TETRAAMINOPYRIMIDINE SULFATE

RestrictedCAS 5392-28-917 regulations across 15 markets

TETRAAMINOPYRIMIDINE SULFATE is a cosmetic ingredient classified as Hair Dyeing. Also known as CAS 5392-28-9. It is regulated in 15 markets including UAE, Bahrain, European Union.

Also Known As

CAS Number
5392-28-9

Market Overview — 29 Markets

European Union1
United Kingdom3
United States
California
Maryland
Washington
Canada
Brazil
South Korea
Japan
Taiwan1
Australia
Singapore1
Malaysia1
Thailand1
Indonesia1
Vietnam1
Philippines1
UAE1
Saudi Arabia1
Qatar1
Oman1
Kuwait1
Bahrain1
Russia
Belarus
Kazakhstan
Armenia
Kyrgyzstan

Detailed Regulations

Europe4 regulations
European UnionRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

Source: EC 1223/2009 Annex III

United KingdomRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Product type
(a) Hair dye substance in oxidative hair dye products
Conditions of use
(a) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary “ black henna ” tattoo in the past. Hair colourants can cause severe allergic reactions. (c) As from 3 March 2018 , to be printed on the label: The mixing ratio. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experie
Other conditions
(a) (c) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 3,4 % (calculated as sulfate)

Source: UK retained EC 1223/2009 Annex III

United KingdomRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4 % (calculated as sulfate)
Product type
(b) Hair dye substance in non-oxidative hair dye products
Conditions of use
Max: (b) 3,4 % (calculated as sulfate) (a) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary “ black henna ” tattoo in the past. Hair colourants can cause severe allergic reactions. (c) As from 3 March 2018 , to be printed on the label: The mixing ratio. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after c

Source: UK retained EC 1223/2009 Annex III

United KingdomRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Product type
(c) Products intended for colouring eyelashes
Conditions of use
(a) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary “ black henna ” tattoo in the past. Hair colourants can cause severe allergic reactions. (c) As from 3 March 2018 , to be printed on the label: The mixing ratio. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “ black henna ” tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experie
Other conditions
(c) Professional use

Source: UK retained EC 1223/2009 Annex III

AmericasNo restrictions

No specific restrictions for TETRAAMINOPYRIMIDINE SULFATE in United States, California, Maryland, Washington, Canada, Brazil.

East Asia & Oceania1 regulation
TaiwanRestrictedAnnex Restricted Ingredients List #139
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(a)3.4% (以sulfate計) (b)3.4% (以sulfate計)
Product type
(a)Oxidative hair dye products (b)Non-oxidative hair dye products

Source: TFDA Cosmetics Regulations

ASEAN6 regulations
SingaporeRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

MalaysiaRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

ThailandRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

IndonesiaRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

VietnamRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

PhilippinesRestrictedAnnex ACD Annex III (Restricted) #255
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate / Tetraaminopyrimidine Sulfate
CAS
5392-28-9
Max concentration
(b) 3.4%(calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products Use for dyeing eyelashes and eyebrows is not permitted.
Conditions of use
(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (calculated as sulphate) (a) and (b): The direction for use 'wear suitable gloves' must be included in label or leaflet text. | Label: (a) The mixing ratio must be printed on the label. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary 'black henna' tattoos may increase your risk of allergy. Do not colour your hair if: - you have a rash on your face or sensitive, irritated and damaged scalp, - you have ever experienced any reaction after colouring your hair, - you have experienced a reaction to a temporary 'black henna' tattoo in the past (a) and (b) Do not use to dye eyelashes or eyebrows

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

GCC6 regulations
UAERestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

Saudi ArabiaRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

QatarRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

OmanRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

KuwaitRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

BahrainRestrictedAnnex III #200
Chemical name
2,4,5,6-Tetraaminopyrimidine sulphate
CAS
5392-28-9
Max concentration
(b) 3,4% (calculated as sulphate)
Product type
(a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (c) Products in­tended for col­ouring eyelashes
Conditions of use
(a) To be printed on the la­bel: The mixing ratio. “Hair colourants can cause severe allergic reac­tions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: — you have a rash on your face or sensitive, irri­tated and damaged scalp, — you have ever experi­enced any reaction after colouring your hair, — you have experienced a reaction to a tempor­ary ‘black henna’ tattoo in the past.” (c) As from 3 March 2018, to be printed on the la­bel: The mixing ratio. “This product can cause severe allergic reactions. Read and follow instruc­tions. This product is not in­tended for use on persons under the age of 16. Tem­porary ‘black henna’ tattoos may increase the risk of al­lergy. Eyelashes shall not be co­loured if the consumer: — has a rash on the face or sensitive, irritated and damaged scalp, — has experienced any re­action after colouring hai
Other conditions
(a) (c) After mixing under oxidative condit­ions the maximum concentration ap­plied to hair or eye­lashes must not ex­ceed 3,4 % (calcu­lated as sulfate) (c) Professional use

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

EAEUNo restrictions

No specific restrictions for TETRAAMINOPYRIMIDINE SULFATE in Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan.

Frequently Asked Questions

Is TETRAAMINOPYRIMIDINE SULFATE banned in any country?

TETRAAMINOPYRIMIDINE SULFATE 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 TETRAAMINOPYRIMIDINE SULFATE in cosmetics?

TETRAAMINOPYRIMIDINE SULFATE is restricted or has conditions of use in UAE, Bahrain, European Union, Indonesia, Kuwait, Malaysia, Oman, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Taiwan, United Kingdom, Vietnam. Restrictions may include maximum concentration limits, product type limitations, or mandatory labeling requirements. See the detailed regulations above for specifics.

Can I use TETRAAMINOPYRIMIDINE SULFATE in cosmetics?

TETRAAMINOPYRIMIDINE SULFATE is regulated in 15 markets. It has restrictions in UAE, Bahrain, European Union, Indonesia, Kuwait, Malaysia, Oman, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Taiwan, United Kingdom, Vietnam. 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.