Safety of active substances derived from Rosa damascena and their potential biological activity in humans: a systematic review

The latest amendments to CLP Regulation (EC) No. 1272/2008 on the classification, labeling, and packaging of chemicals, introduced in 2023, classify essential oils derived from Rosa damascena as potentially hazardous mixtures. This has raised serious concern among manufacturers and scientific circles in all countries where Rosa damascena is traditionally grown, including Bulgaria. Aim : To evaluate the safety of active substances derived from Rosa damascena and their potential biological activity in humans. Materials and methods : We conducted a systematic review of scientific publications using keywords in MEDLINE, the Central Medical Library of the Medical University of Sofia, and national peer-reviewed scientific magazines in Bulgaria for the period from January 1955 to May 2025. The selection of articles was conducted according to PRISMA, and the results were analyzed using the PICOS tool. Results and discussion : Over a period of 70 years, 151 articles were identified. Sixty-five articles that met the inclusion criteria were included in the systematic review. The results obtained confirm a wide range of biological activities of Rosa damascena . There is significant heterogeneity in study designs, dosages used, administration forms, and types of studies. These differences limit the possibility of direct comparison of results and underscore the need for standardized clinical trials with clear protocols and unified criteria, including meta-analyses. The essential oil and plant extracts show antimicrobial and antifungal activity, as well as antioxidant, anti-inflammatory, and analgesic properties. The literature also contains data on neuroprotective, antidiabetic, hepatoprotective, and antiviral effects, as well as the potentiation of sexual function.