Declared vs determined : analysis of cannabinoids in commercially available products on the Maltese market

Abstract

The Cannabis market is rapidly expanding, with an increasing variety of formulations creating a complex regulatory environment. Products containing cannabis fall under different legislative frameworks. Medicinal cannabis products are regulated under pharmaceutical legislation, while commercially available formulations, including oils and cosmetics, containing low concentrations of delta-9-tetrahydrocannabinol (Δ⁹-THC) fall under a combination of national and European Union (EU) regulations, presenting regulatory and analytical challenges due to fragmented frameworks and the absence of standardised quantification methods. This study aimed to develop and validate a High-Performance Liquid Chromatography with Ultraviolet detection (HPLC-UV) analytical method for the simultaneous quantification of five cannabinoids in commercial cannabis-based oils and cosmetics available in Malta. Validation of the method demonstrated specificity, accuracy, linearity and precision. Analysis of 23 oil and 10 cosmetic products revealed discrepancies between labelled and determined cannabinoid content. THC was detected in 6 samples (0.014–0.165 %), with concentrations below the 0.2 % regulatory threshold, while deviations in cannabidiol (CBD) content exceeded ±10 % label accuracy limit in 19 products. These findings indicate the need for routine quality control and regulatory oversight to ensure consumer safety and product transparency on the Maltase market. Future research should expand this analytical framework to a broader range of cannabis products, including edibles and e-liquid formulations.