Granthamphelps2862

1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.Following an application from Zespri International Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to green kiwifruit (lat. Actinidia deliciosa var. Hayward) and maintenance of normal defecation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is green kiwifruit. The Panel considers that green kiwifruit (Actinidia deliciosa var. click here Hayward) is sufficiently characterised. The claimed effect proposed by the applicant is 'maintenance of normal defecation'. Maintenance of normal defecation is a beneficial physiological effect provided that it does not result in diarrhoea. All human intervention studies submitted had differflesh) should be consumed.The food enzyme maltogenic α-amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain ROM by DSM Food Specialities B.V. The genetic modifications do not give rise to safety concerns. The maltogenic α-amylase is considered free from viable cells of the production organism and its recombinant DNA. The food enzyme is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.065 mg TOS/kg body weight (bw) per day. As the production strain of B. subtilis ROM qualifies for the Qualified Presumption of Safety approach to safety assessment and no issue of concern arose from the production process, no toxicological data are required. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and six matches were found. The Panel considered that under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.The food enzyme containing chymosin (EC 3.4.23.4) and pepsin (EC 3.4.23.1) is derived from the abomasum of suckling lambs and goats by Caporal Enzymes, S.L. The food enzyme is intended to be used in milk processing for cheese production. As no concerns arise from the animal source of the food enzyme, from its manufacture, and based on the history of safe use and consumption, the Panel considered that toxicological data were not required and no exposure assessment was necessary. On the basis of literature data, the Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure could not be excluded, but the likelihood for this to occur was considered to be low. link2 Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law'). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for foot and mouth disease (FMD). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of i) clinical and laboratory sampling procedures, ii) monitoring period and iii) the minimum radius of the protection and surveillance zones, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, the transmission kernels used for the assessment of the minimum radius of the protection zone of 3 km and of the surveillance zone of 10 km are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. The monitoring period of 21 days was assessed as effective, and it was concluded that the protection and the surveillance zones comprise > 99% of the infections from an affected establishment if transmission occurred. Recommendations, provided for each of the scenarios assessed, aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to FMD.Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ferric (III) ammonium hexacyanoferrate (II) as technological feed additive for ruminants (domestic and wild), calves prior the start of rumination, lambs prior the start of rumination, kids prior the start of rumination and pigs (domestic and wild). The additive is already authorised for use in ruminants (domestic and wild), calves prior the start of rumination, lambs prior the start of rumination, kids prior the start of rumination and pigs (domestic and wild). The additive is effective at the minimum recommended concentration of 50 mg/kg complete feedingstuffs (corresponding to about 10 mg/10 kg bw) in reducing the contamination of food derived from ruminants (domestic and wild), calves, lambs and kids prior to the start of rumination, and pigs (domestic and wild) by caesium. Considering the scarce information available, the Panel is not in the position to conclude on the safety of the additive for the target species. The use of ferric (III) ammonium hexacyanoferrate (II) in feed for ruminants, calves, lambs, kids and pigs at the maximum recommended concentration of 500 mg/kg feed (corresponding to about 150 mg ferric (III) ammonium hexacyanoferrate (II)/10 kg bw) is safe for the consumer. In the absence of data, the Panel is not in the position to conclude on the safety of the additive for the user. The use of ferric (III) ammonium hexacyanoferrate (II) as a feed additive is considered safe for the environment.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 mandarin oil from the fruit peels of Citrus reticulata Blanco, when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for poultry, 33 mg/kg for pigs, 30 mg/kg for ruminants, 40 mg/kg for horse, and 15 mg/kg for salmon and rabbit. The presence of perillaldehyde was identified as a source of potential concern. link3 However, in target species fed citrus by-products as part of daily feed the use of the expressed mandarin oil in feed was not expected to increase the exposure to perillaldehyde to a relevant extent ( less then 4%). For companion animals and ornamental fish not normally exposed to citrus by-products, no conclusion can be drawn. The FEEDAP Panel considered 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 additive up to the maximum proposed use level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions of use was not expected to pose a risk for the environment. Expressed mandarin oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.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 an essential oil from the leaves of Citrus x aurantium L. (petitgrain bigarade oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentrations in complete feed are 10 mg/kg for chicken for fattening, 14 mg/kg for laying hen, 13 mg/kg for turkey for fattening, 17 mg/kg for piglet, 20 mg/kg for pig for fattening, 25 mg/kg for lactating sow, 43 mg/kg for veal calf (milk replacer), 38 mg/kg for cattle for fattening, sheep, goat and horse, 24 mg/kg for dairy cow, 15 mg/kg for rabbit, 42 mg/kg for salmon, 44 mg/kg for dog and 8 mg/kg for cat. The FEEDAP Panel considered that the use level 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. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Petitgrain bigarade oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.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 an essential oil from the fruits of Litsea cubeba (Lour.) Pers. (litsea berry oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that litsea berry oil is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentration in complete feed are 11 mg/kg for chicken for fattening, 16 mg/kg for laying hen, 14 mg/kg for turkey for fattening, 19 mg/kg for piglet, 23 mg/kg for pig for fattening, 28 mg/kg for lactating sow, 48 mg/kg for veal calf (milk replacer), 43 mg/kg for cattle for fattening, sheep, goat and horse, 28 mg/kg for dairy cow, 17 mg/kg for rabbit, 47 mg/kg for salmon, 50 mg/kg for dog and 8.5 mg/kg for cat. The FEEDAP Panel also concluded that the use of litsea berry oil at the maximum proposed use level in water for drinking of 1 mg/kg is safe for all animal species.