Parabens in cosmetics and drugs

Parabens are widely used in the cosmetic, pharmaceutical and food industries as preservatives. Their use is not prohibited by the FDA of the USA and the Russian Federation, but in EU countries their content, for example, in cosmetic products has a maximum permissible concentration (MPC) — 0.4% for individual substances and 0.8% for mixtures of substances.  What are parabens? Is it dangerous to use products containing substances of this group?

  1. What are parabens and how they are controlled in Russia?

By chemical nature, parabens are esters of para-hydroxybenzoic acid. The most commonly used esters of this group are: methyl paraben, ethyl paraben, benzyl paraben, butyl paraben and propyl paraben.  Substances of this group have a wide range of antimicrobial activity, stable in wide pH ranges and are cheaper than a large number of preservatives. In this regard, their use in various industries is very attractive.

In Russia, parabens are most often found in food, cosmetics and drugs.

According to TR TC 029/2012 esters of para-hydroxybenzoic acid can be included in the following product categories:

1.Jelly, pate — MPC is 1 g/kg

2.Breakfast cereals — MPC is 300 mg/kg

3.Candy, chocolate with filling – MPC is 300 mg/kg

4.Meat products — MPC is indicated in the technical documentation.

Their designations are E214, E215, E218, E219.

According to TR CU 009/2011 the use of parabens as part of perfumery and cosmetic products is also allowed, but their content is not regulated. In addition, parabens are widely used in the production of various dosage forms (gels, creams, syrups, etc.).

      2. What effects can parabens have?

According to the FDA, toxicity of parabens contained in cosmetics is not currently proven, so there is no need for their normalization. At the same time, FDA continue to evaluate new data in this area, and if the toxicity of parabens in cosmetics is proven, the FDA will take appropriate measures. It is worth noting that the FDA is not an authorized body for certification of cosmetic products. In the United States, this is done by industry-sponsored organizations of manufacturers, which often listen to the recommendations of the EU, where the content of parabens in cosmetic products is normalized.

Normalization of paraben content is not groundless. There is evidence in the scientific literature that parabens disrupt the work of the endocrine glands and, in particular, exhibit estrogen-like properties, although this is not the main cause of malignant rebirths caused by the group of substances.  Their contribution to breast cancer is mainly related to the growth of MCF-7 tumor cells. In addition, studies have shown that parabens are much more effectively absorbed through the skin than with oral administration, so their use should be limited primarily in cosmetic products. Studies conducted by Barr L et al have shown that 60% of the incidence of breast cancer of the upper outer part is associated with the regular application of cosmetics to the skin, although the researchers do not make unambiguous conclusions about the relationship of parabens with the development of this disease.

Based on the available data, it can be concluded that further study of the toxic properties of parabens is certainly required and their content in cosmetics, especially in well absorbed through the skin, should be regulated. However, this group of preservatives is one of the most accessible and completely exclude it from the formulations, for example, drugs is impossible.


1.TR CU 029/2012

2.TR CU 009/2011

3.Barr L, Metaxas G, Harbach CA, et al. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. J Appl Toxicology. 2012; 32: 219-232.

4.Błędzka, D., Gromadzińska, J., & Wąsowicz, W. (2014). Parabens. From environmental studies to human health. Environment International, 67, 27–42. doi:10.1016/ j.envint.2014.02.007

5.Konduracka, K. Krzemieniecki, G. Gajos, Relationship between everyday use cosmetics and female breast cancer, Pol. Arch. Med. Wewn. 124 (2014) 264–269.

6.Fonseca Ana Paula PARABENS PARADOXES IN COSMETIC FORMULATIONS: A REVIEW, Volume 3 (Issue 8) : August 2016 DOI: 10.5281/zenodo.61076