2005 ANNUAL SCIENTIFIC SEMINAR 369 No Rechallenge Testing - The rate of death (D-value) is independent of the initial concentration of test organisms present (up to the level at which the preservative system is overwhelmed). The same D-values were obtained on the first and 10th challenge of Staphylococcus aureus and Pseudomonas aeruginosa in product samples. Elimination of rechallenge testing may reduce testing time by one week. No Environmental Isolates - The use of environmental isolates of house organism is not necessary for routine testing. It is wtlikely that anyone can find all of the environmental isolates that may occur when formulas are inadequately preserved, when compliance with GMPs is unsatisfactory, or when test methods are inadequate to control product release. If products meet appropriate acceptance criteria, they will kill house organisms grown on laboratory media. Required D-value -- Three variables that determine whether a product will become contaminated are the preservative system of the formula, which may be expressed as the D-value, a packaging factor, and a consumer use/abuse factor. The required D-value (RDV) may be determined as follows: Maximum acceptable D-value for target organism RDV = (Packaging Factor) (Consumer Use/Abuse Factor) Preservative System Concept Preservative chemicals do not act independently in a formula because they are part of a "system". The preservative system includes preservative chemicals, the physicochemical composition of the product (pH, aw, surfactants, chelating agents, fragrance chemicals, etc.), and protective packaging. Formula ingredients that have antimicrobial activity become "hurdles" for microorganisms. Principles of Preservation The principles of preservation are used throughout the food, drug and cosmetic industries. These principles are: • Asepsis (keeping microorganisms out, microbial control of raw materials/processes, and protective packaging) • Removal of microorganisms (e.g., washing, trimming, filtering to minimize microbial content) • Retarding growth/killing of microorganisms using higMow temperatures, low and high pH, drying to achieve low water activity (aw), removal of substrates and oxygen, use of preservatives or biocides, and irradiation or mechanical disruption. The principles of preservation may be used to reduce and/or eliminate the need for addition of chemical preservatives in a formulation. Formulation components that contribute to the preservative system include compounds that raise/lower pH, compounds that lower aw, lipids and esters, surfactants antioxidants, chelating agents, aroma chemicals, and botanicals. Self-preserving, or "preservative-free" products utilize the principles of preservation (including protective packaging) so that they are adequately preserved without use of chemical preservatives. Summary We will be able to build on the basics of preservation using the chemistry of preservatives, knowing the strategies of preservation, complying with regulatory requirements, and hannonizing test methods for global products. This information will enable us to select appropriate preservative efficacy test methods and acceptance criteria to ensure that our products are adequately preserved.
370 Description: JOURNAL OF COSMETIC SCIENCE D&C BLACK #2 William F. Thys Sensient Cosmetic Technologies Carbon Black is produced by a number of different processes, only 2 of which are relevant to the cosmetic industry, namely channel black and furnace black. Channel black is produced by the combustion of gas burned in iron channels, in which the pigment is deposited. Furnace black is produced by injecting oil into the flame zone of an enclosed reactor. It is used in cosmetics as a colorant. Regulation History: Prior to 1960, when the Color Additive Amendments were issued, carbon black of varying sources was used in foods, drugs and cosmetics. By the stipulation of the amendments, a color additive could only be permanently listed if its safety was proven under all conditions of use. However, it could be provisionally listed while testing was being conducted. All-gas channel black was selected to be provisionally listed while the industry gathered the required data, based on chemical and toxicological testing. The major stumbling block to the approval of carbon black was the possibility that extractable polynuclear aromatic hydrocarbons (commonly referred to as PAH's or PNA's), particularly known carcinogens 3,4-benzpyrene and 1,2-benzantracine, might be present. Since no method for accurately determining the levels of these PNA's, at least not to the ppb level, existed at the time, the provisional listing was withdrawn. That was 29 years ago. In 1982, the FDA "Constituents Policy" allowed that color additives containing trace amounts of carcinogens could be used, provided that the specific materials did not contribute and color function, and further provided that the color additive was shown to be non-carcinogenic by animal testing. In 1986, a petition was put forward by the CTF A, citing improved analytical methods, for the use of carbon black as a cosmetic color additive. Although various delays stalled approval, FDA finally approved the use of carbon black in 2004, although with certain provisions, specifically that the type of carbon black was limited to high purity furnace black, and that it should be subject to FDA certification to ensure compliance with the limits set forth in the final ruling. The approved name, reflecting the need for certification, was to be D&C Black #2. D&C Black #2: Carbon black, in order to be certified as D&C Black #2 for cosmetic use, is required to pass limit level tests for PAH's (benzpyrene and dibenzanthracene), as well as for the usual heavy metals. Surface area is also specified to correspond with a very small particle size, which would limit the potential for binding PAH's. The specifications are as seen in Table 1. Specification Limit Surface Area (Nitrogen BET) 200 - 260 m2/gm. Weight Loss on Heatiniz (950C for 7-min.) 2%max. Ash 0.15% max. Lead IO-ppm max. Heavy Metals: Arsenic 3-oom max. Mercury 1-ppm max. Total Sulfur 0.65% max. Total PAH's 500-ppb max. Benzoovrene 5-ppb max. Dibenzantracene 5-ppb max. Total Color (as Carbon) 95%min. Table 1. D&C Black #2 Specifications
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