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.

If propylene glycol is used in pharmaceuticals applications, strict specifications for quality as laid out in the European Pharmacopoeia, have to be followed. The latest edition of this official document of the European Directorate for the Quality of Medicines (EDQM) was published in 2008; 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.

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

• in direct food contact (Link: Dir95/2/EC and amendments) as food additive E1520;
• in indirect food contact (Link: Dir2002/72/EC and amendments) relating to plastic materials and articles intended to come into contact,

such as packaging material.

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.