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EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non‐viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT‐Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT‐Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT‐Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are ‘partially applicable’, therefore on a case‐by‐case basis for specific NGT‐Ms, fewer requirements may be needed. Some of the EFSA guidances are ‘not sufficient’ and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs.

The 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.

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase, EC 3.2.1.133) is produced with the genetically modified Escherichia coli strain MLAVSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme total organic solids (TOS) are removed in one food manufacturing process, dietary exposure was calculated for the remaining two processes. It was estimated to be up to 0.172 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 5814. A search for the homology of the amino acid sequence of the glucan 1,4‐α‐maltohydrolase to known allergens was made and matches with three respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β‐1,3‐linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK‐u. The toxicological dataset consisted of sub‐chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well‐tolerated with no overt organ‐specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three‐generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment‐related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break‐down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.

The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a‐d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels.

The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive in accordance with Regulation (EC) No 1331/2008. The proposed food additive, LegH Prep, is intended to be used as a colour in meat analogue products. The yeast Komagataella phaffii strain MXY0541 has been genetically modified to produce soy leghemoglobin; the safety of the genetic modification is under assessment by the EFSA GMO Panel (EFSA‐GMO‐NL‐2019‐162). The amount of haem iron provided by soy leghemoglobin from its proposed uses in meat analogue products is comparable to that provided by similar amounts of different types of meat. The exposure to iron from the proposed food additive, both at the mean and 95th percentile exposure, will be below the ‘safe levels of intake’ established by the NDA Panel for all population groups. Considering that the components of the proposed food additive will be digested to small peptide, amino acids and haem B; the recipient (non GM) strain qualifies for qualified presumption of safety status; no genotoxicity concern has been identified and no adverse effects have been identified at the highest dose tested in the available toxicological studies, the Panel concluded that there was no need to set a numerical acceptable daily intake (ADI) and that the food additive does not raise a safety concern at the proposed use in food category 12.9 and maximum use level. The Panel concluded that the use of soy leghemoglobin from genetically modified Komagataella phaffii MXY0541 as a new food additive does not raise a safety concern at the proposed use and use level. This safety evaluation of the proposed food additive remains provisional subject to the ongoing safety assessment of the genetic modification of the production strain by the GMO Panel (EFSA‐GMO‐NL‐2019‐162).

The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a-d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels.The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a-d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels.

Xanthan gum (E 415) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food. As a follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of xanthan gum (E 415) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category (FC) 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 issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for E 415 laid down in Commission Regulation (EU) No 231/2012. Due to the low validity of the available clinical studies, the Panel concluded that a reference point could not be derived from them but the results of the available studies on neonatal piglets could serve to derive a reference point. The Panel calculated the margin of exposure for infants below 16 weeks of age consuming food for special medical purposes (FC 13.1.5.1) for the highest xanthan gum exposure and concluded that there are no safety concerns for the use of xanthan gum (E 415) as a food additive in FC 13.1.5.1.

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of synthesised DNA oligonucleotides as a new food additive, in accordance with Regulation (EC) No 1331/2008. Considering that the additional information requested by the Panel during the risk assessment was not provided by the applicant, the assessment was concluded on the basis of the sole information available in the application. The proposed food additive consists of purified synthetic DNA sequences intended to be used for traceability purposes, alone or combined with carriers. Information provided by the applicant on the identity, characterisation and production process of the proposed food additive was considered insufficient. The Panel considered that the product specifications as proposed by the applicant do not adequately define and characterise the proposed food additive. The applicant proposed for the food additive the maximum use levels of 0.001 mg/kg for a variety of food categories. The food additive was also proposed as a Group I additive at a specific maximum level of quantum satis. The applicant did not provide exposure estimates according to the EFSA ANS Panel guidance (2012). No biological or toxicological data were provided by the applicant for the proposed food additive. Considering the inadequate information available and the uncertainty introduced by the proposal at quantum satis, along with the insufficient specifications, the Panel could not conclude on the safety of the food additive as proposed and described by the applicant.

Abstract EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non‐viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT‐Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT‐Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT‐Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are ‘partially applicable’, therefore on a case‐by‐case basis for specific NGT‐Ms, fewer requirements may be needed. Some of the EFSA guidances are ‘not sufficient’ and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs.