Safety of benzophenone to be used as flavouring

Abstract

Benzophenone .032] has been evaluated as a flavouring substance, in FGE.69, by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food in 2008. Benzophenone was evaluated also by JECFA (2011) and by IARC (2013) based on studies that were not considered in the EFSA opinion on FGE.69. Therefore, the Commission requested the CEF Panel to carry out a review of existing literature on the safety of this flavouring substance. In the framework of the evaluation of benzophenone as a food contact material, the CEF Panel established a tolerable daily intake (TDI) of 0.03 mg/kg body weight (bw) per day (2009). In the present Opinion, the Panel considered the already existing evaluations by EFSA, JECFA, IARC and available literature data on benzophenone toxicity. Moreover, new data on the use levels of benzophenone as a flavouring substance have been provided. The Panel considers that there is no concern with respect to genotoxicity. The Panel considers the endocrine activities of benzophenone and its metabolite 4-hydroxybenzophenone as weak and not directly related to the observed toxic effects including the neoplastic effects in rodents. The Panel confirms that the conservative approach taken by EFSA (2009) to derive a TDI of 0.03 mg/kg bw for benzophenone is appropriate to cover the non-neoplastic effects in the chronic toxicity studies and the neoplastic effects induced in the rodent carcinogenicity studies. The TDI is in the same order of magnitude as the chronic dietary exposure of adults and children to benzophenone (10-20 lg/kg bw per day) for the amount of added flavouring substance. The Panel considers that the calculated TDI and exposure estimate are based on conservative assumptions. The Panel concludes that there is no safety concern for benzophenone under the current condition of use as a flavouring substance.

Comprehensive Survey of 14 Benzophenone UV Filters in Sunscreen Products Marketed in the United States: Implications for Human Exposure

“…The DE dose of BP from the use of octocrylene-containing products (GM: 12 200 ng/kg BW/day) was two orders of magnitude higher than that from the use of octocrylene-free products (GM: 157 ng/kg BW/day) (Table ). The DE doses of BP calculated from the use of octocrylene-free products were below the tolerable daily intake (TDI) proposed by the European Food Safety Authority (EFSA) (30 000 ng/kg BW/day) . However, the expected DE doses of BP from 24% of the octocrylene-containing products exceeded the TDI (Figure ).…”

“…The DE doses of BP calculated from the use of octocrylene-free products were below the tolerable daily intake (TDI) proposed by the European Food Safety Authority (EFSA) (30 000 ng/kg BW/day). 48 However, the expected DE doses of BP from 24% of the octocrylene-containing products exceeded the TDI (Figure 4). In addition, given the twofold higher concentrations of BP in expired products of this type (Table S8 and Figure S5), the use of octocrylene-containing products carry a risk of higher dermal exposure doses of BP.…”

Letter to the Editor Regarding Benzophenone Accumulates over Time from the Degradation of Octocrylene in Commercial Sunscreen Products

“…In long-term rodent studies, carcinogenic effects on the liver, kidney, and hematopoietic system were observed after oral intake. However, no evidence for carcinogenicity after dermal exposure was found, as also indicated by the International Agency for Research on Cancer and EFSA. , …”

“…According to Downs et al, benzophenone is mutagenic, and the authors express concerns about carcinogenicity. In contrast, the European Food Safety Authority (EFSA) classifies benzophenone as not being of genotoxic concern. This assessment is consistent with the substance evaluation of the European Chemicals Agency under REACH .…”

Safety and efficacy of 4‐phenylbut‐3‐en‐2‐one and benzophenone belonging to chemical group 21 when used as flavouring compounds for all animal species

“…The toxicological profile of benzophenone [07.032] has been recently reviewed by the EFSA CEF Panel, which confirmed the conservative approach taken by EFSA in 2009 to derive a tolerable daily intake (TDI) of 0.03 mg/kg body weight (bw) per day when used as a food contact material (EFSA, 2009;EFSA CEF Panel, 2017). This was based on the lower 95% confidence limits of the benchmark dose for a 10% effect (BMDL 10 ) of 3.1 mg/kg bw pw day derived for non-neoplastic kidney effects in male rats in a 2-year study (NTP, 2006).…”