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Abstract 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 ‘Coopbox’ (EU register No RECYC129), 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 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 pre‐heated before being Solid State Polycondensed in a continuous reactor (SSP) at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre‐heating (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 their performance are well defined and are temperature, pressure, residence time and gas flow for step 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 to be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of α‐tocopherol acetate, CAS Nos 7695‐91‐2 and 58‐95‐7, and FCM No 1055, as an antioxidant for its use in polyolefins intended for contact with all food types under any time and temperature conditions. The acetate is intended to hydrolyse with moisture in situ in the plastic and the active antioxidant in the plastic is the free α‐tocopherol. Based on an assumption of total mass transfer for the maximum use level of 650 mg/kg plastic, the worst‐case migration of the substance was calculated to be 56 mg/kg food. The substance readily hydrolyses into α‐tocopherol and acetic acid, which are both authorised without restrictions under Regulation (EU) No 10/2011. dl‐α‐Tocopherol and acetic acid are authorised food additives under Regulation (EC) No 1333/2008 and toxicological data were available for tocopherols that were evaluated as food additives in 2015 (EFSA ANS Panel, 2015). The CEF Panel concluded therefore that the use of the substance in polyolefins does not raise a safety concern.

Abstract 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 ANL (EU register No RECYC132), 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 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 pre‐heated before being Solid State Polycondensed in a continuous reactor (SSP) at high temperature, under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre‐heating (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 their performance are well defined and are temperature, pressure, residence time and gas flow for step 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 to be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Pramia Plastic Oy (EU register number RECYC131), which is based on the Starlinger IV+® technology. The input of the process 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 consumer applications. In this technology, washed PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then pre‐heated in a third reactor and fed to the solid state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP, are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined, and they are the temperature, the gas flow and the residence time for the drying and crystallisation step, and the temperature, the pressure and the residence time for the extrusion and crystallisation step and the SSP step. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 lg/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.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was asked by the European Commission to supply information to supplement the EFSA 2015 opinion on high‐density polyethylene (HDPE) recycling processes in a step‐wise manner. The Terms of Reference required to supply a list of substances for which the most severe exposure threshold is applicable and to consider Table 1 column 1 in the 2004 study by Kroes et al. which lists categories of substances for which this threshold is not applicable. The CEF Panel concludes that it is not possible to provide an exhaustive list of substances ‘for which the most severe exposure threshold is applicable’ as such a list would have to be established based on all known substances, excepting a comparatively small number of substances excluded by the criteria in the approach taken. The CEF Panel has analysed the most recent Carcinogenic Potency Database consisting of 1,547 substances, and identified and listed those substances which are of particular concern even if ingested at, or below an intake level of 0.0025 μg/kg body weight per day, following the approach taken by the 2004 study by Kroes et al. The CEF Panel emphasises that this opinion does not impact the risk assessment approach taken in the opinion, adopted in February 2015, on processes producing recycled HDPE for use as a food contact material, or its conclusions.

Abstract 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 Ecoiberia (EU register No RECYC133), 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 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 pre‐heated before being Solid State Polycondensed in a continuous reactor (SSP) at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre‐heating (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 their performance are well defined and are temperature, pressure, residence time and gas flow for step 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 to be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of tetraethyl orthosilicate (TEOS), Chemical Abstract Service (CAS) No 78‐10‐4, Food Contact Material (FCM) substance No 01013, and hexamethyldisilazane (HMDS), CAS No 999‐97‐3, Ref. No 18455 and FCM substance No 01014. According to the applicant, the two substances are used together as a chain extender for polyethylene terephthalate (PET) to increase the molecular weight of the polymer after recycling. Final articles are intended for contact with all types of foodstuffs for long‐term storage at room temperature, with‐ or without prior pasteurisation at up to 70°C. Specific migration tests for TEOS and HMDS were not performed. Instead, the residual content of the substances in a recycled PET polymer manufactured with the modifier mixture was determined. The substances were not detected at detection levels up to 4 μg/6 dm2, supporting that the substances react completely with the PET chains. In a migration study, a recycled PET modified using the mixture was compared with virgin PET. All detected migrating substances corresponded to oligomers identical to those from the virgin PET, at a detection level estimated to be 3 μg/kg. Based on the toxicological data provided, the CEF Panel concluded that there is no indication of a genotoxic potential for TEOS. HMDS was evaluated in 2007 by the EFSA Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC). As HMDS is rapidly converted into hexamethyldisiloxane (HMDSO) in humid air or aqueous media, the genotoxic potential of HMDS is covered by the genotoxicity data for HMDSO. The AFC Panel concluded that HMDSO was non‐genotoxic. The CEF Panel concluded therefore that the mixture composed of TEOS and HMDS in a ratio of 97:3 does not raise a safety concern for the consumer if it is used at up to 0.12% (w/w) for the production of recycled PET.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 10 tetrahydrofuran derivatives and one furanone derivative evaluated by the JECFA at the 63rd meeting in 2004. This revision is made due to additional toxicity data have become available for anhydrolinalool oxide (5) [FL‐no: 13.097]. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The JECFA concluded all the 11 tetrahydrofuran derivatives at step A3. The Panel agrees with the application of the Procedure as performed by the JECFA for 10 of the 11 substances. For the remaining substance [FL‐no: 13.097] the Panel did not find that it could be metabolised to innocuous products and should accordingly be evaluated via the B‐side of the Procedure scheme. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight was derived from a 90‐day study in rats and compared with an exposure estimate of 0.9 μg/ capita / per day for anhydrolinalool oxide a margin of safety of 3.5 × 106 was calculated. Accordingly, the Panel agrees with the JECFA conclusion ‘No safety concern at estimated level of intake as flavouring substances’ based on the maximised survey‐derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered and for all 11 substances, the information is adequate.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling processes Sumilon Eco PET SARL and ITD (EU register No. RECYC0125 and RECYC0127, respectively) based on the Starlinger IV+® technology. The input of the processes is 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. These flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then pre‐heated in a third reactor and fed to the solid state polycondensation (SSP) reactor. Having examined the challenge tests provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency. The operating parameters controlling the performance are temperature, gas flow and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step and the SSP step. It was demonstrated that the processes Sumilon Eco PET SARL and ITD are able to ensure that the 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 these processes intended to be used up to 100% for the manufacture of bottles (for ITD) or materials and articles (for Sumilon Eco PET SARL) 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 the recycled PET obtained from the process Sumilon Eco PET SARL are not intended to be used, and should not be used in microwave and conventional ovens.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of six aliphatic, acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances evaluated by JECFA at the 68th meeting in 2007. This revision of FGE.90 is made because additional toxicity data have become available for a structurally related substance in FGE.75Rev1, anhydrolinalool oxide (5) [FL‐no: 13.097]. The Panel agrees with the application of the Procedure as performed by the JECFA for four substances [FL‐no: 02.018, 02.245, 02.250 and 02.251]. For two substances [FL‐no: 13.076 and 13.087] it could not be concluded that they are metabolised to innocuous substances. Based on the exposure estimates (MSDI) and the no observed adverse effect level (NOAEL) from 90‐day toxicity study with anhydrolinalool oxide (5), the Panel considered that the substances [FL‐no: 13.076 and 13.087] were not of safety concern at the estimated levels of intake based on the maximised survey‐derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. For substance [FL‐no: 02.251] information on the stereoisomeric composition has not been specified, and for substance [FL‐no: 13.087], the identity of the isomers needs to be specified. For three substances [FL‐no: 02.018, 13.076 and 13.087] the modified theoretical added maximum daily intake (mTAMDI) is above the threshold of concern and therefore more reliable exposure data are required to perform a more refined exposure estimation and to judge whether a re‐evaluation according to the Procedure is needed.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of 24 alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting in 2002 and 63rd meeting in 2004). This revision is made due to inclusion of four additional substances cleared for genotoxicity concern compared to the previous version [FL‐no: 07.033, 07.094, 07.112 and 07.140]. The Panel concluded for 23 substances that these do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach [FL‐no: 02.209, 07.034, 07.035, 07.045, 07.094, 07.095, 07.098, 07.112, 07.126, 07.129, 07.140, 07.148, 07.149, 07.172, 07.179, 07.180, 07.257, 09.027, 09.140, 09.160, 09.230, 09.464 and 09.930]. However, for all substances use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered and are adequate for 21 substances. For [FL‐no: 07.094 and 07.112], information on the solubility in water and ethanol is missing. The chemical identity could not be unambiguously confirmed for substance [FL‐no: 07.033]. Therefore the Panel could not consider the JECFA evaluation of this substance and information as to its chemical identity should be submitted.

Abstract This Opinion describes recent developments in the safety assessment of chemicals in food and explores their potential impact on EFSA evaluation of food contact materials (FCM). It is not intended to be a guidance document. The draft opinion was subject to a public consultation and this final Opinion takes into account the scientific comments received. The Opinion will provide the European Commission with the scientific basis for a discussion among risk managers on possible implications for risk management. One major area to revisit is the estimation of consumer exposure. Four food consumption categories could be set. They are approximately 9, 5, 3 and 1.2 times higher than the current SCF default scenario, i.e. 17 g/kg bw per day, and so using them would afford a higher level of protection, particularly for infants and toddlers. Special exposure scenarios might be used if consumption were lower. The amount of toxicity data needed should be related to the expected human exposure. The tiered approach of the SCF is updated. For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement for additional toxicity data. Regarding the identification and evaluation of migrating substances, experience has shown that more focus is needed on the finished materials and articles. Considering the non‐intentionally added substances (NIAS), such as impurities of the substance along with reaction and degradation products including oligomers, the same approach as is used for authorised substances could, in principle, be applied for their toxicological assessment, as the same degree of safety should be warranted for all migrating substances. However, non‐testing methods could have increased importance for the assessment of genotoxicity of NIAS.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of 4‐acrylamido‐4‐methyl‐2‐pentanone, Chemical Abstracts Service (CAS) No 2873–97‐4, Food Contact Materials (FCM) substance No 986, for use as a comonomer for acrylic copolymers with keto side groups in non‐self‐supporting coatings on plastics. The keto groups are introduced into the polymer chain in order to render the copolymer curable by adipic acid dihydrazide (ADH). The coating is not expected to be used in direct contact with food but used in inner layers of plastics laminates that are intended to be used for all types of foodstuffs at all time–temperature conditions applicable according to the laminate's properties. Specific migration of the substance was measured from a coated low‐density polyethylene film. The substance was not detectable (limits of detection 0.001–0.014 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol, 95 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. Based on the results of the available studies, the substance does not give rise to concerns for genotoxicity. The substance was also studied for neurotoxicity in vitro and in vivo. The Panel concluded that there is no evidence for neurotoxicity in vivo. The CEF Panel concluded that the substance, 4‐acrylamido‐4‐methyl‐2‐pentanone, is not of safety concern for the consumer if it is used as a comonomer in acrylic copolymers to introduce keto side groups, which are crosslinked by adipic dihydrazide (ADH) in non‐self‐supporting coatings on plastics and not in direct contact with food. The migration of the substance should not exceed 0.050 mg/kg food.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of six furanone derivatives evaluated by the JECFA at their 63rd, 65th and 69th meetings. This revision of FGE.99 includes the assessment of the 2,5‐dimethyl‐4‐methoxyfuran‐3(2H)‐one [FL‐no: 13.089] cleared for genotoxicity concern compared to the previous version. The Panel concluded that none of the six substances gives rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach [FL‐nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176]. The specifications of the materials of commerce have also been considered and are adequate for all candidate substances in this FGE. However, for all substances use levels are required to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the additive montmorillonite clay modified by dimethyldialkyl(C16‐C18)ammonium chloride for use at up to 11.4 % w/w in ethylene‐based polymeric materials/blends for sealing layers up to 12.5 µm in direct contact with food. Final articles made with the sealing layers are intended to be used for long‐term storage of dry foods at room or refrigerated temperatures. Partially exfoliated layers of the modified clay can occur when incorporated into a polymer with polar character, but migration of the platelets, which are nano‐sized, is not expected. Migration of the clay and the modifier was not detected. Impurities from the modifier were identified as dimethyl(C16‐C18)amines and 1‐chloroalkanes and their migration was estimated to be below 50 and at 98 µg/kg food, respectively. Migration of dimethyl(C16‐C18)amines is covered by the evaluation of “alkyl, linear with even number of carbon atoms (C12‐C20) dimethyl amines” made by the AFC Panel in 2007, which concluded that the compounds are non‐genotoxic. There is no evidence for a genotoxic potential of 1‐chlorooctadecane, and read‐across from 1‐chlorooctadecane to 1‐chlorohexadecane was applied. Therefore, the CEF Panel concluded that the substance montmorillonite clay modified by dimethyldialkyl(C16‐C18)ammonium chloride does not give rise to safety concerns for the consumer if the substance is used at up to 12 % w/w in polyolefins in contact for long‐term storage of dry foods (foods, to which simulant E is assigned in Annex III of Regulation (EU) No 10/2011) at room or refrigerated temperatures. Since no data were provided on repeated dose toxicity of 1‐chloroalkanes; migration of the sum of 1‐chlorohexadecane and 1‐chlorooctadecane should not exceed 0.05 mg/kg food.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process General Plastic (EU register number RECYC107). According to the applicant, the input to the process is hot caustic washed poly(ethylene terephthalate) (PET) flakes originating from separate collected post‐consumer PET bottles, containing no more than 5% of PET from non‐food consumer applications. In this process, washed post‐consumer PET flakes are dried before being extruded into pellets. The pellets are crystallised and then undergo solid‐state polycondensation. Having examined the challenge test and the information provided, the Panel concluded that the process ‘General Plastic’ is not adequately characterised and the applicant has not demonstrated that the recycling process ‘General Plastic’ is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of 2,4‐di‐tert‐amylphenol, an impurity and hydrolysis product of the antioxidant phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters evaluated in 2011 by the CEF Panel for its uses in all polymers intended for contact with all food types under any time/temperature conditions. Migration of 2,4‐di‐tert‐amylphenol from linear low‐density polyethylene made with the antioxidant was not detected in 3 % acetic acid and water, and was up to 0.1 mg/kg in olive oil. Based on previous considerations and the negative results in two new in vitro genotoxicity tests, the Panel concluded that there is no evidence that 2,4‐di‐tert‐amylphenol has any genotoxic potential. Based on a 90‐day oral toxicity study in rats, a no observed adverse effect level (NOAEL) of 5 mg/kg body weight per day was determined. Considering the metabolism of branched chain alkylphenols and remaining uncertainty related to the potential for accumulation in man, an extra factor of 3 was considered along with the default uncertainty factor of 100. By applying the resulting uncertainty factor of 300 to the NOAEL, the migration of 2,4‐di‐tert‐amylphenol should not exceed 1 mg/kg food. The CEF Panel concluded that the substance 2,4‐di‐tert‐amylphenol does not give rise to safety concerns for the consumer if its migration does not exceed 1 mg/kg food and it is included in the current 5 mg/kg food restriction for the substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters, expressed as the sum of the phosphite and phosphate forms of the substance and 4‐tert‐amylphenol.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 22 flavouring substances in the Flavouring Group Evaluation 9, Revision 6, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances was considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The present revision of FGE.09 includes the assessment of one additional flavouring substance, trans‐3‐methyl‐2‐(2‐pentenyl)‐2‐cyclopenten‐1‐one [FL‐no: 07.219]. The Panel concluded that the 22 substances [FL‐nos: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.219, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for 11 flavouring substances [FL‐nos: 07.059, 07.109, 07.202, 07.203, 09.154, 09.520, 09.618, 09.619, 09.843, 09.935 and 09.949] more reliable exposure data are required for a re‐evaluation. For two substances [FL‐nos: 07.219 and 09.929] no use levels are available and these should be submitted. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered. Specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all candidate substances.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in Flavouring Group Evaluation (FGE) 213. In the first version of FGE.213 the Panel concluded, based on available genotoxicity data, that a concern regarding genotoxicity could be ruled out for 11 substances [FL‐nos: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL‐nos: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL‐no: 07.014] and maltyl isobutyrate [FL‐no: 09.525]. In FGE.213Rev2, new data on maltol were considered and the Panel concluded that for maltol [FL‐no: 07.014] and maltyl isobutyrate [FL‐no: 09.525] in food the concern for genotoxicity could be ruled out. Moreover, the Panel reconsidered the available data on p‐mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127], based on new data on the structurally related substance pulegone, and concluded that additional genotoxicity data are needed to rule out the concern for genotoxicity of p‐mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127].

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process ‘San Miguel Industrias’ which is based on the Starlinger IV+® technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post‐consumer PET containers, containing no more than an average 0.15 % of PET from non‐food consumer applications. In this technology, washed and dried PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are pre‐heated in a third reactor and fed to the Solid State Polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control their performance are the temperature, the gas flow and the residence time for the drying and crystallisation step, the temperature, the pressure and the residence time for extrusion and crystallisation and SSP steps. Under these conditions and using the reference contamination level of 3 mg/kg PET, it was demonstrated that the process 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 recycled PET are not intended to be used, and should not be used in microwave and conventional ovens.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate three flavouring substances in the Flavouring Group Evaluation 35, Revision 1, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revision includes new specification data on quinine sulphate [FL‐no: 14.152] and quinine monohydrochloride dihydrate [FL‐no: 14.155], new intake data on all three candidate substances and toxicological and genotoxicity data on quinine hydrochloride [FL‐no: 14.011] and quinine monohydrochloride dihydrate [FL‐no: 14.155], as well as two structurally related quinine salts (quinine dihydrochloride and deoxyquinine). A search in open literature has been made and the relevant data are presented. This evaluation concerns only the use of these quinine salts in beverages, where they are legally permitted. Because of the availability of well conducted human studies at much higher quinine exposures than those occurring when quinine is used as flavouring substance and which were considered in this FGE.35Rev1, the Panel considered the use of the Procedure for these substances inappropriate. However, based on human data available on quinine, the Panel concluded that the quinine salts are not expected to be of safety concern at their estimated level of intake as flavouring substances, provided that hypersensitivity reactions are avoided by the legally required labelling of quinine‐containing beverages. The Panel noted that a very high intake (e.g. more than 1 litre) of non‐alcoholic beverages containing quinine or its salts at the maximum permitted level could result in adverse health effects in humans. Besides the safety assessment of these three flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity, have been provided for all three candidate substances.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process ExtruPET (EU register number RECYC0124), which is based on the Starlinger IV+® technology. The input of the process 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 consumer applications. In this technology, washed PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then pre‐heated in a third reactor and fed to the solid state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and are the temperature, the gas flow and the residence time for the drying and crystallisation step, and the temperature, the pressure and the residence time for the extrusion and crystallisation step and the SSP step. Under these conditions, it was demonstrated that the recycling process 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 recycled PET are not intended to be used, and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Coveris (EU register No RECYC0126), which is based on the same Starlinger Decon technology. The decontamination efficiency of the process was demonstrated using the same challenge test. The input of this process is 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 pre‐heated before being Solid State Polycondensed in a continuous reactor (SSP) at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre‐heating (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 their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions it was demonstrated that the recycling process under evaluation, using a 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 to be used in microwave and conventional ovens.

Abstract Following a request from the European Commission, EFSA was asked to review Commission proposals for classification of the substances used as sizing agents and provide an opinion on whether or not the proposed classifications could imply an unacceptable risk to human health. Glass fibre‐reinforced plastics are composite materials made of a polymer matrix reinforced with glass fibres. The glass fibres therein are coated with a surface treatment (‘sizing agent’) to hold individual filaments together and to promote adherence to the polymer matrix. Glass fibre‐reinforced plastic is covered by Regulation (EU) No 10/2011, which stipulates that substances used for its manufacture should be listed in the Union List. From January 2016, the Plastics Regulation will also apply to glass fibre‐sizing agents, and these substances shall be included in the Union List. On the basis of the low migration from glass fibre‐reinforced plastics and the low consumer exposure expected, the CEF Panel does not expect any particular health risks from sizing agents compared with other plastics. For substances classed as coupling agents and for the substances considered polymer production aids, aids to polymerisation or solvents used to make plastics, any use of glass fibre‐reinforced plastics does not seem to merit deviation from risk management decisions that were taken earlier. For the reactive polymers used for sizing the glass fibres, two possibilities are presented: evaluation of these polymers by EFSA and then specific authorisation via the Union List or regulation through the starting materials, if already listed, in accordance with the derogation in Article 6(3) of Regulation (EU) No 10/2011. In either case, the data required and the risk assessment process used should be the same or equivalent. The difference will be in the data that are presented to EFSA, and this is a decision in the remit of the Commission.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety re‐evaluation of perfluoromethyl perfluorovinylether, CAS No 1187‐93‐5 and FCM No 391, as a co‐monomer for fluoro‐ and perfluoropolymers. The polymers are intended to be used for the production of O‐rings, gaskets and seals for repeated use in food processing applications that may contact all types of food at temperatures ranging from low up to 200 °C, from a few minutes to hours. The worst‐case specific migration of the substance was estimated to be lower than 0.07 µg/kg food, based on its residual amount in a perfluoropolymer sample containing the maximum level of use of perfluoromethyl perfluorovinylether. The migration of volatile and semivolatile substances was estimated to be lower than 0.07 µg/kg food and lower than 1 µg/kg food, respectively. Overall migration was calculated under repeat use conditions, and was 4 µg/kg in 3 % acetic acid, 3 µg/kg in 20 % ethanol and 9 µg/kg in olive oil. No oligomers below 1 500 Da were detected. Based on toxicological data available and evaluated in 2001 (SCF) and 2004 (EFSA), the CEF Panel concluded that the substance is not of genotoxic concern. Therefore, the CEF Panel concluded that the substance is not of safety concern for the consumer if it is used as a co‐monomer for fluoro‐ and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with not less than 150 kg food.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the recycling process Evertis Iberica (EU register number RECYC0123), which is based on the EREMA Multi‐Purpose Reactor (MPR) technology. The input to this process is washed and dried polyethylene terephthalate (PET) flakes originating from collected post‐consumer PET containers and containing no more than 5 % PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency. The operating parameters which control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that 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 0.15 µg/kg food, derived from an exposure scenario for toddlers. The Panel concluded that the recycled PET obtained from the process Evertis Iberica is not considered of safety concern when used for the manufacture of thermoformed trays and containers made with up to 100 % recycled post‐consumer PET, and used for contact with all types of foodstuffs, except packaged water, for long‐term storage at room temperature, with or without hotfill. Thermoforming trays are not intended to be used, and should not be used, in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Terrachim (EU register number RECYC122), which is based on the VACUREMA Prime® technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post‐consumer PET containers and containing no more than 5 % PET from non‐food consumer applications. Through this technology, washed and dried PET flakes 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 challenge test provided, the Panel concluded that the decontamination in the batch reactors and in the continuous reactor are the critical steps that determine the decontamination efficiency of the process. The operating parameters which control the performance of these critical steps are well defined and are temperature, pressure and residence time. It was demonstrated that 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. Therefore, 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 recycled PET are not intended to be used, and should not be used, in microwave and conventional ovens.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of 28 furan‐substituted compounds evaluated by the JECFA. This revision of FGE.67 is due to new data on toxicity for 3‐(‐methyl‐2‐furyl) butanal [FL‐no: 13.058] providing an appropriate NOAEL for the evaluation of candidate substance [FL‐no: 13.058]. The Panel concluded that 11 substances [FL‐nos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for these eleven candidate substances, except [FL‐no: 13.058], more reliable intake data are required for a re‐evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered, which for all candidate substances are adequate. For 17 substances [FL‐nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] a concern for genotoxicity was raised and therefore these were not evaluated using the Procedure. The Panel noted further that for 7 of these 17 substances [FL‐nos: 13.045, 13.052, 13.054, 13.059, 13.061, 13.069 and 13.083], use levels have not yet been submitted.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 29 flavouring substances in the Flavouring Group Evaluation 18, as laid down in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have a genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. This revision deals with new toxicity data on the supporting substance myrcene [FL‐no: 01.008], providing an appropriate NOAEL for the evaluation of candidate substance [FL‐no: 02.146]. The Panel concluded that all 29 substances [FL‐nos: 02.041, 02.052, 02.054, 02.120, 02.123, 02.129, 02.140, 02.146, 02.144, 02.147, 02.149, 02.150, 02.168, 02.171, 02.181, 02.184, 02.197, 02.203, 02.206, 02.219, 02.226, 02.230, 02.253, 09.171, 09.356, 09.614, 09.617, 09.671 and 09.808] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for all candidate substances except [FL‐no: 02.146] more reliable intake data are required for a re‐evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For four substances [FL‐nos: 02.129, 02.147, 02.168, 02.197] additional information on purity criteria and/or stereoisomeric composition is required.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from FGE.19 subgroup 4.4, in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups: subgroup 4.4a containing [FL‐no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded that for the substances in subgroup 4.4b there is no concern for genotoxicity. In FGE.220, Revision 2, the Panel evaluated genotoxicity studies on two representative substances of subgroup 4.4a: 2,5‐dimethylfuran‐3(2H)‐one [FL‐no:13.119] and 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175]. Based on the submitted data the Panel concluded that 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] does not give rise to concern with respect to genotoxicity. For 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] the concern for genotoxicity could not be ruled out, therefore the Panel requested a repetition of the submitted micronucleus study in the presence of S9‐mix, or a combined in vivo micronucleus and Comet assay, including analysis of the liver. The Flavour Industry has tested again 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] in an in vitro micronucleus assay as was requested by the Panel. This new study is evaluated in FGE.220, Revision 3, where the Panel concluded that [FL‐no: 13.175] does not give rise to concern with respect to genotoxicity and can be evaluated using the Procedure. This is also applicable to other two substances in subgroup 4.4a: 2,5‐dimethyl‐4‐methoxyfuran‐3(2H)‐one [FL‐no:13.089] and 2,5‐dimethyl4‐ethoxyfuran‐3(2H)‐one [FL‐no:13.117]. Based on the available data the substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 22 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212. Based on available genotoxicity data and new genotoxicity data submitted by the Industry, the Panel concluded that genotoxic potential could be ruled out for the six carvone derivatives [FL‐no: 02.062, 07.146, 07.147, 09.143, 09.215 and 09.870], the 11 isophorone derivatives [FL‐no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the five substances [FL‐no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 in FGE.212, FGE.212Rev1 and FGE.212Rev3, respectively. Two substances previously included in FGE.212Rev2, vetiverol and vetiveryl acetate [FL‐no: 02.214 and 09.821], are no longer supported by Industry. Based on the available data, all 22 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 41 flavouring substances in Flavouring Group Evaluation 21, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision was carried out because of the inclusion of the assessment of new toxicity data on the candidate substances, 5‐ethylthiophene‐2‐carbaldehyde [FL‐no: 15.074] and 2‐pentylthiophene [FL‐no: 15.096]. These data on 5‐ethylthiophene‐2‐carbaldehyde [FL‐no: 15.074] should cover 2‐acetylthiophene [FL‐no: 15.040] and 2‐propionylthiophene [FL‐no: 15.097]. These data on 2‐pentylthiophene [FL‐no: 15.096] should cover 2‐butylthiophene [FL‐no: 15.045], 2‐hexylthiophene [FL‐no: 15.076] and 2‐octylthiophene [FL‐no: 15.093]. For two of the substances [FL‐no: 15.060 and 15.119] the Panel concluded that additional genotoxicity data are required. The remaining 39 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern and available data on metabolism and toxicity. The Panel concluded that the 39 flavouring substances [FL‐no: 15.038, 15.039, 15.040, 15.044, 15.045, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.074, 15.076, 15.078, 15.079, 15.080, 15.082, 15.084, 15.085, 15.086, 15.087, 15.089, 15.093, 15.096, 15.097, 15.098, 15.108, 15.115, 15.116, 15.118 and 15.135] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the Maximised Survey‐derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all 41 candidate substances.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling processes Coveris and Envaplaster (RECYC0117 and RECYC0120, respectively), which are based on the same EREMA Basic technology. The input to these processes is washed and dried polyethylene terephthalate (PET) flakes originating from collected post‐consumer PET bottles containing no more than 5 % PET from non‐food consumer applications. In this technology, washed and dried PET flakes are 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 continuous reactor (step 2) is the critical step that determines the decontamination efficiency of the processes. The operating parameters to control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling processes under evaluation are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the processes is not of safety concern when the final thermoformed trays and containers manufactured with the recycled pellets and not used for packaging water contain up to 90 % recycled post‐consumer PET for Envaplaster, and up to 100 % recycled post‐consumer PET for Coveris.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 14 flavouring substances in the Flavouring Group Evaluation 25, Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances was considered to have a genotoxic potential. This revision is made due to the inclusion of new toxicity data on the supporting substances β‐caryophyllene [FL‐no: 01.007] and myrcene [FL‐no: 01.008] considered in FGE.78Rev2 to cover the assessment of 4(10)‐thujene [FL‐no: 01.059], 2,6‐dimethylocta‐2,4,6‐triene [FL‐no: 01.035], cis‐3,7‐dimethyl‐1,3,6‐octatriene [FL‐no: 01.064] and 1‐octene [FL‐no: 01.070]. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all 14 substances [FL‐no: 01.001, 01.027, 01.028, 01.033, 01.034, 01.035, 01.038, 01.039, 01.046, 01.054, 01.057, 01.059, 01.064, 01.070] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity and identity criteria for the materials of commerce have been provided for all 14 candidate substances.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process PET‐M (EU register No RECYC062). The input material for the process is washed and dried polyethylene terephthalate (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing less than 5 % of PET from non‐food consumer applications. In this process, post‐consumer washed and dried PET flakes are heated and dried in a mixing reactor, followed by mixing with a modifier, before being extruded under vacuum into pellets. Having examined the challenge test provided, the Panel concluded that steps 2 (heating and drying under air flow) and 4 (extrusion under vacuum and pelletisation) are the critical steps for the efficiency of decontamination. The operating parameters which control the performance of these steps are temperature, residence time and air flow, for step 2, and temperature, time and pressure, for step 4. It was demonstrated that 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 and 0.15 μg/kg food derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process PET‐M is not of safety concern when it is used up to 60 % to manufacture bottles and up to 90 % to manufacture thermoformed trays and containers not used for packaging water.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns 21 aromatic, aliphatic and alicyclic hydrocarbons [FL‐no: 01.002, 01.003, 01.004, 01.005, 01.006, 01.007, 01.008, 01.009, 01.010, 01.016, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] evaluated by the JECFA in 2005. FGE.78Rev1 considered 24 substances, but 4‐methyl‐1,1′‐biphenyl (JECFA‐no: 1334) and biphenyl (JECFA‐no: 1332) [former FL‐no: 01.011 and 01.013] are no longer supported by Industry for use as a flavouring substance in Europe. Moreover 1‐methylnaphthalene [FL‐no: 01.014] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β‐caryophyllene [FL‐no: 01.007] and 90‐day studies in rats on β‐caryophyllene [FL‐no: 01.007] and myrcene [FL‐no: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structure‐activity 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 [FL‐no: 01.002‐01.010, 01.016‐01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of zinc oxide, nanoparticles, uncoated (FCM No 1050) and coated with [3‐(methacryloxy)propyl] trimethoxysilane (FCM No 1046), for use as a transparent ultraviolet light absorber in all polyolefins at a maximum content of 2 % and 3 % for the uncoated and the coated species, respectively. The substance is used as a powder in nanoform. In the final polymer, nanoparticles are still present but largely aggregated. The specific migration of the substance was tested from low‐density polyethylene films, containing the maximum use level of the substance, into 3 % acetic acid and 10 % and 50 % ethanol for 10 days at 60 °C. Data from a stress test with iso‐octane for 10 days at 20 °C was provided. Migration values into the different simulants and the microscopic analysis of swollen polymers demonstrate that there is no mass transfer of the zinc oxide in nanoform. In 2003 the Scientific Committee on Food established for zinc a no observed adverse effect level of 50 mg/day and an upper limit of 25 mg/person per day was recommended. The CEF Panel concluded that zinc oxide, nanoparticles, uncoated or coated with [3‐(methacryloxy)propyl]trimethoxysilane, does not migrate in nanoform, and therefore the safety evaluation focuses on the migration of soluble ionic zinc. Available migration data for ionic zinc coming from the intended application are in compliance with the current specific migration limit (SML), but in combination with the dietary exposure from other sources the upper limit of 25 mg/person per day could be exceeded. For use of the coated form of zinc oxide, migration of [3‐(methacryloxy)propyl]trimethoxysilane should be within the existing SML for this substance of 0.05 mg/kg.

This scientific opinion of EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of the additive adipic acid dihydrazide, CAS No 1071-93-8, FCM substance No 987 for use as a crosslinker for acrylic polymer with keto side groups coated on polyolefins and adhesives in laminates made from plastics. The coating is not for direct food contact but used in inner layers of plastics laminates which are intended to be used for all types of foodstuffs at all time-temperature conditions applicable according to the laminate’s properties. Specific migration of the substance was measured from a coated low-density polyethylene (LDPE) film, the substance was not detectable (limit of detection (LOD) 0.019 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. According the in vitro and in vivo studies available the substance is not considered genotoxic. Based on an in vivo micronucleus test, the substance is not considered to be clastogenic/aneugenic under the tested conditions. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as a crosslinker for non-self-supporting coatings on polyolefins and adhesives for laminates not in direct contact with food and its migration does not exceed 0.050 mg/kg food.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 30 aliphatic and arylalkyl amines and amides evaluated by JECFA at the 65th meeting in 2005. This revision is required owing to additional available toxicity data on piperine [FL-no: 14.003] and deca-(2E,4E)-dienoic acid isobutyl-amide [FL-no: 16.091]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological thresholds of concern and available data on metabolism and toxicity. The Panel agrees with JECFA’s conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the Maximised Survey-derived Daily Intake (MSDI) approach for all substances considered in this FGE. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 30 substances, the information is adequate.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling processes "Baltija Eco PET", "Eurocast", "Fernholz", "Formas y Envases", and "Klöckner Pentaplast" (EU register numbers RECYC0118, RECYC0111, RECYC0113, RECYC0115 and RECYC0121 respectively), which are all based on the same Starlinger Decon technology. The decontamination efficiency of all these processes was demonstrated using the same challenge test. The input of all the processes is washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % of PET from non-food consumer applications. Through this technology washed and dried PET flakes are pre-heated before being solid state polymerised (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions it was demonstrated that the recycling processes under evaluation, using a Starlinger Decon technology, are 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 these processes intended to be 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.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 22 pyridine, pyrrole and quinoline derivatives evaluated by JECFA (63rd meeting). The revision of this consideration is made since additional toxicity data have become available for 1-furfurylpyrrole [FL-no: 13.134]. The data are intended to cover the re-evaluation of this substance and 2-acetyl-1-ethylpyrrole [FL-no: 14.045] and 2-acetyl-1-methylpyrrole [FL-no: 14.046]. The Panel concluded that for 6-methylquinoline [FL-no: 14.042], the genotoxicity data available do not clear the concern with respect to genotoxicity in vitro and accordingly the substance is not evaluated through the Procedure. For 21 substances [FL-no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 14.045, 14.046, 14.047, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.068, 14.071, 14.072 and 14.164] considered in this FGE, the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been evaluated, and the information is considered adequate for all the substances.

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 Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the flavouring substance spilanthol [FL-no: 16.121] in Flavouring Group Evaluation 303, Revision 1, using the Procedure according to Commission Regulation (EC) No 1565/2000. This revision is made as new 90 days toxicity data have been submitted for spilanthol [FL-no: 16.121]. The substance was considered not to have genotoxic potential. The substance was evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that spilanthol [FL-no: 16.121] does not give rise to safety concern at its level of dietary intake, estimated on the basis of the Maximum Surveyderived Daily Intake (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of the substance 1,7-octadiene, CAS No 3710-30-3, FCM No 1034 for use as a crosslinking co-monomer in polyolefins at a maximum use level of 0.9 %. There were no residues of the substance detectable in the polymer (< 16 μg/kg detection limit) and no detectable migration of the substance itself and its two main impurities into appropriate food simulants (detection limits in the range of 1-8 μg/kg). A comparative migration test between low density polyethylene samples made with and without the substance into 95 % ethanol at 10 days/40 °C showed no qualitative difference between the two gas chromatography–mass spectrometry chromatograms (GC-MS). The GC-MS analysis gave complex chromatograms of oligomeric species, from which it was estimated that overall migration was considerably lower than the overall migration limit of 10 mg/dm². Based on the negative results of three in vitro tests, the Panel considered that the substance is not of genotoxic concern. The CEF Panel concluded that the substance 1,7-octadiene is not of a safety concern for the consumer if the substance is only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature and including hot fill conditions and the migration of the substance does not exceed 0.05 mg/kg food. As the polyolefin oligomers and other reaction products containing the co-monomer are likely to strongly vary in amount and composition, depending on the polymerization and manufacturing process used, they were not evaluated by the Panel. Evaluation of these oligomers and reaction products should be conducted case by case by the business operator.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 15 flavouring substances in the Flavouring Group Evaluation 12, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of three additional candidate substances, beta‐isomethylionone [FL‐no: 07.041], 4‐(2,5,6,6‐tetramethyl‐1‐cyclohexenyl)but‐3‐en‐2‐one [FL‐no: 07.200] and tr‐1‐(2,6,6‐trimethyl‐1‐cyclohexen‐1‐yl)but‐2‐en‐1‐one [FL‐no: 07.224], compared to FGE.12Rev4. These three substances have been cleared for a genotoxic concern in FGE.213Rev1 and can accordingly be evaluated using the Procedure in the present revision of FGE.12. The 15 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all 15 flavouring substances [FL‐no: 02.134, 02.186, 02.216, 02.217, 05.157, 05.182, 05.183, 05.198, 07.041, 07.200, 07.224, 08.135, 09.342, 09.670 and 09.829] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI (Maximised Survey‐derived Daily Intake) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 15 candidate substances.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process SOREPET GR+ (EU register No RECYC074) which is based on Erema basic and Buhler technologies. The input to the 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 % PET from non‐food consumer applications. In this process, washed and dried PET flakes are crystallised and heated to the decontamination temperature, the flakes are extruded into pellets, the pellets are crystallised and heated and are solid state polymerised in a continuous reactor. Having examined the challenge test provided, the Panel concluded that the continuous decontamination (step 2), extrusion (step 3), crystallisation (step 4) and the solid state polymerisation (SSP) (step 5) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control its performance are temperature, pressure and residence time (step 2), temperature (step 3), temperature, pressure, gas flow and residence time (step 4), temperature, pressure, gas flow and residence time, (step 5). Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the modelled migration of 0.1 μg/kg food. The Panel concluded that recycled PET obtained from the process, intended to be used up to 100 % for manufacture of materials and articles for contact with all type of foodstuffs for long term storage at room temperature, with or without hot fill, is not considered of safety concern.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of dodecanoic acid, 12‐amino‐, polymer with ethene, 2,5‐furandione, ±‐hydro‐ɷ‐hydroxypoly (oxy‐1, 2‐ethanediyl) and 1‐propene, CAS No 287916–86‐3, food contact materials substance No 871 for use as a polymeric antistatic additive in hydrophobic plastics (mainly polyethylene and polypropylene) at a maximum used level up to 20 % w/w. The additive is a self‐standing polymer and all starting substances used for its manufacture have already been evaluated from the toxicological point of view and they are listed in the Annex I of Regulation (EU) No 10/2011. Migration tests using food simulants 10 % ethanol and poly(2,6‐diphenyl‐p‐phenylene oxide), at test conditions of 10 days at 40 °C, gave no detectable migration of the oligomeric fraction < 1000 Da (limit of detection ca. 18 μg/6 dm2). Considering the absence of genotoxicity of the starting substances used and of the additive itself, the additive does not give rise to safety concerns. The CEF Panel concluded that the substance dodecanoic acid, 12‐amino‐, polymer with ethene, 2,5‐furandione, ±‐hydro‐ɷ‐hydroxypoly (oxy‐1, 2‐ethanediyl) and propene, is not of safety concern if it is used as an additive in polyolefins at levels of up to 20 weight %, in contact with dry foods as represented by simulant E (poly(2,6‐diphenyl‐p‐phenylene oxide) in Regulation (EU) No 10/2011. The contact conditions should be at ambient temperature or below. Migration of the low molecular weight oligomeric fraction less than 1000 Da should in total not exceed 50 µg/kg food.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling processes Roxane Nord and Stute (EU register number RECYC017 and RECYC104, respectively) which are based on the KRONES® technology. The input to the processes is 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 consumer applications. In this technology, washed and dried PET flakes are transferred by two heated conveyors under atmospheric pressure into a reactor where they are decontaminated at high temperature under vacuum. Having examined the results of the challenge test provided, the Panel concluded that three steps, the pre‐heating and the heating in the conveyors and the decontamination in the vacuum reactor, are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control the performance of these critical steps are temperature, residence time, and, for the vacuum reactor, also pressure. Under these conditions, it was demonstrated that the recycling processes are 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 these processes 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.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process “Petra Polimeri”, EC register number RECYC089. The process recycles polypropylene (PP) trays and inserts trays which have been used for the transport, storage and display of whole, fresh fruits and vegetables at room temperature or below. Trays are returned by consumers and collected in specific containers at the point of sale and insert trays originate from a closed loop of distributors. After collection, trays and insert trays are sorted separately. Through this process, sorted trays and/or insert trays are ground into flakes, which are washed, dried and extruded into granules. This recycled material is used up to 30 % with virgin PP to manufacture new trays and insert trays intended for transport, storage and display of whole, fresh fruits and vegetables. The Panel considered the specific use of the recycled trays and insert trays and the management of the input material as a critical process step. The Panel concluded that exposure of consumers to potential contaminants is unlikely and that the recycled PP obtained from the process Petra Polimeri is not of safety concern when i) made with collected trays from specific containers at the point of sale along with a communication and/or insert trays from the retailer, trays and insert trays being collected and sorted separately; the sorting being positive and manual, and leading to more than 99.9 % PP trays and insert trays, and when ii) intended to be used up to 30 % with virgin PP to manufacture new recycled trays and/or insert trays for contact with whole, fresh fruits and vegetables at room temperature or below.

The food enzyme considered in this opinion is a lipase (triacylglycerol lipase; EC 3.1.1.3) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The lipase is intended to be used in a number of food manufacturing processes, such as in baking and other cereal-based processes. The dietary exposure was assessed on the basis of data retrieved from the EFSA Comprehensive European Food Consumption Database. The food enzyme did not induce gene mutations in bacteria nor micronuclei in human peripheral blood lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90-day subchronic oral toxicity study in rodents. A No Observed Adverse Effect Level was derived, which compared with the dietary exposure results in a sufficiently high Margin of Exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.