Safety assessment of the substance 2,2'-oxydiethylamine for use in plastic food contact materials.

The EFSA Panel on Food Contact Materials assessed the safety of 2,2'-oxydiethylamine, which is intended to be used at up to 14% w/w as a monomer along with adipic acid and caprolactam to make polyamide thin films intended for single use, in contact with all types of food under all conditions of time and temperature. Specific migration of 2,2'-oxydiethylamine was tested from a polyamide film in water and was below the limit of quantification (LOQ) of 0.015 mg/kg.

A comprehensive library of lifetime physiological equations for PBK models: Enhancing dietary exposure modeling with mercury as a case study.

Dietary risk assessment of food contaminants requires a well-established understanding of the exposure in a heterogeneous population. There are many methods for estimating human exposure to food contaminants, such as intake calculations and internal biomarkers of exposure measured in individuals. However, those methods are expensive, partly invasive, and often provide a momentary exposure snapshot.

Integrating the lifelong exposure dimension of a chemical mixture into the risk assessment process. Application to trace elements.

Lifelong, the general population is exposed to mixtures of chemicals. Most often, risk assessment is performed to estimate the probability of adverse effects in the population using external exposures to a single chemical and considering one route of exposure. To estimate whole exposure to a chemical, human biomonitoring studies are used to measure chemical concentrations in biological matrices.

Safety assessment of the process Lietpak, based on the EREMA MPR 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 Lietpak (EU register number RECYC327), which uses the EREMA MPR 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 ■■■■■ reactor under vacuum.

Scientific Guidance on the criteria for the evaluation and on the preparation of applications for the safety assessment of post-consumer mechanical PET recycling processes intended to be used for manufacture of materials and articles in contact with food.

In the context of entry into force of Regulation (EU) 2022/1616, EFSA updated the scientific guidance to assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a 'post-consumer mechanical PET' recycling process (as defined in Annex I of Regulation (EU) 2022/1616) intended to be used for manufacturing materials and articles intended to come into contact with food. This Guidance describes the evaluation criteria and the scientific evaluation approach that EFSA will apply to assess the decontamination capability of recycling processes, as well as the information required to be included in an application dossier. The principle of the scientific evaluation approach is to apply the decontamination efficiency of a recycling process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post-consumer PET, set at 3 mg/kg PET for a contaminant resulting from possible misuse.

Safety assessment of the process Guolong, 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 Guolong (EU register number RECYC323), 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 ■■■■■ reactor under vacuum before being extruded.

Safety assessment of the process Palamidis, 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 Palamidis (EU register number RECYC325), 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 ■■■■■ reactor under vacuum before being extruded.

Safety assessment of the process Ecopacking, 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 Ecopacking (EU register number RECYC324), 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 ■■■■■ reactor ■■■■■ before being extruded.

Safety assessment of the process KGL, 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 KGL (EU register number RECYC326), 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 ■■■■■ reactor under vacuum before being extruded.

Safety evaluation of the food enzyme asparaginase from the genetically modified strain ASP.

The food enzyme asparaginase (l-asparagine amidohydrolase; EC 3.5.1.

Safety evaluation of an extension of use of the food enzyme laccase from the non-genetically modified strain AE-OR.

The food enzyme laccase (benzenediol:oxygen oxidoreductase, i.e. EC 1.

Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified strain AE-LRF.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.

Safety assessment of the process Fucine Film, based on the Reifenhäuser 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 Fucine Film (EU register number RECYC322), which uses the Reifenhäuser technology. The input material consists of 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 extruded under vacuum into sheets.

Safety evaluation of an extension of use of the food enzyme bacillolysin from the non-genetically modified strain AE-NP.

The food enzyme bacillolysin (EC 3.4.24.

Safety evaluation of the food enzyme β-glucosidase from the non-genetically modified strain AE-GLY.

The food enzyme β-glucosidase (β-D-glucoside glucohydrolase; EC 3.2.1.

Safety evaluation of the food enzyme subtilisin from the non-genetically modified strain AP-01.

The food enzyme subtilisin (EC 3.4.21.

Safety evaluation of an extension of use of the food enzyme α-amylase from the non-genetically modified strain AE-TA.

The food enzyme -amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.

Safety evaluation of the food enzyme 3-phytase from the non-genetically modified strain PHY93-08.

The food enzyme 3-phytase (myo-inositol-hexakisphosphate 3-phosphohydrolase EC 3.1.3.

Safety evaluation of an extension of use of the food enzyme glutaminase from the non-genetically modified strain AE-GT.

The food enzyme glutaminase (l-glutamine amidohydrolase; EC 3.5.1.

Safety evaluation of an extension of use of the food enzyme -l-rhamnosidase from the non-genetically modified strain AE-HP.

The food enzyme -l-rhamnosidase (-l-rhamnoside rhamnohydrolase; EC 3.2.1.

Safety evaluation of the food enzyme inulinase from the non-genetically modified strain NZYM-KF.

The food enzyme inulinase (1--d-fructan fructanohydrolase; EC 3.2.1.

Safety assessment of the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of amines, di-C14-C18-alkyl, oxidised, renamed by the Panel as amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil. The substance amines, bis(hydrogenated tallow alkyl) oxidised, consisting of the same components, but originating from tallow, is currently authorised as FCM substance No 768. The vegetable-sourced substance is intended to be used at up to 0.

Safety evaluation of the food enzyme carboxypeptidase D from the genetically modified strain NZYM-MK.

The food enzyme carboxypeptidase D (EC 3.4.16.

Safety evaluation of the food enzyme cellobiose phosphorylase from the genetically modified strain LE1B109-pPB130.

The food enzyme cellobiose phosphorylase (cellobiose: phosphate α-d-glucosyltransferase; EC 2.4.1.