Cosmetic products, nitrosamine

A research program in progress at Raltech Scientific Services is designed to find inhibitors which will prevent nitrosamine formation in cosmetic products, A review of the literature (4) indicated that the oil phase of emulsions may play an important role in nitrosation chemistry. Thus, results from studies in water alone could be misleading when reduced to practice. 

Challis BC, Trew DF, Guthrie WG, Roper DV. Reduction of nitrosamines in cosmetic products. Int J Cosmet Sci 1995 17 119-131. 

In contrast, the International Standard Organization (ISO) Technical Committee on Cosmetics Products is developing suitable methods for the quantitative analysis of nitrosamines (ISOAVD 15819), retinol (ISO/NP 24413) and arbutin (ISO/NP 24414) in cosmetics. 

The NO + 03 chemiluminescent reaction [Reactions (1-3)] is utilized in two commercially available GC detectors, the TEA detector, manufactured by Thermal Electric Corporation (Saddle Brook, NJ), and two nitrogen-selective detectors, manufactured by Thermal Electric Corporation and Antek Instruments, respectively. The TEA detector provides a highly sensitive and selective means of analyzing samples for A-nitrosamines, many of which are known carcinogens. These compounds can be found in such diverse matrices as foods, cosmetics, tobacco products, and environmental samples of soil and water. The TEA detector can also be used to quantify nitroaromatics. This class of compounds includes many explosives and various reactive intermediates used in the chemical industry [121]. Several nitroaromatics are known carcinogens, and are found as environmental contaminants. They have been repeatedly identified in organic aerosol particles, formed from the reaction of polycyclic aromatic hydrocarbons with atmospheric nitric acid at the particle surface [122-124], The TEA detector is extremely selective, which aids analyses in complex matrices, but also severely limits the number of potential applications for the detector [125-127],... 

The presence of non-volatile NOC, i.e. preformed nitrosamines, has been reported in various cosmetics, pharmaceutical products, foods, beverages and dairy products. 

Toxicology Abstracts. U.S.A. Cambridge Scientific Abstracts. Monthly. ISSN 0140-5365. Each issue contains approximately 800 abstracts covering the toxic effects of pharmaceuticals, food, agrochemicals, cosmetics, toiletries, household products, industrial chemicals, metals, natural substances, poisons, polycyclic hydrocarbons, nitrosamines, and radiation. Toxicological methods and papers concerned with legislation are also included. 

Occurrence of A-nitrosamino acids in cured meat products and their effect on formation of A-nitrosamines during heating Food Cosmet. Toxicol. 16 (1978) 343-348. 1933b. 

N-Nitrosamines are widely distributed in various human environments. The concern was initially focused on their widespread occurrence in food and consumer products, as beer, meats cured with nitrite, smoked fish, tobacco and tobacco smoke, rubber products including baby bottle nipples and pacifiers, cosmetics, drug formulations, or herbicides formulations. Much data of their occurrence have been obtained by inadequate analytical methods and must await confirmation. Considerable progress has been made in the development of adequate and specific methods for trace analysis of nitrosamines, and reliable information is expected in the near future. 

Bronidox can be used as preservative for functional industrial fluids including cosmetics within a comparatively broad pH range (5-9). The average concentration is 01%. In terms of degradation and potential nitrosamine formation Bronidox and Bronopol behave analogously. Bronidox is mentioned in the EC list of preservatives for cosmetics (max. authorized concentration 01% limitations and requirements rinse-off products only avoid formation of nitro-samines). 

In the EU these substances therefore may only be used as cosmetic preservatives if nitrosamine production is prevented. 

Cosmetic manufacturers may use essentially any raw material as a cosmetic ingredient insofar as it is not considered as only a drug active ingredient, and market the product without approval. The law regulates only colour additives specifically approved for cosmetics and a few prohibited and restricted ingredients (e.g. bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides). Cosmetics should not be contaminated with nitrosamines, 1,4-dioxane and pesticide residues, whose potential presence is regularly checked by the FDA (see Section 2.1). 

Al-Nitrosamines are potent animal carcinogens which may be present at trace levels in many products. Since the development of the thermal energy analyzer made their detection a relatively simple matter, it has become routine to specify that commercial products be free of these compounds. This is particularly true in cosmetic raw materials, most im-... 

Rosenberg, I. E., J. Gross, T. Spears, U. Caterbone, Nitrite and nitrosamines in cosmetic raw materials and finished products, J. Soc. Cosmet. Chem., 1979,30,127-135. 

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