Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Polycyclic aromatic hydrocarbons in (traditional) herbal medicinal products

Theresa Vavvas (Abschlußjahr: 2018)

Summary
Language: English
Polycyclic Aromatic Hydrocarbons (PAH) are ubiquitous environmental contaminants that are formed during natural or anthropogenic combustion processes from carbon-containing material. By transport through air and water or by the formation during thermal processing methods, PAHs can contaminate herbal substances that are used for the production of herbal medicinal products.
PAHs are a large group of multi-species and multi-organ carcinogens. Several PAH compounds have genotoxic and carcinogenic effects; others appear to act as synergists. Different assessments were made concerning PAHs in food and the environment and the associated risk for human health by international scientific organisations that evaluated mostly 15 or 16 priority PAHs. Most relevant is the Scientific Opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel), which evaluated data for 16 PAHs in food. Using the margin of exposure (MOE) approach for risk characterisation, EFSA concluded that the concern for consumer health based on the average estimated dietary exposures is rather low. Only for high-level consumers, the MOEs were close to or less than 10,000, which indicates a potential concern for consumer health. According to EFSA’s recommendations, a marker system of a total of four substances (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene (PAH4)) was established in food legislation, where maximum levels for benzo(a)pyrene and PAH4 in specific food groups and also food supplements containing botanicals and their preparations are defined. Currently, no regulation for (Traditional) herbal medicinal products (HMPs) exists and the Committee on Herbal Medicinal Products (HMPC) called involved parties in a reflection paper to join the scientific discussion and collect data for a further evaluation and the development of an appropriate guidance.
Available data from different studies analysing medicinal plants, spices, tea and herbs were summarised in this thesis and the PAH4 amounts were compared with each other and with food data from EFSA´s scientific opinion. PAH4 levels were detected in most of the samples in a broad range of values. The compared data were collected in heterogeneous studies, using different sample material and methods. Therefore, only limited conclusions are drawn. Instead, the need for structured data collection under comparable conditions was emphasised for a relieable evaluation. Future risk management would need a sufficient database and appropriate maximum limits for HMPs taking into consideration the contamination levels of herbal substances, transfer rates for herbal preparations and the overall consumption of HMPs.
For producers and suppliers, the Guideline on Good Agricultural and Collection Practice (GACP) provides general recommendations that minimise the risk of contaminated plant material. Hence, manufacturers and marketing authorisation holders must ensure that only raw material from GACP compliant suppliers is used in the production of HMPs.
Pages: 41,
Annexes: 5, Pages: 24