Part 2: General Principles, Toxicological Evaluation of certain food additives. In response to this call, data on polyethylene glycol (E 1521) were submitted to EFSA by industry. synthetic diol alcohol that is an almost tasteless and odorless compound derived from petroleum products At the maximum reported use level, the mean exposure to polyethylene glycol (E 1521) from its use as a food additive ranged between 0.1 and 3.5 mg/kg bw per day, respectively, for adults and children. The current exposure assessment is based on the methodology used in the re‐evaluation of food additives together with reported use levels received following a call for data in 2017. 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. Taking uncertainties into account, the Panel concluded that these exposure estimates very likely overestimate the real exposure to polyethylene glycol (E 1521) from its use as a food additive according to Annex II. Propylene glycol is found in industrial-grade levels in products like antifreeze, polyurethane cushions, paints and the like. Based on the data provided by food industry, the Panel was able to refine the exposure estimates of polyethylene glycol (E 1521), covering a MW range of PEG 300–8000, considering a consumers' only approach to be protective of food supplement users. 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. The Panel also noted that the highest calculated exposure estimate falls within the range of the group ADI previously established by SCF (5 mg/kg bw per day for PEG 300–4000) and of the one set by JECFA (10 mg/kg bw per day for PEG 200–10000). Currently, polyethylene glycol (E 1521) is an authorised food additive in the EU in three food categories: at quantum satis (QS) in the two food categories of table‐top sweeteners and at 10,000 mg/kg in food supplements supplied in a solid form (including capsules and tablets and similar forms, excluding chewable forms), only in capsule and tablet form. The toxicity of PEG 6000 is probably at the same magnitude as the toxicity of PEG 4000. This medicine can also be found in a number of other products including skin creams, eye lubricants, food additives, etc. Polyethylene Glycol is a stool softener used in the treatment of occasional constipation. 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. Ethylene glycol poisoning is poisoning caused by drinking ethylene glycol. The Panel noted that the exposure to polyethylene glycol (E 1521) from its use according the Annex III (Part 4) was not considered in the exposure assessment. Available online: http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple Reported use levels were related to this form of food supplements. Detection of propylene glycol in foods and drugs may be accomplished by chromatography of the sample; for substances with a high fat content, extraction with hexane may be used to remove the fat. Consumption surveys added in the Comprehensive database in 2015 were also taken into account in this assessment.1818 The report “Food additives in Europe 200044 The Panel also noted that the highest calculated exposure estimate falls within the range of the group ADI previously established by SCF (5 mg/kg bw per day for PEG 300–4000) and of the one set by JECFA (10 mg/kg bw per day for PEG 200–10000). No EINECS Number is available, while, according to JECFA specifications (2006), the CAS number is 25322‐68‐3. In 2013, EFSA received a communication from European Commission suggesting to perform a refined exposure assessment of polyethylene glycol (E 1521) by 2018 instead of a full re‐evaluation.55 Uncertainties in the exposure assessment of polyethylene glycol (E 1521) have been discussed above. ?0.5 to + 1.05 millivolt, full span, 1 second full response time. Nevertheless, the EFSA Comprehensive Database includes the currently best available food consumption data across Europe. For those that are highly sensitive, you need to be aware of the exceptions. Assuming similar levels of use and intake of pharmaceutical products and food supplements per day, the combined intake from both would be about 4 mg/kg bw per day. (c) Uses. Percent ethylene glycol = (E * B ) / (A * sample weight in grams), Percent diethylene glycol = (F * D ) / (C * sample weight in grams). Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Chemical formula: (C2H4O)n. H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6,000, about 140) (Figure 1). We present 5 cases of confirmed PEG allergy, which to our knowledge is the largest case series to date. (1) It is used in an amount not greater than that required to produce the intended physical or technical effect. Taking uncertainties into account, the Panel concluded that these exposure estimates very likely overestimate the real exposure to polyethylene glycol (E 1521) from its use as a food additive according to Annex II. Therefore, information on actual use levels is required for performing a more realistic exposure assessment, especially for those food additives for which no MPL is set and which are authorised according to QS. The LNPs are “PEGylated”—chemically attached to PEG molecules that cover the outside of the particles and increase their stability and life span. Instructions for Downloading Viewers and Players. 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. 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. OJ L 354, 31.12.2008, p. 16. 70% of people develop antibodies against this substance – this means that many people can develop allergic, potentially fatal reactions to the vaccination.” It’s true that the BioNTech/Pfizer vaccine does contain polyethylene glycol (PEG). According to the Mintel's GNPD, polyethylene glycol (E 1521) was labelled on 264 products (covering four food subcategories according to the Mintel's GNPD food classification), mainly vitamins and dietary supplements, of which 201 were found to be published in this database between January 2013 and March 2018. Print. 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. These exposure estimates were averaged over the number of survey days, resulting in an individual average exposure per day for the survey period. Polyethylene glycol (E 1521) is only authorised in food supplements ‘in capsule and tablet form’ (Table 2). Please see the previous question posted on 10/7/2011. She said people could be allergic to a part of the lipid nanoparticle known as polyethylene glycol, or PEG, which is a component in other injectable medicines. Diethylene glycol: Commercial grade. 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 … ” submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re‐evaluation. Uncertainties in the exposure assessment were identified and discussed. Data on its safety and efficacy in infants are lacking. Diethylene glycol: 6.5 minutes. Compendium of food additive specifications, Reports of the Scientific Committee for Food on the positive list of substances to be authorized in the manufacture of regenerated cellulose films intended to come into contact with foodstuffs (Opinion expressed 28 September 1978), Reports of the Scientific Committee for food. Working off-campus? This database was used to verify the use of polyethylene glycol (E 1521) in food products. Updated information on the use levels of polyethylene glycol (E 1521) in foods was made available to EFSA by Food Supplements Europe (FSE) and the Association of the European Self‐Medication Industry (AESGP). Please check your email for instructions on resetting your password. This highest percentage related to the Mintel's GNPD food subcategory ‘Vitamins & Dietary Supplements’. The analytical method for determining ethylene glycol and diethylene glycol is as follows: Gas chromatograph with hydrogen flame ionization detector (Varian Aerograph 600 D or equivalent). Purify if necessary, by distillation. PEG's between 700 and 900 are semi‐solid. B = milligrams of ethylene glycol per milliliter of standard solution. The average percentage of foods labelled to contain polyethylene glycol (E 1521) was 0.04%. 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. Diethylene glycol The SCCP adopted this opinion at its 16th ... Opinion on diethylene glycol 2 About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. Early symptoms include intoxication, vomiting and abdominal pain. The food categories in which the use of polyethylene glycol (E 1521) is authorised were selected from the nomenclature of the EFSA Comprehensive Database (FoodEx classification system), at the most detailed level possible (up to FoodEx Level 4) (EFSA, 2011b). Food supplement consumers only scenario at the MPL: Food supplement consumers only scenario at the maximum reported use levels: PEG: polyethylene glycol; MW: molecular weight. The highest mean refined exposure estimate was 3.5 mg/kg bw per day in children (3–9 years) and the highest 95th percentile of exposure was 6.1 mg/kg bw per day for the elderly. for occurrence data (usage level and/or concentration data) on polyethylene glycol (E 1521). The exposure via these routes was not available to the Panel, and could therefore not be taken into account in this opinion. Propylene glycol is commonly found in many packaged foods, such as drink mixes, dressings, dried soups, cake mix, soft drinks, popcorn, food coloring, fast foods, bread and dairy products . It resulted in exposure estimates of polyethylene glycol (E 1521) up to 3.5 mg/kg bw per day at the mean and up to 6.1 mg/kg bw per day at the high level. (3) As an adjuvant in dispersing vitamin and/or mineral preparations. PEG 600 weist einen Schmelzbereich von 17 bis 22 °C und somit eine pastenartige Konsistenz auf. The 95th percentile of exposure was only calculated for those population groups with a sufficiently large sample size (EFSA, 2011a). Martindale: the complete drug reference, is a source of drug information, available here: https://www.medicinescomplete.com/mc/martindale/2009/ Based on these data, the Panel calculated two exposure estimates based on the MPL and on the maximum reported use level from industry of food supplements. 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