The safety of propylene glycol has been evaluated and confirmed by international and national authorities. Both the Organisation for Economic Cooperation and Development (OECD), and the Canadian Centre for Occupational Health and Safety, have published risk assessments that conclude propylene glycol has very low toxicity.
Propylene glycol used in pharmaceuticals applications must follow strict specifications for quality as laid out in the European Pharmacopoeia. The 8th edition of this official document of the European Directorate for the Quality of Medicines (EDQM) was published in 2013 and 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.
The European authorities responsible for consumer health have approved the use of propylene glycol with food:
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 68/2013) 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 in application*.
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, and 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.
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 substance's intrinsic properties and hazards, a detailed use mapping, and, for hazardous substances, an exposure and risk assessment. As propylene glycol is not classified as hazardous, exposure scenarios and risk assessments are not required.
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 dedicated Propylene Oxide-Propylene Glycols REACH webpage managed by REACHCENTRUM.
Please be aware that the registration is valid for the molecule propylene glycol (CAS No 57-55-6) with a defined substance identification agreed in the Consortium, which is different from the quality specifications necessary for industrial vs. pharmaceutical applications.
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.
* 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 that may shorten the life time of the red blood cells. This effect is unique to cats. For more information click here.