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- Flavouring group evaluation 418 (FGE. 418): 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl esterPublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Benigni, Romualdo; Chipman, Kevin; Cordelli, Eugenia; Degen, Gisela; Engel, Karl-Heinz; Fowler, Paul; Carfí, Maria; Gagliardi, Gabriele; Mech, Agnieszka; Multari, Salvatore; Martino, CarlaThe EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.136] was considered sufficient. The chronic dietary exposure to [FL‐no: 16.136] estimated using the added portions exposure technique (APET) is calculated to be 860 μg/person per day for a 60‐kg adult and 540 μg/person per day for a 15‐kg 3‐year‐old child. [FL‐no: 16.136] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. No ADME studies on [FL‐no: 16.136] were provided. In a prenatal developmental toxicity study, no maternal or fetal toxicity was observed in rats dosed up to 1000 mg/kg body weight (bw) per day. In a 90‐day toxicity study in rats, no adverse effects were observed. In this study, the Panel considered that the NOAEL is 777 and 923 mg/kg bw per day (the highest dose tested) for male and female rats, respectively. Considering the lowest NOAEL of 777 mg/kg bw per day, as a reference point, adequate margins of exposure of 55 × 103 and 21 × 103 were calculated for adults and children, respectively, when considering the chronic APET dietary exposure estimates. The Panel concluded that the use of 3‐[3‐(2‐isopropyl‐5‐methylcyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a flavouring substance under the proposed conditions of use does not raise a safety concern at the dietary exposure estimates calculated using the APET approach.
- Flavouring group evaluation 420 (FGE.420): Hesperetin dihydrochalconePublication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Degen, Gisela; Engel, Karl-Heinz; Fowler, Paul; Carfí, Maria; Civitella, Consuelo; Dino, Borana; Gagliardi, Gabriele; Mech, Agnieszka; Zakidou, Panagiota; Martino, Carla; EFSA Panel on Food Additives and Flavourings (FAF)The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of hesperetin dihydrochalcone [FL-no: 16.137] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance is structurally related to the group of flavonoids evaluated in FGE.32 and is the aglycone of neohesperidine dihydrochalcone. Based on the data provided for [FL-no: 16.137], the Panel considered that a read-across between hesperetin dihydrochalcone and the substances in FGE.32 is not needed. Nevertheless, the flavonoids evaluated in FGE.32 were considered in a cumulative exposure assessment. The information provided on the manufacturing process, the composition and the stability of [FL-no: 16.137] was considered sufficient. The Panel concluded that there is no concern with respect to genotoxicity. No absorption, distribution, metabolism and excretion (ADME) studies on [FL-no: 16.137] were provided, but studies investigating the ADME of neohesperidine dihydrochalcone were submitted. The Panel noted that [FL-no: 16.137] has the same fate in the organism, as that of neohesperidine dihydrochalcone and considered that [FL-no: 16.137] can be anticipated to be metabolised to innocuous products only. In a prenatal developmental toxicity study, no maternal or foetal toxicity was observed. In a 90-day toxicity study, indications were obtained that the substance affects thyroid hormone levels at all doses tested (100-1000 mg/kg bw per day). Since these changes were not accompanied by apical findings indicative of hypothyroidism, the Panel considered these hormonal effects as not adverse. Using 1000 mg/kg bodyweight (bw) per day as reference point, adequate margins of exposure were calculated for adults and children, when considering the chronic added portions exposure technique (APET) dietary exposure estimates. Cumulative chronic exposure estimates to [FL-no: 16.137] and the four structurally related substances evaluated in FGE.32 do not raise a safety concern. The use of [FL-no: 16.137] as food flavouring, under the proposed conditions of use, does not raise a safety concern.
- Re‐evaluation of acesulfame K (E 950) as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Bruzell, Ellen; Chipman, James; Cheyns, Karlien; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Halldorsson, Thorhallur; Leblanc, Jean-Charles; Mirat, Manuela; Lindtner, Oliver; Mortensen, Alicja; Barmaz, Stefania; Wright, Matthew; Civitella, Consuelo; Le Gall, Pauline; Mazzoli, Elena; Rasinger, Josef Daniel; Rincon, Ana; Tard, Alexandra; Lodi, FedericaThe present opinion deals with the re‐evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6‐methyl‐1,2,3‐oxathiazin‐4(3H)‐one‐2,2‐dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5‐chloro‐acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).
- Re‐evaluation of citric acid esters of mono‐ and diglycerides of fatty acids (E 472c) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluationPublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Passamonti, Sabina; Wölfle, Detlef; Dusemund, Birgit; Turck, Dominique; Barmaz, Stefania; Tard, Alexandra; Rincon, Ana MariaCitric acid esters of mono‐ and diglycerides of fatty acids (E 472c) was re‐evaluated in 2020 by the Food Additives and Flavourings Panel (FAF Panel) along with acetic acid, lactic acid, tartaric acid, mono‐ and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a,b,d,e,f). As a follow‐up to this assessment, the FAF Panel was requested to assess the safety of citric acid esters of mono‐ and diglycerides of fatty acids (E 472c) for its use as food additive in food for infants below 16 weeks of age belonging to food categories (FCs) 13.1.1 (Infant formulae as defined by Directive 2006/141/EC) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the recommendation of the re‐evaluation of E 472c as a food additive to update the EU specifications in Commission Regulation (EU) No 231/2012. For this, a call for data was published to allow interested partied to provide the requested information for a risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the EU specifications for E 472c. Regarding the safety of the use of E 472c in food for infants below 16 weeks of age, the Panel concluded that there is no safety concern from its use at the reported use levels and at the maximum permitted levels in food for infants below 16 weeks of age (FCs 13.1.1 and 13.1.5.1).
- Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of usePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Frutos Fernandez, Maria Jose; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; Fitzgerald, Reginald; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Aguilera Entrena, Jaime; Gagliardi, Gabriele; Mech, Agnieszka; Medrano-Padial, Concepción; Lunardi, Simone; Rincon, Ana Maria; Smeraldi, Camilla; Tard, Alexandra; Ruggeri, LauraThe present opinion deals with the re‐evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a food‐grade hydrolysed starch with non‐genetically modified Aureobasidium pullulans ■■■■■. Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal iso‐amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels.
- Re‐evaluation of sucralose (E 955) as a food additive and evaluation of a new application on extension of use of sucralose (E 955) in fine bakery waresPublication . EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Fernandez, Maria Jose Frutos; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Dourus, Antonios; Chipman, James; Crebelli, Riccardo; Fürst, Peter; Halldorsson, Thorhallur; Mirat, Manuela; Mortensen, Alicja; Wright, Matthew; Lindtner, Oliver; Barmaz, Stefania; Civitella, Consuelo; Horvath, Zsuzsanna; Levorato, Sara; Mazzoli, Elena; Rasinger, Josef Daniel; Rincon, Ana Maria; Smeraldi, Camilla; Tard, Alexandra; Lodi, FedericaThe present opinion deals with the re‐evaluation of sucralose (E 955) as food additive and with the safety of a proposed extension of use in food category (FC) 7.2 ‘Fine bakery wares’. Based on the available data, no safety concerns arose for genotoxicity of sucralose (E 955) and its impurities and degradation products. Based on the weight of evidence (WoE), the Panel considered the decrease in body weight observed in rats as the relevant endpoint for the derivation of a reference point (RP). The Panel performed a benchmark dose (BMD) analysis on the data from the longest study (combined chronic and carcinogenicity study) with a modified benchmark dose response to account for the poor palatability of sucralose. The resulting RP was 55 mg/kg bw per day (benchmark dose lower confidence limit; BMDL). The Panel considered it appropriate to derive chemical‐specific assessment factor for sucralose and concluded that there is no need to revise the current ADI of 15 mg/kg bw per day of sucralose (E 955) previously established by the Scientific Committee on Food. The exposure estimates considering the currently authorised uses did not exceed the ADI. Therefore, the Panel concluded that there is no safety concern at the reported uses and use levels of sucralose (E 955). The overall exposure did not increase substantially when considering the proposed extension of use. However, based on the available data and the identified uncertainties regarding the potential formation of chlorinated compounds under the wide range of baking processes that may be applicable for FC 7.2, the Panel could not conclude on the safety of the proposed extension of use of E 955 in this FC. The Panel issued recommendations to the European Commission, primarily to consider a revision of the EU specifications for sucralose.
- Safety evaluation of jagua (genipin‐glycine) blue as a food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Civitella, Consuelo; Mech, Agnieszka; Medrano-Padial, Concepción; Tard, Alexandra; Zakidou, Panagiota; Rugger, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin‐glycine) blue as a new food additive. Jagua (genipin‐glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of Genipa americana L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue‐coloured polymer and minor colouring components. In vitro Caco‐2 cell permeability test demonstrated a low permeability of jagua (genipin‐glycine) blue, but repeated dose toxicity studies showed organs discoloration and green‐coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub‐chronic toxicity, genotoxicity studies and also a 12‐month toxicity study including in utero exposure. Jagua (genipin‐glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12‐month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin‐glycine) blue as a food additive at the proposed use and use levels.
- Safety evaluation of pea fibre concentrate (FIPEA) as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Gagliardi, Gabriele; Mech, Agnieszka; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota; Ruggeri, LauraThe EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pea fibre concentrate (FIPEA) as a food additive. FIPEA is a powder consisting mainly of dietary fibres (i.e. pectin and hemicellulose), and low amounts of protein, derived from yellow pea (P. sativum). The manufacturing process includes extensive heat treatments, (e.g. > 100°C for more than 40 min), conditions which lead to inactivation of lectins, that in FIPEA do not pose a safety concern. A specific α‐amylase is used in the manufacturing, and this should be included in the definition of the proposed specifications. The Panel considered that the additional contribution of FIPEA to the total fibre intake in adults and toddlers would be acceptable considering the levels that are considered adequate by the NDA Panel. The Panel recommended to lower the specification limits proposed for the toxic elements. The solubility test indicates that the material does not require specific assessment at the nanoscale. No toxicological data have been submitted on FIPEA. The Panel considered that, similarly to water‐soluble soybean polysaccharides, FIPEA is not absorbed intact but undergoes extensive fermentation by the intestinal microbiota in humans and is not of genotoxic concern. Dry peas (raw material) are a staple food, with a very long history of safe use in the EU. FIPEA is extracted with hot water from the insoluble fibrous material of dehulled yellow peas, therefore the structure of the fibres is not chemically modified, and no new by‐products or components of toxicological concern are expected from the manufacturing process. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that pea fibre concentrate (FIPEA) as a new food additive does not raise a safety concern at the proposed use and use levels.
- Safety evaluation of pectin‐rich extract derived from Coffea arabica as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Rex; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Mech, Agnieszka; Tard, Alexandra; Zakidou, Panagiota; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pectin rich extract derived from Coffea arabica L. as a food additive. The proposed food additive consists of 70%–85% dietary fibres (of which the major part is pectin), 4%–6.5% proteins and substances of potential concern including caffeine, chlorogenic acid, ■■■■■, caffeic acid, ■■■■■, trigonelline. The Panel integrated all available information including existing EFSA evaluations on pectins, coffee fruit pulp, and conducted a new quantitative structure–activity relationship (QSAR) analysis for the substances of potential concern. Studies from literature confirmed that the pectins are not absorbed intact but extensively fermented by intestinal microbiota. No adverse effects were reported in two 90‐day toxicity studies in rats up to 7.8 g/kg body weight (bw) per day and in one human study on sugar beet pectin at 0.2 g/kg bw per day for 4 weeks. The calculated MOE for ■■■■■ indicated that there is a low concern from a public health point of view. The Panel considered that the exposure to caffeine, caffeic acid, ■■■■■, chlorogenic acid, ■■■■■ and trigonelline from use of the proposed food additive would contribute only to a minimal increase over existing dietary exposure and is not of safety concern. Considering the composition of the proposed food additive, the absence of genotoxic concern of its components and lack of adverse effects of the major component (i.e. pectins), the Panel considered that there was no need for a numerical acceptable daily intake. The Panel concluded that the use of pectin‐rich extract derived from Coffea arabica as a new food additive does not raise a safety concern at the proposed use and use levels.
- Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)Publication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Ursula Gundert‐Remy; Gundert-Remy, Ursula; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat-Baviera, José Manuel; Degen, Gisela; Gott, David; Herman, Lieve; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Consuelo, Civitella; Dino, Borana; Lunardi, Simone; Mech, Agnieszka; Multari, Salvatore; Smeraldi, Camilla; Tard, Alexandra; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme‐catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain K. phaffii CGMCC 7539. The final product is composed mostly of rebaudioside M (> 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from K. phaffii CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain K. phaffii CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme‐catalysed bioconversion.