN * From … [ OP please insert the date = the first day of the month following 9 months after the date of entry into force of this Regulation ] cosmetic 
products containing that substance shall not be placed on the Union market. From … [ OP please insert the date = the fi rst day of the month following 
18 months after the date of entry into force of this Regulation ] cosmetic products containing that substance shall not be made available on the Union 
market. ’  
(2) in Annex II I, the following entry is added:   
Refer
ence 
numb
er 
 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 
concentratio
n in ready 
use 
preparation  Other  
a b C d e f g d h 
‘x 
[OP: 
please 
replac
e with 
the 
next 
conse
cutive 
numb
er] Hydroxyapatite * Hydroxyapatite 
(nano)  1306 -06-5  215-145-7  (a) Toothpaste  
 
(b) Mouthwash  
 
 
 
 
 
 
 
 
 
 
 (a) 10 % 
 
(b) 0,465 % For (a) and (b):  
Not to be used in 
applications that 
may lead to 
exposure of the 
end-user’s lungs 
by inhalation.  
 
Only 
nanomaterials 
having the 
following 
characteristics are   
EN 3  EN allowed:  
- [composed of ] 
rod-shaped 
particles of which 
at least 95 ,8 % (in 
particle number) 
have an aspect 
ratio less than 3, 
and the remaining 
4,2 % have an 
aspect ratio not 
exceeding 4 ,9; 
-the particles are 
not coated or 
surface modified  
* From … [ OP please insert the date = the first day of the month following 9 months from the date of entry into force of this Regulation] cosmetic 
products containing that substance and not complying with the restrictions  shall not be placed on the Union market. From … [OP please insert the date 
= the first day of the month following 18 months after the date of entry into force of this Regula tion] cosmetic products containing th at substance shall 
not be made available on the Union market.