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This document supports the revision of the European Commission Guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ with regard to fructose and sorbitol, which are used as excipients in a variety of oral (tablets, capsules, suspensions) and topical formulations (creams, emulsions). Sorbitol (and rarely fructose) is also used as a protein/peptide stabiliser in some medicinal products for parenteral use such as blood products (immunoglobulins) and vaccines.