Kozmetik ürünlerde koruyucu madde kullanımı ve koruyucu etkinlik testleri
Kozmetik ürünlerdeki mikroorganizma kontaminasyonu tüketici sağlığı açısından önemli risk oluşturmaktadır. Mikrobiyal üremeyi önlemek amacıyla ürünlere koruyucu olarak bilinen farklı kimyasal yapıda bazı maddelerin eklenmesi öngörülmektedir. Ancak ürüne eklenecek koruyucu maddelerin formülasyondaki diğer maddelerle uyumlu ve geniş spektrumlu olmaları, kullanıcı üzerine alerjik, toksik ya da tahriş edici etkilerinin olmaması gerekmektedir. 2005 tarihli Türk Kozmetik Kanununa göre, piyasaya sunulan kozmetik ürünlerin güvenlik değerlendirmesinin kullanımına sunuldukları hedef kitlenin sağlığı açısından yapılması zorunludur. Bu derlemede ülkemizde de yaygın kullanım alanına sahip kozmetik preparatlarda kullanılan koruyucu maddeler; özellikleri, ürünlere eklenme ilkeleri ve etkinliğinin belirlenmesi için uygulanan testler açısından değerlendirilmiştir.
The Use of Preservatives in Cosmetic Products and Their Efficiency Testing
Possible microorganism contamination in the widely used cosmetic products may lead to important risks in terms of consumer health. Therefore, there is a requirement of adding preservatives, ingredients with different chemical structures aiming the prevention of microbial reproduction against the risk of contamination in cosmetic products. Preservatives added to cosmetic formulations must be compatible with other ingredients, show broad-spectrum efficiency and have no allergic, toxic or irritant effect on consumers. According to Cosmetics Law, safety evaluation of cosmetic products marketed must be performed for the purpose of health of the target audience. In this review, preservative materials used in widely-used cosmetic products in our Country were evaluated with respect to their properties, principles of their addition to products and tests applied for determination of their efficiency.
___
- Baird RM. Contamination of non-steril pharmaceuticals in hospital and community environments, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.374-84, Blackwell Science, Oxford (1998).
- Brannan DK, Dille JC. Type of closure prevents microbial contamination of cosmetics during consumer use, Appl Environ Microb 1990;56(5):1476-79. PMid:2339896 PMCid:184433
- Beveridge EG. Microbial spoilage and preservation of pharmaceuticals products, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.355-73, Blackwell Science, Oxford (1998).
- Charnock C, Finsrud T. Combining esters of parahydroxy benzoic acid (parabens) to achieve increased antimicrobial activity, J Clin Pharm Ther 2007;32(6):567-72. http://dx.doi.org/10.1111/j.1365-2710.2007.00854.x PMid:18021333
- Common cosmetic preservatives. Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.227- 81, Taylor&Francis Group, New York (2006).
- Curry JC, Brannan DK, Geis PA. History of cosmetic microbiology, Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.3-17, Taylor&Francis Group, New York (2006).
- Darbre PD. Underarm cosmetics and breast cancer, J Appl Toxicol 2003;23(2):89-95. http://dx.doi.org/10.1002/jat.899 PMid:12666152
- Dey BP, Engley FB. Methodology for recovery of chemically treated Staphylococcus aureus with neutralizing medium, Appl Environ Microb 1983;45(5):1533-37. PMid:6870240 PMCid:242496
- Denyer SP, Hodges NA. Sterilization control and sterility assurance, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.439-52, Blackwell Science, Oxford (1998).
- Denyer SP, Wallhaeusser KH. Antimicrobial preservatives and their properties, Denyer S, Baird R (eds). Guide to Microbiological Control in Pharmaceuticals, 1. baskı kitabında s.251-73, Ellis Horwood Limited, West Sussex (1990).
- Doorne HV. Interactions between preservatives and pharmaceutical components, Denyer S, Baird R (eds). Guide to Microbiological Control in Pharmaceuticals, 1.baskı kitabında s.274-91, Ellis Horwood Limited, West Sussex (1990).
- European Commission. The SCCSs Notes Of Guidance For The Testing of Cosmetic Substances and Their Safety Evaluation. Guidelines on microbiological quality of the finished cosmetic product. 8th revision, s.75-76 (2012).
- Geis PA. Preservation strategies, Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.163- 80, Taylor&Francis Group, New York (2006).
- Hammer KA, Carson CF, Riley TV. Antimicrobial activity of essential oils and other plant extracts, J Appl Microbiol 1999;86(6):985-90. http://dx.doi.org/10.1046/j.1365-2672.1999.00780.x PMid:10438227
- Hugo WB. Mode of action of non-antibiotic antibacterial agents, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.256-62, Blackwell Science, Oxford (1998).
- Hugo WB, Russell AD. Evaluation of nonantibiotic antimicrobial agents, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.229-55, Blackwell Science, Oxford (1998).
- Lambert RJ, Hanlon GW, Denyer SP. The synergistic effect of EDTA/antimicrobial combinations on Pseudomonas aeruginosa, J Appl Microbiol 2004; 96(2):244-53. http://dx.doi.org/10.1046/j.1365-2672.2004.02135.x PMid:14723685
- Lee E, An S, Choi D, Moon S, Chang I. Comparison of objective and sensory skin irritations of several cosmetic preservatives, Contact Dermatitis 2007; 56(3):131-6. http://dx.doi.org/10.1111/j.1600-0536.2007.01001.x PMid:17295686
- Lundov MD, Zachariae C. Recalls of microbiologically contaminated cosmetics in EU from 2005 to May 2008, Int J Cosmetic Sci 2008;30(6):471-4. http://dx.doi.org/10.1111/j.1468-2494.2008.00475.x PMid:19099548
- Lundov MD, Moesby L, Zachariae C, Johansen JD. Contamination versus preservation of cosmetics: a review on legislation, usage, infections, and contact allergy, Contact Dermatitis 2009;60(2):70-8. http://dx.doi.org/10.1111/j.1600-0536.2008.01501.x PMid:19207376
- Mehrgan H, Elmi F, Fazeli MR, Shahverdi AR, Samadi N. Evaluation of neutralizing efficacy and possible microbial cell toxicity of a universal neutralizer proposed by the CTPA, Iran J Pharm Res 2006;3(5):173-8.
- Mulhall R, Schmidt E, Brannan DK. Microbial environment of the manufacturing plant, Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.73-96, Taylor&Francis Group, New York (2006).
- Naki Sivri N. Türkiye piyasasında mevcut bazı kozmetiklerin gama radyasyonla dekontaminasyonu, 4. Ulusal Sterilizasyon Dezenfeksiyon Kongresi, Kongre kitabı, s.230-49, Samsun (2005).
- Oishi S. Effects of butyl paraben on the male reproductive system in mice, Arch Toxicol 2002;76(7): 423-9. http://dx.doi.org/10.1007/s00204-002-0360-8 PMid:12111007
- Oishi S. Effects of propyl paraben on the male reproductive system, Food Chem Toxicol 2002;40(12):1807-13. http://dx.doi.org/10.1016/S0278-6915(02)00204-1
- Orth DS. Principles of preservation, Denyer S, Baird R (eds). Guide to Microbiological Control in Pharmaceuticals, 1. baskı kitabında s.241-50, Ellis Horwood Limited, West Sussex (1990).
- Pack LD, Wickham MG, Enloe RA, Hill DN. Microbial contamination associated with mascara use, Optometry 2008;79(10):587-93. http://dx.doi.org/10.1016/j.optm.2008.02.011 PMid:18922495
- Payne DN. Microbial ecology of the production process, Denyer S, Baird R (eds). Guide to Microbiological Control in Pharmaceuticals, 1. baskı kitabında s.53-67, Ellis Horwood Limited, West Sussex (1990).
- Sasseville D. Hypersensitivity to preservatives, Dermatol Ther 2004;17(3):251-63. http://dx.doi.org/10.1111/j.1396-0296.2004.04028.x PMid:15186371
- Scott EM, Gorman SP. Chemical disinfectants, antiseptics and preservatives, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s. 201-28, Blackwell Science, Oxford (1998).
- Smart R, Spooner DF. Microbiological spoilage in pharmaceuticals and cosmetics, J Soc Cosmet Chem 1972;23:721-37.
- Smith CN, Alexander BR. The relative cytotoxicity of personal care preservative systems in Balb/C 3T3 clone A31 embryonic mouse cells and the effect of selected preservative systems upon the toxicity of a standard rinse-off formulation, Toxicol In Vitro 2005;19(7):963-9. http://dx.doi.org/10.1016/j.tiv.2005.06.014 PMid:16055304
- Sutton SV, Wrzosek T, Proud DW. Neutralization efficacy of Dey-Engley medium in testing of contact lens disinfecting solutions, J Appl Bacteriol 1991;70(4):351-4. http://dx.doi.org/10.1111/j.1365-2672.1991.tb02948.x PMid:2055795
- Sutton SVW. Antimicrobial preservative efficacy and microbial content testing, Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.111- 45, Taylor&Francis Group, New York (2006).
- Steinberg DC. Global regulation of preservatives and cosmetic preservatives, Geis PA (ed). Cosmetic Microbiology, 2. baskı kitabında s.215- 26, Taylor&Francis Group, New York (2006).
- Steinberg D. Preservatives for Cosmetics, 2. baskı, s.1-129, Allured Publishing Co., Illinois, USA (2006).
- T.C. Sağlık Bakanlığı. Kozmetik Kanunu, Resmi Gazete, Sayı.5324, (2005).
- T.C. Sağlık Bakanlığı. Kozmetik Yönetmeliği, Resmi Gazete, Sayı.25823, (2005).
- Underwood E. Ecology of microorganisms as it affects the pharmaceutical industry, Hugo WB, Russell AD (eds). Pharmaceutical Microbiology, 6. baskı kitabında s.339-54, Blackwell Science, Oxford (1998).
- The United States Pharmacopoeia, _____51> Anti- microbial Effectiveness Testing, USP 24 - NF 19The United States Pharmacopoeial ConventionInc (2000).
- The United States Pharmacopoeia, Validation of Microbial Recovery from Pharmacopeial ArticlesUSP 29 - NF 24, The United States PharmacopoeiaConvention, Inc (2005).
- Varvaresou A, Papageorgiou S, Tsirivas E et alSelf-preserving cosmetics, Int J Cosmetic Sci 200931(3):163-75. http://dx.doi.org/10.1111/j.1468-2494.2009.00492.x PMid:19302511