SODIUM MONOFLUOROPHOSPHATE

RestrictedCAS 10163-15-216 regulations across 16 markets

SODIUM MONOFLUOROPHOSPHATE is a cosmetic ingredient classified as Antiplaque. Also known as CAS 10163-15-2. It is regulated in 16 markets including UAE, Bahrain, Canada.

Also Known As

CAS Number
10163-15-2, 7631-97-2

Market Overview — 29 Markets

European Union1
United Kingdom1
United States
California
Maryland
Washington
Canada1
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

Europe2 regulations
European UnionRestrictedAnnex III #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Disodium fluorophosphate
CAS
10163-15-2 / 7631-97-2
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 monofluorophosphate. 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

Americas1 regulation
CanadaRestrictedAnnex Table 2 (Restricted)
Chemical name
Fluoride containing substances
CAS
10163-15-2
Conditions of use
a) Not permitted in oral products. b) other products

Source: Health Canada Cosmetic Ingredient Hotlist

East Asia & Oceania1 regulation
TaiwanRestrictedAnnex Restricted Ingredients List #41
Chemical name
Disodium fluorophosphate
CAS
10163-15-2/ 7631-97-2
Max concentration
0.15%(以F計)
Product type
Oral products

Source: TFDA Cosmetics Regulations

ASEAN6 regulations
SingaporeRestrictedAnnex ACD Annex III (Restricted) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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) #27
Chemical name
Disodium fluorophosphate / Sodium monofluorophosphate
CAS
10163-15-2/7631-97-2
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 Disodium fluorophosphate. (a) ' Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimize 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 #27
Chemical name
Sodium monofluorophosphate
CAS
10163-15-2 -- 7631-97-2
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 monofluorophosphate 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 MONOFLUOROPHOSPHATE in Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan.

Frequently Asked Questions

Is SODIUM MONOFLUOROPHOSPHATE banned in any country?

SODIUM MONOFLUOROPHOSPHATE 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 MONOFLUOROPHOSPHATE in cosmetics?

SODIUM MONOFLUOROPHOSPHATE is restricted or has conditions of use in UAE, Bahrain, 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 MONOFLUOROPHOSPHATE in cosmetics?

SODIUM MONOFLUOROPHOSPHATE is regulated in 16 markets. It has restrictions in UAE, Bahrain, 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.