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Chlorhexidine: French ANSM warns of risk of immediate serious allergic reaction

Chlorhexidine : l'ANSM alerte sur les risques de réaction allergique immédiate grave

On 30 November 2023, the French National Agency for Safety and Health Products (ANSM) published a press release warning consumers of the risk of allergic reactions on contact with Chlorhexidine, a substance listed in Annex V (authorised preservatives) to Cosmetics Regulation 1223/2009.

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“We are seeing a steady increase in the number of reports of serious allergic reactions associated with chlorhexidine. Many people in France are exposed to chlorhexidine, which increases the risk of sensitisation and, consequently, the risk of immediate and serious allergic reactions,” the ANSM says. “Such reactions, which are still rare, generally occur within an hour of using chlorhexidine. They manifest as urticaria, facial swelling and breathing difficulties, or even anaphylactic shock.”

Chlorhexidine (CAS No.55-56-1, EC No.200-238-7) is listed in the CosIng with the functions: Antimicrobial, Oral care, Preservative.
It is included, along with three of its derivatives (Chlorhexidine Diacetate, CAS No.56-95-1, EC No.200-302-4; Chlorhexidine Digluconate, CAS No.18472-51-0, EC No.242-354-0; Chlorhexidine Dihydrochloride, CAS No.3697-42-5, EC No.223-026-6), in Annex V/42 to the european Cosmetics Regulation 1223/2009 which sets their maximum authorised concentration at 0.3%.
It is used in a wide range of products (toothpaste, mouthwashes and other cosmetic products for its preservative properties), as well as skin products, mouth spray solutions, sucking tablets, eye drops and urological gels for its antiseptic properties.

In view of the observed upsurge in allergy cases, ANSM is reminding consumers of the precautions to be taken and advising them to use alternatives, particularly for disinfecting the …

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