EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III and V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
(Text with EEA relevance)   EN 1  EN  COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annexes III and V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic 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 31(1) thereof,   
Whereas:  
(1) The substance 1-(4-Chlorophenoxy) -1-(imidazo l-1-yl)-3,3-dimethylbutan -2-one, 
which has been assigned the name Climbazole under the International Nomenclature 
of Cosmetic Ingredients (INCI), is currently allowed as a preservative in cosmetic 
products at a maximum concentration of 0,5 % in ready for use preparation . It is listed 
in entry 32 of  Annex V to Regulation (EC) No 1223/2009 . In accordance with Article 
14(1)(d)(ii) of Regulation (EC) No 1223/2009, Climbazole may also be contained in 
cosmetic products for an intended use other than as preservative, only within the 
concentration limit lai d down in entry 32 of Annex V . 
(2) The Scientific Committee on Consumer Safety (SCCS) concluded at its plenary 
meeting on 21 -22 June 2018, in an addendum to its earlier opinion s on Climbazole2, 
that, under an aggregate exposure scenario, C limbazole is safe whe n used as a 
preservative in face cream, hair lotion and foot care products at a maximum 
concentration of 0,2 %  and when used as a preservative in rinse -off shampoo at a 
maximum concentration of 0,5 % . 
(3) The SCCS also concluded that , under an aggregate exposure scenario, Climbazole is 
safe when used as an anti -dandruff agent in rinse -off shampoo at a maximum 
concentration of 2  %. 
(4) In light of the addendum, there is a potential risk to human health arising from the use 
of Climbazole as a preservative  or as a non -preservative  at the current ly allowed 
maximum concentration of 0,5 % in all cosmetic products. The use of Climbazole as a 
preservative should therefore only be allowed in face cream, hair lotion , foot care 
products and rinse -off shampoo. T he maximum concentration should be 0,2 % for face 
cream, hair lot ion and foot care products and 0,5 % for  rinse -off shampoo .  
(5) The use of Climbazole as a non -preservative should be restricted to rinse -off shampoo , 
when the substance is used as an anti -dandruff agent . For such use, the maximum 
concentration should be 2 %.  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 Addendum to the scientific Opinions on climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17, final 
version adopted on 21 -22 June 2018, SCCS/1600/18.  EN 2  EN   
(6) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(7) The industry should be allowed a reasonable period of time to adapt to the new 
requirements by makin g the necessary adjustments to product formulations to ensure 
that only products complying with the new requirements are placed on the market. The 
industry should also be allowed a reasonable period of time to withdraw products 
which do not comply wi th the  new requirements from the market.  
(8) 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 III to Regulation (EC) No 1223/2009 is amended in accordance with Annex I to this 
Regulation.  
Article 2 
In Annex V to Regulation (EC) No 1223/2009,  entry 32 is replaced by the text set out in 
Annex II to this Regulation.   
Article 3 
1. From [date = 6 months after the date of entry into force] c osmetic products containing 1 -(4-
Chlorophenoxy) -1-(imidazol -1-yl)-3,3-dimethylbutan -2-one for other than preservati on 
purposes and not complying with the restrictions laid down in this Regulation shall not be 
placed on the Union market.  
From [date = 9 mon ths after the date of entry into force] cosmetic products containing 1 -(4-
Chlorophenoxy) -1-(imidazol -1-yl)-3,3-dimethylbutan -2-one for other than preservati on 
purposes and not complying with the restrictions laid down in this Regulation shall not be 
made available on the Union market.  
2. From [date = 6 months after the date of entry into force] cosmetic products containing 1-(4-
Chlorophenoxy) -1-(imidazol -1-yl)-3,3-dimethylbutan -2-one for preservati on purposes and not 
complying with the conditions laid down  in this Regulation shall not be placed on the Union 
market.   
From [date = 9 months after the date of entry into force] cosmetic products containing 1-(4-
Chlorophenoxy) -1-(imidazol -1-yl)-3,3-dimethylbutan -2-one  for preservat ion purposes and 
not complying with the conditions laid down in this Regulation shall not be made available on 
the Union market.  
 
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Eur opean Union . 
Article 2 shall apply from [date = 6 months after the date of entry into force].   EN 3  EN  This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER