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Lysine is an essential amino acid for all animal species; it is the first limiting amino acid in swine nutrition and the second limiting amino acid in poultry nutrition. L-Lysine and its salts are widely used in the feed industry to optimise dietary protein.Neither the production strain nor its recombinant DNA was detected in any of the final products. The final products do not raise any safety concern with regard to the genetic modifications.Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered safe for target species when supplemented in appropriate amounts.Lysine produced by E. coli (FERM BP-10941) is not genotoxic and the results of subchronic studies do not indicate any specific concerns. As there are no lysine metabolites associated with safety concerns in the animal tissues and products, the FEEDAP Panel considers that the use of L-lysine and its hydrochloride salts in animal feed does not pose a risk for the consumer.Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are not considered to have the potential to cause respiratory toxicity, skin or eye irritation or skin sensitisation, but respiratory sensitisation cannot be excluded.L-Lysine is a substance naturally occurring in bacteria, plants and animals. The use of L-lysinecontaining feed additives does not represent a risk to the environment.Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered equivalent in terms of L-lysine availability to the target animals. The efficacy of supplementing L-lysine and its hydrochloride salts is extensively demonstrated in the literature for mammals (except ruminants), poultry and fish, including its use in a liquid or a powder form. Therefore, it does not require any further demonstration. Response in ruminants requires some degree of protection of L-lysine from ruminal degradation.

M. citrifolia is a tropical plant with a long tradition of medicinal use in Polynesia and tropical parts of eastern Asia and Australia. One of its favorite uses is the treatment of painful inflammatory conditions, such as arthritis. The analgesic activity of Noni fruit puree on mice was investigated using the hot plate test. A 10% solution of freeze concentrated Noni fruit puree in the drinking water of mice reduced the pain sensitivity comparably to the central analgesic drug tramadol. This effect was only partly reversed by the application of the morphine antagonist naloxone. An alcohol extract of noni fruit puree also caused an inhibition of MMP-9 release from human monocytes after stimulation with LPS. This effect was comparable to hydrocortisone (10(-5) m). The findings suggest that preparations of noni fruits are effective in decreasing pain and joint destruction caused by arthritis.

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EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. SummaryThe European Food Safety Authority (EFSA) requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not.The guidance clarifies a number of definitions and concepts (such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, biomarkers), which are central to biological relevance, in order to achieve that these concepts are used in a consistent way across EFSA areas of activity.The list of generic issues (e.g. nature and size of the biological changes or differences, including the relevance of the biological systems where the effects are observed) to consider when deciding on whether an observed effect is biologically relevant should be applicable to all relevant EFSA Scientific Panels and Scientific Committee.A framework was developed in which biological relevance is considered at three main stages related to the process of dealing with evidence. Development of the assessment strategy, should specify agents, effects, subjects and conditions in relation to the assessment question(s). The collection and extraction of data should follow identification of potentially biologically relevant evidence/data as specified in the Assessment strategy. The third step should include an appraisal and an integration of the biological relevance for each data set of the agents, subjects, effects and conditions. With regard to the ag...

Chemical group 6 consists of aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers, of which 13 are currently authorised for use as flavours in food. The high use level proposed by the applicant for linalool (25 mg/kg complete feed) is safe for salmonids, veal calves, cattle for fattening and pets (excluding cats) without a margin of safety with the exception of dogs (SF = 1.4). The safe use level for pigs and dairy cows is 20, for piglets 12 and for poultry 10 mg/kg complete feed. The high use level of 5 mg/kg complete feed for linalyl acetate, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, terpineol, α-terpineol and terpineol acetate and 4-terpinenol is safe for all species with a margin of safety of 1.2 to 12. For nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol, the maximum safe concentration is 1 mg/kg complete feed for pigs and poultry and 1.5 mg/kg complete feed for all other species. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of the following compounds: linalool, nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4methylphenyl)propan-2-ol. No safety concern would arise for the consumer from the use of compounds belonging to CG 6 up to the highest safe level in feedingstuffs for all animal species. All compounds should be considered as irritants to skin, eyes and respiratory tract, and as skin sensitisers. All compounds of CG 6 are predicted to be safe to the soil compartment when used at levels safe to the target species. Using predictions based on chemical structure, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol were estimated to be safe to aquatic compartments. In the absence of experimental data, safety to aquatic compartments could not be established for linalyl butyrate, linalyl isobutyrate, terpineol acetate, 4-terpinenol, linalyl formate and linalyl propionate. Since all 13 compounds are used in food as flavourings, no further demonstration of efficacy is necessary