Re-evaluation of pullulan (E 1204) as a food additive and new application for its extension of use.

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 ■■■■■. 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.

Safety evaluation of pea fibre concentrate (FIPEA) as food additive.

The 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.

Re-evaluation of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives.

The Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives. Butane, isobutane and propane are short-chain (C-C) alkanes, which are in gaseous state at room temperature. Their currently permitted use in food is in vegetable oil pan spray (for professional use only) and water-based emulsion spray as propellants at .

Flavouring group evaluation 418 (FGE. 418): 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester.

The 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.

Safety and efficacy of a feed additive consisting of an essential oil derived from the aerial parts of × L. (peppermint oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the aerial parts of  ×  L. (peppermint oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that that peppermint oil is safe for all animal species at the maximum use level of 12 mg/kg complete feed.

Modification of the terms of authorisation of the feed additive consisting of canthaxanthin for chickens for fattening, minor poultry species for fattening, laying poultry and poultry reared for laying, ornamental fish and ornamental birds and ornamental breeder hens to include canthaxanthin produced with CBS 146148 (DSM Nutritional Products Ltd.).

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation of canthaxanthin, regarding the addition of a new production route, by the yeast CBS 146148. The additive is already authorised as sensory feed additive for use in feed for chickens for fattening, minor poultry species for fattening, laying poultry, poultry reared for laying, ornamental fish, ornamental birds and ornamental breeder hens. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that canthaxanthin produced with CBS 146148 is considered safe for the target species, the consumer and the environment under the current authorised conditions of use.

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-evaluation.

Citric 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.

Modification of the terms of authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%) for breeder hens to include canthaxanthin produced with CBS 146148 (DSM Nutritional Products Ltd.).

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation of the feed additive consisting of a preparation of canthaxanthin (CAROPHYLL® Red 10%), regarding the addition of a new production route, by the yeast CBS 146148 and to modify the additive specifications by substituting ethoxyquin by 4.4% butylated hydroxytoluene (BHT) and increasing the limit for dichloromethane to 80 mg/kg. The additive is already authorised as zootechnical feed additive for breeder hens.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of L. (sage oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the leaves of L. (sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sage oil is considered safe up to the maximum proposed use levels in complete feed of 20 mg/kg for ornamental fish.

Scientific opinion on the extension of uses of quillaia extract (E 999) as a food additive.

The EFSA Panel on Food Additives and Flavourings (FAF Panel) evaluated the safety of the extension of uses of quillaia extract (E 999) as a food additive in food supplements supplied in a solid or liquid form, excluding food supplements for infants and young children. Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA FAF Panel, which derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999, while in 2024 a follow-up of the re-evaluation was published by the FAF Panel, recommending some modifications of the existing EU specifications for quillaia extract (E 999). Currently, quillaia extract (E 999) is authorised in two food categories (FCs) i.

Safety and efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (GIFAP).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ponceau 4R as sensory additives (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). The additive is already authorised for use with cats and dogs and ornamental fish. The additive is intended to be incorporated in freshwater fishing baits up to a maximum of 15 mg/kg in complementary feed in order to colour them.

Re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives.

This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954).

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering stems of L. (clary sage oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish.

Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a-d) and the modification of the acceptable daily intake (ADI) for steviol.

The EFSA Panel on Food Additive and Flavourings (FAF Panel) evaluated the safety of proposed changes to the currently permitted uses of the food additive steviol glycosides (E 960a-d) and of a proposed modification of the current acceptable daily intake (ADI) from 4 mg/kg body weight (bw) per day to 6 or 16 mg/kg bw per day, expressed as steviol equivalents. Currently, steviol glycosides (E 960a-d) are authorised in the EU in 32 different food categories (FCs). An extension of use was proposed for four new uses within FC 7.

Safety and efficacy of a feed additive consisting of tartrazine for its use in baits for freshwater fish (GIFAP).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tartrazine as sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum of 30 mg/kg in complementary feed in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture.

Re-evaluation of argon (E 938) and helium (E 939) as food additives.

The Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of the two food additives argon (E 938) and helium (E 939). Argon (Ar) and helium (He) are two noble gases, highly stable single atoms. Their chemical inertness is well known.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering tops of Mill. (lavender oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh flowering tops of Mill. (lavender oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum proposed use levels in complete feed of 30 mg/kg for dogs and ornamental fish.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering tops of (L.) Cav. (Spanish type origanum oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species.

Safety and efficacy of a feed additive consisting of an essential oil derived from leaves and terminal branchlets of (Maiden & Betche) Cheel (tea tree oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long-living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.

Production of bacteriocin-like inhibitory substance (BLIS) by Staphylococcus spp. isolates from dogs.

In the present study, 39 canine isolates of Staphylococcus spp. were tested for antimicrobial substance (AMS) production. Seven AMS producers were identified, whose products exhibited a non-acidic character and a proteinaceous nature, therefore being considered bacteriocin-like inhibitory substances (BLIS).

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of ssp. (Vahl) Gams (Spanish sage oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Spanish sage oil from the leaves of ssp. (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species.

Assessment of the feed additive consisting of a preparation containing a smoke flavouring extract for cats and dogs for the renewal of the authorisation (Azelis Denmark A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment.