Suchergebnisse

The European Commission requested EFSA to evaluate whether a series of dyes are covered by the 'Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non‐allowed pharmacologically active substances present in food of animal origin' and to which group they should be attributed according to this guidance. Although these substances are not registered for use in food‐producing animals in the European Union, they may be used illegally in aquaculture for their antimicrobial properties. It was concluded that acriflavine, 3‐aminoacridine, aminoacridine, basic blue 7, brilliant green, leucobrilliant green, C.I. basic blue 26, chloranil, crystal violet, leucocrystal violet, dichlone, ethyl violet, methylene blue, new methylene blue, Nile blue, pararosaniline base, proflavine, proflavine hydrochloride, rhodamine 6G and trypan red are covered by the guidance document and belong to group I. A toxicological screening value of 0.0025 μg/kg body weight per day is applicable. Azure blue and potassium permanganate were excluded from the evaluation due to their inorganic nature.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4‐amino‐5‐(3‐(isopropylamino)‐2,2‐dimethyl‐3‐oxopropoxy)‐2‐methylquinoline‐3‐carboxylic acid [FL‐no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60‐kg adult and 547 μg/person per day for a 15‐kg 3‐year‐old child. There is no concern with respect to genotoxicity. A 90‐day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL‐no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the flavouring rum ether [FL‐no: 21.001] in the Flavouring Group Evaluation 500 (FGE.500), according to Regulation (EC) No 1331/2008 and Regulation (EC) No 1334/2008 of the European Parliament and of the Council. Rum ether is a complex mixture of volatile substances obtained by distillation of the reaction products of pyroligneous acid and ethyl alcohol under oxidative conditions in the presence of manganese dioxide and sulfuric acid. A total of 84 volatile constituents have been reported by the applicant. It is a colourless liquid with a rum‐like odour and flavour. Its major uses are in the food categories beverages, confectionery and baked goods. The Panel decided to apply a congeneric group‐based approach. The 84 reported constituents were allocated to 12 congeneric groups, based on structural and metabolic similarity. For eight of the congeneric groups, the Panel concluded that there is no safety concern at the intended conditions of use. However, the Panel concluded that substances in congeneric group 1 (ethanol and acetaldehyde) and congeneric group 12 (furan) are carcinogenic and genotoxic. The Panel also identified genotoxicity concerns for substances in congeneric group 3 (3‐pentene‐2‐one). The exposure for congeneric group 10 (ethers of various structures) was above the Threshold of Toxicological Concern (TTC) applicable for this group, but a point of departure or health based guidance value that covers all the substances in this group could not be identified. The Panel concluded that according to the overall strategy for the risk assessment of flavouring substances, the presence of genotoxic substances as process‐derived constituents of rum ether is of safety concern.

The Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the flavouring rum ether [FL-no: 21.001] in the Flavouring Group Evaluation 500 (FGE.500), according to Regulation (EC) No1331/2008 and Regulation (EC) No1334/2008 of the European Parliament and of the Council. Rum ether is a complex mixture of volatile substances obtained by distillation of the reaction products of pyroligneous acid and ethyl alcohol under oxidative conditions in the presence of manganese dioxide and sulfuric acid. A total of 84 volatile constituents have been reported by the applicant. It is a colourless liquid with a rum-like odour and flavour. Its major uses are in the food categories beverages, confectionery and baked goods. The Paneldecided to apply a congeneric group-based approach. The 84 reported constituents were allocated to 12 congeneric groups, based on structural and metabolic similarity. For eight of the congeneric groups, the Panelconcluded that there is no safety concern at the intended conditions of use. However, the Panelconcluded that substances in congeneric group 1 (ethanol and acetaldehyde) and congeneric group 12 (furan) are carcinogenic and genotoxic. The Panelalso identified genotoxicity concerns for substances in congeneric group 3 (3-pentene-2-one). The exposure for congeneric group 10 (ethers of various structures) was above the Threshold of Toxicological Concern (TTC) applicable for this group, but a point of departure or health based guidance value that covers all the substances in this group could not be identified. The Panelconcluded that according to the overall strategy for the risk assessment of flavouring substances, the presence of genotoxic substances as process-derived constituents of rum ether is of safety concern.