CHLORHEXIDINE DIHYDROCHLORIDE

RestrictedCAS 3697-42-513 regulations across 12 markets

CHLORHEXIDINE DIHYDROCHLORIDE is a cosmetic ingredient classified as Antimicrobial. Also known as CAS 3697-42-5. It is regulated in 12 markets including UAE, Bahrain, Canada.

Also Known As

CAS Number
18472-51-0, 3697-42-5, 55-56-1, 56-95-1

Market Overview — 29 Markets

European Union1
United Kingdom1
United States
California
Maryland
Washington
Canada1
Brazil
South Korea1
Japan2
Taiwan1
Australia
Singapore
Malaysia
Thailand
Indonesia
Vietnam
Philippines
UAE1
Saudi Arabia1
Qatar1
Oman1
Kuwait1
Bahrain1
Russia
Belarus
Kazakhstan
Armenia
Kyrgyzstan

Detailed Regulations

Europe2 regulations
European UnionRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: EC 1223/2009 Annex V

United KingdomRestrictedAnnex V #42
Chemical name
N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1, 56-95-1, 18472-51-0, 3697-42-5
Max concentration
0,3 % (as chlorhexidine)
Conditions of use
Max: 0,3 % (as chlorhexidine)

Source: UK retained EC 1223/2009 Annex V

Americas1 regulation
CanadaRestrictedAnnex Table 2 (Restricted)
Chemical name
Chlorhexidine and its salts
CAS
3697-42-5
Max concentration
a) 0.14% calculated as chlorhexidine free base
Conditions of use
b) 0.19% calculated as chlorhexidine diacetate c) 0.20% calculated as chlorhexidine digluconate d) 0.16% calculated as chlorhexidine dihydrochloride

Source: Health Canada Cosmetic Ingredient Hotlist

East Asia & Oceania4 regulations
South KoreaRestrictedAnnex restricted #M936
Chemical name
Chlorhexidine Dihydrochloride
Conditions of use
* 배합한도 : ∙ 점막에 사용하지 않고 씻어내는 제품에 클로헥시딘으로서 0.1%, ∙ 기타 제품에 클로헥시딘으로서 0.05%

Source: MFDS Korea Cosmetics Regulation

JapanRestrictedAnnex Appendix 3 (Preservatives) #3-2
Chemical name
Chlorhexidine hydrochloride
Max concentration
0.10%
Product type
Leave-on (cosmetics not washed away)

Source: MHLW Standards for Cosmetics (Notification No.331 of 2000)

JapanRestrictedAnnex Appendix 3 (Preservatives) #3-2
Chemical name
Chlorhexidine hydrochloride
Max concentration
0.10%
Product type
Rinse-off (cosmetics washed away after use)

Source: MHLW Standards for Cosmetics (Notification No.331 of 2000)

TaiwanRestrictedAnnex Preservatives List #9
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazat-etradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1/ 18472-51-0/ 3697-42-5 56-95-1/
Max concentration
0.3 % (以 chlorhexidine計)

Source: TFDA Cosmetics Regulations

ASEANNo restrictions

No specific restrictions for CHLORHEXIDINE DIHYDROCHLORIDE in Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines.

GCC6 regulations
UAERestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

Saudi ArabiaRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

QatarRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

OmanRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

KuwaitRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

BahrainRestrictedAnnex V #42
Chemical name
N,N'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride
CAS
55-56-1 / 56-95-1 / 18472-51-0 / 3697-42-5
Max concentration
0.3% (as chlorhexidine)

Source: GSO 1943:2024 (based on EU 1223/2009 V)

EAEUNo restrictions

No specific restrictions for CHLORHEXIDINE DIHYDROCHLORIDE in Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan.

Frequently Asked Questions

Is CHLORHEXIDINE DIHYDROCHLORIDE banned in any country?

CHLORHEXIDINE DIHYDROCHLORIDE is not banned in any of the 26 markets tracked by Formpli. However, it may be subject to restrictions or conditions of use in some markets.

What are the restrictions on CHLORHEXIDINE DIHYDROCHLORIDE in cosmetics?

CHLORHEXIDINE DIHYDROCHLORIDE is restricted or has conditions of use in UAE, Bahrain, Canada, European Union, Japan, South Korea, Kuwait, Oman, Qatar, Saudi Arabia, Taiwan, United Kingdom. Restrictions may include maximum concentration limits, product type limitations, or mandatory labeling requirements. See the detailed regulations above for specifics.

Can I use CHLORHEXIDINE DIHYDROCHLORIDE in cosmetics?

CHLORHEXIDINE DIHYDROCHLORIDE is regulated in 12 markets. It has restrictions in UAE, Bahrain, Canada, European Union, Japan, South Korea, Kuwait, Oman, Qatar, Saudi Arabia, Taiwan, United Kingdom. Use Formpli's free screening tool to check your full ingredient list against all 26 markets at once.

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This information is for reference only and does not constitute legal or regulatory advice. Regulations change — always verify with official sources and consult a regulatory specialist before exporting cosmetic products. Data sourced from EU COSING, US FDA, Health Canada, MHLW Japan, MFDS Korea, ASEAN ACD, GCC SFDA, TGA Australia, ANVISA Brazil, EAEU TR CU, and Taiwan TFDA.