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The Dilemma
of Preservatives in Your
Products
A common factor between all product lines is product preservation. We prefer preservative-free products, to date this can be accomplished by the use of reverse air flow pumps and irradiation, and provides a product shelf life of 9-12 months. In June of 2006, the FDA mandated new labeling laws; compliance must be met by June of 2007. All labels must be written in the INCI, or Latin name. Many see this as a move towards global standardization of labels. Many see the next step as a standardization of preservatives. Japan, and many Asian countries require 0.05% Methyl and Propyl Parabens, or recently approved (2007) Iodopropynyl Butylcarbamate, for product entry. NaturDerm TM is a global skin care company and must meet the global requirements for product entry. Several natural-based preservatives are under evaluation for use, but have not passed regulations for non-contamination in products past 12 months. Like Grapefruit Seed Extract, they may not be recognized in the global arena as broad-spectrum preservatives that prove stable enough over the long term to prevent contamination at the required levels to pass approval. In January of 2006, the Global Cosmetic Industry reported, “The area is a minefield… Finding alternatives to Parabens that meet safety levels and shelf-life expectations is proving a major challenge.” Mr. Hooper of Body Blue products notes, "There are some brands on the market that have exploited a loophole in the regulations in order to claim preservative-free," he insisted. "If a raw material used in the product is preserved unnecessarily, or is over preserved using any preservative--whether synthetic or natural--then the preservative does not have to be listed on the ingredient deck. This is misleading to the consumer and is potentially damaging to the whole industry." NaturDerm products list all ingredients, regardless of amounts, and are produced in an FDA certified cGMP approved (certified Good Manufacturing Practices) manufacturing facility. Many products are not, and run the risk of cross contamination by poor quality control standards. To decrease the risk of plastic residue seepage, whenever possible NaturDerm uses glass containers and reverse airflow pumps. Products containing Corundum Crystal require the use of jars, or tubes. This opens contamination issues on two fronts; one when the consumer opens the container introducing possible airborne mold spores, and two contamination from the consumers hands. Nutrient rich products are a perfect medium for the growth of organisms. All raw ingredientsin our products, and all NaturDerm product batches undergo microbiological testing and culture. What risks exist for preservative-free, or inadequately preserved products? Dangerous ones. Let's look at some of the contamination issues, organisms commonly seen and the physical results. Health AtoZ writer, Diane Griffith, in her article entitled “Contamination at the Cosmetic Counter”, cited a study done by New Jersey Rowan University professor, Dr. Elizabeth Brooks who tested skin, eye and lip makeup from over 20 cosmetic companies and found molds, fungi, and E.coli. Brian Perry, PhD in his article entitled, “Cosmetic Microbiology” published in Microbiology Today, Vol. 28/Nov 2001 states, “Organisms commonly isolated from poorly preserved water-based products include Klebsiella, Enterobacter, Staphylococcus and Bacillus species, Pseudomonas, including P. aeruginosa, Burkholderia cepacia, Penicillium and Candida albicans. Gram-negatives are most common and, as they have very diverse metabolic capabilities, can survive in a wide range of environments. They are often introduced through water supplies.” Daniel K. Brannan, in his book entitled, Cosmetic Microbiology: A Practical Handbook, reports the presence of common bacteria cutured from cosmetics and personal care products including: Streptococcus pyogen “S. pyogenes is the cause of many important human diseases ranging from mild superficial skin infections to life-threatening systemic diseases. Infections typically begin in the throat or skin. Examples of mild S. pyogenes infections include pharyngitis ("strep throat") and localized skin infection ("impetigo"). Erysipelas and cellulitis are characterized by multiplication and lateral spread of S. pyogenes in deep layers of the skin. S. pyogenes invasion and multiplication in the fascia can lead to necrotizing fasciitis, a potentially life-threatening condition requiring surgical treatment. Infections due to certain strains of S. pyogenes can be associated with the release of bacterial toxins. Throat infections associated with release of certain toxins lead to scarlet fever. Other toxigenic S. pyogenes infections may lead to streptococcal toxic shock syndrome, which can be life-threatening.” Aspergillus “Aspergillus species are highly aerobic and are found in almost all oxygen-rich environments, where they commonly grow as molds on the surface of a substrate, as a result of the high oxygen tension. Commonly, fungi grow on carbon-rich substrates such as monosaccharides (such as glucose) and polysaccharides (such as amylose). In humans, the major forms of disease are: 1. Allergic aspergillosis (affects asthma, cystic fibrosis and sinusitis patients). 2. Acute invasive aspergillosis (risk increases if patient has weakened immunity such as some AIDS patients and those undergoing chemotherapy). 3. Disseminated invasive aspergillosis (widespread through body).” Serratia marcescens “Only pathogenic species of seratia - tends to colonize in the respiratory and urinary tracts - since 1960' s classifed as an opportunistic pathogen in pneumonia and respiratory infections.” Stachybotrys sp “The genus Stachybotrys species, of which Stachybotrys chartarum (also known as S. atra) is the most common, is capable of producing mycotoxins, which can affect occupants producing both mucosal and neurological symptoms. Acute exposure can cause severe symptoms. All species produce mycotoxins that may be lethal to animals if eaten. The presence of Stachybotrys sp. is often overlooked due to the fact that it is difficult to isolate from the air. However, Stachybotrys sp. needs a substantial amount of water and a suitable nutrient substrate (cellulose) to initiate growth. Most often Stachybatrys sp. is only isolated from bulk and/or swab and tape surface samples where conditions are favorable for growth. It is possible that Stachybotrys sp. could exist in other locations that have been subjected to persistent water intrusion.” The decision then becomes one of which preservatives do we use? Preservatives like Phenoxyethanol, which is associated with high irritation/allergic reactions, and Hydroxymethylglycinates, which often react to essential oils and have a tendency to break down into formaldehyde, also make products waxy. Behentrimonium Methylsulfate is an ammonia based preservative and irritant. TEA and DEA (Tri and Diethanolamines) are known mutagenic compounds. Only Iodopropynyl Butylcarbamate, and Methyl and Propyl Parabens pass the full spectrum 12-month non-contamination requirements. Although Methyl and Propyl Parabens can be derived from natural sources, the majority of companies who utilize parabens use petrochemical based parabens. Valid concern remains both in the scientific communities, and the public with the possible hormonal influence on the body from paraben use. Methyl and Propyl Parabens have a history of over 50 years of use in cosmetics, personal care products and food. They are not known to be mutagenic or carcinogenic. They are linked to estrogenic activity. In the January 2005 issue of the Journal of Applied Toxicology, Darbe, P. et al presented studies of Parabens in 20 breast tumors. The authors stated the importance of studies on normal breast tissue to measure any existing levels of Parabens to determine if a difference exists between normal and cancerous tissue. In October 2002, The Journal of the National Cancer Institute, Marick, D. et al of the Fred Hutchinson Cancer Research Center, Seattle, reported a case-control study of anti-perspirants and deodorants. No linkage was found to increase the risk of breast cancer. In July of 2005, Global Cosmetic Industry reported a study done in 1995 of 215 cosmetic products, which showed 99% of all leave-on products and 77% of rinse-off products, contained Parabens. The use of Parabens in anti-perspirant and deodorant products is still being reviewed. No distinctions are made between the source of Methyl and Propyl Parabens. The anti-perspirants also contained Propylene Glycol, which is significant. Propylene Glycol, aside from being a petrochemical and the basis of anti-freeze, is a solvent. Methyl and Propyl Parabens are lipid-based compounds. Propylene Glycol is able to act as a transfer to drive the Methyl and Propyl Parabens deeper into the tissue where they will seek out lipids, for example breast tissue. Methyl and Propyl Parabens can be synthesized from plant tannins and terpines, as well as petrochemicals. This process can cause confusion. Sometimes phenols are used, which are a class of organic compounds that contain a 6-member aromatic ring bound to a hydroxyl group. Phenols are responsible for the fragrance of an oil and have anti-oxidant properties. Parabens are esters. Esters are a combination of an organic acid and an alcohol. Many fats and oils are esters, and many esters are used for artificial flavorings and fragrances, such as: Ethylheptanoate, which smells of grape and Pentyl Acetate, which smells of banana. Methyl and Propyl Parabens can be derived from plant and some animal sources. For example, Propyl Paraben is a Propyl ester of p-Hydroxybenzoic Acid, which can be from petroleum distillates, and can also be found as a natural substance from plants and the scales of animals. Many preservatives also act as a neutralizer, which can negate the effects of acid-based anti-aging ingredients. NaturDerm is committed to produce the purest, most effective products possible. We are pleased to be able to meet global, consumer, and our own needs and concerns for the safest, most effective product preservation. All NaturDerm products are now preserved with low levels of Iodopropynyl Butylcarbamate. Iodopropynyl Butylcarbamate (IPBC) is the preservative of choice for most natural products. A highly effective broad spectum preservative, IPBC passes full microbiological testing. Commonly used in baby products, the only cautions are as IPBC is Iodine-based, it should not be used in spray products, or at product levels higher than 2% of the formulation. NaturDerm products contain less than a quarter of this amount. As with all preservatives, at higher amounts irritation can result. NaturDerm uses the lowest possible amount of IPBC, less than 0.5% of the formulation. By using a broad spectrum preservative in low amounts, it is not necessary to add other preservatives, this allows for a purer product. The USA based National Institutes of Health, http://toxnet.nlm.nih.gov toxicology website through the National Library of Medicine makes some distinctions on Iodopropynyl Butylcarbamate. Iodopropynyl Butylcarbamate is a broad spectrum, fungicide preservative with a long history of use. First combined with other preservatives and used in amounts of up to 97% in paint and sealants, Iodopropynyl Butylcarbamate is now a favorite with environmental architects who find the short half-life and non-toxic, non-carcinogenic, non-volatile properties of Iodopropynyl Butylcarbamate to benefit green living and working environments. A type of Carbamate fungicide, there are also Carbamate herbicides and Carbamate insecticides, according to the National Institutes of Health, Carbamate fungicides do not affect the body in the same manner as Carbamate insecticides and pesticides. Carbamate insecticides and pesticides inhibit the cholinesterase enzyme, “Reported toxic manifestations have included CNS depression, seizures, extrapyramidal effects, neuropathy, and gastrointestinal effects of nausea, vomiting and diarrhea. These agents are often compounded with hydrocarbon-based solvents, which may be responsible for toxicity.” Internet searches reveal clinical studies on animals with Pesticidal Iodopropynyl Butylcarbamate, these results have been reflected in articles to create issues with humans, “a mutagen in animal testing”, when it is not the same compound. As in all preservatives, skin irritations, and allergic reactions can occur. When reviewing many of the medical articles on contact dermatitis and Iodopropynyl Butylcarbamate, it is interesting to note the base compounds used in the studies include petrolatum and known irritants. Just as Methyl Parabens can be derived from tree bark, and Propyl Parabens from animal scales, Iodopropynyl Butylcarbamate itself can also be solvent derived, or water based. Medical studies do not differentiate which compound was used. NaturDerm products use an organic acid-based aqueous (water), non-solvent based Iodine salt preparation of Iodopropynyl Butylcarbamate. A study of 4,883 patients over 18 months reported that test findings of Iodopropynyl Butylcarbamate in a base of petrolatum showed a reaction rate of 0.3%, and was not able to elicit significant allergic reactions at a concentration of 0.1%, and recommend further studies at a higher level of 0.3%. “The preservative Iodopropynyl Butylcarbamate: frequency of allergic reactions and diagnostic considerations.” Schnuch, A. et al. Contact Dermatitis 2002 Mar; 46(3): 153-6. A second study of 3.5 years length with routine patch testing of 3,168 people (2,093 women and 1,075 men) with a cosmetic that contained Iodopropynyl Butylcarbamate yielded 7 cases, or 0.3%, to be positive for allergic contact dermatitis. Two of the 7 allergic cases also tested positive for another compound in the product. “Allergic contact dermatitis from 3-iodo-2-propynyl-butylcarbamate (IPBC) - an update.” Brvid, L.E., et al. Contact Dermatitis 2001 May; 44 (5): 276-8. In today's world of MRSA, SarS and super bugs, NaturDermTM believes consumer protection is paramount. ________________________________________________________________________ All informative explanations are copyright protected and trademarked! ________________________________________________________________________ |
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| Disclaimer: Individual results may vary. Neither NaturDermTM Inc., Natural Beauty Skin Care nor their employees make any claims, diagnosis, or recommendation for treatment, or bear any responsibility for other use of the information provided herein. We state only what our customers have shared with us. All testimonials are personal testimonies of actual product users. All photos are not retouched, or manipulated, and are of actual product users. Individual results may vary. These comments are not approved by the US-FDA or UK-MHRA and are intended for use in the U.S.A.& EU only for information purposes. © 2000-2008 |
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