This scientific opinion of EFSA deals with the criteria to be used for safety evaluation of a recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food. The principle of the evaluation is to apply the cleaning efficiency of a recycling technology or process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post consumer PET, conservatively set a 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each contaminant in recycled PET (Cres) is then compared to a modelled concentration in PET (Cmod). This Cmod is calculated using generally recognized conservative migration models such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg bw/day, the human exposure threshold value for chemicals with structural alerts raising concern for potential genotoxicity, below which the risk to human health would be negligible. The default scenario, when the recycled PET is intended for general use, is that of an infant weighing 5 kg and consuming every day 0.75 l of water coming from a water bottle manufactured from 100% recycled PET. According to this scenario, it can be derived that the highest concentration of a substance in water that would ensure that the dietary exposure of 0.0025 µg/kg bw/day is not exceeded, is 0.017 μg/kg food. Taking into account that generally agreed diffusion modelling overestimates migration by at least 5 times, a calculated migration less than 0.1 µg/kg in food would satisfy the above criterion for the default exposure scenario. In the case of the other exposure scenarios for adults and toddlers, the relevant migration criterion will accordingly be 0.75 and 0.15 µg/kg food. Spyropoulos for the support provided to this EFSA scientific output. R. Franz participated as hearing expert to answer to questions and to provide comments on the draft opinion.Criteria for safety evaluation of PET recycling processes EFSA Journal 2011;9(7):2184 2 Therefore if a recycling process is able to reduce an input reference contamination of 3 mg/kg PET to a Cres not higher than a Cmod corresponding to the relevant migration criterion, the potential dietary exposure cannot be higher than 0.0025 µg/kg bw/day and recycled PET manufactured with such recycling process is not considered of safety concern. The Panel considered appropriate that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled. SUMMARY Following the publication of the Regulation (EC) No 282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods and the relevant EFSAGuidelines on submission of a dossier for safety evaluation by the EFSA, many dossiers have been submitted to EFSA for evaluation dealing with recycling processes for polyethylene terephthalate (PET) food contact materials.These processes use as an input post consumer PET to produce re...

This opinion describes the assessment of the risks to public health associated with bisphenol A (BPA) exposure. Exposure was assessed for various groups of the human population in three different ways: (1) external (by diet, drinking water, inhalation, and dermal contact to cosmetics and thermal paper); (2) internal exposure to total BPA (absorbed dose of BPA, sum of conjugated and unconjugated BPA); and (3) aggregated (from diet, dust, cosmetics and thermal paper), expressed as oral human equivalent dose (HED) referring to unconjugated BPA only. The estimated BPA dietary intake was highest in infants and toddlers (up to 0.875 µg/kg bw per day). Women of childbearing age had dietary exposures comparable to men of the same age (up to 0.388 µg/kg bw per day). The highest aggregated exposure of 1.449 µg/kg bw per day was estimated for adolescents. Biomonitoring data were in line with estimated internal exposure to total BPA from all sources. BPA toxicity was evaluated by a weight of evidence approach. “Likely” adverse effects in animals on kidney and mammary gland underwent benchmark dose (BMDL10) response modelling. A BMDL10 of 8 960 µg/kg bw per day was calculated for changes in the mean relative kidney weight in a two generation toxicity study in mice. No BMDL10 could be calculated for mammary gland effects. Using data on toxicokinetics, this BMDL10 was converted to an HED of 609 µg/kg bw per day. The CEF Panel applied a total uncertainty factor of 150 (for inter‐ and intra‐species differences and uncertainty in mammary gland, reproductive, neurobehavioural, immune and metabolic system effects) to establish a temporary Tolerable Daily Intake (t‐TDI) of 4 µg/kg bw per day. By comparing this t‐TDI with the exposure estimates, the CEF Panel concluded that there is no health concern for any age group from dietary exposure and low health concern from aggregated exposure. The CEF Panel noted considerable uncertainty in the exposure estimates for non‐dietary sources, whilst the uncertainty around dietary estimates was relatively low.

The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO 2 nanoparticles ( NP s) and data from an extended one‐generation reproductive toxicity ( EOGRT ) study. Less than 50% of constituent particles by number in E 171 have a minimum external dimension < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO 2 NP s < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO 2 particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO 2 NP s (> 30 nm) up to the highest dose tested of 100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to a dose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However, observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity with TiO 2 NP s, together with the potential induction of aberrant crypt foci with E 171, may indicate adverse effects. With respect to genotoxicity, the Panel concluded that TiO 2 particles have the potential to induce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlation was observed between the physico‐chemical properties of TiO 2 particles and the outcome of either in vitro or in vivo genotoxicity assays. A concern for genotoxicity of TiO 2 particles that may be present in E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate in parallel and the relative contributions of different molecular mechanisms elicited by TiO 2 particles are not known. There was uncertainty as to whether a threshold mode of action could be assumed. In addition, a cut‐off value for TiO 2 particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO 2 NP s. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel concluded that E 171 can no longer be considered as safe when used as a food additive.

ABSTRACT

The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re-evaluating the safety of phosphates (E 338-341, E 343, E 450-452) as food additives. The Panel considered that adequate exposure and toxicity data were available. Phosphates are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. Exposure to phosphates from the whole diet was estimated using mainly analytical data. The values ranged from 251 mg P/person per day in infants to 1,625 mg P/person per day for adults, and the high exposure (95th percentile) from 331 mg P/person per day in infants to 2,728 mg P/person per day for adults. Phosphate is essential for all living organisms, is absorbed at 80-90% as free orthophosphate excreted via the kidney. The Panel considered phosphates to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies. The Panel derived a group acceptable daily intake (ADI) for phosphates expressed as phosphorus of 40 mg/kg body weight (bw) per day and concluded that this ADI is protective for the human population. The Panel noted that in the estimated exposure scenario based on analytical data exposure estimates exceeded the proposed ADI for infants, toddlers and other children at the mean level, and for infants, toddlers, children and adolescents at the 95th percentile. The Panel also noted that phosphates exposure by food supplements exceeds the proposed ADI. The Panel concluded that the available data did not give rise to safety concerns in infants below 16 weeks of age consuming formula and food for medical purposes.

] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β-caryophyllene .007] and 90-day studies in rats on β-caryophyllene .007] and myrcene [FLno: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structureactivity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons 01.024, 01.026, 01.029, 01.040, 01.045 .029] based upon the respective MSDI for these substances and the NOAEL for ß-caryophyllene, range between 7400 and 1.1x10 7 . The Panel agrees that this provides sufficient safety margins and that these flavouring substances can be evaluated at step B4 in the Procedure as being of no safety concern.For four substances 01.018, 01.040 and 01.061] adequate margins of safety compared to the estimated levels of intake were estimated based upon a NOAEL from a 90-day study in rats, for the representative substance myrcene . The NOAEL of 44 mg/kg bw per day provides a margin of safety of 9100 for myrcene. The margins of safety for 01.040 and 01.061] based upon the respective MSDI for these substances and the NOAEL for myrcene are 4.8x10 5 , 4.4x10 6 and 1.1x10 7 , respectively. The Panel agrees that this provides sufficient safety margins and that these flavouring substances can be evaluated at step B4 in the Procedure as being of no safety concern. .026] and the mTAMDI have been considered. The mTAMDI figures calculated were above the threshold of concern for all four substances and more reliable exposure data are needed. On the basis of such additional data these flavouring substances should be reconsidered using the Procedure. For the remaining 17 substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.In order to determine whether the conclusion for the 21 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications.Adequate specifications including complete purity criteria and identity are available for all 21 JECFA evaluated substances.Thus, for the 21 substances 4

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.024] and 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL‐no: 07.024] and [FL‐no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL‐no: 07.024] and for the structurally related substances 4‐phenylbut‐3‐en‐2‐ol [FL‐no: 02.066] and 3‐methyl‐4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030], the Panel concluded that [FL‐no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow‐up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030] and the structurally related substances vanillylidene acetone [FL‐no: 07.046] and 1‐(4‐methoxyphenyl)‐4‐methylpent‐1‐en‐3‐one [FL‐no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4‐(2,3,6‐trimethylphenyl)but‐3‐en‐2‐one [FL‐no: 07.206] is to be considered as a stand‐alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL‐no: 07.206]. Industry communicated that the evaluation of [FL‐no: 07.206] is not supported any longer, therefore additional data were not submitted.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established in its latest evaluation a group ADI of 0–1 mg/kg bw per day, expressed as quillaia saponins, for Quillaia extract for Type 1 and Type 2. The Panel considered it likely that intact Quillaia extract saponins are absorbed to a low extent, are hydrolysed in the gastrointestinal (GI) tract and that the aglycone is absorbed only to a limited extent. The Panel considered that the genotoxicity data available did not indicate a concern for genotoxicity. Taking into account the available toxicological database, various no observed adverse effect levels (NOAELs) relevant for the derivation of an ADI were identified. The Panel considered that the 2‐year study in rats was the most robust and that the NOAEL of 1,500 mg Quillaia extract/kg bw per day could be used to derive the ADI for E 999. Considering that the adverse effects reported were due to the presence of saponins in the extract, that saponins were present in Quillaia extract Type 1 (around 20%) and using an uncertainty factor of 100, the Panel derived a ADI of 3 mg saponins/kg bw per day for E 999. None of the exposure estimates for the different population groups of the refined brand‐loyal scenario exceeded the ADI of 3 mg saponins/kg bw per day. The proposed extension of use also would not result in an exceedance of this ADI for the refined scenario. The Panel proposed some recommendations for the European Commission to consider, in particular revising the EU specifications for E 999 in order to differentiate the extracts of Quillaia according to the saponins content and to include other parameters to better characterise the food additive.