TRICLOSAN

US FDA substance register · UNII 4NM5039Y5X · registered name TRICLOSAN · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Triclosan is an aromatic ether that is phenol which is substituted at C-5 by a chloro group and at C-2 by a 2,4-dichlorophenoxy group. It is widely used as a preservative and antimicrobial agent in personal care products such as soaps, skin creams, toothpaste and deodorants as well as in household items such as plastic chopping boards, sports equipment and shoes. It has a role as an EC 1.3.1.9 [enoyl-[acyl-carrier-protein] reductase (NADH)] inhibitor, a fungicide, an antibacterial agent, a xenobiotic, an antimalarial, an EC 1.5.1.3 (dihydrofolate reductase) inhibitor, a persistent organic pollutant and a drug allergen. It is a dichlorobenzene, a member of phenols, an aromatic ether and a member of monochlorobenzenes.

Source: PubChem

Triclosan is the substituted organic ether that conforms to the formula:

Restricted

South Korea · Taiwan

Allowed preservative

Taiwan · United Kingdom

Source: ASEAN Cosmetic Directive · Health Canada Cosmetic Ingredient Hotlist · MFDS (Korea) cosmetic regulatory information · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Maximum concentration permitted at final product : 0.3%

ASEAN

• Field of application and/or use : a) Toothpastes Hand soaps Body soaps/Shower gels Deodorants (non-spray) Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems Shampoos Hair Conditioners Facial Cleansers (b) Mouthwashes
• Maximum authorised concentration in the finished cosmetic product : (a) 0.3 % (b) 0.2 %

Canada

• Conditions of Use by product type : (a) Mouthwashes (b) Other cosmetics (c) All oral products must meet the following conditions: Manufacturers must ensure that polychlorinated dibenzo‐p‐dioxin (PCD(d) and polychlorinated dibenzofuran (PCDF) impurities must not be present in quantities that exceed: (i) 0,1 ng/g 2,3,7,8‐tetrachlorodibenzo p‐dioxin and 2,3,7,8‐tetrachlorodibenzofuran. (ii)10 μg/g total other PCDD/PCDF impurities, with no individual impurity greater than 5 μg/g. Manufacturers must possess the following: (i) Raw material specifications for triclosan; (ii) Identification of the method of analysis used to determine the levels of PCDDs and PCDFs in triclosan; (iii) Finished product specifications.
• Maximum Concentration Permitted : ((a) 0.03% (b) 0.3%
• Warnings and Cautionary Statements: (to the effect of) : (a) "Avoid swallowing." "The product is not to be used by children under the age of 12." (c) “Avoid swallowing.” “The product is not to be used by children under the age of 12.”

Japan

• Maximum amount per 100 g(Maximum amount of ingredient per 100 g) : 0.10 g(0.10 g)

China

• Maximum concentration : 0.3%

European Union

• Product Type, body parts : (a) Toothpastes, hand soaps, Body soaps/Shower gels, Deodorants (non-spray), Face powders and blemish concealers. Nail products for cleaning the fingernails and toenails before the application of artificial nail systems. (b) Mouthwashes
• Maximum concentration in ready for use preparation : (a) 0.3% (b) 0,2%

Korea’s toxic-substance GHS classification: Warning · H410 (category 1) · H315 (category 2) · H400 (category 1)

Source: Korea toxic substances GHS register (NIER)

EU Cosmetics Regulation, Annex V (allowed preservatives), entry 25 · maximum concentration 0.3% · applies to Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems;

Source: EU allowed preservatives (Annex V)

Restriction V/25 · Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Oinion on Triclosan Addenum to the SCCP opinion on Triclosan; Opinion concerning Triclosan; Opinion on Triclosan; Opinion on Triclosan Anti-microbial Resistance

Source: EU CosIng ingredient list

Reviewed by CIR: Final Report: Safety Assessment of Triclosan as a Used in Cosmetics

Source: US Cosmetic Ingredient Review (CIR)