Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Bastos Maria, Bories Georges, Brantom Paul, Gropp Jürgen, Svensson Kettil, Tosti Luca, Finizio Antonio, Dioni Anna, Galobart Jaume, Holczknecht Orsolya, Pizzo Fabiola, Vettori Maria Vittoria, Amaduzzi Angelica
EFSA J. 2024 Nov 15;22(11):e9072. doi: 10.2903/j.efsa.2024.9072. eCollection 2024 Nov.
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. The additive is intended to be incorporated into feed directly in solid form or via an aqueous solution. The additive is not intended for use in aquaculture. The FEEDAP Panel concluded that ponceau 4R is considered safe when used in fish baits for freshwater fish at the maximum proposed dose of 15 mg/kg complementary feed. The use of the feed additive ponceau 4R fish baits for freshwater fish under the conditions of use proposed is of no concern for consumer safety. Ponceau 4R is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. In absence of data no conclusion can be reached on the efficacy of ponceau 4R in freshwater fish baits.
应欧盟委员会的要求,欧洲食品安全局被要求就胭脂红4R作为感官添加剂(功能组:(a) 色素:(i) 在饲料中添加或恢复颜色的物质)的安全性和有效性提供科学意见。该添加剂已被批准用于猫、狗和观赏鱼。该添加剂旨在以最高15毫克/千克的剂量添加到淡水鱼饵的补充饲料中,以便为其增色。该添加剂旨在以固体形式或通过水溶液直接添加到饲料中。该添加剂不打算用于水产养殖。饲料添加剂和动物营养产品专家委员会得出结论,当以15毫克/千克补充饲料的最高建议剂量用于淡水鱼鱼饵时,胭脂红4R被认为是安全的。在所建议的使用条件下,将饲料添加剂胭脂红4R用于淡水鱼鱼饵对消费者安全没有影响。胭脂红4R不是皮肤刺激物,但应被视为皮肤和呼吸道致敏剂。吸入和皮肤接触被认为有风险。饲料添加剂和动物营养产品专家委员会无法就该添加剂的眼刺激潜力得出结论。由于缺乏数据,无法就胭脂红4R在淡水鱼鱼饵中的功效得出结论。