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COSMETICS PRESERVATION tion of drugs under the strong requirements of the pharmaceutical GMP (Good Manufacturing Practice). Additionally the Table 14 Test results lotion preservative 1 useable lifespan after opening of cosmetic products are generally longer than for pharmaceutical products. The schülke KoKo test is specifically verified for the assessment of cosmetic products. From more than 25 years of experience (11, 12) with this test method, we can state a 30 month microbiological stability for a product passing criteria A, which is recommended for cosmetic products. The lotion with the preservative system 1 passed only ISO 11930 and Ph. Eur. criteria B. Nevertheless, even 28 days after the inoculation with Aspergillus brasiliensis it was still detectable. Within 7 days the decrease of moulds is insufficient, the KoKo failed. The lotion with the preservative system 2 and 3 passed ISO 11930 and Ph. Eur.; KoKo showed only slight growth in the last cycles, it fulfils criteria B. Table 15 Test results lotion preservative 2 Table 16 Test results lotion preservative 3 Precision and reproducibility of preservative efficacy tests To assess the differences of the results in the various test methods, it is important to realise the variation in microbiological test results. The GÖCH has published the results of a round robin test for Ph. Eur. - 5.1.3 »Efficacy of Antimicrobial Preservation« (10). The microbial counts differed widely between the laboratories. Fig. 2 shows an overview of the results including expanded uncertainty. For the other methods this data is not available, probably however it can be assumed that it will be in the same range. Borderline results with low reduction in microbial counts might fail in a replicate. Uncertain contaminations during production combined with an insufficient speed of killing may lead to detection of contamination in the market place. The worst case is the inclusion in the RAPEX notifications (13). ■ Conclusion Table 17 Test results lotion preservative 4 The ISO 11930 as new standard to evaluate the antimicrobial protection of a cosmetic product includes reference method to evaluate the preservation, as well as a decision diagram to evaluate the microbiological risk. The recommended preservation efficacy test is less strict than the Ph. Eur. and the KoKo test (see Experimental data). The microbial strains SOFW-Journal | 138 | 7-2012 51
COSMETICS PRESERVATION Table 18 Test results lotion preservative 5 did not include typical product spoiling microorganisms alongside the pathogenic germs as required by the SCCS (7). The stability of a preservative is not taken into account by ISO 11930. Formulations passing KoKo or Ph. Eur. criteria A can be also evaluated as safe according to ISO 11930 criteria A. It is likely that products tested according to CTFA M-3 or M-4 will be safe as the requirement for a germ count reduction within seven days is more rigorous than that of ISO 11930 and comparable to the KoKo test. The ASEAN test is comparable to ISO 11930. The USP 35 can be considered as a weak standard; the demands are below those for ISO 11930. It is advisable to perform a test according to one of the methods designed for cosmetics. References Table 19 Test results lotion preservative 6 Table 20 Summary experimental data (1) ISO 11930, Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product (2) Regulation (EC) No 1223/2009 of the European parliament and the council of Europe of 30 November 2009 on cosmetic products http://eur-lex.europa.eu/LexUriServ/LexUri Serv.do?uri=OJ:L:2009:342:0059:0209:EN: PDF (3) European Pharmacopeia 7 th edition, 5.1.3. Efficacy of antimicrobial preservation (4) United States Pharmacopoeia (USP 35); 51 Antimicrobial effectiveness testing (5) Association of Southeast Asian Nations, Preservative efficacy test for cosmetic product, Document N° ACM MAL 08 (6) Personal Care Products Council (PCPC - formerly the Cosmetic, Toiletry and Fragrance Association); CTFA Microbiology Guidelines 2007 (7) Scientific Committee on Consumer Safety (SCCS), The SCCS's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 7 th Revision Fig. 2 GÖCH results of round robin test including expanded uncertainty (8) ISO 29621, Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products 52 SOFW-Journal | 138 | 7-2012
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