Re‐evaluation of polyglycerol polyricinoleate (E 476) as a food additive

Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of polyglycerol polyricinoleate (PGPR, E 476) used as a food additive. In 1978, the Scientific Committee for Food (SCF) established an acceptable daily intake (ADI) of 7.5 mg/kg body weight (bw) per day for PGPR. PGPR is hydrolysed in the gut resulting in the liberation of free polyglycerols, polyricinoleic acid and ricinoleic acid. Di-and triglycerol are absorbed and excreted unchanged in the urine; long-chain polyglycerols show lower absorption and are mainly excreted unchanged in faeces. Acute oral toxicity of PGPR is low, and short-term and subchronic studies indicate PGPR is tolerated at high doses without adverse effects. PGPR (E 476) is not of concern with regard to genotoxicity or carcinogenicity. The single reproductive toxicity study with PGPR was limited and was not an appropriate study for deriving a health-based guidance value. Human studies with PGPR demonstrated that there is no indication of significant adverse effect. The Panel considered a 2-year combined chronic toxicity/carcinogenicity study for determining a reference point and derived a no observed adverse effect level (NOAEL) for PGPR (E 476) of 2,500 mg/kg bw per day, the only dose tested. Therefore, the Panel concluded that the present data set give reason to revise the ADI of 7.5 mg/kg bw per day allocated by SCF to 25 mg/kg bw per day. Exposure estimates did not exceed the ADI of 25 mg/kg bw per day and a proposed extension of use would not result in an exposure exceeding this ADI. The Panel recommended modification of the EU specifications for PGPR (E 476).

A natural, cellulose-based microgel for water-in-oil emulsions

“…For example, polyglycerol polyricinoleate (PGPR) has a maximum level of 4g/kg in dressings, spreadable fats and similar spreadable products, and of 5g/kg in chocolate in Europe (Bastida-Rodríguez, 2013). Whilst PGPR is considered to have no toxicity and carcinogenicity at these levels, it has been removed from certain chocolate brands due to consumer demand (Mortensen et al, 2017;Wilson & Smith, 1998) (Fox Business, https://www.foxbusiness.com/features/hersheys-remake-of-the-great-americanchocolate-bar, accessed March 2020). Furthermore, PGPR is conventionally produced via a four-stage chemical process, requiring long reaction times and high operating temperatures (Bastida-Rodríguez, 2013).…”

Re‐evaluation of polyglycerol esters of fatty acids (E 475) as a food additive

“…The Panel recommended that: the European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for PEFA (E 475 in order to ensure that the food additive will not be a significant source of exposure to these toxic elements in food. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for epichlorohydrin and glycidol, given that during the manufacturing processes of polyglycerols these genotoxic impurities could be present. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for trans fatty acids because PEFA (E 475) can be manufactured by glycerolysis of hydrogenated fats and/or oils, which contain significant amounts of trans fatty acids. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for glycidyl esters/glycidol and 3‐monochloropropane‐1,2‐diol (3‐MCPD) esters, because it is likely that residues of those substances occur in the food additive PEFA (E 475), if they were present in the raw materials used in the manufacturing of the food additive by transesterification. the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for erucic acid since erucic acid can be present among the fatty acids in edible oils, which can be used for manufacturing of PEFA (E 475). the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for impurities currently included in the EU specifications for glycerol (E 422) or recommended by the Panel in the re‐evaluation of glycerol (E 422) (EFSA ANS Panel, ,b,c). …”

“…The preparation of polyglycerols was reported by the Panel in the re‐evaluation of polyglycerol polyricinoleate (E 476) (EFSA ANS Panel, ). According to Bastida‐Rodriguez (), the polyglycerol portion can be prepared by three routes: (1) polymerisation of glycerol using a strong base as a catalyst, (2) polymerisation of glycidol, which leads to linear polyglycerols or (3) polymerisation of epichlorohydrin, followed by hydrolysis, which also leads to linear polyglycerols.…”

Preparation of Water-in-Oil Nanoemulsions Loaded with Phenolic-Rich Olive Cake Extract Using Response Surface Methodology Approach

“…These optimal W/O nanoemulsions may be suitable for application in the food industry, but the following research would need to be conducted to ensure suitability: (i) a microbiological analysis of the olive cake extract used as the aqueous phase should be carried out before it is used in food applications; (ii) Miglyol oil can be replaced by most common and healthy edible oils, such as olive oil; (iii) a maximum daily limit of 2.6 mg of PGPR emulsifier per kilogram of body weight is suggested [47]; therefore, natural alternatives, such as lecithins [48,49], are strongly recommended for PGPR substitution in food products [50].…”