The European Commission asked EFSA to provide a technical assistance on the request for a modification of the specification on the solubility of the food additive polyvinyl alcohol (E 1203) in ethanol and its possible impact on the safety assessment.
Polyvinyl alcohol (E 1203) is authorised as a food additive in food supplements in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. In 2005, the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) evaluated the use of polyvinyl alcohol (PVA) as a coating agent for food supplements (EFSA, 2005) based on the information provided in an application dossier and concluded that “the consumption of the PVA, as specified by the petitioner, through the use as a coating agent for food supplement tablets and/or capsules at its intended use level is not of safety concern”. This conclusion was reached based on two toxicological studies conducted with a test material in compliance with the applicant’s specifications. In the application dossier on polyvinyl alcohol provided in 2005, there was also a statement about the solubility of the final substance in ethanol as “sparingly soluble”, although without any experimental quantification of its solubility.
A solubility test of polyvinyl alcohol (E 1203) in ethanol was carried out by the European Commission Joint Research Centre (Institute for Health and Consumer Protection, IHCP) under a Service Legal Agreement with EFSA. The IHCP report concluded that the solubility of polyvinyl alcohol (E 1203) in ethanol (> 99.8 %) was in the range of 106 parts of solvent required for 1 part of polyvinyl alcohol (around 1 mg/kg). According to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additives Specifications (JECFA, 2006), the descriptive term of the solubility of polyvinyl alcohol in ethanol (> 99.8 %) should be “practically insoluble or insoluble”.
Having evaluated the results of the solubility tests carried out by the IHCP with food grade polyvinyl alcohol and the information provided by the applicant, EFSA recommends that the specification on the solubility of polyvinyl alcohol (E 1203) in ethanol (> 99.8 %) should be solely modified to “practically insoluble or insoluble”.This modification has no impact on the safety of polyvinyl alcohol (E 1203) as a food additive given the fact that the new solubility tests were conducted with a sample of polyvinyl alcohol (E 1203) provided by the owner of the toxicological studies evaluated by the EFSA AFC Panel in 2005.