Guidance on the identity, characterisation and conditions of use of feed additives.
TL;DR: This guidance document is intended to assist the applicant in the preparation and the presentation of an application for the authorisation of additives for use in animal nutrition.
Abstract: [Table: see text]. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the identity, characterisation and conditions of use of the additives.
Citations
More filters
TL;DR: The EFSA has updated the guidance on nano risk assessment (SC Guidance on Nano-RA), which has taken account of relevant scientific studies that provide insights to physico-chemical properties, exposure assessment and hazard characterisation of nanomaterials and areas of applicability as discussed by the authors.
Abstract: The EFSA has updated the Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain, human and animal health. It covers the application areas within EFSA’s remit, including novel foods, food contact materials, food/feed additives and pesticides. The updated guidance, now Scientific Committee Guidance on nano risk assessment (SC Guidance on Nano‐RA), has taken account of relevant scientific studies that provide insights to physico‐chemical properties, exposure assessment and hazard characterisation of nanomaterials and areas of applicability. Together with the accompanying Guidance on Technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (Guidance on Particle‐TR), the SC Guidance on Nano‐RA specifically elaborates on physico‐chemical characterisation, key parameters that should be measured, methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. The SC Guidance on Nano‐RA also details aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to in vitro/in vivo toxicological studies are discussed and a tiered framework for toxicological testing is outlined. Furthermore, in vitro degradation, toxicokinetics, genotoxicity, local and systemic toxicity as well as general issues relating to testing of nanomaterials are described. Depending on the initial tier results, additional studies may be needed to investigate reproductive and developmental toxicity, chronic toxicity and carcinogenicity, immunotoxicity and allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. The possible use of read‐across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes or mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis.
53 citations
TL;DR: The FEEDAP Panel concludes that the additives under assessment are safe at the maximum proposed or at reduced use levels in complete feed and the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed.
Abstract: Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of expressed lemon oil and distilled lemon oil from Citrus limon (L.) Osbeck and lime oil from Citrus aurantiifolia (Christm.) Swingle, when used as sensory additives in feed for all animal species. The use of the expressed lemon oil and its residual fraction and the use of lime oil in feed is not expected to increase the exposure to furocoumarins and methoxycoumarins and perillaldehyde of those target species that are already fed citrus by‐products a relevant extent (< 10%). For companion animals and ornamental fish not normally exposed to citrus by‐products, no conclusion can be drawn. For the other species and for the distilled fraction of expressed lemon oil, the FEEDAP Panel concludes that the additives under assessment are safe at the maximum proposed or at reduced use levels in complete feed. The Panel considers that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additives at the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes and the respiratory tract and as skin sensitisers. Since expressed lemon oil and its fractions contain furocoumarins, they may cause phototoxicity. The use of the additives under the proposed conditions of use in animal feed is not expected to pose a risk for the environment. Since C. limon and C. aurantiifolia and their preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.
19 citations
TL;DR: In this paper, a guidance document is presented to assist the applicant in the preparation and presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition.
Abstract: This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition. [Table: see text].
18 citations
TL;DR: The FEEDAP Panel concluded that sodium carboxymethyl cellulose is considered safe for all animal species and safe for the environment, and the additive is considered to be efficacious in feedingstuffs for allAnimal species.
Abstract: Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on sodium carboxymethyl cellulose as a feed additive for all animal species. Sodium carboxymethyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of sodium carboxymethyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to sodium carboxymethyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that sodium carboxymethyl cellulose is considered safe for all animal species. The use of sodium carboxymethyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of sodium carboxymethyl cellulose for the user. The use of sodium carboxymethyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.
17 citations
TL;DR: In this article , the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of olibanum extract from Boswellia serrata Roxb. ex Colebr., when used as a sensory additive (flavouring) in feed for all dogs and horses.
Abstract: Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of olibanum extract from Boswellia serrata Roxb. ex Colebr., when used as a sensory additive (flavouring) in feed for all dogs and horses. The FEEDAP Panel concluded that the additive under assessment is safe for horses at the maximum proposed use level of 100 mg/kg in complete feed. For dogs, the calculated safe concentration in feed is 330 mg/kg complete feed. The additive is considered safe for consumers when used at the proposed conditions of use in horses. The additive under assessment should be considered as non‐irritant to skin and eyes, but in the absence of data, no conclusion can be drawn on its potential to be a dermal and respiratory sensitiser. The use of the additive under the proposed conditions of use in feed for horses was not expected to pose a risk for the environment. Boswellia species and their preparations were recognised to flavour food. Since their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.
15 citations