SODIUM FLUORIDE

RestrictedCAS 7681-49-417 regulations across 17 markets

SODIUM FLUORIDE is a cosmetic ingredient classified as Antiplaque. Also known as CAS 7681-49-4. It is regulated in 17 markets including UAE, Bahrain, Brazil.

Also Known As

CAS Number
7681-49-4

Market Overview — 29 Markets

European Union1
United Kingdom1
United States
California
Maryland
Washington
Canada1
Brazil1
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

Europe2 regulations
European UnionRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

Source: EC 1223/2009 Annex III

United KingdomRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Max: 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains sodium fluoride. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. ‘ for adult use only ’ ) the following labelling is obligatory: Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Source: UK retained EC 1223/2009 Annex III

Americas2 regulations
CanadaRestrictedAnnex Table 2 (Restricted)
Chemical name
Fluoride containing substances
CAS
7681-49-4
Conditions of use
a) Not permitted in oral products. b) other products

Source: Health Canada Cosmetic Ingredient Hotlist

BrazilRestrictedAnnex RDC_530 #64
Chemical name
Fluoreto de Sódio
Product type
a) Dentifrício b) Enxaguatóri o bucal
Conditions of use
Application: a) Dentifrício b) Enxaguatóri o bucal

Source: ANVISA RDC 530

East Asia & Oceania1 regulation
TaiwanRestrictedAnnex Restricted Ingredients List #45
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15%(以F計)
Product type
Oral products

Source: TFDA Cosmetics Regulations

ASEAN6 regulations
SingaporeRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

MalaysiaRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

ThailandRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

IndonesiaRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

VietnamRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

PhilippinesRestrictedAnnex ACD Annex III (Restricted) #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0.15% calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0.15%
Product type
(a) Oral hygiene products (except mouthwash) (b) Mouthwash
Conditions of use
(a) & (b) Contains sodium fluoride (a) "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor." (12) (b) Do not use for children below 6 years of age

Source: ASEAN Cosmetic Directive (HSA Dec 2025)

GCC6 regulations
UAERestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

Saudi ArabiaRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

QatarRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

OmanRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

KuwaitRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

BahrainRestrictedAnnex III #31
Chemical name
Sodium fluoride
CAS
7681-49-4
Max concentration
0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Product type
Oral products
Conditions of use
Contains sodium fluoride For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

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

EAEUNo restrictions

No specific restrictions for SODIUM FLUORIDE in Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan.

Frequently Asked Questions

Is SODIUM FLUORIDE banned in any country?

SODIUM FLUORIDE 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 SODIUM FLUORIDE in cosmetics?

SODIUM FLUORIDE is restricted or has conditions of use in UAE, Bahrain, Brazil, Canada, 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 SODIUM FLUORIDE in cosmetics?

SODIUM FLUORIDE is regulated in 17 markets. It has restrictions in UAE, Bahrain, Brazil, Canada, 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.