Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs.

In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 µg/kg body weight (bw) per day. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health from the presence of BPA in foodstuffs and to establish a tolerable daily intake (TDI). For this re-evaluation, a pre-established protocol was used that had undergone public consultation. The CEP Panel concluded that it is Unlikely to Very Unlikely that BPA presents a genotoxic hazard through a direct mechanism. Taking into consideration the evidence from animal data and support from human observational studies, the immune system was identified as most sensitive to BPA exposure. An effect on Th17 cells in mice was identified as the critical effect; these cells are pivotal in cellular immune mechanisms and involved in the development of inflammatory conditions, including autoimmunity and lung inflammation. A reference point (RP) of 8.2 ng/kg bw per day, expressed as human equivalent dose, was identified for the critical effect. Uncertainty analysis assessed a probability of 57-73% that the lowest estimated Benchmark Dose (BMD) for other health effects was below the RP based on Th17 cells. In view of this, the CEP Panel judged that an additional uncertainty factor (UF) of 2 was needed for establishing the TDI. Applying an overall UF of 50 to the RP, a TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure.

Re-evaluation of polydextrose (E 1200) as a food additive.

This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a food additive (E 1200) is no longer marketed in the EU.

Re-evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acids, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives. All substances had been previously evaluated by the Scientific Committee for Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Hydrolysis of E472a,b,c,e was demonstrated in various experimental systems, although the available data on absorption, distribution, metabolism, excretion (ADME) were limited. The Panel assumed that E472a-f are extensively hydrolysed in the GI tract and/or (pre-)systemically after absorption into their individual hydrolysis products which are all normal dietary constituents and are metabolised or excreted intact. No adverse effects relevant for humans have been identified from the toxicological database available for E472a-f. The Panel considered that there is no need for a numerical acceptable daily intake (ADI) for E 472a,b,c. The Panel also considered that only l(+)-tartaric acid has to be used in the manufacturing process of E472d,e,f. The Panel established ADIs for E 472d,e,f based on the group ADI of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)-tartaric acid-tartrates (E334-337, 354) and considering the total amount of l(+)-tartaric acid in each food additive. Exposure estimates were calculated for all food additives individually, except for E 472e and f, using maximum level, refined exposure and food supplements consumers only scenarios. Considering the exposure estimates, there is no safety concern at their reported uses and use levels. In addition, exposure to tartaric acid released from the use of E 472d,e,f was calculated. The Panel also proposed a number of recommendations.

Re-evaluation of stearyl tartrate (E 483) as a food additive.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of stearyl tartrate (E 483) as a food additive. The previously evaluated toxicological studies were not available, in addition to no genotoxicity data being available. Thus, adequate toxicity data on stearyl tartrate were not available for its re-evaluation. In addition, adequate data demonstrating the complete hydrolysis of stearyl tartrate (E 483) in the gastrointestinal tract and/or presystemically, that could allow read-across from data on its constituents, were lacking. Therefore, the safety of the use of stearyl tartrate as a food additive could not be assessed and the acceptable intake established by the Scientific Committee on Food (SCF) in 1978 could not be confirmed. Exposure to stearyl tartrate (E 483) was calculated using the maximum level exposure assessment scenario as neither use levels nor analytical data were available. Mean exposure to stearyl tartrate (E 483) as a food additive ranged from 0.1 mg/kg body weight (bw) per day in infants to 82.5 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 0 mg/kg bw per day in adults to 192.7 mg/kg bw per day in toddlers. The Panel also noted that information from the Mintel's GNPD indicates that only two products have been labelled with stearyl tartrate (E 483) since 1996. Some recommendations were proposed by the Panel.

Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. The Scientific Committee for Food (SCF) assigned these food additives together with other aluminium-containing food additives a provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw). In 2008, EFSA established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week. Sodium aluminium silicate was shown in rats to be absorbed to a limited extent at 0.12 ± 0.011%. The Panel considered that potassium aluminium silicate would be absorbed and become systemically available similarly to sodium aluminium silicate. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives has been submitted and only very limited toxicological data were available for sodium aluminium silicate. Exposure to E 554 was calculated based on the reported use levels in food supplements. Exposure to aluminium from this use of E 554 was calculated to exceed the TWI for aluminium. Based on the data provided by interested business operators, the Panel considered that E 555 is not being used as a carrier, but as an inseparable component of 'potassium aluminium silicate-based pearlescent pigments'. The Panel calculated the regulatory maximum exposure to E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172). Exposure to aluminium from this single use at the maximum permitted level could theoretically far exceed the TWI. Considering that only very limited toxicological data and insufficient information on the physicochemical characterisation of both food additives were available, the Panel concluded that the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) could not be assessed.

Re-evaluation of polyvinylpyrrolidone (E 1201) and polyvinylpolypyrrolidone (E 1202) as food additives and extension of use of polyvinylpyrrolidone (E 1201).

The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvinylpolypyrrolidone (E 1202, PVPP) when used as food additives. One request for extension of use of PVP (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation (EU) No 257/2010 and considered that: the exposure assessment was based on the reported use and use levels (one food category out of the two food categories in which PVP and PVPP are authorised); the 95th percentile of exposure to PVP and PVPP of maximally 23.7 and 25 mg/kg body weight (bw) per day in children, respectively, was overestimated, because it was assumed that 100% of the food supplements consumed contained PVP or PVPP at the maximum reported use levels; the extension of use of PVP (E 1201) to foods for special medical purposes (FC 13.2) would result in an exposure of PVP of 4.3 mg/kg bw per day for children; the absorption of PVP and PVPP is very low; sufficient toxicity data were available for PVP; there is no concern with respect to the genotoxicity of PVP and PVPP; no carcinogenic effects were reported in carcinogenicity studies in rats at a dose of 2,500 mg PVP/kg bw per day, the highest dose tested; there is no need for chronic toxicity/carcinogenicity data for PVPP for the safety assessment of PVPP given the chemical similarity between PVP and PVPP, and the lack of adverse effects in the available repeated dose toxicity studies. Therefore, the Panel concluded that there is no need for numerical acceptable daily intakes (ADIs) for PVP and PVPP, and that there is no safety concern for the reported uses and use levels of PVP and PVPP as food additives. The Panel further concluded that the proposed extension of use is not expected to be of safety concern at the proposed maximum permitted level (MPL) and recommended consumption level.

Re-evaluation of dimethyl polysiloxane (E 900) as a food additive.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of dimethyl polysiloxane (E 900) as a food additive. E 900 was evaluated by the Scientific Committee on Food (SCF) in 1990 and agreed with the Acceptable Daily Intake (ADI) of 1.5 mg/kg body weight (bw) per day previously established by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. Dimethyl polysiloxane was only absorbed to a very limited extent from the gastrointestinal tract following oral administration and the vast majority was excreted unchanged in the faeces. Corneal opacities and other effects on cornea were observed in studies in rats. These effects are considered to be caused by direct contact with the test substance in the feed and/or with the test substance in the faeces and not due to systemic exposure. The Panel considered that oral exposure of dimethyl polysiloxane did not result in any systemic adverse effects in any species and dose tested and there is no concern with respect to genotoxicity of dimethyl polysiloxane (E 900). From a 26-month toxicity study in rats, a No Observed Adverse Effect Level (NOAEL) of 1,742 and 2,055 mg dimethyl polysiloxane/kg bw per day for female and male, respectively, was identified. Using the NOAEL 1,742 mg/kg bw per day, the Panel established an ADI of 17 mg/kg bw per day for E 900 by applying an uncertainty factor of 100. Accordingly, the ADI for dimethyl polysiloxane (E 900) of 1.5 mg/kg bw per day, established by SCF in 1990, is withdrawn. The exposure estimates for the different population groups of all exposure scenarios did not exceed the ADI of 17 mg/kg bw per day for E 900. The Panel concluded that there is not a safety concern at the reported uses and use levels for dimethyl polysiloxane (E 900). The Panel also proposed a number of recommendations for the EU specifications to be amended.

Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive.

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.