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Use of parabens in STOKO® products

The use of parabens is a controversial discussion point at the moment. The scientific view is that parabens are currently the most suitable and safest preserving agents available on the market. On account of the unavailability of well-documented, safe alternatives, we at STOKO® Skin Care continue to use parabens alongside other highly skin-compatible preserving agents.

Please read our comments on the issues under discussion:

“Allergic potential of parabens”

The up-to-date literature shows that parabens are, from the point of view of allergology, among those preserving agents which have a particularly low allergenic potential.
While there are reports of allergies, if these are viewed in relation to the frequent use (a large number of products, including consumer products, are preserved with parabens), parabens have to be described as inconspicuous with regard to allergology – see also the data compiled by IVDK (Informationsverbund dermatologischer Kliniken = Information Network of Dermatologic Hospitals)[1,2].

In FDA (Food and Drug Agency/USA) [3] and CDC (Center of Disease Control/USA) [4] publications, as well as in NICNAS (National Industrial Chemicals Notification and Assessment Scheme/Australia) [5] publications, the use of parabens for the conservation of cosmetic products continues to be viewed as safe. The scientific consultation committee at the European Union SCCS (Scientific Committee on Consumer Safety) [6] comes to the conclusion in one of its recent publications that the use of parabens, in the concentrations currently used, can continue to be regarded as safe. The IKW (Industrieverband Körperpflege und Waschmittel = Industrial Association for Toiletries and Washing Products) [7] reaches the same conclusion in its summary and refers, with regard to the need for a preservation of cosmetic products, to the comment by the GDCh (Gesellschaft Deutscher Chemiker = Association of German Chemists) [8].

“Hormone-like effect of parabens”

Theoretically, a hormone-like effect from parabens appears possible on account of their chemical structure, depending on the chain length of the molecules. However, the available studies and reports do not document any proven hormone-like effect in humans of any of the approved parabens if used in the current concentrations.

Preserving agents improve the safety of cosmetic products. As part of microbial quality management, which is required as part of GMP (Good Manufacturing Practice), a bioburden test is required. After the production of every batch of the finished product, a germ count is carried out. We guarantee after production a bioburden of fewer than 100 germs or colony-forming units (CFU) per gram of product.
During application of the product, contamination of the product is possible in certain circumstances, even with pathogenic germs. The bioburden test indicates whether these germs are able to grow to a pathologically relevant quantity. In order to prevent the growth of the germs which have contaminated the product, and therefore to guarantee product safety, preserving agents are used.
The BfR [9] statement documents the safety of parabens. It is also mentioned that for long-chained parabens (e.g. isobutylparaben), sufficient data for evaluation are not available. However, this does not mean that there is a problem.

It goes without saying that we continuously read the scientific literature on the ingredients we use. Should there be any indication that the safety of a raw material used by us is doubtful, we immediately react and modify our products accordingly. Of course, the STOKO® product range also includes paraben-free products.

If you have any further questions, please contact the scientific STOKO® consultation service!

1 Schnuch, A., Uter, W., Geier, J., Brasch, J., Frosch, P.J. (2005) "Überwachung der Kontaktallergie: zur Wächterfunktion des IVDK" Alllergo J 14, 618-629
2 Schnuch, A., Mildau, G., Kratz, E.-M., Uter, W. (2011) "Risk of sensitization to preservatives estimated on the basis of patch test data and exposure, according to a sample of 3541 leave-on products" Contact Dermatitis 65, 167-174
3 www.fda.gov/cosmetics/productandingredientsafety/selectedcosmeticingredients/ucm128042.htm
4 www.cdc.gov/exposurereport/data_tables/Parabens_ChemicalInformation.html
5 www.healthy-communications.com/parabensaustrailia.htm
6 ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_041.pdf
7 IKW Infos für Verbraucher: Sicherheit von Parabenen in kosmetischen Mitteln www.ikw.org
8 www.lallf.de/fileadmin/media/PDF/lebensm/KonservierProuContra.pdf
9 www.bfr.bund.de/

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