Regulatory

Authorities confirm safety of propylene glycol

Several international authorities investigated the safety of propylene glycol. Both the Organisation for Economic Cooperation and Development (OECD), and the Canadian Centre for Occupational Health and Safety, have published risk assessments that indicate the very low toxicity of propylene glycol.

Pharmaceuticals

If propylene glycol is used in pharmaceuticals applications, strict specifications for quality as laid out in the European Pharmacopoeia, have to be followed. The 8th edition of this official document of the European Directorate for the Quality of Medicines (EDQM) was published in 2013; it is used in more than 37 countries in Europe. In the US, propylene glycol is listed as GRAS – Generally Recognized as Safe – for use in food and pharmaceuticals in the US-Pharmacopoeia (Ref21CFR), the official FDA (US Food & Drug Administration) document.

Food

The European authorities responsible for consumer health have approved the use of propylene glycol with food:

  • in direct food contact (EU Regulation 10/2011 and amendments) as food additive E1520. In 2011 Propylene Glycol was included in te Union list of food additives approved for us in food additives, food enzymes, food flavouring and nutrients (EU Regulation 1130/2011);
  • in indirect food contact (Dir2002/72/EC and amendments) relating to plastic materials and articles intended to come into contact with food, such as packaging material.

Animal Feed

As of October 2010 propylene glycol is an approved animal feed material according to EU Regulation 892/2010. It is listed in the Catalogue of Approved Feed Materials (EU Regulation 575/2011, no. 13.11.1) and in the EU Register of Feed Materials.  Previous restrictions related to the authorization as feed additive only prior to October 2010 are no longer application*.

* Western European producers of propylene glycol in Cefic do not support its use in cat food: when fed with propylene glycol containing feed, cats show an increase in Heinz body formation, which are deformities of erythrocytes and shorten the life time of the red blood cells.  This effect is unique to cats. For more information
click
here.

Cosmetics

In 1994, the Cosmetics Industry Safety Panel (of CTFA, Cosmetic, Toiletry and Fragrance Association, known today as “The Personal Care Products Council”) confirmed propylene glycol to be safe for use in cosmetic articles, even at higher concentrations than those actually used in consumer products.

EU Regulation (EC) No 1223/2009 on Cosmetic Products works on the principle of a “negative” list which defines substances that are prohibited or restricted for use in cosmetics. Propylene Glycol is not on this list.

REACH

The Regulation (EC) No 1907/2006 concerning Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires producers and importers of chemical substances in quantities of above 1 ton per year to register with the European Chemicals Agency (ECHA). The registration dossier contains detailed information on the intrinsic properties, a risk assessment of the substance and a detailed use mapping. Exposure scenarios do not have to be provided, because Propylene Glycol is not classified.

The Propylene Glycol Producers in the EU have worked together in a Consortium to jointly address the registration requirements of Propylene Glycol. For further details on this please visit the following webpage: Propylene Oxide-Propylene Glycols REACH managed by REACHCENTRUM.

Please be aware that the registration is valid for the molecule Propylene Glycol (CAS No 57-55-6) with a defined and in the Consortium agreed substance identification, which is different from the quality specifications necessary for industrial vs. pharmaceutical applications.

CLP

The EU has adopted the UN Globally Harmonised System (GHS) of Classification and Labelling of Chemicals and transferred into the EC Regulation 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (CLP). It replaces Directive 67/548/EEC (substances) and Directive 1999/45/EC (preparations). Propylene Glycol remains not classified as hazardous under the CLP Regulation.

In 1994, the Cosmetics Industry Safety Panel (of CTFA, Cosmetic, Toiletry and Fragrance Association, known today as “The Personal Care Products Council”) confirmed propylene glycol to be safe for use in cosmetic articles, even at higher concentrations than those actually used in consumer products.

 

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