Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: A systematic evidence map.

BACKGROUND: The presence of polyethylene terephthalate (PET) oligomers in food contact materials (FCMs) is well-documented. Consumers are exposed through their migration into foods and beverages; however, there is no specific guidance for their safety evaluation. OBJECTIVES: This systematic evidence map (SEM) aims to identify and organize existing knowledge and associated gaps in hazard and exposure information on 34 PET oligomers to support regulatory decision-making. METHODS: The methodology for this SEM was recently registered. A systematic search in bibliographic and gray literature sources was conducted and studies evaluated for inclusion according to the Populations, Exposures, Comparators, Outcomes, and Study type (PECOS) framework. Inclusion criteria were designed to record hazard and exposure information for all 34 PET oligomers and coded into the following evidence streams: human, animal, organism (non-animal), ex vivo, in vitro, in silico, migration, hydrolysis, and absorption, distribution, metabolism, excretion/toxicokinetics/pharmacokinetics (ADME/TK/PK) studies. Relevant information was extracted from eligible studies and synthesized according to the protocol. RESULTS: Literature searches yielded 7445 unique records, of which 96 were included. Data comprised migration (560 entries), ADME/TK/PK-related (253 entries), health/bioactivity (98 entries) and very few hydrolysis studies (7 entries). Cyclic oligomers were studied more frequently than linear PET oligomers. In vitro results indicated that hydrolysis of cyclic oligomers generated a mixture of linear oligomers, but not monomers, potentially allowing their absorption in the gastrointestinal tract. Cyclic dimers, linear trimers and the respective smaller oligomers exhibit physico-chemical properties making oral absorption more likely. Information on health/bioactivity effects of oligomers was almost non-existent, except for limited data on mutagenicity. CONCLUSIONS: This SEM revealed substantial deficiencies in the available evidence on ADME/TK/PK, hydrolysis, and health/bioactivity effects of PET oligomers, currently preventing appropriate risk assessment. It is essential to develop more systematic and tiered approaches to address the identified research needs and assess the risks of PET oligomers.

Evaluating the food safety and risk assessment evidence-base of polyethylene terephthalate oligomers: Protocol for a systematic evidence map.

BACKGROUND: Polyethylene terephthalate (PET) oligomers are ubiquitous in PET used in food contact applications. Consumer exposure by migration of PET oligomers into food and beverages is documented. However, no specific risk assessment framework or guidance for the safety evaluating of PET oligomers exist to date. AIM: The aim of this systematic evidence map (SEM) is to identify and organize existing knowledge clusters and associated gaps in hazard and exposure information of PET oligomers. Research needs will be identified as an input for chemical risk assessment, and to support future toxicity testing strategies of PET oligomers and regulatory decision-making. SEARCH STRATEGY AND ELIGIBILITY CRITERIA: Multiple bibliographic databases (incl. Embase, Medline, Scopus, and Web of Science Core Collection), chemistry databases (SciFinder-n, Reaxys), and gray literature sources will be searched, and the search results will be supplemented by backward and forward citation tracking on eligible records. The search will be based on a single-concept PET oligomer-focused strategy to ensure sensitive and unbiased coverage of all evidence related to hazard and exposure in a data-poor environment. A scoping exercise conducted during planning identified 34 relevant PET oligomers. Eligible work of any study type must include primary research data on at least one relevant PET oligomer with regard to exposure, health, or toxicological outcomes. STUDY SELECTION: For indexed scientific literature, title and abstract screening will be performed by one reviewer. Selected studies will be screened in full-text by two independent reviewers. Gray literature will be screened by two independent reviewers for inclusion and exclusion. STUDY QUALITY ASSESSMENT: Risk of bias analysis will not be conducted as part of this SEM. DATA EXTRACTION AND CODING: Will be performed by one reviewer and peer-checked by a second reviewer for indexed scientific literature or by two independent reviewers for gray literature. SYNTHESIS AND VISUALIZATION: The extracted and coded information will be synthesized in different formats, including narrative synthesis, tables, and heat maps. SYSTEMATIC MAP PROTOCOL REGISTRY AND REGISTRATION NUMBER: Zenodo: https://doi.org/10.5281/zenodo.6224302.

Risk assessment of chlorinated paraffins in feed and food.

The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of chlorinated paraffins in feed and food. The data for experimental animals were reviewed and the CONTAM Panel identified the liver, kidney and thyroid as the target organs for the SCCP and MCCP mixtures tested in repeated dose toxicity studies. Decreased pup survival and subcutaneous haematoma/haemorrhage were also identified as critical effects for an MCCP mixture. For the LCCP mixtures tested, the liver was identified as the target organ. The Panel selected as reference points a BMDL 10 of 2.3 mg/kg bw per day for increased incidence of nephritis in male rats, and of 36 mg/kg bw per day for increased relative kidney weights in male and female rats for SCCPs and MCCPs, respectively. For LCCPs, a reference point relevant for humans could not be identified. Due to the limitations in the toxicokinetic and toxicological database, the Panel concluded that derivation of a health-based guidance value was not appropriate. Only limited data on the occurrence of SCCPs and MCCPs in some fish species were submitted to EFSA. No data were submitted for LCCPs. Thus, a robust exposure assessment and consequently a complete risk characterisation could not be performed. A preliminary risk characterisation based only on the consumption of fish was performed, and the calculated margins of exposure suggested no health concern for this limited scenario. The Panel noted that dietary exposure will be higher due to the contribution of CPs from other foods. The Panel was not able to identify reference points for farm animals, horses and companion animals. No occurrence data for feed were submitted to EFSA. Therefore, no risk characterisation could be performed for any of these animal species.

Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH), CAS No 147398-31-0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl-terminated or with crotyl- and hexenyl end-groups from dehydration of hydroxyl end-groups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCMs with a specific migration limit (SML) of 0.05 mg/kg food. For (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group evaluation of flavouring substances in FGE.05Rev2 (EFSA CEF Panel, 2010b). The other migrating substances detected, ■■■■■, are from the authorised substance 'palm oil and/or palm fatty acid distillate' (FCM substance No 9) used as a carbon source for the fermentation and do not give rise to safety concern. A PHBH oligomer mixture was synthesized to simulate that migrating. It did not give rise to concern for genotoxicity. From the repeated dose 90-day oral toxicity study in rats, the Panel identified the no-observed-adverse-effect level (NOAEL) at the highest dose tested in males, 1,364 mg/kg body weight (bw) per day. The Panel concluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel concluded that the substance PHBH is not of safety concern for the consumer if it is used alone or blended with other polymers in contact with all kinds of food during more than 6 months at room temperature or below, including hot-fill or a short heating up phase. The specific migration of all oligomers < 1,000 Da should not exceed 5 mg/kg food. The migration of crotonic acid should not exceed the SML of 0.05 mg/kg food. As the migration of (E)-2-hexenoic acid can be expected to be always lower than that of crotonic acid, no individual restriction is necessary.

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long-term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 µm or less and the average size is 9 µm, has a layered structure with layers of a thickness below 100 nm. When incorporated in PLA, nanosized layers can be dispersed in the matrix, but are not expected to migrate. Thermal degradation is not expected at the maximum manufacturing temperature. No loss of integrity of the PLA surface due to interaction with bottled water was observed. The overall migration was very low. No migration of HDTA was detected at the limit of detection ■■■■■. Migration of aluminium was below or at the limit of detection ■■■■■, which would conservatively correspond to approximately ■■■■■. Comparative analysis of bottled water with and without the modified clay did not reveal additional peaks corresponding to impurities identified in the modifier and/or in the modified clay. Moreover, ■■■■■, and the modifier HDTA have been evaluated and authorised. Therefore, the CEP Panel concluded that the substance montmorillonite clay modified with HDTA bromide is not of safety concern for the consumer if the substance is used as an additive at up to ■■■■■ in PLA plastic bottles and other containers intended for long-term storage of water at ambient temperature or below, as requested by the applicant.

Safety assessment of the process Sharpak Bridgewater, based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Sharpak Bridgewater (EU register number RECYC166). The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, with no more than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and gas flow. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET are not intended to be used, in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2-ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 µg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90-day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2-ethylhexyl) ester (DEHP). Assuming that impurities migrate pro-rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.

Safety assessment of the process 'Jász-Plasztik', based on Vacurema Prime technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Jász-Plasztik (EU register number RECYC0157). The input are hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers and containing no more than 5% PET from non-food applications. They are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the decontamination in the batch reactors (step 2) and in the continuous reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the process Alimpet, based on EREMA MPR B2B technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the Alimpet recycling process (EU register number RECYC159), which is based on the EREMA Multi-Purpose Reactor (MPR) technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% PET from non-food consumer applications. They are treated in a continuous reactor under vacuum and high temperature. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg/kg food, derived from the exposure scenario for infants. Therefore, the Panel concluded that recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact applications if it is produced in compliance with the conditions specified in the conclusion of this opinion. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the process Texplast, based on EREMA Advanced technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the Texplast recycling process (EU register number RECYC158), which is based on the EREMA Advanced technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% PET from non-food consumer applications. They are heated in a continuous reactor under vacuum. Having examined the results of the challenge test provided, the Panel concluded that this continuous reactor step (step 3) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg/kg food, derived from the exposure scenario for infants. Therefore, the Panel concluded that recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact applications if it is produced in compliance with the conditions specified in the conclusion of this opinion. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

Safety assessment of the substance phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the substance 'phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters', obtained by reaction of ■■■■■, when used as an additive at up to 0.2% w/w in high impact polystyrene. The plastic, in the form of films and articles, is intended for contact with aqueous, acidic, low-alcohol and fatty foods for long-term storage at room temperature and below, after hot-fill and/or heating up to 100°C for up to 2 h. Based on genotoxicity tests with negative results, the Panel considered that there is no evidence of mutagenicity and chromosomal damage of the substance and its phosphate form. From a repeated dose 90-day oral toxicity study in rats, the Panel identified the no-observed-adverse-effect level as 50 mg/kg body weight (bw) per day. No effects of induced delayed neurotoxicity in hens were observed. Migration from high impact polystyrene containing the substance at 0.2%, measured through the phosphorous content of the substance, reached 0.001 mg/kg in 10% ethanol and 0.1 mg/kg in 95% ethanol. Migration into acidic food/simulant is expected to be below 0.001 mg/kg. Regarding the oligomers and other reaction/degradation products detected, the phosphorous-containing substances were adequately represented in the toxicity experiments conducted. Those not containing phosphorous were hydrolysis products either listed in Regulation (EU) 10/2011 and their estimated worst-case migrations were well below their respective specific migration limits (SMLs) or no alerts for genotoxicity were noted. Overall, the CEP Panel concluded that the substance 'phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters' does not raise a safety concern for the consumer if it is used at up to 0.2% w/w in high impact polystyrene materials and articles and its migration does not exceed 0.05 mg/kg food.

Safety assessment of the substance, titanium dioxide surface treated with fluoride-modified alumina, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) is a safety assessment of the additive titanium dioxide surface treated with fluoride-modified alumina, a defined mixture of particles of which ■■■■■% in number have a diameter in the range of 1-100 nm. It is intended to be used as filler and colourant up to 25% w/w in potentially all polymer types. Materials and articles containing the additive are intended to be in contact with all food types for any time and temperature conditions. The data provided demonstrate that the additive particles stay embedded even in swollen polar polymers such as polyamide, and do not migrate. Moreover, the additive particles resisted release by abrasion and did not transfer into a simulant for solid/dry foods. Thus, the additive particles do not give rise to exposure via food and to toxicological concern. Migration of solubilised ionic fluoride and aluminium occurs from the surface of the additive particles and particularly from swollen plastic. The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers swelling in contact with foodstuffs simulated by 3% acetic acid should be limited to conditions simulated by contact up to 4 h at 100°C. This is due to the fact that when used at 25%, and contact was followed by 10 days at 60°C, the migration of aluminium and fluoride largely exceeded the specific migration limit (SML) of 1 and 0.15 mg/kg food, respectively. The Panel emphasises that the existing SMLs for aluminium and fluoride should not be exceeded in any case.

Update of the risk assessment on 3-monochloropropane diol and its fatty acid esters.

The CONTAM Panel updated the assessment of the risks for human health related to the presence of 3-monochloropropane diol (3-MCPD) and its fatty acid esters in food published in 2016 in view of the scientific divergence identified in the establishment of the tolerable daily intake (TDI) in the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (FAO/WHO) report published in 2017. In this update, dose-response analysis was performed following the recent EFSA Scientific Committee guidance on the use of benchmark dose (BMD) approach in risk assessment, and a review of available data on developmental and reproduction toxicity was included. The outcome of this review indicates that in rats short-term exposure to 3-MCPD above 1 mg/kg body weight (bw) per day can induce reduced sperm motility associated with reduced male fecundity. Decreased sperm count and histopathological changes in the testis and epididymis were observed following longer treatment periods at higher doses. Regarding increased incidence kidney tubular hyperplasia, BMD analysis using model averaging resulted in a BMDL 10 of 0.20 mg/kg bw per day in male rats, which was selected as the new Reference Point (RP) for renal effects. For the effects on male fertility, decreased sperm motility was selected as the most sensitive relevant endpoint and a BMDL 05 of 0.44 mg/kg bw per day was calculated. The RP for renal effects was considered to derive an updated group TDI of 2 µg/kg bw per day for 3-MCPD and its fatty acid esters and was considered protective also for effects on male fertility. The established TDI of 2 µg/kg bw per day is not exceeded in the adult population. A slight exceedance of the TDI was observed in the high consumers of the younger age groups and in particular for the scenarios on infants receiving formula only.

Safety assessment of the active substance polyacrylic acid, sodium salt, cross-linked, for use in active food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross-linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polyacrylic acid, sodium salt, cross-linked is used not in direct contact with food and placed in a pad under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. The Panel also considered that the non-cross-linked polymer and the cross-linkers do not raise a concern for genotoxicity. The CEP Panel concluded that the use of this polyacrylic acid, sodium salt, cross-linked, does not raise a safety concern when used in absorbent pads in the packaging of fresh or frozen foods. The absorbent pads must be used only under conditions in which the absorption capacity of the active substance is not exceeded and direct contact with food is excluded.

Safety assessment of the substance Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4-benzene dicarboxylate complexes, used as a taggant in plastics for authentication and traceability purposes. The powdered additive, not in nano form, is intended to be used at up to 100 mg/kg in polyethylene, polypropylene and polybutene. Materials and articles made of these plastics are intended for contact with all foods types at up to 4 h/100°C or for long-term storage at ambient temperature. In tests with food simulants, migration of each Ln was below 5 µg/kg. The Panel considered that irrespective of the composition of the lanthanides, these would dissociate completely from the terephthalic acid salt under aqueous conditions. Evaluation of the genotoxicity studies provided on the individual complexes (La, Eu, Gd and Tb) and on their mixture, taken together with data available in the scientific literature, allows ruling out concern for genotoxicity. Consequently, the CEP Panel concluded that the substance Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) does not raise a safety concern for the consumer under the proposed conditions of use and if the migration of the sum of the four lanthanides in ionic form does not exceed 50 µg/kg food.

Safety assessment of the process 'RecyPET Hungária', based on RecyPET Hungária technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% of PET from non-food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater chamber and then recrystallised. The crystallised pellets may then be fed into a solid-state polycondensation (SSP) reactor. The recycled plastic is intended for manufacture of bottles for soft drinks or water. The applicant provided a challenge test, but the flakes contaminated with the surrogates and the pellets obtained after extrusion and crystallisation were extracted with n-hexane without showing sufficient recovery. The Panel considered the extraction as unreliable and could therefore not conclude on the efficiency of the decontamination process. Furthermore, the flow charts provided by the applicant did not enable a clear identification of the steps relevant for the decontamination efficiency, and no sufficiently clear overview of the operational parameters of the steps of the process and the challenge test was provided. Without this information, a proper safety evaluation could not be performed. The Panel concluded that the process RecyPET Hungária is not sufficiently characterised and the applicant has not demonstrated in an adequately performed challenge test or by other appropriate evidence that the recycling process RecyPET Hungária is able to reduce contamination of the PET input to a concentration that does not pose a risk to human health.

Assessment of a decontamination process for dioxins and PCBs from fish meal by hexane extraction and replacement of fish oil.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on the assessment of a decontamination process for fish meal. This process entails solvent (hexane) extraction of fish oil from fish meal to remove dioxins (polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)) as well as dioxin-like (DL-) and non-dioxin-like (NDL-) polychlorinated biphenyls (PCBs) followed by replacement with decontaminated fish oil. All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. The data provided by the feed business operator were assessed with respect to the efficacy of the process, absence of solvent residues, and on information demonstrating that the process does not adversely affect the nature and characteristics of the product. According to data provided, the process was effective in removing PCDD/Fs and DL-PCBs by approximately 70% and NDL-PCBs by about 60%. The data showed that it is possible to meet the current EU requirements with respect to these contaminants, provided that the level of contamination of untreated fish meal is within the range of the tested batches. It is unlikely that hazardous substances (i.e. hexane) remain in the final product. The Panel considered that there is no evidence that fish oil extraction followed by replacement with decontaminated fish oil leads to detrimental changes in the nutritional composition of the fish meal, although some beneficial constituents (e.g. lipophilic vitamins) might be depleted. The feed business operator submitted information to demonstrate safe disposal of the waste material. The CONTAM Panel concluded that the proposed decontamination process to remove dioxins (PCDD/Fs) and PCBs from fish meal by means of solvent extraction and fish oil replacement was assessed to be compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.

Assessment of a decontamination process for dioxins and PCBs from fish meal by replacement of fish oil.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on the assessment of a decontamination process of fish meal. It consisted of extraction of the fish oil, filtration and adsorption with activated carbon, and replacement with decontaminated fish oil in order to reduce the amount of dioxins (polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)), and dioxin-like (DL-) and non-dioxin-like (NDL-) polychlorinated biphenyls (PCBs). All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. Data provided by the feed business operator were assessed for efficacy of the process and to demonstrate that the process did not adversely affect the characteristics and the nature of the product. The process was effective in removing PCDD/Fs (97%) and DL- and NDL-PCBs (93%). The fish meal produced complied with EU regulations for these contaminants. The Panel considered that the reference to information available in published literature was a pragmatic approach to demonstrate that the replacement of fish oil and the use of activated carbon to adsorb these contaminants does not lead to any detrimental changes in the nature of the fish meal. However, it was noted that the process could deplete some beneficial constituents (e.g. oil-soluble vitamins). Information was provided to demonstrate the safe disposal of the waste material. The CONTAM Panel concluded that on the basis of the information submitted by the feed business operator the proposed decontamination process to remove dioxins (PCDD/Fs) and PCBs from the fish meal by oil extraction followed by replacement with decontaminated fish oil, was compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.

Appropriateness to set a group health-based guidance value for fumonisins and their modified forms.

The EFSA Panel on Contaminants in the Food Chain (CONTAM) established a tolerable daily intake (TDI) for fumonisin B1 (FB 1) of 1.0 µg/kg body weight (bw) per day based on increased incidence of megalocytic hepatocytes found in a chronic study with mice. The CONTAM Panel considered the limited data available on toxicity and mode of action and structural similarities of FB 2-6 and found it appropriate to include FB 2, FB 3 and FB 4 in a group TDI with FB 1. Modified forms of FBs are phase I and phase II metabolites formed in fungi, infested plants or farm animals. Modified forms also arise from food or feed processing, and include covalent adducts with matrix constituents. Non-covalently bound forms are not considered as modified forms. Modified forms of FBs identified are hydrolysed FB 1-4 (HFB 1-4), partially hydrolysed FB 1-2 (pHFB 1-2), N-(carboxymethyl)-FB 1-3 (NCM-FB 1-3), N-(1-deoxy-d-fructos-1-yl)-FB 1 (NDF-FB 1), O-fatty acyl FB 1, N-fatty acyl FB 1 and N-palmitoyl-HFB 1. HFB 1, pHFB 1, NCM-FB 1 and NDF-FB 1 show a similar toxicological profile but are less potent than FB 1. Although in vitro data shows that N-fatty acyl FBs are more toxic in vitro than FB 1, no in vivo data were available for N-fatty acyl FBs and O-fatty acyl FBs. The CONTAM Panel concluded that it was not appropriate to include modified FBs in the group TDI for FB 1-4. The uncertainty associated with the present assessment is high, but could be reduced provided more data are made available on occurrence, toxicokinetics and toxicity of FB 2-6 and modified forms of FB 1-4.

Safety assessment of the process 'General Plastic', based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5% of PET from non-food consumer applications. In this technology, washed and dried PET flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control the process performance are well defined and are temperature, pressure, residence time and gas flow for steps 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not be used, in microwave and conventional ovens.