Fact sheets

What role do preservatives play in cosmetics?

What role do preservatives play in cosmetics?

Fact sheet on preservatives in cosmetics

 

What are preservatives?

According to the Cosmetics Regulation (Regulation (EC) No 1223/2009), preservatives are defined as: "substances which are used in cosmetic products exclusively or predominantly to inhibit the development of microorganisms."

 

What legal regulations apply?

In cosmetics, only preservatives listed in Annex V may be used according to Art. 14(1)(d) of the Cosmetics Regulation. Currently, approximately 50 substances are listed in Annex V. This list is exhaustive. Annex V also specifies maximum concentrations and permitted uses. If the conditions of the Cosmetics Regulation are not met, the use of the respective preservative is prohibited.

 

Which preservatives exist?

Preservatives according to Annex V:

The preservatives are listed in Annex V of the Cosmetics Regulation (note updates to the Annex in case of legal changes). These include, among others:

 

Preservative group Examples
Organic acids
  • Benzoic acid
  • Sorbic acid
  • Salicylic acid
Parabens
  • Methylparaben
  • Butylparaben
Formaldehyde releasers
  • Bronopol
  • Diazolidinyl urea
Isothiazolinones
  • Methylisothiazolinone

 

In cosmetic products, several different preservatives are usually used to achieve a broad spectrum of activity. The maximum concentrations for preservatives may also differ depending on the region of application/product category. For benzoic acid, for example, the following conditions apply:

 

Type of product/body parts Maximum concentration in the ready-for-use preparation
Rinse-off/rinsed-off products, excluding oral products 2.5 % (as acid)
Oral products 1.7 % (as acid)
Leave-on products for skin/hair 0.5 % (as acid)

 

Other substances with preservative properties:

In addition to the preservatives defined in Annex V, there are a number of substances in cosmetics that may also have more or less pronounced preservative or antimicrobial effects.

These substances include, among others:

  • Essential oils
  • Plant extracts
  • Plant parts (mustard seeds, eucalyptus leaves, etc.)

These substances can exhibit preservative properties as mentioned. Because these substances are not regulated in Annex V, their primary intended purpose must be different (e.g., fragrance, masking, moisturizing). Otherwise, their use does not comply with the requirements of the Cosmetics Regulation.

 

What should be considered for marketing claims?

The so-called "Claims Regulation" (Regulation (EU) No 655/2013) governs promotional statements for cosmetic products. This also covers advertising regarding the absence of preservatives and the omission of certain compounds (e.g., "preservative-free", "paraben-free").

According to the Annex to this Regulation, such promotional statements are subject, among other things, to truthfulness, honesty and fairness. Therefore, any promotional statement must be assessed on a case-by-case basis with regard to these criteria (see also literature from the GDCh).

Note:

For so-called microbiologically low-risk products, the use of preservatives is generally not required. These include, for example, products with pH values ≤ 3 or ≥ 10 or a water activity value (aW) ≤ 0.75. Further examples can be found in ISO 29621 (standard for microbiologically low-risk products). Promotional claims of preservative-free formulations for these products are generally considered misleading.

 

Analytical aspects:

The analysis of preservatives is performed within our Tentamus laboratory group as an accredited test method. Determination is carried out by liquid chromatography coupled with mass spectrometric detection (LC-MS/MS).

 

References:

 

 

 

 

 

 

 

 

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