Previous assessments

European Food Safety Authority 2012 opinion

7.             In 2012, the European Food Safety Authority (EFSA) assessed the risks to public and animal health related to the presence of citrinin in food and feed. Based on the available evidence, EFSA concluded that the establishment of a health-based guidance value (HBGV) would not be appropriate. While a concern for genotoxicity and carcinogenicity could not be excluded, EFSA did not consider the database sufficient to apply a margin of exposure (MOE) approach. Instead, the risk of citrinin was characterised and an intake of 0.2 ug/kg bw per day identified as a level of no concern for nephrotoxicity in humans. The available exposure data did not permit EFSA to reach a firm conclusion regarding the likelihood of consumers exceeding the level of no concern for nephrotoxicity on a daily basis over a prolonged period. A concern for genotoxicity and carcinogenicity could not be excluded at the level of no concern for nephrotoxicity. The derivation of the HBGV is discussed in more detail from paragraph 38.

Netherlands Food and Consumer Product Safety Authority (NVWA) 2015 risk assessment

8.             The Netherlands Food and Consumer Product Safety Authority (NVWA) monitors the occurrence of mycotoxins in the Netherlands and advises the Dutch government on food safety risks related to mycotoxins. In 2015, NVWA commissioned the National Institute for Public Health and Environment (RIVM) to undertake a literature search (covering the period 2011 to 2015) to find out whether any new toxicity studies had been published since the EFSA opinion that could be used to derive a benchmark dose (BMD) or a HBGV (RIVM, 2017). The point of departure (POD) selected was 48 μg/kg bw/day, the lower 95% confidence bound of the benchmark dose (lower confidence limit) (BMDL05) in a reproductive toxicology study in rats (Singh et al., 2014). In their assessment, RIVM agreed with EFSA’s concern regarding the genotoxicity and/or carcinogenicity of citrinin and found a lack of new evidence published since the EFSA opinion. The approach and outcomes are discussed further from paragraph 42.