What You Need to Know About Formaldehyde

What is Formaldehyde?

Formaldehyde is a naturally occurring organic compound that is part of the cellular metabolic process in the human body. It is also found in vegetables and fruits such as carrots, apples, bananas, etc. People wonder: since formaldehyde is already in our bodies and in our food, is it still harmful?

The International Agency for Research on Cancer (IARC) and the National Toxicology Program classify formaldehyde as a human carcinogen; it is associated with an increased risk of nasopharyngeal and sinus cancers and a type of leukemia. What's more, formaldehyde fume is a known carcinogen, which is a key point when talking about formaldehyde in beauty products. As safety awareness continues to increase, people are paying more attention to the ingredients used in beauty products, and there is more discussion about some potentially-questionable ingredients and chemicals. At present, formaldehyde is in the spotlight, and its role in the embalming process makes it applicable not only in cosmetics but in many industries.

As a contact allergen, the prevalence of formaldehyde contact allergy has been found to be 8-9% in the USA and 2-3% in European countries in recent decades. Formaldehyde itself is rarely found in cosmetics, but preservatives that release formaldehyde when exposed to water are widely used in many cosmetics (such as shampoos, face creams, etc.), household products (such as dishwashing liquid), and topical medicines. These preservatives are known as formaldehyde-donors or formaldehyde-releasers. It is important for consumers allergic to formaldehyde to be fully aware of the potential for exposure to formaldehyde to avoid allergic contact dermatitis (ACD).

Which Products Contain Formaldehyde?

Formaldehyde is added to cosmetics as a preservative to prolong shelf life and prevent bacterial contamination. Formaldehyde is a gas, so cosmetic companies typically use not pure formaldehyde but formaldehyde-releasers, which slowly release over time to form formaldehyde molecules. During release, formaldehyde levels remain stable, extending shelf life. Common formaldehyde releasers you may see in products include: DMDM hydantoin, methylene glycol, quaternium 15, and 3 dioxane, among others. Although most cosmetic products contain low levels of formaldehyde, people who are highly sensitive to formaldehyde may suffer redness, itching and scaling of the skin, as well as irritation of the eyes, nose and throat.

Commission Regulation (EU) 2022/1181: warnings for products containing formaldehyde-releasers modified.

Formaldehyde is forbidden by the Cosmetics Regulation (EC) No. 1223/2009, it is included in Annex II (List of Substances Prohibited in Cosmetic Products) and is classified as a carcinogen (category 1B) and a skin sensitizer (category 1) ((EC) No. 1272/2008). Manufacturers cannot intentionally add formaldehyde, but formaldehyde-releasing substances are permitted, which are listed on Annex V of the Cosmetics Regulation and are required to be used within the given restrictions. The previous regulation was that when the amount of formaldehyde released in the final product exceeds 0.05%, the warning label "contains formaldehyde" must be affixed to avoid allergic reactions to sensitised customers.

The SCCS now considers a threshold of 0.05% (500 ppm) insufficient to protect formaldehyde-sensitive consumers from exposure to free formaldehyde in cosmetics, and concludes that the threshold should be lowered to 0.001%. This threshold should apply to final products. This opinion has been adopted by European Commission, amending the preamble of Annex V to Regulation (EC) No. 1223/2009, " All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde." (Regulation (EU) 2022/1181)

Creative BioMart has established a professional analysis platform to provide customers with accurate, comprehensive, and quality-guaranteed cosmetic testing services. We have developed an analytical method for the determination of trace levels of formaldehyde in cosmetics containing formaldehyde-releasing preservatives for a range of substrates in raw materials and finished products such as creams, lotions, shampoos, soaps, etc. Additionally, our team can design custom solutions for complex samples to meet all client needs.
Welcome to contact us for project quotations and more detailed information.