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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.
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