Are you sure your shampoo, shower gel, or liquid soap is completely safe? A little-known fact in the cosmetics industry is that certain formulations can generate nitrosamines, potentially carcinogenic chemicals.
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Did you know that some common ingredients in your personal hygiene products could be reacting to form these harmful substances?
As a formulator or manufacturer, you have a critical choice: continue using ingredients that can generate nitrosamines, putting your customers’ health and your brand’s reputation at risk, or take a proactive approach and reformulate your products with safe, biodegradable alternatives? Which path do you choose to ensure consumer trust and long-term success?
What are nitrosamines?
Nitrosamines are chemical compounds that can be present as contaminants in various products, including foods (such as certain beverages), tobacco, rubber, and cosmetics. Some of these nitrosamines, such as N-nitrosodiethanolamine (NDELA) and N-nitrosodimethylamine (NDMA), are classified as category 1B carcinogens.
N-nitrosation is conditional, depending on both the nitrosating agent and the substrate, and can occur under acidic, neutral, or alkaline conditions.
Although N-nitrosamines can be formed from primary, secondary, and tertiary amines, the formation of N-nitrosamines is most favored with secondary amines under manufacturing, storage, or use conditions. For amines with different degrees of substitution (i.e., non-secondary), the likelihood of N-nitrosation is much lower.
Attention in cosmetic products should be focused primarily on secondary amines, since the resulting N-nitrosamines are the most stable and are likely to result in consumer exposure. Primary amines do not produce stable N-nitrosamines.
These can readily interact with nitrosating agents, leading to the formation of unstable N-nitroso compounds, but they decompose rapidly, resulting in diazonium salts rather than producing N-nitrosamines. Nitrosation of most tertiary amines occurs at a remarkably slow rate and is generally not a concern for cosmetics.
How are Nitrosamines Formed in Cosmetics?
Nitrosamines form when certain compounds such as diethanolamine (DEA) or triethanolamine (TEA) are used in products along with preservatives that can break down into nitrates. The formation of N-nitrosamines in cosmetic products can result from the confluence of three factors:
The presence of precursor ingredients with structures capable of nitrosation (i.e., nitrosatable structures)
Availability of a nitrosating agent
The existence of suitable reaction conditions.
As these compounds break down over time, they can recombine into nitrosamines. DEA and TEA are commonly used additives in cosmetics to adjust pH levels or act as humectants.
Other ingredients with the word “amine” in their name (indicating amino acids, the building blocks of proteins) may indicate the possibility of nitrosamine contamination. Nitrosamines can form in almost any personal care product, including mascara, concealer, conditioner, baby shampoo, pain relief balm, and sunless tanning lotion.
Since nitrosamines are created through chemical reactions in products and are therefore not listed on the ingredient label, consumers cannot easily identify which products contain them.
A good start is to avoid products with DEA, TEA, and other ethanolamine compounds, as they contribute to the formation of nitrosamines.
Why are they dangerous?
Ignoring nitrosamines in cosmetics can have serious health consequences:
- Carcinogenic effects: Linked to stomach, liver, and esophageal cancers.
- DNA damage: Nitrosamines can induce genetic mutations.
- Skin absorption: Prolonged exposure can lead to systemic absorption.
The FDA began monitoring personal care products for nitrosamines in 1979 and issued a report indicating that products containing nitrosamines could be considered adulterated and subject to FDA enforcement. This led to a notable decrease (from 150 ppm to 3 ppm) in concentrations of a form of nitrosamine, n-nitrosoethanolamine (NDELA) in tests conducted 12 years later.
In 1996, the FDA encouraged cosmetic manufacturers to voluntarily eliminate ingredients that could combine to form NDELA and to conduct testing to understand why cosmetics are contaminated with NDELA. Despite these recommendations, it was found that one in 10 products contains ingredients that can combine with others to form nitrosamines.
Cosmetic products containing nitrosamines, including NDELA, are prohibited by European Cosmetic Regulation (EC) No. 1223/2009. Annex III of this regulation refers to a limit of 50 µg/kg that may be present in cosmetic ingredients, which is associated with a MoS (margin of safety) of 10,000, using BMDL10 (a reference dose associated with a 10% additional background-adjusted tumor risk) at 0.73 mg/kg of body weight/day as the starting point (PoD).
The adverse reaction thate da origen a las nitrosaminas ocurre al combinar surfactantes derivados de dietanolaminas (DEA, MEA, TEA) con ciertos conservantes, como los liberadores de formaldehído o nitritos.
Surfactants Commonly Associated with Nitrosamines:
- Cocamide DEA
- Lauramide DEA
- TEA-Lauryl Sulfate
There Are Safe Alternatives. If a formula includes DEA or MEA amides, it’s a good time to reformulate. Fortunately, there are safe, biodegradable, and nitrosamine-free alternatives:
- Sodium Lauroyl Sarcosinate
- Sodium Cocoyl Glutamate
- Sodium Lauroyl Glutamate
- Potassium Cocoyl Glycinate
- Sodium Cocoyl Alaninate
- Sodium Methyl Cocoyl Taurate
Why Choose These Alternatives?
These surfactants are not only gentle and safe, but also biodegradable, ideal for natural formulas and all skin types. Improving product safety not only protects consumers but also enhances the value proposition, demonstrating a commitment to quality, safety, and the well-being of the planet.
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