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

] 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