Chlorhexidine Gluconate 20% matches all the regulatory standards with a CEP covering 2 production sites, the ECHA Authorization to sell for biocidal use under Art 95 and a REACH registration

API (Ph. Eur.)

  • CEP (Certificate of suitability of monographs of the European Pharmacopoeia) issued R1-CEP 2006-171-REV 02
  • EU-GMP (Good Manufacturing Practice)
  • DMF (Drug Master File) issued 2006 No.21946

Biocidal use (Art 95)

  • RN Laboratories is allowed to sell chlorhexidine digluconate as a biocidal active under Art 95 through an approved letter of access to the original dossier of Evonik/Medichem for the following product types:
  • Product type 1: Human hygiene biocidal products
  • Product type 2: Private area and health are disinfectants
  • Product type 3: Veterinary hygiene biocidal products


  • Chlorhexidine digluconate is registered under REACH No. 01-2119946568-22-0005
  • Chlorhexidine digluconate is registered in the CosIng (Cosmetic Ingredient Database).
    This means that it can be used in cosmetics as a preservative with a maximum concentration of 0.3%.