EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) 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 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 Platinum, Acetyl t etrapeptide -17 Colloidal Platinum 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 protection 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 collective consideration of the 
physicochemical, toxicol ogical and exposure aspects of Styrene/Acrylates copolymer 
(nano)   and Sodium styrene/Acrylates copolymer (nano)  (CAS No. 9010 -92-8) there is 
a basis for concern that these nano materials as notified through the CPNP  can pose a  
health  risk to the consumer.   
(3) On 5 March 2021, the SCCS adopted a n Opinion on Copper (nano) 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  may lead to a ccumulation in certain organs , notably the liver an d spleen . 
In addition, the potential mutagenic/genoto xic and immunotoxic/nephrotoxic effects of 
Copper nanomaterials  raise concerns.  
(4) On 30 March 2021, the SCCS adopted a n Opinion on Hydroxyapatite (nano)4 (CAS 
No. 1306 -06-5 / 12167 -74-7). The SCCS could not conclude on the safety of 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1618/20 . 
3 SCCS/1621/20 .  
4 SCCS/1624/20.  EN 2  EN Hydroxyapatite (nano) composed of rod -shaped nanoparticles for use in oral -care 
cosmetic products remarking that the available data/information is not sufficient to 
exclude concerns over its genotoxic potentia l. 
(5) On 25 June 2021, the SCCS adopted two Opinions, one 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)5 (CAS No. 
not reported)   and a second one on Platinum (nano), Colloidal Platinum (nano) (CAS 
No. 7440 -06-4) and Acetyl tetrapeptide -17 Colloidal Platinum (nano)6 (CAS No. not 
reported) . In either case, the SCCS was not able to carry out a safety assessment due to 
the limited or m issing essential information.  However, the SCCS concluded that based 
on the collective consideration of the physicochemical, toxicological and exposure 
aspects the use of such nanomaterials  in cosmetic products raise concern s regarding  
consumer  safety.  
(6) To ensure a high level of protection of human health for  cosmetic products that 
contain  nanomaterials , even when there is insufficient data , it is necessary to 
uniformly  implement within the internal market the prohibition to use the 
nanomaterials for which the SCCS has identified  a basis of concern in their Opinions 
and Advice . 
(7) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(8) 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 comply 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 conce rns and the potential  risk to human health  
associated to the specific nanomaterials, as well as the number of cosmetic products 
concerned . 
(9) 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 II to Regulation (EC) No 1223/2009 is 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 i n 
the Official Journal of the European Union.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
5 SCCS/1629/21.  
6 SCCS/1630/21.  EN 3  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen