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. The LNPs are “PEGylated”—chemically attached to PEG molecules that cover the outside of the particles and increase their stability and life span. http://www.efsa.europa.eu/sites/default/files/consultation/170223.pdf Record the values as follows: A = Peak height in millimeters of the ethylene glycol peak. Lyn Redwood, RN, MSN . It contains information of over 2.5 million food and beverage products of which more than 1,000,000 are or have been available on the European food market. 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. Pathological lesions were encountered only in monkeys and these consisted of intratubular deposition of small numbers of oxalate crystals in the renal cortex. Working off-campus? PEG 600 weist einen Schmelzbereich von 17 bis 22 °C und somit eine pastenartige Konsistenz auf. Purify if necessary, by distillation. 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. This scenario is estimated as follow: EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS Panel), I have read and accept the Wiley Online Library Terms and Conditions of Use, Scientific opinion of the Scientific Committee related to uncertainties in dietary exposure assessment, Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment, Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database, Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of polyethylene glycol (PEG) as a film coating agent for use in food supplement products, Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to D‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes, Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (E 1209), Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. 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. Print. In 2007, in another opinion of the AFC Panel related to d‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes, the Panel noted that TPGS intakes would correspond to intake to PEG 1000 at levels equivalent to 3.3–8.5 mg/kg body wieght (bw) per day which are within the range of group acceptable daily intakes (ADIs) of the SCF (1997) and JECFA (1980). Consumption data were available through the EFSA Comprehensive Database. synthetic diol alcohol that is an almost tasteless and odorless compound derived from petroleum products D = Milligrams of diethylene glycol per milliliter of standard solution. Learn about our remote access options. I.D. Polyethylene glycols are also referenced in the Martindale77 In April 2007, the AFC Panel (EFSA AFC Panel, 2007b) adopted an opinion related to D‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes. ?0.5 to + 1.05 millivolt, full span, 1 second full response time. Link copied. Propylene glycol is also quite common in fast foods, bread-based products, highly processed snack foods, flavored popcorn and cake frosting. Published: 23 February 2017: http://www.efsa.europa.eu/sites/default/files/consultation/170223.pdf. Treatment for prolonged periods may be required in children, although safety and efficacy have only been proved for up to 3 months of treatment. In both exposure scenarios, it was assumed that 100% of food supplements contained polyethylene glycol (E 1521) whereas information from the Mintel's GNPD showed that the additive was used in only a small percentage of food supplements. The restrictions which apply to the use of polyethylene glycol (E 1521) for the FC 17.1 (Food supplements supplied in a solid form, only in capsule and tablet form) could not be taken into account, neither can the form of the food supplements (between FCs 17.1/17.2/17.3 Food supplements, in solid, liquid, syrup‐type or chewable form) consumed be distinguished in the database. In response to this call, data on polyethylene glycol (E 1521) were submitted to EFSA by industry. Recorder: â? Submitted to EFSA on 30 November 2017. 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. Data on usage levels of polyethylene glycol (E 1521) in foods in response to the EFSA call for food additives usage level and/or concentration data in food and beverages intended for human consumption (2018). Table 2 summarises foods that are permitted to contain polyethylene glycol (E 1521) and the corresponding MPLs as set by Annex II to Regulation (EC) No 1333/2008. Summary of the reported use levels (mg/kg or mg/L as appropriate) of polyethylene glycol (E 1521) provided by industry, Number and percentage of food products labelled with polyethylene glycol (E 1521) out of the total number of food products present in the Mintel GNPD per food sub‐category between 2013 and 2018, Concentration levels of polyethylene glycol (E 1521) used in the food supplements consumers' only exposure scenario (mg/kg or ml/kg as appropriate), Summary of total estimated exposure of polyethylene glycol (E 1521) from its use as a food additive for the food supplements consumers only scenario using MPLs and food supplements consumers only scenario using maximum reported use levels per population group and survey: mean and 95th percentile (mg/kg bw per day). No data were provided for table‐top sweeteners. 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. OJ L 354, 31.12.2008, p. 16. (c) Uses. Polyethylene glycols are permitted as a binding, emulsion stabilising and solvent in cosmetic products (European Commission database‐CosIng99 The Food and Drug Administration (FDA), in a toxicological profile, has deemed propylene glycol as “generally recognized as safe.” OJ L 83, 22.3.2012, p 1. Purify, if necessary, by distillation. Chromatograph column: 5 feet * (3) As an adjuvant in dispersing vitamin and/or mineral preparations. No use levels were submitted to EFSA for its authorised use in the two QS food categories on table‐top sweeteners. 2‐11, 1979, Geneva, Monograph 17. The average percentage of foods labelled to contain polyethylene glycol (E 1521) was 0.04%. According the usual dose for treatment of chronic constipation, exposure via this source was estimated in children 2–6 years at 0.55 g/kg bw per day up to 1.37 g/kg bw per day in infants. • PEG is the basis of a number of laxatives. Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username, Structural formula of polyethylene glycol (EFSA, 2006). The calculated exposure to ethylene glycol and diethylene glycol showed no exceedance of the group TDI of 0.5 mg/kg bw per day set by the SCF for these impurities (SCF, 1986, 2002). According to Annex III, Part 1 of Regulation (EC) No 1333/2008, polyethylene glycol (E 1521) is also authorised as carrier in sweeteners with a maximum level at QS. 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). PEG 4000, PEG 6000 and PEG 8000 are very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils. inactive ingredient in the pharmaceutical industry as a solvent Added to these new data, information on the presence of food additives on the label of foods was retrieved from the Mintel's Global New Products Database (GNPD), an online database monitoring new introductions of packaged goods in the market worldwide. (2) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols when tested by the analytical methods prescribed in paragraph (b) of this section. Martindale: the complete drug reference, is a source of drug information, available here: https://www.medicinescomplete.com/mc/martindale/2009/ [42 FR 14491, Mar. You will find it in things like ice cream, soda, salad dressings, baking mixes, frosting, candies, frosting, and premade teas and coffee drinks. Ethylene glycol: Commercial grade. In 2017, the EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS Panel, 2017) prepared a scientific opinion on safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (E 1209). Consumption records were codified according to the FoodEx classification system (EFSA, 2011b). Polyethylene glycol (CAS 25322‐68‐3) has been registered under the REACH Regulation 1907/200688 Available online: http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple Should I avoid certain foods while taking Polyethylene Glycol 3350 17 Gram/Dose Oral Powder? Consumption surveys added in the Comprehensive database in 2015 were also taken into account in this assessment.1818 It is widely used as an additive in pharmaceuticals, cosmetics and food [ 1 ]. Weigh approximately 4 grams of polyethylene glycol sample accurately into a 10-milliliter volumetric flask. (2) A tolerance of zero is established for residues of polyethylene glycol in milk. Polyethylene glycol 6000 (PEG 6000) has also been reviewed by the Nordic Council of Ministers (TemaNord, 2002) which, based on a long‐term study on PEG 4000, considered that the long‐term toxicity of polyethylene glycols with high molecular weight is low. 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. 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. 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). Very Important. This database was used to verify the use of polyethylene glycol (E 1521) in food products. On the basis of these distributions, the mean and 95th percentile of exposure were calculated per survey and per population group. Polyethylene glycol (PEG) (Fig. The Mintel's GNPD is an online database which monitors new introductions of packaged goods in the market worldwide. Härte und Schmelzbereich steigen mit zunehmender Molekülmasse an. Polyethylene glycols were evaluated by several international bodies and the AFC Panel previously adopted scientific opinions on the safety polyethylene glycol (E 1521). Polyethylene glycol (E 1521) is an authorised food additive in the European Union (EU) according to Annexes II and III to Regulation (EC) No 1333/2008. In this document, these levels are named maximum permitted levels (MPLs). Reported use levels were related to this form of food supplements. 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. PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION. The present opinion deals with the refined exposure estimation of polyethylene glycol (E 1521) when used as a food additive. 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 Panel noted that information from the Mintel's GNPD shows that no table‐top sweeteners were labelled with E 1521. Based on a no‐observed adverse effect level (NOAEL) in rats of 20,000 ppm (2%) in the diet equivalent to 1,000 mg/kg bw, JECFA set an acceptable daily intake (ADI) of 10 mg/kg bw. The following conditions shall be employed with the Varian Aerograph 600 D gas chromatograph: Carrier gas (nitrogen) flow rate: 70 milliliters per minute. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm. “Refined exposure assessment of polyethylene glycol (E 1521) from its use as a food additive.” Considering the uncertainties of the exposure assessment, these estimates very likely overestimated the real exposure to polyethylene glycol (E 1521). Toxicity and death may occur after drinking even a small amount. 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. A change in your diet, medicine, or dosage may be necessary. Diethylene glycol: 6.5 minutes. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. 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 goal of this study was to determine safety, efficacy, and optimal dose of polyethylene glycol powder for treatment of constipation in patients younger than 18 months. While Processed Foods That Contain Propylene Glycol Often List It As An Ingredient, Be Aware of the Exceptions . 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). 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. It prevents dry and hard stools and allows for easy passage of stools. Uncertainties in the exposure assessment were identified and discussed. Parma, Italy. 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 … OJ L 83, 22.3.2012, p. 1–295. Competent authorities in the European countries provide EFSA with data on the level of food consumption by the individual consumer from the most recent national dietary survey in their country (cf. In 2017, EFSA launched a public call for data aiming at collecting reported use levels from industry or analytical data on several food additives, including polyethylene glycol (E 1521). 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