on food additives, as amended. PEG 8000: Not less than 87.5% and not more than 112.5%, PEG's having molecular weight below 1,000: not less than 95.0% and not more than 105.0% of the declared value. This assessment could only take into account the use of polyethylene glycol (E 1521) in food supplements and thus the food supplements consumers only scenario was performed. Pathological lesions were encountered only in monkeys and these consisted of intratubular deposition of small numbers of oxalate crystals in the renal cortex. The estimated daily intakes of the polyethylene glycols from the use as a coating agent for food supplements were below the ADI of 0–10 mg/kg body weight allocated by JECFA and the group TDI of 5 mg/kg body weight established by the SCF for the polyethylene glycols. of 2001. Therefore, the whole food category (FC 17) was considered in the exposure scenarios. The Panel also noted that the refined exposure estimates are based on information provided on the reported levels of use of polyethylene glycol (E 1521). Polyethylene glycol “The mRNA vaccines from BioNTech/Pfizer contain polyethylene glycol (PEG). In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. The ANS Panel assessed the dietary exposure to polyethylene glycol (E 1521) as a food additive in line with the principles laid down in Regulation (EU) 257/2010 and in the EFSA Statement on the approach followed for the refined exposure assessment as part of the safety assessment of food additives under re‐evaluation (EFSA ANS Panel, 2017). No data were provided for the two authorised food categories related to table‐top sweeteners. Solubility: According to Commission Regulation (EU) No 231/2012, PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils. Diethylene glycol: 6.5 minutes. The present opinion deals with the refined exposure estimation of polyethylene glycol (E 1521) when used as a food additive. As E 1521 is authorised at QS in these two FCs, exposure assessment to polyethylene glycol (E 1521) was only carried out by the ANS Panel based on MPL and the reported use levels of food supplements (FC 17) as detailed below (Appendix C). Dietary exposure to polyethylene glycol (E 1521) was calculated by multiplying concentrations of polyethylene glycol (E 1521) for food supplements (Appendix C) with their respective consumption amount per kilogram body weight for each individual in the Comprehensive Database. Skin tests were undertaken to the … Polyethylene glycols are also used in medicinal products for the treatment of chronic constipation or the management of faecal impaction for prolonged periods up to 3 months. Polyethylenglycole mit einer mittleren Molekülmasse zwischen 200 g/mol und 400 g/mol sind bei Raumtemperatur nichtflüchtige Flüssigkeiten. The ANS Panel was not provided with a newly submitted dossier. The SCF also evaluated the use of polyethylene glycol 6000 (PEG 6000) in preparations for sweetener‐based sodas in 1994 (SCF, 1997) and concluded that the use of the food additive as excipient for sweetener tablets was acceptable. OJ L 80, 26.3.2010, p. 19–27. of the European Parliament and of the Council on food additives requires that food additives are subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union. PEG 3350: Not less than 90% and not more than 110%. While Processed Foods That Contain Propylene Glycol Often List It As An Ingredient, Be Aware of the Exceptions . Use levels were reported by industry. Published: 23 February 2017: http://www.efsa.europa.eu/sites/default/files/consultation/170223.pdf. and reported use levels by industry submitted to EFSA following a call for data. The report “Food additives in Europe 200044 Association of the European Self‐Medication Industry (AESGP), 2017. Recorder: â? The metabolic studies show that PEG 6000 is not absorbed and if it enters the bloodstream, it is excreted fast. This is within the range of the group ADIs established by the European Commission SCF (5 mg/kg bw for PEG 300–4000) and JECFA (10 mg/kg bw for PEGs 200–10000). Polyethylene glycols (PEGs) or macrogols are hydrophilic polymers found in everyday products such as foods, cosmetics, and medications. http://www.gnpd.com/sinatra/home/ accessed on 02/03/2018. (Opinion expressed 16 December 1994). Dietary exposure to polyethylene glycol (E 1521) from its use as a food additive was estimated combining food consumption data available within the EFSA Comprehensive European Food Consumption Database with the maximum levels according to Annex II to Regulation (EC) No 1333/20081212 Table 4 summarises the estimated exposure to polyethylene glycol (E 1521) from its use as a food additive in four population groups (Table 3) according to the food supplements consumers only exposure scenario. However, in the assessment it was not possible to distinguish between the different forms of food supplements (solid – including capsule and tablet form – liquid, syrup‐type or chewable form), and therefore, the whole food supplements category (irrespective of form) was taken into account. In 2006, the Panel concluded that based on all the data, consumption of PEG through use as plasticisers in film‐coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern. ” submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re‐evaluation. Bei Molekülmassen über 3000 g/mol sind die PEG feste Substanzen und werden als Schuppen oder Pulver in den Handel gebracht. PEG 3000 and PEG 3350 are very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils. The 95th percentile of exposure to polyethylene glycol (E 1521) ranged between 0.6 and 6.1 mg/kg bw per day respectively for adolescents and the elderly. Polyethylene glycol (E 1521) is authorised in the FC 17.1 Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children. Percent ethylene glycol = (E * B ) / (A * sample weight in grams), Percent diethylene glycol = (F * D ) / (C * sample weight in grams). ). Considering the uncertainties of the exposure assessment, the assumption that 100% of the food supplements contain polyethylene glycol (E 1521) as opposed to only a few percent according to the Mintel's GNPD and the fact that according to the Mintel's GNPD polyethylene glycol (E 1521) is not used in table‐top sweeteners, the Panel considered that the exposure estimates resulted in overestimates of the exposure to polyethylene glycol (E 1521) from its use as a food additive according to Annex II to Regulation (EC) No 1333/2008. Mix the solution thoroughly and inject a 2-microliter aliquot into the gas chromatograph. Appendix B lists the percentage of the food products labelled with polyethylene glycol (E 1521) out of the total number of food products per food subcategories according to the Mintel's GNPD food classification. PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils, Polyethylene glycols having a molecular weight of 1,000 or above are freely soluble in water; polyethylene glycols are soluble in many organic solvents, including aliphatic ketones and alcohols, chloroform, glycol ethers, esters, and aromatic hydrocarbons; they are insoluble in ether and in most aliphatic hydrocarbons; with increased molecular weight, water solubility and solubility in organic solvents decrease, PEG 400: 264–300; PEG 3000: 34–42; PEG 3350: 30–38; PEG 4000: 25–32; PEG 6000: 16–22; PEG 8000: 12–16, Total not more than 0.25% °w/w individually or in combination, Total not more than 0.25%°w/w individually or in combination, Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms, From 36 months up to and including 9 years of age, Finland, Germany, Italy, Netherlands, Sweden, UK, From 10 years up to and including 17 years of age, From 18 years up to and including 64 years of age, Finland, Germany, Ireland, Italy, Netherlands, Romania, UK, Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard, Use of data from food consumption surveys covering only a few days to estimate high percentiles (95th) long‐term (chronic) exposure, Uncertainty in possible national differences in use levels of food categories, Food categories selected for the exposure assessment: inclusion of food supplements without considering their form (solid/liquid/syrup‐type or chewable form), Food categories included in the exposure assessment: no data for table‐top sweeteners which were therefore not considered in the exposure estimates (n = 2/3 food categories), Foods which may contain the food additive according to Annex III to Regulation (EC) No 1333/2008 not taken into account. stainless steel tube packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, or equivalent) 12 percent in H2O by weight on 60-80 mesh nonacid washed diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent). In November 2006, the AFC Panel (EFSA AFC Panel, 2007a) evaluated the safety of an additional use of polyethylene glycol as a film coating agent for use in food supplement products. C = Peak height in millimeters of the diethylene glycol peak. Macrogols can also be used for children aged under 1 year for the treatment of chronic constipation, the dose can be up to 1.37 g/kg bw per day (using the default body weight of 4.8 kg for 0–3 months old infants). The Panel noted that food categories which may contain polyethylene glycol (E 1521) due to carry‐over (Annex III, Part 4) were not considered in the current exposure assessment. However, as a result of adoption of Regulation (EU) 257/2010 the 2003 Terms of References are replaced by those below. Dilute to volume with water. Polyethylene glycols are permitted as a binding, emulsion stabilising and solvent in cosmetic products (European Commission database‐CosIng99 23rd JECFA Session, Apr. This medicine can also be found in a number of other products including skin creams, eye lubricants, food additives, etc. The toxicity of PEG 6000 is probably at the same magnitude as the toxicity of PEG 4000. The viscosity ranges at 100±0.3°, in cSt for PEG's of various molecular weight should be: For PEG's not listed in the table, calculate the limits by interpolation, PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils. In the EU, the Scientific Committee for Food (SCF), in 1978, advised on the toxicological acceptability of substances proposed for use in the manufacture of regenerated celluloses films intended to come into contact with foodstuffs. Polyethylene Glycol 400 | USP Grade | PEG 400 Food Grade | NF Grade | Used For Toothpaste, Skin, Wax | Clear, Colorless, Viscous Liquid | For Food Processing, Cosmetic Manufacturing, Pharmaceutical Formulations | CAS # 25322-68-3 | Thinning Agent, Solvent/ Solubilizing Agent | Formula C2nH4n+2On+1,n=8.2to9.1 | Low-Molecular-Weight Grade of 400 | Average Molecular Weight Is 400 … (4) As a coating on sodium nitrite to inhibit hygroscopic properties. OJ L 83, 22.3.2012, p. 1–295. Polyethylene glycol (E 1521) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/201266 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. It is also used before certain medical procedures to empty the bowels. For the purpose of this Scientific Opinion, the Mintel's GNPD1717 This highest percentage related to the Mintel's GNPD food subcategory ‘Vitamins & Dietary Supplements’. Polyethylene oxide (polyethylene glycol – PEG 300–4000) was classified in the list of substances for which a tolerable daily intake (TDI) has been established and which are therefore toxicologically acceptable for use in the manufacture of regenerated celluloses films. OJ L 354, 31.12.2008, p. 16–33. In food, the levels are considered pharmaceutical-grade. Ethylene glycol: Commercial grade. Detailed results per population group and survey are presented in Appendix D. Using the MPL of 10,000 mg/kg, the mean exposure to polyethylene glycol (E 1521) from its use as a food additive via the intake of food supplements ranged between 0.1 and 3.6 mg/kg bw per day, respectively, for adults and children. PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION Subpart I - Multipurpose Additives Sec. Four of the 5 cases developed anaphylaxis to medications containing PEGs, with 1 near-fatal case resulting in cardiac arrest. PEG's having molecular weight between 1,000 and 7,000: not less than 90.0% and not more than 110.0% of the declared value. Polyethylene glycol (E 1521) is only authorised in food supplements ‘in capsule and tablet form’ (Table 2). PEG 4000: Not less than 90% and not more than 110%. 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