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On April 30, 2019, European Commission published regulation (EU) 2019/698 to restrict the use of Climbazole in cosmetics. This regulation will come into force on May 22, 2019.

SAFEGUARDS | Cosmetics, Personal Care and Household NO. 082/19

Face

Currently, CLIMBAZOLE (CAS No. 38083-17-9) is allowed in cosmetic products at a maximum concentration of 0.5% in ready for use preparations when it is a preservative. Referring to the final opinion of Europe’s Scientific Committee on Consumer Safety (SCCS),SCCS/1600/18, considering an aggregate exposure scenario, Climbazole is considered as safe for use as a preservative at a maximum concentration of 0.2% in face cream, hair lotion and foot cream, and at 0.5% in rinse-off shampoo. It is also concluded to be safe in rinse-off shampoo as an anti-dandruff agent at a maximum concentration of 2%. In the light of this opinion, there is a potential risk to keeping the current regulatory limit. Therefore, the European commission has adopted and amended the regulation accordingly. This regulation will come into force on May 22, 2019, while amendment to Annex V shall apply from November 27, 2019.

 Changes Annex & 
Reference number
Substance identification  Restrictions
Chemical name/INN INCI Name  CAS number EC number
Add III/310 1-(4-Chlorophenoxy)-1-(imidazole-1-yl)-3,3-dimethylbutan-2-one Climbazole 38083-17-9 253-775-4 Max. Concentration: 2.0% in rinse-off anti-dandruff shampoo
(For purposes other than inhibiting the development of micro-organisms in the product, the purpose has to be apparent from the presentation of the product.)
  • From November 27, 2019, cosmetic products containing Climbazole for purposes other than preservation and not complying with the restriction in this regulation shall not be placed on the Union market 
  • From February 27, 2020, cosmetic products containing Climbazole for purposes other than preservation and not complying with the restriction in this regulation shall not be made available on the Union market
 Changes Annex &
Reference number
Substance identification Restrictions
Chemical name/INN INCI Name  CAS number EC number
 Amendment V/32 1-(4-Chlorophenoxy)-1-(imidazole-1-yl)-3,3-dimethylbutan-2-one Climbazole 38083-17-9 253-775-4 Max. Concentration as a preservative
(1) 0.2% in hair lotion
(2) 0.2% in face creams
(3) 0.2% in foot care products
(4) 0.5% in rinse-off shampoo
  • From November 27, 2019, cosmetic products containing Climbazole for preservation purpose and not complying with the restriction in this regulation shall not be placed on the Union market
  • From February 27, 2020, cosmetic products containing Climbazole for preservation purpose and not complying with the restriction in this regulation shall not be made available on the Union market

Next step

Cosmetic industry shall pay attention to the new limit of Climbazole and its intended function in cosmetic product. Reducing the usage level of Climbazole may be necessary. 

It is crucial for all cosmetic, personal care and household products to be safe effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. Our state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. We also have extensive capabilities in performance testing, claim support studies and consumer panels. Our testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. Our cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.

  1. COMMISSION REGULATION (EU) 2019/698 of 30 April 2019 amending Annex III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
  2. SCCS/1600/18, Scientific Committee on Consumer Safety (SCCS) Addendum to the scientific Opinions on Climbazole (P64) ref. SCCS/1506/13 and SCCS/1590/17 adopted on 21-22 June 2018

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