Health & Safety Issues

For details of potentially harmful ingredients of cosmetics not required to be listed on labels, see Ingredient’s We Don’t Use under Ethoxylates, 1,4-Dioxane and Nitrosamines.

Disclosure Regulations

Law requires all ingredients to be identified on cosmetic goods sold in Australia and most countries around the world. The stated purpose of these regulations is:

• to enable consumers to identify products containing ingredients which may irritate them, cause an allergic reaction, or be potentially harmful;
  

• to enable consumers to make value comparisons between similar products.

We are active in raising the following important product safety issues to public view:

1. Allergens in Cosmetic Raw Materials

Many cosmetic raw materials are preserved with objectionable preservatives such as parabens and formaldehyde. Cosmetics that contain these raw materials are not required to list these preservatives on the label - only preservatives added by the manufacturer to the finished cosmetic product are required to be listed on the label. Hence many cosmetics on the market contain objectionable preservatives that are not listed on the label, so consumers beware!

The DBF Company do not use any raw materials that are preserved with parabens and formaldehyde (also called formalin).

2. Potentially Harmful Impurities in Cosmetics

For details of potentially harmful ingredients of cosmetics not required to be listed on labels, see ethoxylates, 1,4-dioxane, and Nitrosamines.

3. Value comparisons between products

The regulations currently state that "ingredients must be listed in descending order by volume or mass, however ingredients present at less than one-per cent may be listed in any order."

Consumers should be aware that very dilute herbal extracts such as certified organic floral waters (a by-product of making essential oils) are commonly added to cosmetic products. This to us is a deceptive practice in that consumers believe these products are more “herbal” or “natural” than is actually the case.

The DBF Company use only special ingredients that have a proven beneficial effect to the skin when applied externally. Even more importantly these special ingredients are used in concentrations at which beneficial effect is proven.

Ethoxylates

"A lot of chemicals used in cosmetic formulations are synthesised by ethoxylation: the bulk of anionic and nonionic cleansers and certain thickeners, for instance. Ethylene Oxide is a hazardous and very toxic reactant, which is classified by the International Agency for Research on Cancer (IARC) as category 2A, probably carcinogenic for humans. The eventual presence of free ethylene oxide in PEG derivatives or ethoxylates is a concern for food and pharmaceutical authorities worldwide.The problem of 1,4-dioxane affects the same type of chemical substances. In fact, dioxane is a derivative of ethylene oxide and is often present in ethoxylates. Dioxane is considered to give possible risks of irreversible toxicological damage. "

- Extracted from academic cosmetic chemist, Denis Rebut, and is taken from Cosmetics and Toiletries Journal, Vol 104, April 1994.
The following is a list of some of the most commonly used ethoxylated ingredients:

• Sodium laureth sulfate (SLES)

• Ammonium laureth sulfate

• Triethanolamine laureth sulfate

• All ingredients with "eth" in the name eg Ceteth 20

• All ingredients with "PEG" in the name

• All the Polysorbates

It should also be noted that ethoxylated ingredients are inherently unstable (due to the presence of an ether linkage). They have been shown in a Sicilian study to break down when applied to the skin in a cosmetic cream to form skin-damaging free radicals.

For purity and safety reasons, The DBF Company do not use of any ethoxylated ingredients.

Sulfates and Petrochemical Cleansers

• Sulfates is the colloquial name for a group of cleansing ingredients called alkyl sulfates, which are amongst the most irritating ingredients in personal care products, yet used by almost every manufacturer worldwide. Ammonium lauryl sulfate is the most strongly irritant, followed by sodium lauryl sulfate.

• Petrochemical cleansers tend to be harsh and irritating. Examples include sodium dodecyl benzene sulfonate and sodium C12-16 olefin sulfonate.

• Ammonium lauryl sulfate is commonly used to replace sodium lauryl sulfate, which is the subject of negative publicity.

The following table shows this replacement is significantly more irritating than SLS. See FAQ for further details.

A primary irritation index of over 5 means the test material is rated as a primary irritant, 2-5 means moderately irritating. Reproduced from RP Brandau, Detergent Age, Jan (1967).

Preservatives

Preservatives are the most common cause of allergic reaction to cosmetics. Toxic preservatives such as methylchloroisothiazolinone (KATHON CG) and formaldehyde (formalin), should be avoided. The more irritating and allergeric preservatives, such as the formaldehyde donors imidazolidinyl urea, diazolidinyl urea, 2-bromo-2-nitropropane-1,3 diol, iodopropynyl butylcarbamate and DMDM hydantoin and quaternium 15, should also be avoided.

Take care when looking at products which make a feature of using "natural" preservatives. Such ingredients generally have a narrow spectrum of activity and other preservatives must supplement their action. A well-known example is grapefruit seed extract which itself has minimal or even zero antibacterial properties. Most grades on the market have been tested and shown to contain the synthetic preservatives, parabens and benzethonium chloride. Visit this link for further information http://www.ars.usda.gov/research

Parabens are the most commonly used preservative in a wide range of cosmetic and toiletry products. They are also the most common ingredient (apart from water) in personal care products and can be present in high concentrations. The DBF Company do not use ingredients which have been preserved with parabens.

Formaldehyde

Formaldehyde is an effective and cheap preservative which is used in some major brand hair care products. It is toxic, carcinogenic, and probably the most irritating ingredient used in personal care products. It is listed as "formalin" on product labels instead of its common name, formaldehyde, to veil its presence. This is currently legally acceptable practice. Consumers beware!

Formaldehyde also finds its way into a wide range of cosmetics and toiletries as a preservative of raw materials. Formaldehyde is termed an "incidental ingredient" by the current Cosmetic Ingredient Disclosure Regulations when used in this way, and is exempted from having to be listed on the label! People with sensitivities should check with their cosmetics supplier for an assurance that formaldehyde is not used to preserve any raw ingredients used in their products.

"Formaldehyde is intensely irritating to mucous membranes, is toxic and a known skin sensitiser."
- Anthony L. Hunting, Encyclopedia of Conditioner Rinse Ingredients, 1987

Propylene Glycol & Organochlorines

Propylene glycol is an ingredient in most cosmetics and toiletry formulations. It is a humectant, which attracts water to itself and prevents creams from drying out. It is also a solvent. In fact, most herbs are extracted into propylene glycol. Propylene glycol is a petrochemical derivative - it is a primary irritant and can cause delayed contact hypersensitivity. It is commonly used instead of glycerin or sorbitol, both particularly safe and highly effective plant-derived humectants, because it is cheap. Consumers who are concerned about allergies and sensitivities to cosmetics would be well advised to avoid products containing propylene glycol, choosing instead those which use glycerin or sorbitol.

Avoid chlorinated organic compounds, as chlorine in its organic form (ie combined with carbon) is a chemical recipe for toxicity. In the personal care arena, for example, the quaternaries (or quats) containing chlorine eg stearalkonium chloride are amongst the most irritating ingredients used in personal care products. It is therefore wise to choose quats which do not contain chlorine - if, for example, the methosulphate grouping replaces chlorine, extremely mild detanglers such as behentrimonium methosulfate can be formed.

Solubilisers, Colours & Foam Boosters (DEAs)

Solubilisers are used to dissolve small amounts of oil (usually fragrances) in water-based products, such as skin toners and floral waters. Solubilisers are not used in our products for two reasons. Firstly, they are powerful solvents, and can have a detrimental effect on the skin. And secondly, they are all ethoxylated ingredients, and are therefore always contaminated with toxic impurities.

The solubilisers most commonly used include:

• PEG-40 glyceryl cocoate (sometimes called glyceryl cocoate)
  

• PEG-40 castor oil
  

Colours do not have any function in cosmetics and toiletries (except for colour cosmetics) other than to make the product look more appealing to consumers. A common industry practice is to add a colouring material to make the product appear to contain a higher level of a featured ingredient eg adding green chlorophyl to a Rosemary Shampoo. Added colours are also a leading cause of allergies and it is best avoided. The DBF Company do not use any colour additives; hence most of the shampoos are clear (exception is the Lemongrass Shampoo which has a rosy or orangey colour depending on the season) and other products are cream.

Foam boosters are used in virtually all shampoo and body wash formulations. These ingredients, being derivatives of monoethanolamine (MEA), or diethanolamine (DEA), are known to be always contaminated with varying levels of toxic Nitrosamines. The most commonly used foam boosters are Cocamide MEA or DEA and Lauramide MEA or DEA. The DBF Company do not use these foam boosters.

1,4-dioxane

 "A lot of chemicals used in cosmetic formulations are synthesised by ethoxylation: the bulk of anionic and nonionic cleansers and certain thickeners, for instance. Ethylene Oxide is a hazardous and very toxic reactant, which is classified by the International Agency for Research on Cancer (IARC) as category 2A, probably carcinogenic for humans. The eventual presence of free ethylene oxide in PEG derivatives or ethoxylates is a concern for food and pharmaceutical authorities worldwide.

The problem of 1,4-dioxane affects the same type of chemical substances. In fact, dioxane is a derivative of ethylene oxide and is often present in ethoxylates. Dioxane is considered to give possible risks of irreversible toxicological damage."
-Extracted from Cosmetics & Toiletries Journal, Vol 109, April 1994, author Denis Rebut, Ph.D.

For details of commonly used ethoxylates, click here.

"Cosmetics containing ethoxylated surfactants may be contaminated by 1,4 dioxane, which has been shown to be carcinogenic in rats and mice and to be absorbed through the intact skin of animals. Furthermore, this compound has been classified as a possible carcinogen to humans. According to the European Economic Community directive on cosmetics, 1-4-dioxane must not be present in commercial products. Consequently, the assay of this substance in marketed cosmetics is of direct concern to consumers.”

- J. Soc. Cosmetic. Chemist, 43, 207-213 (July/August 1992)
Department of Pharmaceutical Science, University of Ferrara, Italy
Santo Scalia, Fabio Testoni, Giuseppe Frisina and Mario Guarneri

"Within the shampoo manufacturing sector of the cosmetics industry there is concern about the level of residual 1,4-dioxane present in final shampoo products. The 1,4-dioxane is introduced into the product via the use of ethoxylated fatty alcohol sulfates as cleansing agents. During the process of alcohol ethoxylation, ethylene oxide can dimerize to form 1,4-dioxane, which is subsequently carried through the shampoo manufacturing process. This compound has been shown to be carcinogenic in animals and is listed as a carcinogen with NIOSH.

Concern over the health risks, along with the probability that the ethoxylated surfactants in use contain a fair amount of residual 1,4-dioxane, has lead many cosmetic and toiletry companies to examine the levels of dioxane in both their raw materials and their finished products. Although many producers have begun vacuum stripping procedures in their manufacture of the fatty alcohol sulfates, there can still be high levels of 1,4-dioxane remaining in the materials that will be inadvertently added into finished product."

"A variety of commercially available cosmetics were analyzed for 1,4-dioxane. The products included shampoos, liquid soaps, sun creams, bath foams, moisturizing lotions, cleansing milks, after-shave balms, baby lotions, day creams, and hair lotions. Of the total products investigated, 56% contained 1,4-dioxane with levels ranging from 3.4 to 108.4mg/kg."

"It should be stressed that even when the 1,4-dioxane content is low, under appropriate conditions of cosmetic use, long-term application to skin is common."
- Johnson & Johnson Consumer Products Company NJ
Mark P. Italia and Mathews A. Nunes, J. Soc. Cosmet. Chem., 42, 97-104 (March/April 1991)

Nitrosamines

The presence of nitrosamines in personal care products is a major concern within the cosmetics industry. Nitrosamines are formed as pollutant by-products in a number of cosmetic raw materials. They may also be formed within the cosmetic itself after it is made. As a group, nitrosamines are toxic and carcinogenic. They are commonly found in association with ingredients such as the foam boosters lauramide DEA, cocamide DEA and the amine oxides, and the hair detangler stearalkonium chloride.

The DBF Company do not use ingredients known to be contaminated with Nitrosamine impurities.

"N-nitrosamines are a group of chemical compounds which have been found in a variety of consumer products, including cosmetics and toiletries."

"N-nitrosamines found in a variety of personal care products are either introduced by contaminated raw materials, or formed within the product itself by the reaction of precursors. Limited surveys of cosmetic raw materials have shown that N-nitrosamines are present in approximately 30% of the raw materials analyzed, occasionally at levels up to 1 ppm. However, a comparison of the N-nitrosamine levels found in cosmetic raw materials with those reported in the finished products shows that although some degree of N-nitrosamine contamination of personal care products may be due to the raw materials, formation in the product from precursors is the principal source of N-nitrosamines in these products."

- US Food and Drug Administration, Washington DC, USA
Donald C Harvery and Hardy J Chou, Cosmetics & Toiletries Vol. 109, May 1994

"The contamination of cosmetics by N-nitrosamines is a problem of international concern. Most of the ca. 130 - N-nitrosamines (NNA) tested to date have proven to be potent carcinogens in a number of animal species, including primates, and they have been ranked as second in carcinogenic potential only to the aflatoxins. The N-nitrosamine of chief concern to the cosmetic and toiletries industry and regulatory agencies is NDELA, whose carcinogenicity was first reported by Druckrey et al in 1976 and later identified as a potent animal carcinogen."

"Reports of widespread NDELA occurrence in a variety of cosmetics and toiletries by Fan et al., the FDA and Spiegelhalder and Preussman have taken on added significance with the demonstration that NDELA is absorbed percutaneously and has been found to be excreted in the urine of a human subject, following topical application of an NDELA-contaminated cosmetic. Qualitatively, topical administration of NDELA has been shown to induce the same types of tumors in hamsters as either oral swabbing or subcutaneous injection."
-The Andrew Jergens Company, Steven W Collier, Stanley R Milstein and Donald S Orth, , Cincinnati. OHIO, and University of Cincinnati Medical Center, Koka Jayasimhulu J Soc. Cosmet. Chem., 39, 329-346 (November/December 1988)

"The next troublesome impurities are N-nitrosamines. Here, I believe all will accept that there is a genuine cause for concern, with a general recognition within the industry that N-nitrosamines are potential carcinogens in man."
- 'How Green is My Shampoo' by J E Hodgson, et al, Albright & Wilson Ltd, UK. Presented at the Joint ASCC/NZSCC Conference, Tororua, New Zealand, March 1991.