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

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids assessed the safety of the recycling process Martogg Group (EU register number RECYC321), which uses the EREMA Advanced technology. The input material is ■■■■■ washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are heated in continuous reactors ■■■■■ before being extruded. Having examined the challenge test provided, the Panel concluded that the continuous decontamination steps (Steps 2 and 3), for which a challenge test was provided, are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 µg/kg food derived from the exposure scenario for infants when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

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

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Novatex (EU register number RECYC313), which uses the EREMA Basic technology. The input material is ■■■■■ washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the continuous decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 µg/kg food derived from the exposure scenario for infants when such recycled PET is used at up to 95% in mixtures with virgin PET, and of 0.15 µg/kg food, derived from the exposure scenario for toddlers when used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 95% in mixtures with virgin PET for manufacturing of materials and articles for contact with all types of foodstuffs, including drinking water bottles, and at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs except drinking water, for long-term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

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

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Reciclar (EU register number RECYC314), which uses the EREMA Basic technology. The input material is ■■■■■ washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the continuous decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 µg/kg food, derived from the exposure scenario for infants, when such recycled PET is used at up to 95% in mixtures with virgin PET, and of 0.15 µg/kg food, derived from the exposure scenario for toddlers, when used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 95% in mixtures with virgin PET for manufacturing of materials and articles for contact with all types of foodstuffs, including drinking water bottles, and at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, except drinking water, for long-term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

Safety assessment of the process ISKO, based on Gneuss 4 technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process ISKO (EU register number RECYC287), which uses the Gneuss 4 technology. The input consists of washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are melted in an extruder (step 2), decontaminated during a melt-state polycondensation step ■■■■■ and vacuum (step 3) and finally pelletised. Having examined the challenge test provided, the Panel concluded that the melt-state polycondensation (step 3) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of the critical step are the pressure, the temperature, the residence time and the characteristics of the reactor. It was demonstrated by the challenge test that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Safety assessment of the process Plastipak Iberia, based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Plastipak Iberia (EU register number RECYC268), which uses the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are pre-decontaminated in a first ■■■■■ reactor at high temperature under vacuum, before being extruded, pelletised and crystallised. The crystallised pellets are then ■■■■■ and submitted to solid-state polycondensation (SSP) in two parallel ■■■■■ reactor lines at high temperature, under ■■■■■ and ■■■■■. Having examined the challenge test provided, the Panel concluded that step 2 (■■■■■ reactor) and steps 4 and 5 (■■■■■) are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 2, 4 and 5, as well as gas velocity for steps 4 and 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Safety assessment of the process Poly Recycling, based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Poly Recycling (EU register number RECYC262), which uses the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology. The input is ■■■■■ and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are pre-decontaminated in a first ■■■■■ reactor at ■■■■■ under ■■■■■ before being extruded and pelletised. The pellets are crystallised, preheated and then submitted to solid-state polycondensation (SSP) in a continuous reactor at ■■■■■ under ■■■■■ and ■■■■■. Having examined the challenge test provided, the Panel concluded that the ■■■■■ reactor (step 2), preheater (step 4) and the SSP reactor (step 5) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 2, 4 and 5 as well as gas velocity for steps 4 and 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Safety assessment of the process Polyfab Plastics, based on Starlinger deCON technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Polyfab Plastics (EU register number RECYC245), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, including no more than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and gas flow rate. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

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

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Buergofol (EU register number RECYC179) which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers including no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded. The Panel concluded that the continuous reactor (step 2, for which a challenge test was provided) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.15 µg/kg food derived from the exposure scenario for toddlers when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of thermoformed trays and containers for contact with all types of foodstuffs, except drinking water, for long-term storage at room temperature. Trays made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

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

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Reco-Kavala (EU register number RECYC164) using the Starlinger Decon technology. The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, with no more than 5% PET from non-food consumer applications. They are preheated before being submitted to solid state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and gas flow. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. Trays made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.

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

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

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

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

Safety assessment of the process 'Krones' 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 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 Panel concluded 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 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET should not be used in microwave and conventional ovens.

Safety evaluation of the food enzyme peroxidase obtained from soybean (Glycine max) hulls.

The food enzyme considered in this opinion is a peroxidase (hydrogen-peroxide oxidoreductase; EC 1.11.1.7) obtained from hulls of soybeans (Glycine max) by the company Kerry Ingredients & Flavours. The compositional data provided were considered sufficient. The manufacturing process did not raise safety concerns. The enzyme is intended to be used in baking processes. Based on the maximum recommended use level, dietary exposure to the food enzyme total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is lower than the exposure to the fraction of soybean comparable to the food enzyme TOS resulting from the consumption of whole soybean-derived foods by roughly an order of magnitude. As the food enzyme is derived from edible parts of soybean, in line with the requirements of the guidance document on food enzyme assessment, the Panel concluded that the provision of toxicological data was unnecessary. The potential allergenicity was evaluated by searching for similarity between the amino acid sequence of soybean peroxidase retrieved from the database Uniprot and the sequences of known food allergens; no match was found. Peroxidase from soybean hulls is not listed as an allergen in allergen databases. However, several soybean- and soybean hull proteins are known to be respiratory or food allergens. Based on the origin of the food enzyme from edible parts of soybean, the enzyme manufacturing process, the compositional and biochemical data provided, and the dietary exposure assessment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. However, the Panel noted that this food enzyme may contain allergenic soybean proteins, thus, adverse reactions in susceptible soybean-allergic individuals cannot be ruled out.

Safety evaluation of a ß-amylase food enzyme obtained from wheat (Triticum spp.).

The food enzyme considered in this opinion is a ß-amylase (EC 3.2.1.2), obtained from the grain of wheat (Triticum spp.) by Roquette (France). The ß-amylase is intended to be used in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. Since the presence of residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing is negligible, no dietary exposure was calculated. As the food enzyme is derived from edible parts of wheat, no toxicological tests are required. Wheat is known as a gluten-containing cereal. However, the gluten content of the food enzyme was shown to be below the limit of quantification of the applied analytical method and well below the threshold value of 20 mg/kg for 'gluten-free' products. Furthermore, the potential allergenicity was evaluated by searching for similarity between the amino acid sequence of the ß-amylase and the sequences of known food allergens; no match was found. Although ß-amylase from wheat is described as a potential occupational respiratory allergen, and oral wheat challenges in wheat allergic patients may result in clinical symptoms, the enzyme and the low levels of other wheat proteins will be removed from the final food ingredients through a downstream purification process. Based on the origin of the food enzyme from edible parts of grain, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Safety evaluation of the food enzyme endo-1,4-ß-xylanase from genetically modified Aspergillus niger strain XYL.

The food enzyme considered in this opinion is an endo-1,4-ß-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger. The genetic modifications do not give rise to safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo-1,4-ß-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the respective food process, dietary exposure to the food enzyme-total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is below 0.013 mg TOS/kg body weight (bw) per day in European populations. No safety concerns were identified in relation to the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, allergenicity and exposure assessments. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that the likelihood of allergic reactions to dietary intake of endo-1,4-ß-xylanase is low and, therefore, does not give rise to safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level was derived (4,095 and 4,457 mg TOS/kg bw per day for males and females, respectively), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. However, the genotoxicity data were incomplete. Due to the absence of the recommended combination of microbial strains used in the Ames test (i.e. lack of Salmonella Typhimurium TA102 and Escherichia coli WP2), no conclusions can be drawn on potential DNA oxidising or cross-linking mechanisms giving rise to gene mutations. Consequently, no final conclusions can be drawn on genotoxicity.

Safety evaluation of the food enzyme ß-amylase obtained from barley (Hordeum vulgare).

The food enzyme considered in this opinion is a 4-α-d-glucan maltohydrolase (EC 3.2.1.2) obtained from grain of barley (Hordeum vulgare), by the companies Genencor International B.V. and Senson Oy. This ß-amylase is intended to be used in several food-manufacturing processes: baking and brewing processes, distilled alcohol production, and starch processing for the production of glucose syrups. The compositional data provided for the food enzyme were considered sufficient. The manufacturing process did not raise safety concerns. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme-total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is similar to or lower than the exposure to a fraction of barley comparable to the food enzyme-TOS, resulting from the consumption of barley-derived foods. As the food enzyme is derived from edible parts of barley, in line with the requirements of the guidance document on food enzyme assessment, the Panel accepted that there was no need for the provision of toxicological data for this food enzyme and the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. Considering the potential for allergenicity, the gluten content of the food enzyme was below the detection limit of the analytical method, which is well below the level of 20 mg/kg for 'gluten-free' products. The amino acid sequence of the ß-amylase was compared to those of known allergens and no match was found. The food enzyme ß-amylase from barley is an occupational respiratory allergen and may contain low levels of other allergenic barley proteins that may trigger adverse reactions upon oral challenges in individuals with an oral sensitisation to cereals. The Panel considers that dietary exposure to the food enzyme ß-amylase from barley may result in incidental cases of food allergic reactions.

Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with α,ß-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL-no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p-Mentha-1,8-dien-7-al [FL-no: 05.117] and four substances not supported by industry (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]) have been deleted from the Union List.

A statement on the developmental immunotoxicity of bisphenol A (BPA): answer to the question from the Dutch Ministry of Health, Welfare and Sport.

This statement addresses a request to EFSA from the Dutch Ministry of Public Health, Welfare and Sport to assess the impact of recent evidence underlying the conclusions of the 2016 RIVM report on the current temporary tolerable intake (t-TDI) for BPA of 4 µg/kg bw/day set by EFSA in 2015. The CEF Panel has then evaluated the results of two studies published by Ménard et al. in 2014, suggesting food intolerance and impaired immune response to parasitic infection in rats exposed perinatally to BPA doses in the microgram/kg bw/day range. The same appraisal criteria and weight-of-evidence analysis used for the 2015 EFSA opinion on BPA were applied to these studies. This new evidence adds to the indications of immunotoxicity of BPA in animals reported in previous reviews. For the only endpoint for which three BPA doses were tested (IgG levels), a benchmark dose analysis of the dose-response data was carried out. Due to the high inter-animal variability within the treatment groups resulting in high confidence intervals and limited dose-response, the CEF Panel concluded that these data on anti-OVA IgG antibodies are not suitable to derive a reference point for BPA on immunotoxicity. Furthermore, the limitations of both Menard et al. studies observed by the Panel confound the interpretation of the study results and prevent the assessment of the relevance to human health. The CEF Panel overall considers that the results from the two Menard et al. studies are not sufficient to call for a revision of the EFSA t-TDI for BPA. EFSA will start a review of all the scientific evidence published after 2012 and relevant for BPA hazard assessment (including immunotoxicity) in 2017. The results of immunological studies such as the two evaluated here would form a useful contribution to this evaluation provided that the limitations identified herein were addressed.