PRESERVATIVES - BE INFORMED NOT HOODWINKED

All products that contain natural ingredients must contain preservatives

FACT: It would take at least 72,000 layers of a product containing the permitted amount of parabens, applied one layer after another to human skin, to produce an oestrogenic effect from topical application, thus demonstrating an unbelievable margin of safety.

• The safest form used by most cosmetic houses in the world are parabens.
• Parabens are also the preservatives of choice for most food stuffs, milk, jam etc. baby foods and breast cancer treatments.
• These preservatives have been used successfully and safely for more than 50 years.
• Other product preserving ingredients can cause more harm to the skin. These can be in the form of Ethanol (alcohol) which should only really ever be used in anti-acne products and in minimal percentages. All the scientific literature states that ethanol should never be used on a continual basis on any skins as it has dehydrating effects which long-term will be harmful and in many cases will lead to pigmentation, premature wrinkling/ageing of the skin. If the percentage of ethanol is high within a product it then requires a substance such as glycerine to help prevent total skin dehydration.
• Benzoates are also used as preserving agents and these are potential carcinogens.
• Tea Tree Oil is also used as a preservative, but, is not compatible with ingredients that are used for hydration etc.
• Newer preservatives were released a couple of years ago in Europe and have already been withdrawn because of their potential long-term risks.
• The percentage of preservative within a product is important. One will know the percentage of preservative there is within a product by looking at the ingredient list and seeing whether the preserving ingredients are near the top or bottom of the list.
• Within RégimA we use the lowest necessary for preservation of 0.1% to a maximum of 0.2%.

Be very wary of companies stating that their products are preservative-free. There could be a few explanations for this. Either, the formulation is purely chemical, there are no or extremely low actives, or there are ingredients within the formulation that have preserving effects (like those stated above) and they are just not telling you that.

If the main concern is that certain preservatives may have an oestrogenic effect then just think about every time you purchase any meat, chicken, milk, eggs – with every bite or sip of the above one is ingesting (which is worse) high percentages of hormones that have been fed to all animals. One would need to become a vegan vegetarian to try and avoid this. If one considers this route then also consider the pesticides that are used on almost all farms.

• Parabens applied topically would not even give as much potential oestrogenic effect as one cup of coffee with milk per week!

WHAT ARE PARABENS?

• Parabens are a very common group of organically synthesized preservatives used in cosmetics as well as drugs and foods.
• As a group of multiple compounds, they include methylparaben, ethylparaben, propylparaben, isobutylparaben, and butylparaben.
• Like most preservatives, they are antimicrobial, meaning they prevent the growth and reproduction of bacteria, mold, and fungi.
• This attribute allows parabens to keep products safe for repeated consumption.
• All daily use, personal care products must contain some form of preservation.

HOW ONE USES PARABENS

Parabens are used to maintain product freshness because of their proven safety record and low irritation profile and at extremely low levels (usually between 0.1% to 0.8%). RégimA formulates its products within the lowest range of the guidelines (0.1% to 0.2%) for the beneficial qualities and safety that parabens provide.

FDA AND CTFA PROCLAIM PARABENS SAFE FOR COSMETIC USE

The US Food and Drug Administration (FDA) and the Cosmetic Toiletries and Fragrance Association (CTFA) have thoroughly researched the use of parabens in cosmetics. The FDA regulates product safety, and the CTFA provides specific ingredient safety through the Cosmetic Ingredient Review Board (CIR). The CIR is an independent panel of renowned physicians and scientists that reviews ingredients used in cosmetics since 1976. Both organizations continue to review research on parabens and proclaim them safe and effective for use in cosmetic formulations.

COMMITMENT TO SAFETY

RégimA monitors scientific research on all our ingredients, including parabens, to ensure our distributors can offer safe and efficacious products. The majority of paraben research for the past 50 years supports the safety of parabens in consumer use. However, misinformation circulated about paraben studies has caused undue concern that parabens may have weak oestrogenic effects. Putting these study results into perspective is important as we determine whether or not parabens are safe for use in cosmetics. There are many other common substances, such as SOY, that have more substantial oestrogenic properties, but because these substances have been used culturally for centuries without harmful effects they do not raise concern. Additionally, the recent paraben studies were conducted with exaggerated levels of test material ingested or injected into rats rather than applied topically to humans. The conclusion that parabens at extremely low levels in a topical application would produce a similar outcome as an exaggerated use test is without direct evidence and unproven. Since cosmetic products have very low levels of parabens, it is unscientific to assume they could be absorbed through the skin in any significant amount to create adverse effects. In fact, to date there are no scientific studies that show a causal link between topical products that contain parabens and detrimental effects. The CTFA asserted in a statement:-

Suggestions that parabens have an oestrogenic potential or affect the male reproductive system are not relevant to the cosmetic use of these ingredients. The level of parabens used in cosmetics is extremely low. (CTFA Response Statement, April 17, 2003; RSPT 03-12).

The long history of paraben use in cosmetics, backed by the continued, careful research of the cosmetic industry, FDA, and other qualified sources, reassures our pledge of "all of the good, none of the bad."

PARABENS: CRITICAL INFORMATION

The controversy regarding parabens was started by a British researcher who conducted a study strictly on under arm deodorants and she was giving high doses to rats orally and via injections! Rats are in no way like humans and the percentages were astronomical in comparison.

RégimA is totally against animal testing and will not use any animal derived ingredients. In order to get a fair and correct result for any product we believe it is critical that human volunteers, who have a choice, should be used. This is the way RégimA conducts testing on all our products. Always put things in perspective and realize that if tests are conducted on animals then question what dosage and application has been used as well as the cruelty aspect. Note below the parabens tests were NOT undertaken topically.

The studies that were conducted in the UK by Dr. Phillippa Darbre, a researcher, were controversial and denounced by the scientific world. Her findings were strongly contradicted by other doctors, including Dr. Christopher Flowers a toxicologist and the Director General of the CTPA (Cosmetic Toiletries and Perfumes Association) in London, England. (see references below). Her report was conducted claiming that underarm deodorants can be harmful. This was proven not to be the case. At that point there were 3,324 new deodorants on the market and only 12 contained parabens (many being preserved with alcohol etc.).

The studies were conducted on rats using totally unrealistic levels of parabens injected subcutaneously and given orally. Even under normal circumstances the levels given to the rats equate with the overall effect of parabens being 2.4 billion times weaker than oestrodial. Compare this with dietary phyto-estrogens consumed orally daily via milk, soya, jam, royal jelly etc. The daily dose of 'the pill' taken by women is 10,000 times more oestrogenic than parabens.

The studies showed that even with the huge oral intake given to the rats there was no harm to them because there was rapid and complete biodegradation and excretion from the body. Parabens have a large molecular structure so do not penetrate into the system. Their function is to catch microbials and therefore they stay on the membrane. There is complete biodegradation with topical application of parabens.

RégimA uses the lowest levels of parabens between 0.1 to 0.2% maximum and the accepted normal levels approved by the FDA are 0.8%. We also use EDTA which has a preservation effect. What must be stressed is that there are worldwide regulations regarding cosmetics and all RégimA products are submitted for strict toxicology testing and toxicology certificates are obtained. One must always look realistically at the comments given and always obtain the necessary data. The only people who can legitimately make any claims are toxicologists who would be testing particular products. Do not listen to the scare tactics banded about by cosmetic houses in order to promote their own ranges of products. If products contain any natural ingredients it is essential that they are preserved in one way or another otherwise they will deteriorate rapidly. Be warned that many are using ETHANOL which has extreme dehydrating effects on most skins and this can in turn lead to pigmentation when exposed to the sun and premature wrinkling/ageing. Other product houses are using BENZYL ALCOHOL or other preservatives from the benzoate family. These substances are toxic and known to be carcinogenic. All RégimA ingredients are approved by the world authorities and all RégimA products undergo very regular stringent testing.

Articles denouncing the study from Dr. Darbre as being unscientific:

• April 2004 in Soap, Perfumery and Cosmetics by Dene Godfrey of Micro Pure Ltd.
• 2004 in Soap, Perfumery and Cosmetics; entitled Trust in Scientific Expertise by Dr. Chris Flower, Director General CTPA (Cosmetic, Toiletries and Perfume Association).

Remember that parabens have one of the longest histories regarding preservation and if they were so harmful they would not be used in most baby products and most foodstuffs and in some breast cancer treatments. Many other new preservatives do not have the history and there are some that have only been in use in Europe for a couple of years and have already been withdrawn due to lack of safety.

One must always be wary of lectures regarding ingredients where the speakers are in the employ of, or benefit financially from particular product houses for making certain statements. The lecturer must be qualified to speak on the particular subject.

FDA ON PARABENS

Source: U. S. Food and Drug Administration

March 24, 2006; Updated October 31, 2007

FDA has received a number of inquiries on safety.

The Cosmetic Ingredient Review (CIR) reviewed the safety of methylparaben, propylparaben, and butylparaben in 1984 and concluded they were safe for use in cosmetic products at levels up to 25%.

In December 2005, after considering the margins of safety for exposure to women and infants, the Panel determined that there was no need to change its original conclusion that parabens are safe as used in cosmetics. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature. FDA participates in the CIR in a non-voting capacity.)

FDA is aware that oestrogenic activity in the body is associated with certain forms of breast cancer. Although parabens can act similarly to oestrogen, they have been shown to have much less oestrogenic activity than the body's naturally occurring oestrogen. For example, a 1998 study (Routledge et al., in Toxicology and Applied Pharmacology) found that the most potent paraben tested in the study, butylparaben, showed from 10,000- to 100,000-fold less activity than naturally occurring oestradiol (a form of oestrogen). Further, parabens are used at very low levels in cosmetics. In a review of the oestrogenic activity of parabens, (Golden et al., in Critical Reviews in Toxicology, 2005) the author concluded that based on maximum daily exposure estimates, it was implausible that parabens could increase the risk associated with exposure to oestrogenic chemicals.