EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
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  
(Text with EEA relevance)    
EN 1  EN 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, Gold Thioethylamino Hyaluronic Acid, Acetyl heptapeptide -9 Colloidal 
gold, Platinum, Colloidal Platinu m, Acetyl tetrapeptide -17 Colloidal Platinum and 
Colloidal Silver in cosmetics products  
(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 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 16( 6) thereof,  
Whereas:  
(1) Regulation (EC) No 1223/2009 provides that for every cosmetic product that contains 
nanomaterials, a high level of pr otection of human health is to  be ensured . That 
Regulation further provides that, in the event that the Commission has concerns 
regarding the safety of a nanomaterial, the Commission is to make a  request  to the 
Scientific Committee on Consumer Safety (SCCS) for its opinion on the safety of the 
nanomaterial for use in cosmetic products . 
(2) On 8 January  2021  the SCCS adopted a Scientific advice  on the safety of 
nanomaterials in cosmetics2 concluding  that with a c ollective consideration of the 
physicochemical, toxicological and exposure aspects of Styrene/Acrylates Copolymer 
(nano) , Sodium Styrene/Acrylates Copolymer (nano)  (CAS No. 9010 -92-8) and 
Colloidal Silver (nano) (CAS No . 7440 -22-4) there is a basis for concern that those 
nano materials , as notified through the cosmetic products notification portal (CPNP ), 
can pose a  health  risk to the consumer  when used in cosmetic products .  
(3) On 5 March 2021, the SCCS adopted a n Opinion on Copper (nan o) and Colloidal 
Copper (nano)3 (CAS  No. 7440 -50-8), concluding that it is not possible to carry out a 
safety assessment due to the limited or missing essential information.  However, the 
SCCS indicated that based on the available information from scientific literature and 
in the CPNP , a systemic uptake of Copper nanoparticle (and/or ionic Copper)  is 
possible and  could  lead to a ccumulation in certain organs , notably the liver and spleen . 
In addition, the SCCS found that  the potential mutagenic/genot oxic and 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific  Committee on Consumer Safety), Scientific advice on the safety of nanomaterials in 
cosmetics, preliminary version of 6 October 2020, final version of 8 January 2021, SCCS/1618/20, 
Corrigendum of 8 March 2021 . 
3 SCCS (Scientific Committee on Consumer Safety), Opinion on Copper (nano) and Colloidal Copper 
(nano), preliminary version of 27 -28 October 2020, final version of 5 March 2021, SCCS/1621/2020   
EN 2  EN immunotoxic/nephrotoxic effects of C opper nanomaterials  raise concerns  that warrants 
further safety evaluation of copper nanomaterials used as cosmetic ingredients . 
(4) On 25 June 2021, the SCCS adopted an Opinion4 on Gold (nano), Colloidal Gold 
(nano ) (CAS No. 7440 -57-5), Gold Thioet hylamino Hyaluronic Acid (nano) (CAS No. 
1360157 -34-1) and Acetyl heptapeptide -9 Colloidal gold (nano)  (CAS No. not 
reported)  and an Opinion5 on Platinum (nano), Colloidal Platinum (nano) (CAS No. 
7440 -06-4) and Acetyl tetrapeptide -17 Colloidal Platinum (nano)  (CAS No. not 
reported) . In both opinions , the SCCS  concluded that it  is not possible  to carry out a 
safety assessment due to the limited or missing essential information.  However, based 
on the collective considerat ion of the physicochemical, toxicological and exposure 
aspects , it also concluded that  the use of such nanomaterials  in cosmetic products can 
pose a health risk to the consumer . 
(5) In light of  the Opinion s and the Advice  of the SCCS, it can be concluded that there is 
insufficient data to assess the safety of Styrene/Acrylates copolymer (nano), Sodium 
Styrene/Acrylates copolymer (nano), Copper (nano), Colloidal Copper, Colloidal 
Silver (nano), Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic 
Acid (nano), Acetyl heptapeptide -9 Colloidal gold (nano), Platinum (nano), Colloidal 
Platinum (nano) and Acetyl tetrapeptide -17 Colloidal Platinum ( nano ) in cosmetic 
products and , therefore , a potential risk to human health arising from the use of those 
substances in such products.  
(6) On 22 March 2023, the SCCS adopted an Opinion on Hydroxyapatite (nano)6  (CAS 
No.  1306 -06-5/12167 -74-7). The SCCS concluded that Hydroxyapatite (nano) is safe 
when used at concentrations up to 10  % in toothpaste, and up to 0 ,465 % in 
mouthwash. The SCCS also stressed that their conclusions apply only to  
Hydroxyapatite (nano) composed of rod -shaped particles , that are not coated or 
surface modified,  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. In 
addition, no data was provided to allow an assessment of consumer safety from 
inhalation exposure  and, t herefore, the SCCS stressed that their conclusions are  not 
applicable to sprayable produ cts that might lead to exposure of the consumer’s lungs 
to nanoparticles by inhalation . 
(7) In light of the SCCS opinion, it can be concluded that there is a potential risk to human 
health arising from the use of Hydroxyapatite (nano) in cosmetic products when  the 
concentration of th at substance exceeds certain levels  or when it is used in sprayable 
products that might lead to exposure of the consumer’s lungs to nanoparticles by 
inhalation . Therefore, the use of Hydroxyapatite (nano) in cosmetic products should  be 
restricted to a maximum concentration of 10 % in toothpaste and  of 0,465 % in 
mouthwash  with the respective characteristics , while the use of Hydroxyapatite (nano) 
in applications that may lead to exposure of the end user's lungs by inhalation  should 
not be allowed . 
                                                 
4 SCCS (Scientific Committee on Consumer Safety), Opinion on Gold (nano), Colloidal Gold (nano), 
Gold Th ioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide -9 Colloidal gold (nano), final 
version of 24 -25 June 2021, SCCS/1629/2021.  
5 SCCS (Scientific Committee on Consumer Safety), Opinion on Platinum (nano), Colloidal Platinum 
(nano) and Acetyl tetrap eptide -17 Colloidal Platinum (nano), final version of 24 -25 June 2021, 
SCCS/1630/21  
6 SCCS (Scientific Committee on Consumer Safety), Opinion on Hydroxyapatite (nano), preliminary 
version 4 January 2023, final version 21 -22 March 2023, SCCS/1648/22   
EN 3  EN (8) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(9) The industry should be allowed a reasonable period of time to adapt to the new 
requirements , including  by making the necessary adjustments to product formulations 
and to labelling  in order to ensure that only cosmetic products complying with the new 
requirements are placed on the market. Economic operators should also be allowed a 
reasonable period of time to withdraw from the market those cosmetic products that do 
not com ply with the new requirements and which were placed on the market before 
the new requirements become applicable. The length of those periods should be 
determined considering the SCCS concerns and the potential  risk to human health  
associated to the nanomat erials  concerned , as well as the number of cosmetic products 
concerned . 
(10) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on Cosmetic Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es II and II I to Regulation (EC) No 1223/2009 are amended in accordance with the 
Annex to this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen