The Validated Hypoallergenic Cosmetics Rating System: Its 30-Year Evolution and Effect on the Prevalence of Cosmetic Reactions

Abstract

Background:

The validated hypoallergenic (vh) rating system was initiated in 1988 to try to objectively validate the “hypoallergenic” claim in cosmetics.

Objectives:

To show how the system rates cosmetic hypoallergenicity and to compare the prevalence of cosmetic contact dermatitis (CCD) among users of regular cosmetics versus cosmetics with high VH numbers.

Methods:

(1) Made a VH list based on top allergens from patch-test results published by the North American Contact Dermatitis Group (NACDG) and the European Surveillance System on Contact Allergies (ESSCA); (2) reviewed global regulatory, cosmetic, drug, packaging, and manufacturing practices to show how allergens may contaminate products; (3) compared cosmetic ingredients lists against the VH list to obtain the VH rating (the more allergens absent, the higher the VH rating); and (4) obtained CCD prevalence among users of regular cosmetics versus users of cosmetics with high VH ratings.

Results:

(1) Two VH lists (1988, 2003) included only cosmetic allergens in the NACDG surveys, the third (2007) included cosmetic and potential contaminant noncosmetic allergens, and the fourth (2010) adds ESSCA patch-test surveys. (2) CCD prevalence is 0.05 to 0.12% (average, 0.08%) among users of cosmetics with high VH ratings versus 2.4 to 36.3% among users of regular cosmetics.

Conclusion:

The VH rating system is shown to objectively validate the hypoallergenic cosmetics claim.

Get full access to this article

View all access options for this article.

References

Estrin

, Akerson

, editors. Cosmetic regulation in a competitive environment. New York: Marcel Dekker; 2000. p. 43-54.

Hypoallergenic cosmetics. Available at: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/LabelClaimsandExpirationDating/ucm2005203.htm (accessed Mar 4, 2010).

Draelos

, Rietschel

. Hypoallergenicity and the dermatologist’s perception. J Am Acad Dermatol, 1996; 35:248-51.

Engasser

PG.

Cosmetics and contact dermatitis. Dermatol Clin, 1991; 9:69-80.

Vigan

Urticaire de contact aux cosmeétiques. In: Libbey

, editors. Progre‘s en dermato-allergologie. Paris: Eurotext; 2007. p. 17-34.

Ale

, Maibach

. Irritant contact dermatitis versus allergic contact dermatitis. In: Chew

, Maibach

, editors. Irritant dermatitis. Berlin: Springer; 2006. p. 11-8.

Shenoi

, Rao

. Pigmented contact dermatitis. Indian J Dermatol Venereol Leprol, 2007; 73:285-7.

Ferguson

, DeLeo

Drug and chemical photosensitivity: exogenous. In: Lim

, Honigsmann

, Hawk

JLM

, editors. Photodermatology. New York: Informa Health Care; 2007. p. 200-17.

Verallo-Rowell

VM.

Photopatch testing of melasma with hyperpigmentation at classic photosensitivity sites: sequential case series from the Philippines. Oral presentation at Contact Dermatitis 2010: Blending Science with Best Practice (joint meeting of the Experimental Contact Dermatitis Research Group and the American Contact Dermatitis Society) 2010 Oct. p. 14-16; Dallas, TX.

10.

Kligman

AM.

Pathogenesis of acne vulgaris. II. Histopathology of comedones induced in the rabbit ear by human sebum. Arch Dermatol, 1968; 98:58-66.

11.

Kligman

, Mills

. Acne cosmetica. Arch Dermatol, 1972; 106: 843-50.

12.

Draelos

, DiNardo

. A re-evaluation of the comedogenicity concept. J Am Acad Dermatol, 2006; 54:507-12.

13.

Grove

, Soschin

, Kligman

. Adverse subjective reactions to topical agents. In: Drill

, Lazar

, editors. Cutaneous toxicology. New York: Raven Press; 1984. p. 200-10.

14.

, Lee

, Kim

, et al. Comparison and correlation between stinging responses to lactic acid and bioengineering parameters. Contact Dermatitis, 2007; 57:158-62.

15.

Basketter

, Griffiths

. A study of the relationship between susceptibility to skin stinging and skin irritation. Contact Dermatitis, 1993; 29:185-8.

16.

Jacob

Burning and stinging skin. In: Baumann

, editor. Cosmetic dermatology, 2nd ed. New York: McGraw-Hill; 2009. p. 136-44.

17.

Farage

, Katsarous

, Maibach

. Sensitive skin: sensory, clinical and physiological factors., In: Barel

, Paye

, Maibach

, editors. Handbook of cosmetic science and technology, 3rd ed. New York: Informa; 2009. p. 59-77.

18.

Verallo-Rowell

VH number: a proposed dermatologic method for validating hypoallergenicity. Journal of the Philippine Dermatological Society, 1992; 3:21-2.

19.

Fregert

Hjorth N, Magnusson B, et al. Epidemiology of contact dermatitis. Trans St Johns Hosp Dermatol Soc, 1969; 55:17-35.

20.

Lachapelle

JM.

Historical aspects. In: Frosch

, Menneé

, Lepoittevin

, editors. Contact dermatitis, 4th ed. Berlin: Springer; 2006. p. 1-7.

21.

Rudner

, Clendenning

, Epstein

, et al. Epidemiology of contact dermatitis in North America: 1972. Arch Dermatol, 1973; 108:537-40.

22.

Rudner

, Clendenning

, Epstein

, et al. The frequency of contact sensitivity in North America: 1972-1974. Contact Dermatitis, 1975; 1:277-80.

23.

Rudner

EJ.

North American group results. Contact Dermatitis, 1977; 3:208-9.

24.

Uter

, Schnuch

, Geier

, Frosch

. The epidemiology of contacts dermatitis—the Information Network of Departments of Dermatology (IVDK) in Germany. Eur J Dermatol, 1996; 8:36-40.

25.

European Surveillance System on Contact Allergies. Available at: http://www.ESSCA-dc.org (accessed Oct 10, 2010).

26.

Uter

, Arnold

, Wilkinson

, et al. A multilingual European patch test software concept: WinAlldat/ESSCA. Contact Dermatitis, 2003; 49:270-1.

27.

Uter

, Hegewald

, Aberer

, et al. The European standard series in 9 European countries, 2002/2003—first results of the European Surveillance System on Contact Allergies. Contact Dermatitis, 2005; 53:136-45.

28.

Hegewald

, Uter

, Aberer

, et al. The European Surveillance System of Contact Allergies (ESSCA): results of patch testing the standard series, 2004. J Eur Acad Dermatol Venereol, 2008; 22:174-81.

29.

Uter

, Ramsch

, Berer

, et al. The European baseline series in 10 European Countries, 2005/2006—results of the European Surveillance System on Contact Allergies (ESSCA). Contact Dermatitis, 2009; 61:31-8.

30.

Nethercott

, Holness

. Validity of patch test screening trays in the evaluation of patients with allergic contact dermatitis. J Am Acad Dermatol, 1989; 21:568.

31.

Storrs

, Rosenthal

, Adams

, et al. Prevalence and relevance of allergic reactions in patients patch tested in North America: 1984 to 1985. J Am Acad Dermatol, 1989; 20:1038-45.

32.

Nethercott

, Holness

, Adams

, et al. Patch testing with a routine screening tray in North America 1985-1989. I. Frequency of response. Am J Contact Dermat, 1991; 2:122-9.

33.

Verallo-Rowell

, Pineda

. The European standard and the SSLI patch test trays: a preliminary paired comparison study. The Philippine Journal of Dermatology and Dermatologic Surgery of the Skin and Cancer Foundation Inc, 1991; 2:73-7.

34.

David

R&D and quality control of the locally produced SSLI patch test tray and aluminum chamber patch. Journal of the Philippine Dermatological Society, 1991; 22:69-72.

35.

Marks

, Belsito

, Deleo

, et al. North American Contact Dermatitis Group standard tray patch test results (1992 to 1994). Am J Contact Dermat, 1995; 6:160-5.

36.

Marks

, Belsito

, Deleo

, et al. North American Contact Dermatitis Group standard tray patch test results (1994 to 1996). J Am Acad Dermatol, 1998; 38:911-8.

37.

Marks

Jr , Belsito

, DeLeo

, et al. North American Contact Dermatitis Group patch test results, 1996-1998. Arch Dermatol, 2000; 136:272-3.

38.

Marks

, Belsito

, DeLeo

, et al. North American Contact Dermatitis Group patch-test results, 1998 to 2000. Dermatitis, 2003; 14:59-62.

39.

Pratt

, Belsito

, DeLeo

, et al. North American Contact Dermatitis Group patch-test results, 2001-2002 study period. Dermatitis, 2004; 15:176-83.

40.

Warshaw

, Belsito

, DeLeo

, et al. North American Contact Dermatitis Group patch test results, 2003-2004 study period. Dermatitis, 2008; 19:129-36.

41.

Zug

, Warshaw

, Fowler

, et al. Patch-test results of the North American Contact Dermatitis Group 2005-2006. Dermatitis, 2009; 20:149-60.

42.

Woo

, Wolfgang

, Batista

. The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety. Clin Pharmacol Ther, 2008; 83:494-7.

43.

Payne

. Contamination—taking control. Cosmetic

Business [Serial online] 2009

. http://www.cosmeticsbusiness.com/story.asp?storycode=3470/ (accessed February 10, 2011).

44.

Nuthall

, Ryall

, Jackson

, Germain

. F for fake. [Serial Online] 2009. Available at: http://www.cosmeticsbusiness.com/story.asp?storycode=3973 (accessed February 10, 2011).

45.

Characterising contaminants, 2008. Reading Scientific Services. July 19, 2008. Available at: http://www.manufacturingchemist.com/index.php/technical/article_page/title/41008 (accessed February 10, 2011).

46.

Sherrie

Heart healthy. Cosmetics that contain topical anesthetics can be dangerous. 2009. Available at: http://themedicalupdate.blogspot.com/2009/08/cosmetics-that-contain-topical.html (accessed February 10, 2011).

47.

Jin

, Yang

Y-J

, Wang

W-Y

, Ye

J-N

. Simultaneous determination of antibiotics in anti-acne cosmetics by Rapid LC with DAD. Chromatographia, 2009; 69:1-6.

48.

Rathi

Abuse of topical steroid as cosmetic cream: a social background of steroid dermatitis. Indian J Dermatol, 2006; 51:154-5.

49.

US Food & Drug Administration Cosmetics: Cosmetic labeling guide from the cosmetic labeling manual

October

. 1991. Available at: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/ucm126444.htm#clgl9 (accessed April 5, 2010).

50.

Doskow

Market research: new world economy drives shift in global cosmetics and toiletries retailing. Available at: http://www.klinegroup.com/reports/emailings/newsletters/consumer/september2009/timely_trends.asp (accessed Mar 21, 2010).

51.

Eiermann

, Larsen

, Maibach

, Taylor

. Prospective study of cosmetic reactions: 1977-1980. J Am Acad Dermatol, 1982; 6: 909-17.

52.

Adams

, Maibach

. A five-year study of cosmetic reactions. J Am Acad Dermatol, 1985; 13:1062-9.

53.

Emmons

, Marks

Jr . Immediate and delayed reactions to cosmetic ingredients. Contact Dermatitis, 1985; 13:258-65.

54.

Berne

, Bostrom

A Å

, Grahnen

, et al. Adverse effects of cosmetics and toiletries reported to the Swedish Medical Products Agency 1989-1994. Contact Dermatitis, 1996; 34:359-62.

55.

Skog

Incidence of cosmetic dermatitis. Contact Dermatitis, 1980; 6:449-51.

56.

Romaguera

, Camarasa

JMG

, Alomar

, Grimalt

. Patch tests with allergens related to cosmetics. Contact Dermatitis, 1983; 6: 167-8.

57.

DeGroot

AC.

Contact allergy to cosmetics: causative ingredients. Contact Dermatitis, 1987; 17:26-34.

58.

De Groot

, Beverdam

, Ayong

, et al. The role of contact allergy in the spectrum of adverse effects caused by cosmetics and toiletries. Contact Dermatitis, 1988; 19:195-201.

59.

Goossens

, Beck

, Haneke

, et al. Adverse cutaneous reactions to cosmetic allergens. Contact Dermatitis, 1999; 40:112-3.

60.

Nielsen

, Linneberg

, Menneé

, et al. Allergic contact sensitization in an adult Danish population: two cross-sectional surveys eight years apart (the Copenhagen Allergy Study). Acta Derm Venereol, 2001; 81:31-4.

61.

Hasan

, Rantanen

, Alanko

. Patch test reactions to cosmetic allergens in 1995-1997 and 2000-2002 in Finland—a multicentre study. Contact Dermatitis, 2005; 53:40-5.

62.

Duarte

, Lage

. The frequency of cosmetic dermatitis and the main dermatosis mistaken as cosmetic reaction. J Am Acad Dermatol, 2007; 56 (2 Suppl 2):AB75.

63.

Vij

, Murthy

, Ravindra

Study of contact dermatitis due to topical medicaments and cosmetics by patch testing. Indian J Dermatol, 2007. 194-7.

64.

WangWh, Li

, Lu

, Jing

. Cosmetic dermatitis in Chinese eczema patients patch tested with a modified European Standard series of allergens. Contact Dermatitis, 2005; 53:314-9.

65.

Biebl

, Warshaw

. Allergic contact dermatitis to cosmetics. Dermatol Clin, 2006; 24:215-32.

66.

Warshaw

, Buchholz

, Belsito

, et al. Allergic patch test reactions associated with cosmetics: retrospective analysis of crosssectional data from the North American Contact Dermatitis Group, 2001-2004. J Am Acad Dermatol, 2009; 60:23-38.

67.

Miyar

, Baumann

. Focus on: color cosmetics and contact dermatitis. Skin Aging, 2009; 17:3.

68.

Orton

, Wilkinson

. Cosmetic allergy: incidence, diagnosis and management. Am J Clin Dermatol, 2004; 5:327-37.

69.

Kohl

, Blondeel

, Song

. Allergic contact dermatitis from cosmetics: retrospective analysis of 819 patch tested patients. Dermatology, 2002; 204:334-7.

70.

Wolf

, Wolf

, Tuzun

, et al. Contact dermatitis to cosmetics. Clin Dermatol, 2001; 19:502-15.

71.

Dorado

Reviewer of the archives and current records of VMV Hypoallergenics Inc. Philippines. Available at: http://www.vmvgroup.com (accessed January 15, 2010).

72.

Greif

, Maibach

. United States cosmetic ingredient labeling. Contact Dermatitis, 2006; 3:94-7.

73.

Cosmetics directive. Available at: http://ec.europa.eu/enterprise/sectors/cosmetics/documents/directive/index_en.htm#h2-consolidatedversion-of-cosmetics-directive-76/768/eec (accessed Nov 1, 2009).

74.

Geffken

Rules and revelations: REACH - the cosmetic impact. Global Cosmetic Industry (GCI) Magazine. June 2007. p. 4-7.

75.

Standards for cosmetics. Available at: http://www.mhlw.go.jp/english/topics/cosmetics/index.html (accessed Nov 1, 2009).

76.

International Cooperation on Cosmetic Regulation: Meeting summary; International Cooperation on Cosmetic Regulation (ICCR-3); September. 2009. Sep. Available at: http://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/ucm182661.htm (accessed Dec 4, 2009).

77.

Cosmetics in Australia. Available at: http://www.nicnas.gov.au/Chemicals_In_Australia/Cosmetics_In_Australia.asp (accessed November 1, 2009).

78.

General information booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme: Jakarta: ASEAN Secretariat 2006.

79.

Beijing Directive on Cosmetic Labeling by Mid2010. Hong Kong: BDL Media; 2009. Available at: http://www.chinacsr.com/en/2009/01/07/4068-beijing-directive-on-cosmetic-labeling-by-mid-2010/ (accessed February 10, 2011).

80.

Nigam

PK.

Review article. Adverse reactions to cosmetics and methods of testing. Indian J Dermatol Venereol Leprol, 2009; 75: 10-9.