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RECENT NEWS ON FORMALDEHYDE

A recent News reveals that a list of incompliance cosmetics products was found and reported by Taiwan Food and Drug Administration. The incompliance relates to excessive content of free formaldehyde in nail polish products. Formaldehyde is a restricted substance for cosmetic products in Taiwan and has a tolerance limit of free formaldehyde at 75ppm.

KNOW MORE ABOUT FORMALDEHYDE


Exposure to excessive formaldehyde may cause short term and long term adverse heath effect. For example, formaldehyde of 0.2% might be skin-sensitizing to some individuals, and formaldehyde of 5% or more might cause irritation to both eyes and skin. In this connection, formaldehyde and formaldehyde releasing agents are restricted in cosmetic products worldwide.


PRESERVATIVES IN COSMETIC PRODUCTS


Some preservatives are considered as formaldehyde releasers for the use in the cosmetics formulations. These substances are found to have decomposition and release formaldehyde, depending on temperature, pH and storage period of solution. Imidazolidinyl Urea and Diazolidinyl Urea are well known preservatives which are also formaldehyde releasers.


RESTRICTION IN COSMETIC PRODUCTS


How does each country regulateFormaldehyde in Cosmetic Products?



Taiwan Food and Drug Administration (TW FDA) published a notice No. 1021604026 and restricts cosmetics products with a maximum tolerance limit of free formaldehyde level at 75ppm, except products containing DMDM hydrantonin, Imidazolidinyl Urea, Quaterium-15, Diazolidinyl Urea, Hexamethylenetetramine, Benzylhemiformal, 5-Bromo-5-nitro-1,3-dioxane, Bronopol and Sodium Hydroxymethyl Glycinate. For products with these preservatives, free formaldehyde should not exceed 1,000ppm as tolerance level.

ASEAN regulates cosmetics products under Cosmetics Directive. Formaldehyde is only permitted as a preservative at a maximum level of 0.1% for oral hygiene products and 0.2% for other products (except aerosol dispensers and sprays). All products containing formaldehyde or free formaldehyde at a level of 0.05% more must be labeled with the warning ‘contains formaldehyde’. Formaldehyde is allowed at a maximum level of 5% on Nail hardeners only.

China Food and Drug Administration (CFDA) has published a New Cosmetics Standard, named Safety and Technical Standards for Cosmetics, which is going to be effective from 1 Dec 2016. According to the Standard, Formaldehyde is permitted as a preservative at a maximum level of 0.2% for all products, except aerosol and sprays. Similarly, all products containing formaldehyde or free formaldehyde at a level of 0.05% more must be labeled with the warning ‘contains formaldehyde’. Particularly, Formaldehyde is allowed at a maximum level of 5% on Nail hardeners.

Country Regulation No. Restriction Warning Remarks 
European Countries

Cosmetics Regulation (EC) No. 1223/2009, Article III 5% calculated as formaldehyde in nail hardeners Protect cuticles with grease or oil.
Contains formaldehyde(2)
 For nail hardeners only. 
Cosmetics Regulation (EC) No. 1223/2009, Article V 0.1% for oral products
0.2% for other products
(expressed as free formaldehyde)
Protect cuticles with grease or oil.
Contains formaldehyde(2)
 Prohibited in aerosol dispensers (sprays). 
 Taiwan
 
TW FDA Notice No. 1021604026  75ppm  N/A  As a tolerance limit for all products without listed preservatives(1) 
 TW FDA List of restriction and usage on permitted preservatives (103.5.15 amendment) 1,000ppm   N/      As a tolerance limit for all products without listed preservatives(1)
 ASEAN Countries
 
 ASEAN Cosmetics Directive, Annex III 5% calculated as formaldehyde in nail hardeners Protect cuticles with grease or oil.
Contains formaldehyde(2)
 For nail hardeners only.
ASEAN Cosmetics Directive, Annex V 0.1% for oral products
0.2% for other products
(expressed as free formaldehyde)
Contains formaldehyde(2)  Prohibited in aerosol dispensers (sprays)
 China
 
Safety and Technical Standards for Cosmetics, Table 3  5% calculated as formaldehyde in nail hardeners  Protect cuticles with grease or oil(3)
Contains formaldehyde(2)(3)
 For nail hardeners only.
Safety and Technical Standards for Cosmetics, Table 4 0.2% (expressed as free formaldehyde) Contains formaldehyde(2)(3)  Prohibited in aerosol
dispensers (sprays)
  1. DMDM HYDANOIN, IMIDAZOLIDINYL UREA, QUATERNIUM-15, DIAZOLIDINYL UREA, HEXAMETHYLENETETRAMINE, BENZYLHEMIFORMAL, 5-BROMO-5-NITRO-1,3-DIOXANE, BRONOPOL AND SODIUM HYDROXYMETHYLGLYCINATE
  2. WHEN CONCENTRATION OF FORMALDEHYDE IN FINISHED PRODUCT EXCEEDS 0.05%
  3. WARNING SENTENCES SHALL BE INDICATED IN CORRESPONDING CHINESE LAID DOWN IN SAFETY AND TECHNICAL STANDARDS FOR COSMETICS.

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