648 research outputs found
Correction to: Mode of action-based risk assessment of genotoxic carcinogens
No full textThe author would like to thank N. Bakhiya, S. Hessel-Pras, B. Sachse, and B. Dusemund for their support in the chapter about pyrrolizidine alkaloids
Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: Testing an EFS tired approach
No full textThis article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety
Undesired Plant-Derived Components in Food
No full textAmong the various chemical compounds, the class of natural plant-derived substances in the modern food chain is generating increasing concern. Adverse effects encountered may be various and pose risks of acute, subchronic, or chronic toxicity. The underlying mechanisms of toxicity may be thresholded, or the contaminants may pose risks because of genotoxicity and carcinogenicity. This chapter gives an overview of the major classes of plant-derived undesired substances including contaminants of present concern in the modern food chain, describing their mode of action and adverse effects
Risk assessment of pyrrolizidine alkaloids in food of plant and animal origin
No full textAcute liver toxicity, specifically in the form of hepatic veno-occlusive disease (HVOD), is known from reports on human poisonings following ingestions of 1,2-unsaturated pyrrolizidine alkaloids (PAs) containing herbs. Recently PA exposure via common foods contaminated via PA-producing plants raised concern, especially regarding the potential of genotoxicity and carcinogenicity. The health risks related to the estimated exposures to PAs from food were assessed. With respect to common foods, herbal teas and teas are the main sources through which consumers can be exposed to PAs. For high long-term consumption of these foods a possible health concern has been revealed in the assessment of chronic risks referring to a BMDL10 of 237 μg/kg bw per day recently established by EFSA based on model averaging for data on riddelliine. However, acute health damage from acute or short-term intake of PAs via common food is considered to be unlikely. Food supplements on the basis of PA-producing plants may significantly contribute to PA exposures and their intake is associated with risks of acute and chronic toxicity. However, no health risks have to be expected from the consumption of food supplements based on oil-based preparations of PA-producing plants, which were described to be free of PAs
Assessment of the efficacy of a feed additive consisting of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 for dogs (NBF LANES)
No full textFollowing a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 as a zootechnical additive for dogs. The additive is a preparation of viable cells of L. reuteri DSM 32203 and it has not been previously authorised as a feed additive in the European Union. The additive is intended for use in complete feed for dogs at a minimum use level of 6 × 10(9) colony forming units (CFU) per animal and day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM 32203 for dogs. The applicant has provided supplementary information to support the efficacy of the additive to dogs. Based on the data provided, the FEEDAP Panel concludes that L. reuteri DSM 32203 has the potential to improve faecal consistency by reducing the moisture content of stools from dogs receiving the additive at 1 × 10(10) CFU/kg feed. However, the Panel has some reservations on the effects in the moisture content of stools, which if maintained over time might cast doubts on the benefits on the long‐term use of the additive since it could lead to constipation
Safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs
No full textFollowing 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 Levucell® SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell® SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell® is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell® SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 9 109 colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell® SB has the potential to be efficacious in all pigs at 1 9 109 CFU/kg feedingstuffs
Safety and efficacy of a feed additive consisting of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32264 as a feed additive for cats (NBF Lanes s.r.l.)
No full textFollowing a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32264 as a zootechnical additive for cats. The additive is a preparation of viable cells of L. reuteri DSM 32264 and it has not been previously authorised as a feed additive in the European Union. The additive is intended for use in complete feed for cats at a minimum inclusion level of 6 × 10(9) colony forming units (CFU) per animal and day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM 32264 for cats. The applicant has provided supplementary information to support the efficacy of the additive for cats. Based on the data provided, the FEEDAP Panel concluded that L. reuteri DSM 32264 has the potential to improve faecal consistency by reducing the moisture content of stools from cats receiving the additive at 1 × 10(10) CFU/kg feed. However, the Panel had some reservations on the effects in the moisture content, which if maintained overtime, might cast doubts on the benefits on the long‐term use of the additive since it could lead to constipation
Safety and efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase EC 3.2.1.8 produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for gestating sows (Puratos NV)
No full textAbstract 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 and efficacy of Belfeed B MP/ML as a feed additive for gestating sows when used at 10 IU/kg feed. The additive contains endo‐1,4‐b‐xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S‐15136). The FEEDAP Panel concluded that the additive is safe for the target species at the proposed use level and that there are no concerns regarding the use of Belfeed B MP/ML for the consumers and for the environment. The two formulations of the additive were considered skin and eye irritants and respiratory sensitisers. The Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in sows during the gestation period at 10 IU/kg feed
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