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International audience; The substance isobutane is intended to be used as a foaming agent at max 4.5% to produce expanded polystyrene (EPS) to be used for packaging foods, such as fruits, vegetables, meat, fish and cheese, at room temperature or lower. Isobutane is approved in Europe as a food additive (E943b) to be used quantumsatis as a gas propellant only in vegetable oil pan spray (for professional use only) and water-based emulsion spray according to Regulation (EC) No1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No231/2012. The substance is a gas at room temperature. It is a saturated hydrocarbon, obtained with a high level of purity, and is not expected to react under the processing conditions used to make foamed polystyrene materials and articles. Data on migration of isobutane from trays at 20 degrees C for 10days ranged from 0.2 to 0.4mg/kg food. Considering the intended applications, estimated exposure is extremely low based on migration data. In the absence of genotoxicity alerts and given the very low toxicity following repeated exposure with no observed adverse effect concentration (NOAEC) of several thousands of mg/m(3) by inhalation, it was considered that the use of isobutane as a foaming agent, at the expected exposure from food, does not raise a safety concern.

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 EstPak Plastik (EU register No RECYC150), 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 (one single reactor or several reactors in parallel) 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 performance of the process 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.

International audience; 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 Gneuss 1 (EU register No RECYC0143). The input 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. They are extruded under vacuum into pellets or sheets. Having examined the challenge test provided, the Panel concluded that the decontamination in the extruder under vacuum degassing is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are temperature, pressure, residence time, throughput rate, rotor speed and satellite screws speed. The operating parameters of this step are at least as severe as those obtained from the challenge test. It was demonstrated that this 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 mu g/kg food. Therefore, the recycled PET obtained from the process Gneuss 1 intended for the manufacture of articles made with up to 100% recycled post-consumer PET and intended for contact for long-term storage at room temperature with all types of foodstuffs 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.

International audience; 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 BTB PET direct IV+ (EU register number RECYC0152). The input of the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer food contact PET containing no more than 5% of PET from non-food consumer applications. In this technology, washed PET flakes are extruded into pellets which are further crystallised. Crystallised pellets are then preheated and fed to the solid-state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that extrusion, 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 temperature, pressure and residence time. 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 conservatively modelled migration of 0.1 mu g/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.

International audience; 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 Gneuss 2 (EU register No RECYC0144). The input 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. They are extruded under vacuum into pellets or sheets. Having examined the challenge test provided, the Panel concluded that the decontamination in the extruder under vacuum degassing is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are temperature, pressure, residence time, throughput rate, the rotor speed and the satellite screws speed. The operating parameters of this step are at least as severe as those obtained from the challenge test. It was demonstrated that this 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 mu g/kg food. Therefore, the recycled PET obtained from the process Gneuss 2 intended for the manufacture of articles made with up to 90% recycled post-consumer PET and intended for contact for long-term storage at room temperature with all types of foodstuffs 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.

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

International audience; This scientific opinion of the EFSA Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of selenium nanoparticles, FCM substance No 1070, which is intended to be used as an antioxidant. Selenium nanoparticles are incorporated into the adhesive middle layer of multilayer laminates with an outside polyethylene terephthalate (PET) layer and an inner polyolefin (food contact) layer. The final materials are intended to be used for contact with all food types that are susceptible to oxidation. The specific migration of total selenium was tested using multilayer pouches containing selenium nanoparticles at 0.002mg/dm(2) and filled with 3% acetic acid and 20%, 50% or 95% ethanol for 10 days at 60 degrees C. In all tests, migration of selenium was not detectable. Taking into account current knowledge on the diffusional properties of nanoparticles in polymers, the CEF Panelconcluded that there is no safety concern for the consumer if selenium nanoparticles are used in multilayer films and separated from the food by a polyolefin food contact layer for any type of food and under any food contact conditions.

International audience; 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 Linpac recycling process (EU register number RECYC0148), which is based on the Linpac super clean technology. The input to this process is hot 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. In this technology post‐consumer washed and dried PET flakes are heated in continuous driers under gas flow before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the decontamination in the driers (steps 2 and 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are residence time, ‘air flow per mass of flakes’ and temperature in the driers. 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 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when used at up to 100% to make articles intended for contact with all types of foodstuffs, except packaged water. These articles should be used at conditions covered by migration testing of 10 days at 20°C. The articles are not intended to be used, and should not be used, in microwave and conventional ovens.

International audience; his scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the 4PET recycling process (EU register number RECYC0139), which is based on the EREMA Basic technology. The input to this process is hot 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. In this technology, post-consumer washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded. 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 of the process. The operating parameters controlling its performance are well defined and 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 0.15 lg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when the final thermoformed trays and containers and PET beverage bottles manufactured with the recycled pellets and not used for packaging water or ready-to-feed liquid infant formulae contain up to 90% recycled post-consumer PET. These thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

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 substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters. The substance was evaluated by the CEF Panel in 2011 and 2,4‐di‐tert‐amylphenol, an impurity and hydrolysis product was re‐evaluated by the CEF Panel in 2015. In this application, the applicant requested an increase of the specific migration limit of the substance, currently established at 5 mg/kg food, to 10 mg/kg food, and provided new toxicological studies. Findings from three new in vitro mutagenicity assays on the oxidation products support the conclusion from 2011 that the substance and its oxidation products are not genotoxic. A new toxicokinetic study on the substance supports the consideration from the evaluation in 2011 that the substance does not raise concern for accumulation. The outcome of a new delayed neurotoxicity study on a structurally related substance, phosphorous acid, tris (2,4‐di‐tert‐butylphenyl) ester, which was considered not to cause neurotoxicity in hens, strengthens the conclusion of the Panel in 2011 that the substance does not represent a concern for neurotoxicity. From a new two‐generation reproduction toxicity study and a prenatal developmental toxicity study on the substance, a new subchronic toxicity study on its oxidation products that completes the one submitted in 2011 on the substance itself, and a 2‐year oral toxicity study on the structurally related substance, the lowest NOAEL was 58–147 mg/kg bw per day (from the 2‐year oral toxicity study). Compared to the requested increase of the migration limit, this gives an acceptable margin of safety of 348. Therefore, the CEF Panel concluded that an increase of the specific migration limit of the substance from 5 to 10 mg/kg food is not a safety concern for the consumer.

International audience; 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 Coexpan Montonate (EU register No RECYC0141), 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 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 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 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. Trays made of this PET are not intended to be used, and should not to be used in microwave and conventional ovens.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids 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 Commission Regulation No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96. Official Journal of the European Communities L 180, 19.7.2000, 8–16. . The present consideration concerns a group of 29 aliphatic secondary alcohols, ketones and related esters evaluated by JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to the inclusion of nine additional substances cleared for genotoxicity concern in FGE.205 Revision 1. 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 Panel agrees with the application of the Procedure as performed by JECFA for all 29 substances considered in this FGE. For all substances, the Panel concludes that there is ‘no safety concern at the estimated levels of intake as flavouring substances based on the MSDI approach’. For all 29 substances, the specifications for the materials of commerce have also been considered and found adequate. Ten out of the 14 substances for which use levels became available exceed the modified theoretical added maximum daily intake (mTAMDI) and more reliable exposure data are required to finalise their evaluation. On the basis of such data, additional toxicological data might become necessary. For 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.

International audience; 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 Alimpet (EU register number RECYC0136), which is based on the EREMA Multi-Purpose Reactor (MPR) technology. The input to this process is hot 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. 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 of the process. The operating parameters controlling its performance are well defined and 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 0.15 lg/kg food derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when used in extruded PET sheet for thermoforming trays and containers made with up to 100% recycled post-consumer PET, and used for contact with all types of foodstuff except packaged water, for long-term storage at room temperature. Thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids 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 four flavouring substances consisting of isopulegone and three other substances evaluated by JECFA at the 55th meeting. This revision is made due to additional toxicity data available for (1R,2S,5R)‐isopulegol [FL‐no: 02.067]. 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. p‐Mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with JECFA, the Panel evaluated the candidate substances in this Flavouring Group Evaluation (FGE) via the B‐side of the Procedure. Based on a no observed adverse effect level (NOAEL) from a 90‐day oral toxicity study on [FL‐no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, the Panel agrees with the JECFA conclusion, ‘No safety concern at estimated levels of intake as flavouring substances’ based on 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 and found adequate. For the three substances evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For [FL‐no: 02.067 and 07.067], the mTAMDI exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate 53 flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but‐3‐en‐2‐ol, non‐1‐en‐e‐ol, hex‐1‐en‐3‐one and 1‐nonene‐3‐one [FL‐nos: 02.131, 02.187, 07.161 and 07.210] in this Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the 53 substances was considered to have genotoxic potential. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that all 53 substances 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 the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For 50 substances, further information is required based on comparison of the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data.

International audience; This scientific opinion of the EFSA Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process PEGRA-V (EU register number RECYC0137), which is based on the Starlinger IV+((R)) 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 preheated in a third reactor and fed to the solid-state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panelconcluded 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 0.1g/kg food. Therefore, the Panelconcluded 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 to be used in microwave and conventional ovens.

International audience; The EFSA Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panelconcluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panelhas evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 mu g/person per day for a 60-kg adult and 2,233 mu g/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 mu g/person per day. The Panelconsidered that based on the available data, which covers all relevant genetic endpoints (i.e.gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panelevaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Pane lconcluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6‐hexanediol and then reacted with 4,4′‐methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4‐butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short‐term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6‐hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.

International audience; his scientific opinion of the EFSA Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Krones pellet (EU register number RECYC0149). The input to the process 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 extruded to pellets that are then crystallised and decontaminated in a reactor at high temperature under vacuum. Having examined the results of the challenge test provided, the Panelconcluded that two steps, the extrusion (step 2) and the decontamination in the vacuum reactor (step 4), 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, residence time and, for the vacuum reactor, also pressure. 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 conservatively modelled migration of 0.1 g/kg food. Therefore, the Panelconcluded 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 should not be used in microwave and conventional ovens.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester (TDCM) for use as a co‐monomer to manufacture polyester layers. The polyester layer is not intended to be in direct contact with food. The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs. Contact conditions include sterilisation followed by long‐term storage at room temperature. No thermal degradation of TDCM is expected during the manufacture of the middle polyester layer and of the multilayer articles. Total mass transfer of the substance from a polyester monolayer was calculated to be up to 0.032 mg/kg food. Based on three in vitro genotoxicity tests, the CEF Panel considered that the substance does not raise concern for genotoxicity. When tested behind a polypropylene layer, migrating TDCM‐related oligomers, their oxidation products and other related reaction products were identified. The major components were TDCM dimers. When tested behind a cyclo‐olefin polymer layer, none of the TDCM‐related substances were found to migrate. Based on the lack of genotoxicity of the co‐monomer, the ester nature of the oligomers and on (quantitative) structure–activity relationship ((Q)SAR) analysis, the CEF Panel considered that there is no indication of genotoxicity for the oligomers, their oxidation products and other TDCM‐related reaction products. The CEF Panel concluded that the substance is not of safety concern for the consumer if used as a co‐monomer for the manufacture of a polyester layer intended to be used as an inner (non‐food contact) layer of a multilayer material for contact with foods simulated by simulants A, B, C, D1 (as set in Regulation (EU) 10/2011). The migration of the sum of the substance and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food.

International audience; 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 Märkische Faser (EU register number RECYC0135), which is based on the Next Generation Group (NGR) technology. The input to this process is hot 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. In this technology, post-consumer washed and dried PET flakes are melted and degassed in an extruder under vacuum (step 2) and decontaminated during a melt-state polycondensation under high temperature and vacuum (step 3). In step 4, the melt material is homogenised, extruded under vacuum and subsequently pelletised. Having examined the results of the challenge test provided, the Panel concluded that the steps 2, 3 and 4, are the critical steps for the decontamination efficiency of the process. The operating parameters which control the performance of these steps are well defined and are the temperature and pressure in all steps and the exposed surface area of the melt and its residence time of step 3. 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. The Panel concluded that recycled PET obtained from the process Märkische Faser is not of safety concern 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. Thermoforming trays are not intended to be used and should not be used in microwave and conventional ovens.

International audience; 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 EREMA recycling process (the EREMA Multi-Purpose Reactor (MPR), EREMA Basic and EREMA Advanced technologies), with EU register number RECYC0134. The input to this process is hot 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. In the MPR technology, post-consumer washed and dried PET flakes are heated in a continuous reactor under vacuum. The EREMA MPR decontamination technology can be combined with an extrusion line for pellets or sheet (EREMA Basic) or with an additional reactor (EREMA Advanced). The decontamination efficiency of the main continuous reactor (EREMA MPR technology) was determined by the challenge test. The Panel noted that this reactor is the critical step that determines the decontamination efficiency of these three EREMA technologies. The operating parameters controlling its performance are well defined and 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 mu g/kg food, derived from the exposure scenario for infants, and 0.15 mu g/kg food, derived from the exposure scenario for toddlers, when recycled PET is used at up to 100%. 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 and the percentage of recycled PET added to virgin PET specified in this opinion.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4‐amino‐5‐(3‐(isopropylamino)‐2,2‐dimethyl‐3‐oxopropoxy)‐2‐methylquinoline‐3‐carboxylic acid [FL‐no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60‐kg adult and 547 μg/person per day for a 15‐kg 3‐year‐old child. There is no concern with respect to genotoxicity. A 90‐day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL‐no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL‐no: 16.016] and theobromine [FL‐no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11% of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long‐term basis to a specific category of food (i.e. non‐alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL‐no: 16.016] and theobromine [FL‐no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.

International audience; The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 12 flavouring substances in Flavouring Group Evaluation 12, Revision 4 (FGE.12Rev4), including two additional substances, using the Procedure in Commission Regulation (EC) No 1565/2000. The present revision includes two additional flavouring substances: 12-beta-santalen-14-ol [FL-no: 02.216] and 12-alpha-santalen-14-ol [FL-no: 02.217]. 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 and the toxicological threshold of concern and available data on metabolism and toxicity. The Panel concluded that none of the 12 substances [FL-nos: 02.134, 02.186, 02.216, 02.217, 05.157, 05.182, 05.183, 05.198, 08.135, 09.342, 09.670 and 09.829] gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 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. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all 12 candidate substances