Statement on the Re-evaluation of 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] based on additional data on a supporting substance

In 2010 the CEF Panel concluded in its Opinion FGE.18Rev2 that for the substance 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146], no appropriate NOAEL was available in order to establish a margin of safety, and additional data were requested (90 days study or ADME). 3,7-Dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] is allocated to subgroup 3 of FGE.18. In 2012, EFSA received new data on linalool [FL-no: 02.013], a supporting substance in FGE.18Rev2 (subgroup 2). However, the CEF Panel concluded that linalool [FL-no: 02.013] is not sufficiently structurally related to 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] for the re-evaluation of [FL-no: 02.146]. Accordingly, a 90-day study on 3,7-dimethylocta-1,5,7-trien-3-ol [FL-no: 02.146] or on a sufficiently structurally related substance has to be provided in order to establish an appropriate NOAEL

Scientific Opinion on the safety evaluation of the active substances, iron, polyethyleneglycol, disodium pyrophosphate, monosodium phosphate and sodium chloride for use in food contact materials

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of an iron based oxygen absorber, comprising polyethyleneglycol, disodium pyrophosphate, monosodium phosphate and sodium chloride. This mixture is incorporated in polyethylene (PE) or polypropylene (PP) articles intended to be in contact with foodstuffs for hot fill/pasteurisation and/or long term storage at room temperature. For dried and fatty foods, direct contact with the materials is envisaged whereas other food types will be separated from the active material by a layer that does not contain the active components. All the substances constituting the oxygen absorber system have been evaluated and authorised for use as plastic food contact materials, as food additives or as food supplements. Based on migration results, the specific migration limits for iron, polyethyleneglycol, pyrophosphoric acid salts, phosphoric acid salts and sodium chloride, and the tolerable intake of phosphorus (phosphate) are not expected to be exceeded when the oxygen absorber system is used under the intended conditions of use, notably behind a layer not containing the active substance for contact with aqueous or acidic foods. Therefore, the CEF Panel concluded that the use of the substances, iron, polyethyleneglycol, disodium pyrophosphate, monosodium phosphate and sodium chloride do not raise a safety concern when used as oxygen absorbers incorporated in polyethylene and in polypropylene articles used for long time storage and/or hot fill up to 95 °C for several minutes in i) direct contact with dry and fatty foods and ii) indirect contact with aqueous or acidic foods, separated from the active material by a layer of at least 10 µm polyethylene or polypropylene that does not contain the oxygen absorber formulation

Scientific Opinion on the safety evaluation of the substance, 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine, CAS No. 6607-41-6, for use in food contact materials

<p>This scientific opinion of EFSA deals with the risk assessment of the substance 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine with the CAS No. 6607-41-6 and the FCM substance No 872, for use as a co-monomer for manufacturing polycarbonate polymers intended to be used for single and repeated contacts with all kinds of foodstuffs without restriction in time and temperature. Based on three <em>in vitro</em> genotoxicity tests and a mouse micronucleus test in vivo on the substance, the Panel considered that there is no concern with respect to genotoxicity of the substance. The CEF Panel concluded that there is no safety concern for the consumer if 2-phenyl-3,3-bis(4-hydroxyphenyl)phthalimidine is used as a co-monomer in polycarbonate copolymer and its migration does not exceed 0.05 mg/kg food. Potential migration of aniline, an impurity of the substance, should be in compliance with the restriction set in the Commission Regulation (EU) No 10/2011, i.e. not detectable.</p&gt

Scientific Opinion on the safety assessment of the process Greenfiber based on VACUREMA Prime ® technology used to recycle post-consumer PET into food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Greenfiber (EU register No RECYC108) 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, containing no more than 5 % of 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 two steps, the decontamination in batch reactors and the decontamination in continuous reactor are the critical steps that determine the decontamination efficiency of the process. The operating parameters to 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 should not be used in microwave and conventional ovens

Statement on the safety assessment of the substance silicon dioxide, silanated, FCM Substance No 87 for use in food contact materials

The substance silicon dioxide, silanated, with FCM substance No 87, is authorised for use as an additive in all types of plastics, without restriction. The re-evaluation of the substance was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nanoform. Information on the basic (untreated) silicon dioxide, the surface treated silicon dioxide, silanated, and a study investigating the migration potential of the silanated silicon dioxide were provided. Having examined the information provided, the CEF Panel concluded that the information provided demonstrates adequately the absence of isolated primary nanoparticles in the basic silicon dioxide and in the silanated silicon dioxide since only aggregates larger than 100 nm along with larger agglomerates were observed using two independent measurement techniques, one of which was transmission electron microscopy (TEM). The particle size range was not affected when the silanated product was incorporated into a low density polyethylene film at 3 % w/w. Furthermore, there was no detectable migration of silicon dioxide, of any particle size, from this film into appropriate food simulants. Therefore at the particle sizes reported, the substance silicon dioxide, silanated, does not raise a safety concern for the consumer in the currently authorised conditions of use

Scientific Opinion on the safety evaluation of the active substance, acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked for use in active food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked (CAS No. 117675-55-5, FCM Substance No 1022), to be used as liquid absorber in the form of fibres in absorbent pads for the packaging of fresh or frozen meat, poultry, and fish as well as fresh fruits and vegetables. The Panel considered that migration is not expected when the absorption capacity of the pads is not exceeded. Therefore no exposure from the consumption of the packed food is expected. The Panel also considered that none of these starting substances and the cross-linked polymer gives rise to concern for genotoxicity. Therefore the CEF Panel concluded that the use of the substance acrylic acid, sodium salt, co-polymer with acrylic acid, methyl ester, methacrylic acid, 2 hydroxypropylester, and acrylic acid cross-linked does not raise a safety concern when used as fibres in absorber pads for the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables under conditions under which the absorption capacity of the pads is not exceeded and mechanical release of the fibres from the pads is excluded

Scientific Opinion on the safety evaluation of the following processes based on BUHLER C technology used to recycle post-consumer PET into food contact materials “Buhler C” and “FENC”

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 ‘’Buhler C’’ and “FENC’’ (EC register numbers RECYC037 and RECYC083 respectively) which are based on the same BUHLER C technology. The decontamination efficiency of these processes was demonstrated using the same challenge tests. The input of the BUHLER C technology is washed and dried PET flakes originating from collected post-consumer PET containers containing no more than 5% of PET from non-food consumer applications. Through this technology, washed and dried flakes are dried and extruded in a ring extruder into pellets which are further crystallised in a reactor then fed into the Solid State Polymerisation (SSP) reactor. After having examined the challenge tests provided, the Panel concluded that the two steps, the drying and crystallisation step and the SSP step are the most critical steps that determine the decontamination efficiency of the processes. The operating parameters to control the performance of these critical steps are well defined and are the temperature and the residence time for the drying and crystallisation, and the temperature, the gas flow and the residence time for SSP. The operating parameters of these steps in the processes are at least as severe as those obtained from the challenge tests. 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 a conservatively modelled migration of 0.1μg/kg food. Therefore the Panel concluded that the recycled PET obtained from these processes intended 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

Scientific Opinion on the safety evaluation of the substance, 1,3,5-tris(2,2-dimethylpropanamido)benzene, CAS No. 745070-61-5, for use in food contact materials

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the additive 1,3,5-tris(2,2-dimethylpropanamido)benzene with the CAS No. 745070-61-5, the Ref. No 95420, the FCM Substance No 784, for use as a nucleating agent/clarifier at a maximum use level of 250 mg/kg in polyprolylene (PP). Final articles are intended to be used in contact with all type of foods for short term contact (1 hour) at temperatures up to 100 ºC and/or for long term storage at ambient temperature or below. Specific migration of the substance into 3 % acetic acid, 10 % ethanol and olive oil, was measured to be up to 48 µg/kg, 79 µg/kg and 94 µg/kg, respectively. In vitro and in vivo genotoxicity tests showed no evidence for a genotoxic potential of the substance. A 90-day dietary toxicity study in Wistar rats showed no effects at any dose and the NOAEL was considered to be 961 mg/kg bw/day in males and 1104 mg/kg bw/day in females or higher. Therefore, the CEF Panel concluded that the substance 1,3,5-tris(2,2-dimethylpropanamido)benzene does not raise a safety concern for the consumer if it is used in polyolefins and the migration does not exceed 5 mg/kg food

Scientific Opinion on the safety evaluation of the active substances citric acid (E330) and sodium hydrogen carbonate (E500ii), used as carbon dioxide generators, together with liquid absorbers cellulose and polyacrylic acid sodium salt crosslinked, in active food contact materials

This scientific opinion of EFSA Panel on food contact materials, enzymes, flavourings and processing aids deals with the safety evaluation of the mixture of the active substances citric acid (E330, CAS No 77-92-9, FCM Substance No 139) and sodium hydrogen carbonate (E500ii, CAS No 144-55-8, FCM Substance No 21), which is intended to be used as a carbon dioxide generator in liquid absorbent pads in the packaging of fresh or frozen meat, poultry, fish, fruits and vegetables. Depending on absorption capacity needed, pure cellulose or a mixture of cellulose and polyacrylic acid sodium salt crosslinked may be used as absorber. The Panel noted that if the active substances are used not in direct contact with food, but are placed in a pad under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. Therefore the CEF Panel concluded that the use of the mixture of the active substances citric acid (E330) and sodium hydrogen carbonate (E500ii), as carbon dioxide generator in liquid absorbent pads in the packaging of food such as fresh or frozen meat, poultry, fish, fruits and vegetables, does not raise a safety concern. The absorbent pads should be used only under conditions in which the liquid absorption capacity is not exceeded and direct contact between the substance and the food is excluded