Preservation
Parabens are the most commonly-used preservatives in conventional cosmetic products but could they also be the most problematic? What kind of preservation is good? What kind is questionable from a health point of view? I would give parabens a “satisfactory” evaluation. However, a number of other preservatives have received “deficient” and “unsatisfactory” evaluations. These differences highlight the fact that certain preservatives are clearly more problematic than parabens. The opposite is also true: preservatives also exist which are better than those containing parabens. As my product analyses demonstrate, the range of possibilities for a preservative goes from “very good” to the lowest evaluation of “unsatisfactory”.

Preservation: a difficult task which is dealt with in many different ways
All cosmetic products must be stable from a microbiological point of view. This means that only a limited quantity of micro-organisms such as bacteria, yeasts or moulds must be allowed to form once the products have been opened. Micro-organisms of this type cannot exist without water. Because most cosmetic products contain water, they must be preserved in one way or another. A product can easily be preserved if chemicals are used. Formaldehyde, one of the first preservatives, works wonders. Formaldehyde is incredibly effective even in small doses. It is also extremely dangerous, as we now know. Formaldehyde has now been classified as carcinogenic.
Every competent head of a Research and Development department knows that there is no such thing as an problem-free preservative. Preservatives are intended to kill micro-organisms. If they do this, they have fulfilled their purpose. However, every substance that kills micro-organisms can also be damaging to the skin or even present a health risk if it is not carefully dosed and carefully examined to identify unwanted side effects.

Specific know-how: the preservation concept used by manufacturers of natural cosmetics
The issue of preservation presented one of the greatest challenges for the pioneers of European natural cosmetics in the 1960s and 1970s. Lengthy development work and a great deal of experience were required in order to obtain positive results and develop cosmetics without synthetic preservatives.
A number of factors determine what needs to be done in order to guarantee the microbiological stability of a product, including the composition of the product, its production and even the type of packaging. A comprehensive range of measures needs to be applied in order to manage without synthetic preservatives. Firms involved in the production of natural cosmetics have been working on this issue for many years. Their system is based above all on producing and packing a product in such a way that the development of micro-organisms is kept to a minimum and their entry in the product during use is limited as far as possible. The more successful this system, the smaller the amount of preservative required and the gentler the effect of the preservative used.

Preservatives presenting the highest potential risks
Information on which preservatives should be used is provided in an appendix to the Cosmetics Directive. It would be negligent to lump these substances together, as they differ considerably. The manufacturer alone is responsible for determining how and with which substances he preserves a product. It is also up to the manufacturer to ensure that no unwanted preservatives enter the substance through pre-preserved purchased raw materials.
Manufacturers have a choice. A mixture of synthetic preservatives is generally used with standard cosmetic products.
The highest potential risk is presented by preservatives belonging to the halogenated organic compounds category.
Halogenated substances have considerable allergenic potential; they are reactive and can disintegrate, accumulate and create damage when they penetrate tissue.
•   Because nobody knows exactly what form they take on the skin of an individual user, highly-reactive substances present a particular risk. They can create serious effects when combined with other reactive substances. This so-called "cocktail effect" has not yet been researched in detail.

Potential risk of formaldehyde and formaldehyde releasers
Formaldehyde releasers such as DMDM hydantoin have emerged as replacement substances for formaldehyde. They release formaldehyde under specific conditions, e.g. lengthy contact with water. In June 2004, the IACR (International Agency for Research on Cancer) stated that 26 scientists from 10 countries had reached the conclusion that formaldehyde was carcinogenic for humans.

How problematic are formaldehyde releasers?
As shown in the following examples, formaldehyde releasers are used as preservatives in all kinds of cosmetic products. This raises the question as to whether or not they should be treated in the same way as pure formaldehyde. Experts' opinions differ. The releasing of formaldehyde also occurs in nature. In stored fish, for example, formaldehyde originates from the enzymatic separation of the trimethylamine oxide in the fish. In certain vegetables such as tomatoes, cauliflower, green onions and spinach, the formaldehyde content is between 3 and 60 ppm. Formaldehyde is also contained naturally in fruit (grapes, apples, pears) and fish. A number of conclusions can be drawn from this information. A considerable amount of data is available concerning the dangers of formaldehyde. Assertions about the harmlessness of formaldehyde produced by breakdown are generally based on deductions and assumptions.
When they purchase a product preserved with formaldehyde releasers, consumers never know how much formaldehyde it contains. Not all formaldehyde releasers release exactly the same number of formaldehydes. One may release fewer and others more. Cigarette smoke, for example, releases formaldehyde in quantities of between 57 and 115 ppm. Non-smoker protection exists to ensure that other people do not breathe in this smoke and health risks are highlighted on cigarette packets. By comparison, formaldehyde is authorised up to 1,000 ppm in oral hygiene products, which can easily be swallowed, and up to 2,000 ppm in other cosmetic products. In view of the information available on pure formaldehyde, I consider blanket evaluations such as "formaldehyde releasers are harmless" to be unjustifiable.
Is the dose contained in a cosmetic product really kept to a minimum (on a level with that contained in certain food products)? Or is it higher? The consumer does not know the quantity of formaldehyde involved. I have therefore given formaldehyde releasers the mark "unsatisfactory".
The preservation of a cosmetic product does not involve a single preservative, but rather a mixture. Halogenated organic compounds or formaldehyde releasers are still part of the standard repertoire.

The halogenated organic compounds category and the group of formaldehyde releasers include the following:

	Iodopropynyl Buthylcarbamate
	Chloroxylenol
	Methylchloroisothiazolinone
	Methyldibromo Glutaronitrile
	Diazolidinyl Urea
	Chlorphenesin
	Methylisothiazolinone
	Imidazolidinyl Urea
	DMDM Hydantoin
	MDM Hydantoin

Preservation with parabens
In my books I have expressed the opinion (and nothing has changed in this respect) that the consumer should reach a decision based on safety in case of doubt. When a study by British scientists hit the headlines in 2004 and presented the interpretation that there was a link between parabens in deodorants and breast cancer, it was necessary to clarify how sound the basis for this link was. Because I work on the principle of opting for safety in case of doubt, I have for a while been allocating mark 4 (adequate) to parabens. They were previously allocated mark 3 (satisfactory). So why were they marked down a level? Because there was uncertainty in the air regarding cancer. It was important to determine the grounds for these doubts. In my opinion, the British study was not suitable for justifying suspected cancer. This also explains why I did not give parabens mark 5 or 6. The doubts were not totally eliminated, however, which explains why mark 4 was given. However, this mark should not allow us to forget that preservatives are being used whose potential risks are considerable and have been proven by investigations. They include, for example, substances which denature proteins.

No link between parabens and breast cancer
The SCCP (Scientific Committee on Consumer products) of the European Commission worked intensively on parabens during the period from 2004 to 2006. The main result of the concerns surrounding parabens was the fact that the suspected cancer threat could not be confirmed. The authors of the British study (Darbre and Harvey) have distanced themselves from the inference of a link between parabens and breast cancer. They unambiguously stated that their study did not indicate any link between parabens and breast cancer. Other studies, such as the one conducted by the "Danish Institute of Food and Veterinary Research" reached the conclusion that: there is no link between parabens and breast cancer. The German "Institute for Risk Evaluation" reached the same conclusion. Allergies may arise but, compared with other substances, parabens play a limited role in terms of allergy frequency.

The SCCP mechanism is extremely slow
Although the SCCP was once active, it could take years or even decades before the tests are complete. A decision concerning methyl and ethyl parabens was reached in 2005. On the basis of this decision, there is no reason to change the previous regulations concerning these two parabens. The SCCP requested further details relating to propyl, isopropyl, butyl and isobutyl parabens. This was based on the assumption that the industry was in possession of data which had not previously been made available. It was decided in 2006 that data which had previously been presented (for example, two studies on the basis of animal experiments) contained too many deficiencies to be classified as being scientifically valid. Was there a problem with propyl, isopropyl, butyl and isobutyl parabens? Was something wrong with the test and its organisation? What was the problem? It is not a matter of confirming or refuting the specific details of a possible risk created by these parabens. There have been no findings to support this. The question raised by the SCCP was: should the maximum concentration of these parabens which has been allowed so far be maintained or not? The decision-making process is complex. The conclusions to be drawn from the fact that the process is particularly drawn out are limited or non-existent. A central problem in the evaluation of studies is the fact that there is no "stand-alone" material. The studies presented stem from different laboratories and each study is a science in itself. They conduct investigations with other methods, problems, subjects and doses with a range of different parabens. The data obtained can generally be interpreted in a number of different ways. Some studies raise more questions than answers because, for example, results from one study contradict those of another. However, indications of adverse effects on health as a result of chemical principles (such as protein denaturing for example) have not yet been identified with the above-named parabens.

Paracelsus is still setting the guidelines
The fact that the dose is of the essence, as stated by the famous naturopath Paracelsus, is being confirmed again and again. This is also true of everything that we consider to be good and healthy, such as vitamins for example. If we eat a balanced diet, then we consume a healthy amount of vitamins. It can be very dangerous to use food supplements, particularly in high doses. This is particularly true of vitamins which are stored in the body fat (such as vitamin A). Continuous high doses can result in serious diseases such as liver damage and even an increased risk of cancer. Extensive investigations have been and are still being conducted on the subject of vitamins in order to determine the maximum levels which should not be exceeded. The fact that parabens are classified in a grey area between "good" and "evil" does not mean, however, that preservation involving parabens is the best possible solution. There are alternatives and large quantities of certified natural cosmetic products are being produced without any synthetic preservatives. Parabens are used as preservatives above all in brands which award themselves a natural, plant-based "green glaze" but which are not certified organic cosmetics. However, there is no guarantee that a given brand dispenses totally with preservatives that present a high potential risk. Information on the actual content of preservatives can only be obtained by consulting the list of ingredients in the product itself.

Preserving certified organic cosmetics
One thing is certain in the case of certified organic or natural cosmetics: no product is capable of containg or authorised to contain a preservative which belongs to the group of problematic preservatives outlined above. The corresponding certification guideline stipulates which preservatives may be used. In general, they are so-called "nature identical" preservatives such as benzoic acid, salicylic acid and sorbic acid. In reality, these preservatives are also synthetic; nonetheless they are the mildest ones contained in the appendix to the Cosmetics Directive.

Differences exist, however, according to the certification.
The British Soil Association, for example, allows phenoxyethanol and parabens to be used as preservatives. According to the "BDIH certified natural cosmetics" guideline and the Ecocert guidline, these preservatives are not authorised. Phenoxyethanol can also be used according to the Australian Organic Standard. The American labels also allow different preservatives from the German BDIH and the French certifier Ecocert/Cosmebio.
The know-how available to a cosmetics manufacturer is highly dependent on experience and lengthy development work.
• A sound natural cosmetics preservation system involves the entire manufacturing process, from the composition of the product formulation to production and filling in appropriate containers such as tubes or spray bottles. The containers used ensure that the germs entering the product on extraction are kept to a minimum.

"Free from synthetic preservatives": what is possible?
Products are preserved in different ways even in the case of certified natural and bio cosmetics.
• Possibility 1: the product contains preservatives consisting of substances allowed by natural and organic cosmetics regulations such as benzyl alcohol, potassium sorbate or benzyl salicylate. If one of the authorised substances is used, the wording "preserved with… [name of the preservative]" must be added for products with BDIH certification. This is not necessary for products which are certified according to the French Ecocert/Cosmebio system.
• Possibility 2: none of the substances allowed for natural and organic cosmetics is used. The product can then be labelled as being "free from synthetic preservatives".
The question is often raised as to whether preservation is possible without synthetic preservatives. This is possible in the presence of all the relevant factors: product design, quality of raw materials, manufacturing, filling in appropriate containers under particularly sterile conditions, for example feeding with extremely pure air. If no synthetic preservatives are used, the product formulation is generally designed in such a way that it contains ingredients which also have preserving properties such as alcohol or essential oils.

Making progress through research & experience
The great success of natural and organic cosmetics is enticing large numbers of cosmetics manufacturers worldwide who are keen to take advantage of this phenomenon. The range of suppliers currently populating the natural cosmetics market ranges from firms that have been in the market for decades with their own research and development departments and own production to brands that are more akin to marketing agencies. These brands develop and manufacture their products externally.
Anyone wishing to offer a mature, modern, comprehensive range of cosmetic products will struggle to deal with the preservation issue without extensive knowledge. This is a stumbling block for many who fail to obtain certification for their products. Manufacturers of cosmetic raw materials worldwide are constantly offering new products but new preservatives should be accepted with extreme caution. There is no "miracle solution" for obtaining a safe, gentle preservative. Even certain substances which appeared to solve all preservation problems naturally have proven to be problematic or even dangerous in more specific tests.