History and Status of Formaldehyde in the ... - ACS Publications

15 History and Status of Formaldehyde in the Cosmetics Industry H E R M A N E . JASS Downloaded by PENNSYLVANIA STATE UNIV on August 11, 2014 | http://pubs.acs.org Publication Date: August 21, 1985 | doi: 10.1021/ba-1985-0210.ch015

29 Platz Drive, Skillman, NJ 08558 Although formaldehyde has been found to be a mucosal and dermal irritant and contact sensitizer, regulatory and industry experts have concluded that the use of formaldehyde as a preservative is safe to the majority of consumers. A review of evidence indicates that formaldehyde is not carcinogenic when applied to the skin at normal concentrations, but evidence is insufficient to conclude that HCHO in sprayed cosmetics is safe. By regulation, formaldehyde, when used as a nail hardener, must be adequately labeled and limited to concentrations of 5 %. Although formaldehyde is still the sixth most popular cosmetic preservative, used primarily in shampoos and bubble baths, its use appears to be declining. Equipment sanitation applications of HCHO are also decreasing. Uses of Formaldehyde Formaldehyde has been used historically in the cosmetics industry in three principal areas: preservation of cosmetic products and raw materials against microbial contamination, certain cosmetic treatments such as hardening of fingernails, and plant and equipment sanitation. By far the major use of formaldehyde is as an antimicrobial preservative. Certain categories of cosmetic and toiletry products that contain high concentrations of surfactants, such as shampoos and bubble baths, have traditionally required formaldehyde to preserve them against contamination by Gram-negative microorganisms, particularly members of the Pseudomonas family (2). According to the U.S. Food and Drug Administration (FDA) computerized information file (2), formaldehyde was the sixth most frequently used cosmetic preservative in 1982. As shown in Table I, formaldehyde was listed as being used in 734 cosmetic products. This information is obtained from cosmetic formulation data submitted to F D A by companies participating in the FDA voluntary registration program (3). Because this regulatory program is voluntary, some formulations are not registered. Therefore, the frequency of use reported here is somewhat understated. 0065-2393/85/0210/0229$06.00/0 © 1985 American Chemical Society

In Formaldehyde; Turoski, V.; Advances in Chemistry; American Chemical Society: Washington, DC, 1985.

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F O R M A L D E H Y D E : A N A L Y T I C A L CHEMISTRY A N D T O X I C O L O G Y

Downloaded by PENNSYLVANIA STATE UNIV on August 11, 2014 | http://pubs.acs.org Publication Date: August 21, 1985 | doi: 10.1021/ba-1985-0210.ch015

Table I. Frequency of Preservative Use in Cosmetic Formulas, 1982 Preservative

Frequency of Use

Methylparaben Propylparaben Imidazolidinylurea Quaternium-15 Butylparaben Formaldehyde solution BHA 2-Bromo-2-nitropropane-l ,3-diol BHT Sorbic acid

7148 6274 1820 1079 739 734 618 546 475 361

a

used.

0

The number of cosmetic products in which each preservative is

Table II. Product Formulation Data for Cosmetics Containing Formaldehydie Product Category Shampoos (noncoloring) Bubble baths Hair conditioners Wave sets and hair rinses (noncoloring) Other bath preparations Other hair preparations (noncoloring) Bath oils, tablets, and salts Other products in categories listing H C H O

Total No. of Products

No. Containing Formaldehyde

Percent

909 475 478

316 109 95

34.8 22.9 19.9

338 132

69 24

20.4 18.2

177 237

13

10

7.3 4.2

4999

78

1.56

According to the data obtained through the voluntary registration regulation (4), approximately 35% of marketed cosmetic shampoos, 23% of bubble bath formulations, and 20% each of hair rinses and hair conditioners contain H C H O as an antimicrobial preservative (Table II). The usual H C H O concentration in these products is approximately 0.10% or less, and probably does not exceed 0.20 % in most commercial formulations (5). Concentrates that are to be diluted prior to application may have a higher concentration, usually up to approximately 1.0%. As shown in Table II, H C H O is used somewhat in other cosmetics, also. The concentrations shown in all of these tabulations of F D A data are usually expressed as 40 % formalin solutions, the form used in the cosmetic industry. The frequency of use in these other products is low, and, in some cases, may merely represent obsolete information.



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Formaldehyde in the Cosmetics Industry

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Another cosmetic use of formaldehyde is as a nail hardener. Fingernails treated with H C H O solutions become harder and more resistant to breakage. For this application, the H C H O concentration is significantly higher, up to approximately 5 %. However, because of safety considerations, F D A has placed restrictions on the use and labeling of such products (6). As a result, such products represent only a very small segment of the cosmetic market. Some drug products that are related to cosmetic applications use formaldehyde. For example, abnormally excessive perspiration, known as hyperhydros is, may be controlled with topical applications of H C H O (7). However, this use is limited by law to a prescription-only basis. Formaldehyde has also been used as a tooth desensitizer dentifrice for persons whose teeth are abnormally sensitive to touch and temperature variations. This type of product was reviewed by an F D A advisory panel (8), which determined that insufficient evidence was available to determine the effectiveness of this agent in over-the-counter drug use. If additional data that would be considered by F D A sufficient to establish the drug's effectiveness are not submitted by the dentifrice's sponsors by the time a final monograph for this category of drug is published by the agency, it will become illegal. Meanwhile, it cannot be determined if any products of this type, in which H C H O is present at 1.4%, are still being marketed. Formaldehyde has had a long history of use by the cosmetic industry for plant and equipment sanitation. Sanitizing agents are not used on a routine basis but as a procedure to reduce or remove contamination by resistant microorganisms that can pose a serious preservation problem in finished cosmetics. Emergence of strains of microorganisms resistant to normal concentrations of germicidal agents has been a frequent occurrence in cosmetic plants. This resistance is due in part to the use of many natural and earth-derived ingredients, such as natural pigments and gums, that are difficult to render free of microorganisms. Also, many raw materials contain high concentrations of ingredients, such as ethoxylated surfactants, which form complexes with many preservatives including the parabens, the most commonly used agents. This complexing of preservatives reduces their effectiveness. Many cosmetic ingredients, like many food ingredients, actually provide a good nutritional medium for microorganisms. These factors, coupled with the continual use of processing equipment, have a tendency to produce dominant populations of mutant bacterial strains that are very difficult to eradicate once they are established in manufacturing facilities. Formaldehyde, in aqueous solution at concentrations of 0.10.5 %, has proved to be extremely efficacious for ridding the plant and processing equipment of these resistant bacteria. However, in recent years, a number of factors have combined to make outcropping of troublesome resistant bacterial strains much less frequent.



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These factors include the introduction of better plant sanitation features such as sanitary piping, regular hot water or steam cleaning, and generally improved housekeeping. In addition, raw materials can now be purified by suppliers with methods that drastically reduce their natural microorganism content; such methods have had a major impact in the fight against bacterial contamination. As a result, the need for heroic measures to combat plant infections has lessened recently. Furthermore, because of occupational safety considerations, formaldehyde, once the primary agent for this use, has been largely supplanted by other agents such as hypochlorite or hydrogen peroxide solutions. However, H C H O is still employed when particularly difficult situations arise. One such situation involves water-deionizer beds. Cosmetic manufacturing requires huge amounts of deionized water, and although maintenance of deionizer bacterial standards has improved greatly over the years, an occasional contamination problem may still occur. Because of its nonionic character, H C H O is particularly suited for this type of use. However, current use concentrations of H C H O in sanitation tend to be lower than in the past and range from 0.05 % to 0.10 % . In all uses of formaldehyde by the cosmetic industry, the material typically used is formalin, an aqueous 40 % solution of formaldehyde. Safety of Formaldehyde The main manifestations of toxicity by formaldehyde topical application to humans or animals have been irritation and sensitization. Thus, dermatitis due to occupational exposure to formaldehyde solutions is a well-recognized problem (9,10). Eye irritation can occur due to formaldehyde vapor (10) or aqueous solutions of formaldehyde (11). However, minimal irritation, at most, was observed when cosmetic products containing 0.074% and 0.0925% formaldehyde were instilled into rabbit eyes (12). Most cosmetic applications of H C H O are in shampoos and similar compositions in which high surfactant content may produce much higher levels of eye irritation than would be expected from formaldehyde at preservative concentrations. Similarly, the skin irritation levels resulting from normal use concentrations of H C H O or even exaggerated levels were found to be moderately irritating, at most, in animal tests (10, 13). The North American Contact Dermatitis Group (14) reported a 5 % incidence of skin sensitization among 2374 patients exposed to 2% formaldehyde in aqueous solution. Data submitted by cosmetic firms in cosmetic product experience reports to F D A under the voluntary cosmetics regulatory program for the period 1979-82 are shown in Table III (25). Shampoos, the leading product category employing formaldehyde as a preservative, had a reported incidence of 2.26 consumer experiences per million units sold. Bubble bath products, the next most frequent use of H C H O , had an incidence of 1.14 per million units sold. By contrast, product categories using formaldehyde


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Table III. Selected Values of Cosmetic Experience Reports Submitted to the F D A Under the Voluntary Cosmetics Regulatory Program, 1979-82


Product Category Bath soaps Shampoos Colognes and toilet waters Other personal cleanliness products Lipstick Face, body, and hand care preparations Hair sprays Hair dyes and colors Make-up foundations Face powders Bubble baths

Estimated Units Distributed in Millions

Total Number of Experiences

Number of Experiences per Million

4157.64 1070.29

1187 2415

0.29 2.26

850.11

377

0.44

646.27 625.35

2170 587

3.36 0.94

590.51 501.01 273.20 145.81 116.51 135.75

751 339 3477 662 162 155

1.27 0.68 12.73 4.54 1.39 1.14

infrequently had incidences as follows (per million units sold): hair dyes, 12.73; make-up foundations, 4.54; lipsticks, 0.94; and face powders, 1.39. These data suggest that the inclusion of formaldehyde in cosmetics does not, per se, create a public health problem. In an extensive review of the literature and of safety information submitted by individual companies, the Expert Panel of the Cosmetic Ingredient Review (CIR) (4) concluded that formaldehyde " . . . is an irritant at low concentration, especially to the eyes and the respiratory tract in all people. It induces hypersensitivity, but not as often as might be expected considering the frequency and extent of exposure. Perhaps the single, most important attribute common to these toxic effects of formaldehyde is that they are all concentration-time dependent." The panel then concluded that formaldehyde in cosmetic products is safe to the great majority of consumers. However, because of skin sensitivity of some individuals to this agent, CIR recommended that formaldehyde be formulated in cosmetics at its minimal effective concentration, not to exceed 0.2% as free formaldehyde. The attitude of F D A is reflected in a statement by Heinz Eiermann, director of the Division of Cosmetics Technology of F D A (5): "When used as a preservative, the concentration of H C H O is usually too low and the exposure too short to induce sensitization. However, it is then quite capable of eliciting a skin reaction in some HCHO-sensitive consumers." After citing the data of the International Contact Dermatitis Group, which ranked 7

The Expert Panel of the Cosmetic Ingredient Review is an independent group of scientific experts funded by an industry association, the Cosmetic, Toiletry, and Fragrance Association, to review and determine the safety of cosmetic ingredients. 1



234


formaldehyde among the 10 most prominent contact sensitizers, Eiermann then stated: "However, we must remember that while a relatively large number of consumers may react to H C H O when patch tested, few of them are expected to present the same reaction under actual use conditions, and millions can use a HCHO-preserved cosmetic without showing any sign of harm." However, nail hardeners, which employ a much higher concentration of formaldehye, present a greater concern to safety evaluators. The policy of FDA (6) is that the agency does not object to the use of formaldehyde as an active ingredient in nail hardeners provided that the product contains no more than 5% H C H O , provides the user with nail shields to restrict application to nail tip, furnishes adequate directions for safe use, and carries a label that warns of danger of misuse and potential for allergic reactions. The CIR Expert Panel reviewed submitted comments relating to the use of formaldehyde at a concentration of 4.5% in nail hardeners but concluded that the submitted evidence was inadequate to ensure that formaldehyde could be safely used above 0.2%. Since the results of the Chemical Industry Institute of Toxicology (CUT) inhalation study in rats and mice were made public, the significance of the findings to the use of cosmetics containing formaldehyde has been analyzed. However, although expressing concern, both F D A and CIR concluded that the current evidence does not indicate a risk of carcinogenicity for cosmetic use of H C H O . The conclusions include the fact that all tumors in the C U T study occurred in the nasal cavity and not systemically and that cancers in the C U T study occurred in only one of the two species exposed and none at the 2-ppm level. Also, the level of exposure to H C H O vapor from cosmetic use would be significantly less than the lowest dose to which the rodents in the C U T study were exposed. However, conclusions reached at the Consensus Workshop on Formaldehyde in October 1983 (17) include the fact that epidemiological studies involving embalmers, medical personnel, and industrial workers exposed to H C H O have shown an excess of brain cancer and leukemia relative to the general population. They further stated that no dose-response information is currently available for quantitative risk assessment of these findings. Taking all of these facts into consideration, the CIR panel stated, after a review of the evidence, that it could not be concluded that formaldehyde is safe in cosmetic products intended to be aerosolized, that is, sprayed. However, this reservation was based not on positive evidence of hazard, but on a lack of submitted data in support of aerosolized cosmetics containing formaldehyde. This lack, in turn, is due to the rarity in the marketplace of spray cosmetics that contain formaldehyde. The use of formaldehyde for plant and equipment sanitation has also declined dramatically. As a result of the findings of C U T , the National Institute of Occupational Safety and Health has recommended that formal-


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dehyde in work environments be handled as a potential human carcinogen. This recommendation has been an important factor in leading companies to seek alternative sanitizing agents and systems in plants.


Other Factors Influencing Cosmetic Use of Formaldehyde Federal regulations require the listing of ingredients on cosmetic package labels ( 16). Cosmetic marketers, concerned about the publicity over the C U T study results, as well as the controversy over the possible hazards of formaldehyde from the use of urea-formaldehyde foam insulation, have become uneasy over the listing of formaldehyde as a cosmetic ingredient. The two major claims for cosmetics in marketing and advertising are that cosmetics enhance beauty and that they are safe to use. The presence on a product label of an ingredient such as formaldehyde, which has become associated in consumers' minds with potential hazards and other unpleasant aspects, is contradictory to these claims of benefit and innocuity. That the implied hazard is cancer is even more worrisome. This situation has led to an attempt by many marketers to replace formaldehyde with other preservatives and thus avoid listing this troublesome ingredient. However, when the product is one with a high concentration of surfactant, such as a shampoo, the discovery of a suitably effective alternative system is not an easy matter. Ironically, formulators have often turned to preservatives that are formaldehyde donors. That is, their preservative effectiveness is due to the formation of formaldehyde in situ at low levels by hydrolytic action. Such HCHO-donor preservatives include quaternium-15 [ds-l-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride], 2-bromo-2-nitropropane-l,3-diol, and D M D M hydantoin (dimethylol dimethyl hydantoin). Use of these preservatives in some cases provides the benefits of H C H O without the need to list formaldehyde as an ingredient on the label. Newer preservatives with even greater effectiveness against Gramnegative organisms have recently been introduced and may further decrease the use of H C H O . However, adoption of new preservatives has traditionally been a slow, gradual process because of the desire of industrial microbiologists and safety specialists to acquire a history of safe use before incorporating a biologically active material into a valuable product. Such history includes the record of gradually increasing use of the product over an extended period of time with no apparent health problems by competitive companies plus an acceptable judgment by CIR. Overall, the factors of contact sensitization potential and unfavorable publicity have led to a gradual decrease in the use of formaldehyde. For example, the number of shampoo and bubble bath products registered with F D A in the last 3 years has grown from 1384 to 1455, whereas the frequency of use of formaldehyde has decreased from 425 to 403 in these two types of products. This decline in usage is expected to continue.


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Literature Cited 1. 2. 3. 4. 5.


6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.

Orth, D . S. J. Soc. Cosmet. Chem. 1980, 31, 165-72. Decker, R. L.; Wenninger, J. A. Cosmet. Toiletries 1982, 92 (11), 57-59. “Code of Federal Regulations,”Title 21, Part 720, 1982, p. 190-95. Cosmetic Ingredient Review In “Final Report of the Safety Assessment for For maldehyde”; Washington, D . C . , 1983, p. 4. Eiermann, H . J., presented at the Conference of Consumer Federation of America, Washington, D . C . , 1983. Food and Drug Administration, “Cosmetic Handbook”; Government Printing Office: Washington, 1983; p. 13. Marcy, R.; Quermonne, M . A . J. Soc. Cosmet. Chem. 1976, 27, 333-44. Food and Drug Administration, Fed. Regis., 1982, 47, 22753. Proctor, Ν. H.; Hughes, J. P. In “Chemical Hazards of the Workplace”; Lippincott: Philadelphia, 1978; pp. 272-74. Fielder, Ν. H. In “Toxicity Review 2—Formaldehyde”; Eyre & Spotteswoode: Portsmouth, U . K . , 1981. Carpenter, C . P.; Smyth, H . F. Am. J. Ophthalmol. 1946, 29, 1368-72. Cosmetic Ingredient Review In “Team Report on Formaldehyde”; Washing ton, D . C . , 1982, p. 11. “Primary Skin Irritation and Sensitization Test on Guinea Pigs”; Ε. I. Du Pont de Nemours & Company, Inc.: Wilmington, Del., 1970. “Standard Screening Tray Versus 1980 Summary”; North American Contact Dermatitis Group: 1980. Food and Drug Administration, “Tabulation of Cosmetic Experience Reports Submitted to F D A under the Voluntary Cosmetics Regulatory Program, 1979-82”; Government Printing Office, Washington, 1983. “Code of Federal Regulations,”Title 21, Part 701.3, 1982, p. 177. Hart, R. “Report on the Consensus Workshop on Formaldehyde,”Jefferson, Ark., 1983.

RECEIVED

for review September 28, 1984.

ACCEPTED

December 26, 1984.


History and Status of Formaldehyde in the ... - ACS Publications

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