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Formaldehyde in cosmetic preparation

Generally formaldehyde contains 30% to 56% of aqueous solution which is known as formaline and the main component in aqueous solution is methylene glycol.

Formaldehyde is mainly used as preservative in hair product such as shampoo, in skin product such as lotion, deodorant and toiletries, and in eye products such as mascara. Besides, formaldehyde also can be used as a part of formulation in nail treatment such as nail hardener.

FDA allows formaldehyde to be used in nail hardener but with a few conditions:

  1. Concentration of formaldehyde must not exceed 5%
  2. Provide nail stopper to consumer in order to allow the product to only be applied on the nail
  3. Instruction of use is clearly stated on the label of the product
  4. Provide warning to consumer regarding adverse effects if the product containing formaldehyde is being misused and it may potentially cause allergy to consumer who is sensitive to formaldehyde.

Countries in Asia especially Malaysia, all nail hardener products must be label as ‘Protect cuticles with grease or oil’ and ‘contains formaldehyde’ if the concentration of formaldehyde is more than 0.05%.

Formaldehyde-Releasing Preservatives [FRP].

Besides being used as preservative in cosmetic products, there are also other preservatives that can release formaldehyde such as formaldehyde-releasing preservatives [FRP]. Examples of the preservative that can produce formaldehyde are as below:

  • Quaternium-15
  • Imidazolidinyl urea
  • Diazolidinyl urea
  • DMDM Hydantoin
  • 2-Bromo-2-nitropropane-1,3-diol
  • Tri(hydroxymethyl)nitromethane
  • Hydroxymethylglycinate

The properties of FRP which release concentration of formaldehyde slowly in cosmetic product can prevent consumers from getting allergy.

Allowable Concentration Limit in Cosmetic

These ingredients did not listed as prohibited ingredients in cosmetic preparation. Based on the available scientific data, the concentration limit has been agreed by different panels of international cosmetic safety assessor including European Union (EU), United State of America and ASEAN Cosmetic Scientific Body (ACSB) as a safe ingredients to be used in cosmetic preparation. Thus, usage of these ingredients are allowed in a lot of country including European Union (EU), United State of America, China and ASEAN countries if these ingredients are used within the limit and requirement.

The concentration limit for formaldehyde depends on the purpose or function of the ingredient. Product formulation owner must know the purpose and function of this ingredient in each particular product. The requirements are available in ‘Guideline Control of Cosmetic Products in Malaysia’; Annex VI Part 1 Reference Number 5 as a function as preservative, while Annex III Part 1 Reference Number 13 as a function as nail hardeners.

The allowed concentration limit for formaldehyde can be used in product formulation as preservative is 0.2% except for products for oral hygiene. For oral hygiene the allowable concentration limit is 0.1%. Both concentrations must be calculated as free formaldehyde. Meanwhile for nail hardeners, the concentration of formaldehyde used is 5% and is calculated as formaldehyde.

Safety Issues

Cosmetic Ingredients Review (CIR) Expert Panel had concluded that formaldehyde and methylene glycol are safe to be used as preservative in cosmetic preparation but the concentration of formalin must not exceed 0.2% (w/w) which equivalent to 0.074% (w/w) concentration of formaldehyde or 0.118% (w/w) concentration of methylene glycol.

Besides, formaldehyde and methylene glycol are also safe to be used in nail hardener product with maximum concentration of 5%. However, formaldehyde and methylene glycol are not safe to be used in hair straightening product..

To ensure safety and quality of cosmetic products, National Pharmaceutical Regulatory Agency (NPRA) shall monitor compliance of cosmetic products in the market through Post Market Surveillance programme. If there are any enquiry regarding safety and quality, experience adverse reaction or allergy effect following the used of cosmetic products containing formaldehyde, consumers are advised to contact NPRA at 03-78835400 ext 8495 or email to kosmetik@npra.gov.my.

References

  1. http://www.cosmeticsandtoiletries.com/formulating/function/preservatives/The- Importance-of-Formaldehyde-Donor-Preservatives-in-Personal-Care-Products-213895441.html
  2. http://www.petervadasmd.com/images/Formaldehyde.pdf
  3. http://safecosmetics.org/article.php?id=599)
  4. http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127068.htm
Last Reviewed : 19 October 2017
Writer/Translator : Nurhirza bt. Shaiful Yamin
Accreditor : Munira bt. Muhammad