Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 224
Filtrar
1.
Environ Res ; 151: 478-492, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27567352

RESUMO

Chemicals may persist in the environment, bioaccumulate and be toxic for humans and wildlife, posing great concern. These three properties, persistence (P), bioaccumulation (B), and toxicity (T) are the key targets of the PBT-hazard assessment. The European regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires assessment of PBT-properties for all chemicals that are produced or imported in Europe in amounts exceeding 10 tonnes per year, checking whether the criteria set out in REACH Annex XIII are met, so the substance should therefore be considered to have properties of very high concern. Considering how many substances can fall under the REACH regulation, there is a pressing need for new strategies to identify and screen large numbers fast and inexpensively. An efficient non-testing screening approach to identify PBT candidates is necessary, as a valuable alternative to money- and time-consuming laboratory tests and a good start for prioritization since few tools exist (e.g. the PBT profiler developed by US EPA). The aim of this work was to offer a conceptual scheme for identifying and prioritizing chemicals for further assessment and if appropriate further testing, based on their PBT-potential, using a non-testing screening approach. We integrated in silico models (using existing and developing new ones) in a final algorithm for screening and ranking PBT-potential, which uses experimental and predicted values as well as associated uncertainties. The Multi-Criteria Decision-Making (MCDM) theory was used to integrate the different values. Then we compiled a new set of data containing known PBT and non-PBT substances, in order to check how well our approach clearly differentiated compounds labeled as PBT from those labeled as non-PBT. This indicated that the integrated model distinguished between PBT from non-PBT compounds.


Assuntos
Substâncias Perigosas , Simulação por Computador , Medição de Risco
2.
Environ Res ; 142: 529-34, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26282223

RESUMO

The bioconcentration factor (BCF) is the ratio of the concentration of a chemical in an organism to the concentration in the surrounding environment at steady state. It is a valuable indicator of the bioaccumulation potential of a substance. BCF is an essential environmental property required for regulatory purposes within the Registration, Evaluation, Authorization and restriction of Chemicals (REACH) and Globally Harmonized System (GHS) regulations. In silico models for predicting BCF can facilitate the risk assessment for aquatic toxicology and reduce the cost and number of animals used. The aim of the present study was to examine the correlation of BCF data derived from the dossiers of registered chemicals submitted to the European Chemical Agency (ECHA) with the results of a battery of Quantitative Structure-Activity Relationship (QSAR). After data pruning, statistical analysis was performed using the predictions of the selected models. Results in terms of R(2) had low rating around 0.5 for the pruned dataset. The use of the model applicability domain index (ADI) led to an improvement of the performance for compounds falling within it. The variability of the experimental data and the use of different parameters to define the applicability domain can influence the performance of each model. All available information should be adapted to the requirements of the regulation to obtain a safe decision.


Assuntos
Bases de Dados Factuais , Substâncias Perigosas/química , Substâncias Perigosas/toxicidade , Indústrias , Modelos Teóricos , Relação Quantitativa Estrutura-Atividade , Alternativas aos Testes com Animais , Interpretação Estatística de Dados , Bases de Dados Factuais/legislação & jurisprudência , Europa (Continente) , Órgãos Governamentais , Substâncias Perigosas/classificação , Indústrias/normas , Medição de Risco
3.
Mol Divers ; 19(3): 563-75, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25850638

RESUMO

The in vivo repeated dose toxicity (RDT) test is intended to provide information on the possible risk caused by repeated exposure to a substance over a limited period of time. The measure of the RDT is the no observed adverse effect level (NOAEL) that is the dose at which no effects are observed, i.e., this endpoint indicates the safety level for a substance. The need to replace in vivo tests, as required by some European Regulations (registration, evaluation authorization and restriction of chemicals) is leading to the searching for reliable alternative methods such as quantitative structure-activity relationships (QSAR). Considering the complexity of the RDT endpoint, for which data quality is limited and depends anyway on the study design, the development of QSAR for this endpoint is an attractive task. Starting from a dataset of 140 organic compounds with NOAEL values related to oral short term toxicity in rats, we developed a QSAR model based on optimal descriptors calculated with simplified molecular input-line entry systems and the graph of atomic orbitals by the Monte Carlo method, using CORAL software. Three different splits into the training, calibration, and validation sets are studied. The mechanistic interpretation of these models in terms of molecular fragment with positive or negative contributions to the endpoint is discussed. The probabilistic definition for the domain of applicability is suggested.


Assuntos
Modelos Teóricos , Relação Quantitativa Estrutura-Atividade , Software , Animais , Determinação de Ponto Final , Nível de Efeito Adverso não Observado , Compostos Orgânicos/química , Compostos Orgânicos/toxicidade , Ratos
4.
Ecotoxicol Environ Saf ; 113: 314-20, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25528487

RESUMO

Domoic acid (DA) is a potent neurotoxin produced by alga Pseudo-nitzschia spp. and has been associated with reproductive disorders in mammals. The aim of this study was to investigate if DA can affect the reproductive system via direct action on ovarian function. Bovine granulosa and theca cells were used as in vitro models for evaluating DA effects on ovarian cell proliferation and steroid production. In small-follicle granulosa cells (SMGC), cell proliferation and estradiol (E2) production was not affected (P>0.05) while progesterone (P4) production was inhibited (P<0.05) by DA at all doses tested. In large-follicle granulosa cells (LGGC), DA had no effect (P>0.05) on cell proliferation or P4 production while E2 production was stimulated by 1 and 5 µg/ml DA (P<0.05). DA (1 µg/ml) attenuated (P<0.05) insulin-like growth factor 1 (IGF-1)-induced P4 production by large-follicle theca cells (LGTC), but did not affect androstenedione (A4) production or proliferation of LGTC. In glutamate-free medium, DA inhibited (P<0.05) SMGC E2 production and this inhibition was similar to inhibition of E2 by trans-(±)-1-amino-1,3-cyclopentanedicarboxylic acid monohydrate (ACPD; a selective metabotropic glutamate receptor subtype agonist) while kainic acid (KA; an ionotropic glutamate receptor subtype agonist) had no effect (P>0.10) on E2 production. Collectively, these results show for the first time that DA has direct effects on ovarian GC and TC steroidogenesis. Because DA inhibited E2 and P4 production, DA has the potential to be an endocrine disruptor.


Assuntos
Células da Granulosa/efeitos dos fármacos , Ácido Caínico/análogos & derivados , Células Tecais/efeitos dos fármacos , Androstenodiona/biossíntese , Animais , Bovinos , Proliferação de Células/efeitos dos fármacos , Células Cultivadas , Estradiol/metabolismo , Agonistas de Aminoácidos Excitatórios , Feminino , Ácido Glutâmico , Células da Granulosa/metabolismo , Ácido Caínico/toxicidade , Folículo Ovariano , Progesterona/biossíntese , Esteroides/metabolismo , Células Tecais/metabolismo
5.
Altern Lab Anim ; 42(4): 223-33, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25290943

RESUMO

The use of alternative methods for teaching purposes is gradually increasing in higher education. In order to evaluate the usefulness of non-animal based practical classes in veterinary science, and to inform on possible benefits and limitations of these teaching tools, a questionnaire was designed and distributed to students. Although there was no complete agreement among the student responses, it was apparent that the majority of the students would like traditional training methods to be paired with alternative approaches, and expressed their desire to be exposed to as many humane modes of learning as possible. In addition, the students agreed that alternative teaching methods for training in veterinary science can reinforce existing knowledge that is required at the clinical stage, and that they can be effective supplements to traditional training methods. It was also concluded from the study that the use of new alternative approaches is very much appreciated by the students, whereas the validity and effectiveness of these methods are debatable, suggesting that further optimisation, proper application and evaluation of these alternative methods is required.


Assuntos
Alternativas ao Uso de Animais , Educação em Veterinária , Ensino/métodos , Docentes , Humanos , Estudantes
6.
Food Chem Toxicol ; 188: 114654, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38608926

RESUMO

In view of a continuous trend in replacing synthetic feed additives and especially flavouring compounds by botanical preparations, different aspects of the safety evaluations of plants and plant-derived preparations and components in feed are discussed. This includes risk assessment approaches developed by the European Food Safety Authority (EFSA) for phytotoxins regarding unintentional exposure of target animals and of consumers to animal derived food via carry-over from feed. Relevant regulatory frameworks for feed additives and feed contaminants in the European Union are summarised and the essentials of existing guidelines used in the safety evaluation of botanicals and their preparations and components in feed are outlined. The examples presented illustrate how the safety of the botanicals, their preparations and components present in feed is assessed. An outlook on possible future developments in risk assessment by applying new in vitro and in silico methodologies is given.


Assuntos
Ração Animal , União Europeia , Medição de Risco , Ração Animal/análise , Animais , Humanos , Contaminação de Alimentos/análise , Inocuidade dos Alimentos , Aditivos Alimentares/toxicidade , Aditivos Alimentares/análise
7.
EFSA J ; 22(4): e8729, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38601863

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate as a zootechnical feed additive for dogs. The additive is already authorised for use in feed for cats. The FEEDAP Panel concluded that the additive lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Panel also concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed.

8.
EFSA J ; 22(6): e8857, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38938408

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the consumer of products from animals fed diets with feed additives containing selenium as an active substance. Based on the limited data set available and the several uncertainties, the FEEDAP Panel concluded that the use of organic selenium at the currently maximum authorised use level of 0.2 mg supplemented selenium from organic sources/kg complete feed (within a maximum of 0.5 mg total selenium/kg complete feed) leads to an exceedance of the UL for all the population categories (except elderly and very elderly), suggesting a concern for consumer safety. It was not possible to conclude on the safety of the currently maximum use level of 0.5 mg total selenium/kg complete feed for all consumer categories. Additional data from studies specifically designed to measure deposition of selenium in tissues and products from animal origin resulting from the use of the different sources of selenium would be required to perform a proper risk assessment.

9.
EFSA J ; 22(7): e8901, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39036774

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of calcium D-pantothenate for the renewal of its authorisation as a nutritional feed additive for all animal species. The additive calcium D-pantothenate is already authorised for use in all animal species (3a841). The applicant provided evidence that the additive currently in the market complies with the existing conditions of the authorisation and that the production process has not been modified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Calcium D-pantothenate is not irritant to skin and eyes and is not a skin sensitiser. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive, and therefore, there is no need for re-assessing the efficacy.

10.
EFSA J ; 22(7): e8906, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39086459

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of Carum carvi L. (caraway oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel concluded that the use of caraway oil is of no concern up to the following concentrations in complete feed: 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 16 mg/kg for piglets, 19 mg/kg for pigs for fattening, 24 mg/kg for sows, 35 mg/kg for veal calves (milk replacer), 11 mg/kg for cattle for fattening, 10 mg/kg for dairy cows, sheep, goats, horses and rabbits, 25 mg/kg for salmonids and dogs. These conclusions were extrapolated to other physiologically related species. For cats, ornamental fish and other species, no conclusion can be drawn. The use of caraway oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a respiratory and skin sensitiser. When handling the essential oil, exposure of unprotected users to perillaldehyde may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since C. carvi and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

11.
EFSA J ; 22(7): e8950, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39086458

RESUMO

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 liquid l-lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l-lysine base liquid produced with C. glutamicum NRRL B-67535 and NRRL B-67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B-68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B-68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l-Lysine base produced using C. glutamicum NRRL B-68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l-Lysine base produced with C. glutamicum NRRL B-68248 is considered to be an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

12.
EFSA J ; 22(5): e8799, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38756350

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil), 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 the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered 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 consumers and the environment were identified following the use of the additive up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

13.
EFSA J ; 22(4): e8722, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38585216

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non-food-producing animals. The additive is already authorised for use with non-food-producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non-compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid.

14.
EFSA J ; 22(2): e8632, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38361796

RESUMO

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 the safety of a feed additive consisting of endo-1,4-ß-d-mannanase produced by Thermothelomyces thermophilus DSM 33149, intended for use as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds. The safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable data on the potential genotoxicity of the additive. In the present assessment, the applicant submitted a new in vitro mammalian cell micronucleus test. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for target species and consumer safety. The additive is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Panel cannot conclude on the potential of the additive to be a skin sensitiser.

15.
EFSA J ; 22(4): e8734, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38591026

RESUMO

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the users of the feed additive consisting of ferric tyrosine chelate (TYFER™) when used as a zootechnical additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The European Commission request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. In the current application, the applicant proposed a maximum content of nickel (50 mg/kg). No changes in the manufacturing process have been reported by the applicant. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be as an irritant to skin, eyes and mucous membranes and as a dermal and respiratory sensitiser.

16.
EFSA J ; 22(8): e8938, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39114323

RESUMO

Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of sodium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Considering the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

17.
EFSA J ; 22(4): e8627, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38601869

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance-efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust-free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

18.
EFSA J ; 22(7): e8846, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39005714

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha-amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non-irritant to the skin and the solid form was shown to be non-irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.

19.
EFSA J ; 22(7): e8849, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39005715

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Quillaja saponaria powder and Yucca schidigera powder (Magni-Phi®) for all avian species (to slaughter age/weight, or to the point of lay) and ornamental birds, as a zootechnical additive (digestibility enhancer and other zootechnical additives). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening at the level of 250 mg/kg complete feed with a margin of safety of 20 assuming that the additive contains 3.58% of saponins. This conclusion was extrapolated to all growing poultry species and ornamental birds. The Panel concluded that the use of the feed additive in animal nutrition at 250 mg/kg complete feed is of no concern for the safety for the consumer and the environment. The Panel also concluded that the additive is not irritant to skin, but irritant to the eyes and to the respiratory system. Due to the lack of data, the FEEDAP Panel could not conclude on the skin sensitisation potential of the additive. The FEEDAP Panel was not in the position to conclude on the efficacy of the additive for all poultry species and ornamental birds.

20.
EFSA J ; 22(7): e8909, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39071236

RESUMO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of indigo carmine as a colourant feed additive for cats, dogs and ornamental fish. In its previous opinion, the FEEDAP Panel concluded that indigo carmine is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1000 mg/kg complete feed. These conclusions were limited to indigo carmine with a purity of at least 93% colouring matter. For the current assessment, the applicant submitted additional data on the characterisation and on the toxicological profile to support the safety of the additive with the purity of at least 85% colouring matter. Based on the new data submitted, the FEEDAP Panel concludes that indigo carmine (purity of at least 85% colouring matter) is safe for cats and dogs at levels up to 250 mg/kg complete feed and for ornamental fish up to 1000 mg/kg complete feed.

SELEÇÃO DE REFERÊNCIAS
Detalhe da pesquisa