The PPR Panel was asked to deliver a scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). Specific protection goals options were suggested based on the ecosystem services approach. The different routes of exposure were analysed in detail for different categories of bees. The existing test guidelines were evaluated and suggestions for improvement and further research needs were listed. A simple prioritisation tool to assess cumulative effects of single pesticides using mortality data is suggested. Effects from repeated and simultanous exposure and synergism are discussed. Proposals for separate risk assessment schemes, one for honey bees and one for bumble bees and solitary bees, were developed.

Following a request of the European Commission, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by France in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 34 of Regulation (EC) No 1829/2003. The EFSA GMO Panel notes that some publications referred to by France were already part of the submission package by France for its safeguard clause and emergency measure on maize MON 810 in 2008. Those publications were addressed previously by the EFSA GMO Panel in its 2008 Scientific Opinion on the safeguard clause and emergency measure notified by France on maize MON 810. In the remaining documentation provided by France in support of the current emergency measure on maize MON 810, the EFSA GMO Panel could not identify any new science-based evidence indicating that maize MON 810 cultivation in the EU poses a significant and imminent risk to the human and animal health or the environment. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMO Panel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of an emergency measure under Article 34 of Regulation (EC) No 1829/2003 and that would invalidate its previous risk assessments of maize MON 810.

L-Carnitine has a key role in the metabolism of fatty acids as a ‘substrate’ for the reversible acetylation of coenzyme A and as a carrier for the transport of long chain fatty acids from cytosol across the inner mitochondrial membrane. L-Carnitine administered via feed or water for drinking is considered safe for the target species. The additive appears to have a wide margin of safety (> 10) at the levels typically used (10–50 mg/kg feed). Very little information is available on the toxicology of L-carnitine. Nevertheless, based on residue data obtained from multi-fold doses of the typical use levels, the FEEDAP Panel concluded that typical supplementation of feed with L-carnitine would not substantially increase human exposure to carnitine from food of animal origin. Therefore, the FEEDAP Panel considers that the use of L-carnitine as an additive in animal nutrition is safe for the consumer. No data were provided to address user safety. In the absence of data, L-carnitine should be considered as potentially irritant to skin and eye, and as a potential skin sensitiser and inhalatory toxicant. The use of L-carnitine in animal nutrition is not expected to pose a risk to the environment. L-Carnitine was regarded as an effective source of L-carnitine in all animal species.

L-Carnitine has a key role in the metabolism of fatty acids as a ‘substrate’ for the reversible acetylation of coenzyme A and as a carrier for the transport of long-chain fatty acids from cytosol across the inner mitochondrial membrane. L-Carnitine and L-carnitine L-tartrate administered via feed or water for drinking are considered safe for the target species. The additives appear to have a wide margin of safety (> 10) at the levels typically used in feed (10–50 mg/kg feed). Very little information is available on the toxicology of L-carnitine. Nevertheless, based on residue data obtained from multi-fold doses of the typical use levels, the FEEDAP Panel concluded that typical supplementation of feed with L-carnitine or L-carnitine L-tartrate would not substantially increase human exposure to carnitine from food of animal origin. Therefore, the FEEDAP Panel considers that the use of L-carnitine and L-carnitine L-tartrate as additives in animal nutrition is safe for the consumer. L-Carnitine and L-carnitine L-tartrate are not irritant to skin and eyes nor are they skin sensitisers. L-Carnitine and L-carnitine L-tartrate showed limited dust formation. As inhalation toxicity studies were not available, adverse effects in the respiratory tract cannot be fully excluded. The use of L-carnitine and L-carnitine L-tartrate in animal nutrition is not expected to pose a risk to the environment. L-Carnitine and L-carnitine L-tartrate are regarded as an effective source of L-carnitine in all animal species.

Allura Red AC is intended to be used as a colourant in feedingstuffs for cats and dogs without quantitative limitations. Since the additive is only applied for non-food-producing animals, the assessment of safety is limited to the target species and the user. The FEEDAP Panel considered that (i) genotoxicity of Allura Red AC cannot be excluded; (ii) the mouse carcinogenicity study may not be appropriate for investigating the risk of colon cancer that might result from local DNA damage; and (iii) Allura Red AC is proposed for lifetime use in cats and dogs, leading to a much higher exposure in target animals than in humans. The FEEDAP Panel concluded that the available data are insufficient to demonstrate the safety of Allura Red AC for cats and dogs. In the absence of any information, the substance should be considered to be potentially harmful as a result of skin, eye, or inhalation exposure by users of the additive. Its colouring efficacy in a typical complementary feed for dogs was demonstrated at a minimum dose of 50 mg/kg feed. Allura Red AC is considered efficacious in adding colour to feed for cats and dogs.

Following an application from Merck Consumer Healthcare, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucosamine, formulated as glucosamine sulphate or hydrochloride, and maintenance of normal joint cartilage. Glucosamine is sufficiently characterised. The claimed effect is “contributes to the maintenance of normal joint cartilage”. The target population as proposed by the applicant is the general population, and in particular people exposing their joints to high mechanical load and people with joint cartilage deterioration due to normal ageing. The Panel considers that the maintenance of normal joint cartilage is a beneficial physiological effect. The applicant provided references to studies in patients with osteoarthritis, in healthy subjects, in animals and in vitro as being pertinent to the health claim. In weighing the evidence, the Panel took into account that no human studies were provided from which conclusions could be drawn on the effect of dietary glucosamine on the maintenance of cartilage in individuals without osteoarthritis, and that the evidence provided in the in vitro and animal studies in support of the biological plausibility for a possible contribution of dietary glucosamine to the maintenance of joint cartilage in humans is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of glucosamine and maintenance of normal joint cartilage in individuals without osteoarthritis.

Folic acid, a synthetic folate compound, is converted in animals to biologically active folates. These are essential for DNA synthesis, repair and methylation, in particular nucleotide biosynthesis and remethylation of homocysteine. Oral administration routes of folic acid via feed or water for drinking are considered bioequivalent. Folic acid is safe for the target animals and there is no need to define a maximum content in feed. Population exposure to folic acid/folates in Europe is below the tolerable upper intake level (1 mg/adult/day and 200 µg/toddler/day). As folic acid supplementation of animal feedingstuffs is widespread and routine, exposure figures already contain the contribution from edible tissues and the products of animals fed folic acid-supplemented diets. Liver and milk folate is not influenced by dietary folic acid. The only variation to be expected is in the concentration of folates in eggs and meat. The potential exposure of adults and toddlers resulting from the consumption of eggs and meat from treated animals is, however, small and would be about 60 and 27 µg/person/day, respectively. The FEEDAP Panel concluded that the use of folic acid in animal nutrition is not of concern for the safety of consumers. In the absence of any information, the FEEDAP Panel considers it prudent to treat folic acid as an irritant to skin, eyes and the respiratory tract and as a sensitiser. Folates occur widely in nature (in green vegetables and certain fruits, e.g. citrus). Folic acid added to feed would be excreted as the physiological end-products of folate metabolism. The use of folic acid in animal nutrition does not pose a risk to the environment. Folic acid is regarded as an effective source of folate in animal nutrition.

The feed additive is a mixture of sodium benzoate 140 g/kg, propionic acid 370 g/kg and sodium propionate 110 g/kg and is intended to be used as a preservative for cereals high with a high moisture content. The applicant has now resubmitted the studies already considered, seeking a reassessment of the data on efficacy for all cereals with a broad range of moisture content. The FEEDAP Panel concluded, on the basis of the evidence provided, that the additive is efficacious in preserving high-moisture grains other than maize kernels at a minimum dose of 3 000 mg/kg cereal and maize kernels at a minimum dose of 13 000 mg/kg. For complete feed containing cereals with a moisture content greater than 12 %, the minimum effective dose is 5 000 mg/kg. The Panel also considered that the currently authorised maximum concentration for cereal grain of 22 000 mg/kg (equivalent to 10 000 mg/kg complete feed) should be retained for all cereals to preserve target animal safety. The FEEDAP Panel recognised that the effective dose of the additive depends largely on the initial moisture content of the cereal at harvest, the form (whole grain vs. ground) and the intended storage period. For this reason, the actual effective dose may lie between the minimum and maximum concentration authorised under present legislation.

Following an application from Unilever PLC and Unilever NV, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of an application to modify the conditions of use of an authorised Article 14 claim related to 1.5 - 3.0 g plant sterols/stanols per day and lowering blood LDL-cholesterol by 7 - 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration to obtain the effect be one to two weeks. The applicant provided a published systematic review and meta-analysis that evaluated the comparative efficacy of plant sterols and plant stanols for lowering blood LDL-cholesterol in healthy and hypercholesterolaemic subjects and an unpublished meta-analysis on 27 randomised controlled human studies on the LDL-lowering efficacy at a dose range between 2.6 and 3.4 g per day. On the basis of the data presented, the Panel concludes that plant sterols and stanol esters at daily intakes ranging from 1.5 to 3.0 g plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) have a similar efficacy on blood LDL-cholesterol lowering, that plant sterols and stanol esters at a daily intake of 3 g (range 2.6 g to 3.4 g) plant sterols/stanols in matrices approved by Regulation (EC) No 376/2010 lower LDL-cholesterol by 11.3 % (95 % CI: 10.0 - 12.5), and that the minimum duration required to achieve the maximum effect of plant sterols and stanols on LDL-cholesterol lowering is two to three weeks.

Following an application from Raisio Nutrition Ltd, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to 3 g/day plant stanols as plant stanol esters per day and lowering blood LDL-cholesterol by 12 % and reduced risk of (coronary) heart disease. The applicant has further requested that the minimum duration to obtain the effect be stated to be one to two weeks, and that the claims be authorised for an extended range of foods, including yellow fat spreads, dairy products, cheese, rye bread, oatmeal, fermented soy milk based products (drinkable and spoonable yoghurt-type products), and oat based milk drinks. The applicant provided an unpublished meta-analysis with 18 randomised, controlled human studies on the LDL-lowering efficacy of plant stanol esters at intakes between 2.7 to 3.3 g per day plant stanols. On the basis of the data presented, the Panel concludes that plant stanol esters at a daily intake of 3 g plant stanols (range 2.7 g to 3.3 g) in matrices approved by Regulation (EC) No 376/2010 (yellow fat spreads, dairy products, mayonnaise and salad dressings) lowers LDL-cholesterol by 11.4 % (95% CI: 9.8 – 13.0), that the minimum duration required to achieve the maximum effect of plant stanol esters on LDL-cholesterol lowering is two to three weeks, and that while plant stanol esters added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-cholesterol levels, the size of the cholesterol-lowering effect of plant stanols added to other food formats is less well established.

Information given in previous Opinions “Welfare of cattle kept for beef production” (SCAHAW, 2001) and “The risks of poor welfare in intensive calf farming systems” (EFSA, 2006) is updated and recent scientific evidence on the topics reviewed. Risks of poor welfare are identified using a structured analysis, and issues not identified in the SCAHAW (2001) beef Opinion, especially effects of housing and management on enteric and respiratory diseases are reviewed. The Opinion covers all systems of beef production, although the welfare of suckler cows or breeding bulls is not considered. The Chapter on beef cattle presents new evidence and recommendations in relation to heat and cold stress, mutilations and pain management, digestive disorders linked to high concentrate feeds and respiratory disorders linked to overstocking, inadequate ventilation, mixing of animals and failure of early diagnosis and treatment. Major welfare problems in cattle kept for beef production, as identified by risk assessment, were respiratory diseases linked to overstocking, inadequate ventilation, mixing of animals and failure of early diagnosis and treatment, digestive disorders linked to intensive concentrate feeding, lack of physically effective fibre in the diet, and behavioural disorders linked to inadequate floor space, and co-mingling in the feedlot. Major hazards for white veal calves were considered to be iron-deficiency anaemia, a direct consequence of dietary iron restriction, enteric diseases linked to high intakes of liquid feed and inadequate intake of physically effective fibre, discomfort and behavioural disorders linked to inadequate floors and floor space.

The additive tetra-basic zinc chloride (TBZC) consists of ≥ 84 % zinc chloride hydroxide monohydrate, ≤ 9 % zinc oxide and about 5 % starch. The additive TBZC is a safe source of zinc for all animal species, considering the maximum contents for total zinc in feedingstuffs set by the European Union. The use of the additive TBZC as a source of zinc in animal nutrition would not lead to different zinc concentrations in food of animal origin compared with another authorised inorganic zinc source, and consequently it is considered safe for consumers. The additive TBZC should be considered as a potential irritant to skin and eyes and a potential skin sensitiser. The risk of respiratory exposure is considered to be minimal. The use of zinc-containing feed additives does not pose a direct environmental concern for agricultural soils, but the available data were not sufficient to exclude any risk related to drainage and the run-off of zinc to surface water. The use of zinc-containing additives in aquaculture up to maximum authorised zinc level in feeds is not expected to pose an appreciable risk to the environment. The additive TBZC is an efficacious source of zinc in terms of meeting animal requirements.

This Opinion reviews the factors that affect microbial survival and growth in composite products, and in foods in general. It concludes that the main factors to be considered are: water activity, pH, temperature and duration of storage, processing, and intensity and duration of other non-thermal physical processes applied. Prevalence and concentration of the pathogens in food are important to determine the risk for consumers. The opinion presents a review of the quantitative microbiology models and databases that can be used to provide quantitative estimations of the impact of the above factors on the survival and growth of the main bacterial pathogens. In composite products, migration and diffusion of moisture and substances among the ingredients may change their physico-chemical parameters, particularly at the interfaces. Therefore, the assessment of the risk posed by composite products needs to consider the combinations of parameters most permissive to survival and growth of pathogens. Two complementary approaches are proposed for the identification and profiling of microbiological hazards in different specific composite products. The first one is based on past outbreaks and prevalence of hazards in the products and leads to the conclusion that the most frequent hazard-composite product combinations are Salmonella in cakes and bakery products. The second one consists in decision tools based on the impact on the pathogens of food composition and food processing. Categorisation of the risk for composite products requires information on their composition, processing and further handling, which can largely differ for foods belonging to the same category. Further conditions may influence the risk and should be verified, i.e. hygienic conditions during preparation of the composite products and their ingredients, shelf-life conditions, and reliability of cooking by consumers to inactivate pathogens. The decision tools developed apply to all composite products considered by the mandate, as well as to all other foods.

AviPlus^® is the trade name for a feed additive based on two organic acids (citric and sorbic acids), the monoterpene thymol and vanillin. The additive is currently authorised as a zootechnical feed additive for weaned piglets at a dose of 1000 – 3000 mg/kg complete feed. The applicant is now applying for the further authorisation of AviPlus^® for use with chickens and minor avian species for fattening and reared for laying at a dose of 200-500 mg/kg complete feed, and for minor porcine species (weaned) at a dose of 1000 – 3000 mg/kg complete feed. Data was provided in the form of two tolerance studies and a further six efficacy trials which showed that AviPlus^® has the potential to be efficacious at a minimum dose of 200 mg/kg complete feedingstuffs and is safe up to a dose of 500 mg/kg complete feedingstuffs in chickens for fattening. This conclusion also applies to chickens reared for laying. As safety and efficacy has been demonstrated in a physiologically-relevant major species, safety and efficacy can be presumed for all minor avian species for fattening or reared for laying when the additive is used at the same dose range. Since AviPlus^® has been previously demonstrated as efficacious and safe for piglets (weaned) and is authorised for a dose range of 1000 - 3000 mg /kg complete feedingstuffs, safety and efficacy can be presumed for use in minor porcine species over a developmental period corresponding to the weaned piglet at the same dose range.

The European Commission has received requests for a modification of the authorisations of certain microbial products, all based on species considered by EFSA as suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment. Applicants are seeking the removal of the maximum dose specified in the current authorisation on the basis that such a dose is not consistent with the QPS approach. Therefore, EFSA has been requested to provide an opinion on the implications of the deletion of the maximum dose currently applied to those authorised microbial products for which safety was assessed using the QPS approach and, more generally, in the case of all microorganisms for which this approach is used. Since the QPS assessment is not related to a specific purpose but has to take account of any reasonable use of the organism under consideration, no restrictions on the amount of the organism used for any particular application are made. Although, in principle, such a provision could be included as a “qualification” this has not proved necessary to date. Consequently, all pre-assessments made by EFSA for the microorganisms currently listed as suitable for QPS have been made independent of dose. As a consequence, unless a specific provision relating to dose is included in the “qualification” for a given taxonomic unit, safety is presumed at any reasonable dose. In such cases the setting of a maximum dose in an authorisation does not offer any additional degree of safety for target animals, consumers or the environment and, in the view of the FEEDAP Panel, is unnecessary.

The strain of Propionibacterium acidipropionici under application is intended for use as a technological additive to improve the ensiling process at a proposed dose of 1.0 x 10⁸ CFU/kg fresh material. The bacterial species P. acidipropionici is considered by EFSA to be suitable for the Qualified Presumption of Safety approach. As the identity of the strain has been clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Given the lack of information and its proteinaceous nature, the active agent should be considered to have a potential to be a skin and respiratory sensitiser. Three studies with laboratory-scale silos are described, each lasting at least 90 days, made using samples of grass forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared to identical silos containing the same untreated forage at 20 ºC. No evidence of beneficial effects on fermentation characteristics or on the nutritional value of the final products was observed. However, the additive has the potential to improve aerobic stability of silage once exposed to air. This was demonstrated in moderately difficult and difficult to ensile forage species covering a range dry matter contents from 24 to 40 %.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety of use of stigmasterol-rich plant sterols in ready-to-freeze alcoholic cocktails as a stabiliser. Biological and toxicological data on stigmasterol-rich plant sterols were not provided, but the available data on phytosterols and their esters can be used to evaluate the safety of stigmasterol-rich plant sterols provided that the studies are performed with phytosterol preparations containing also a well-defined percentage of stigmasterol. Less than 5% of dietary phytosterols, phytostanols, and their esters are absorbed by the gastrointestinal tract of rats and human. The metabolic fate of phytosterols and their esters is similar between rats and humans. No evidence of mutagenicity or genotoxicity of phytosterols or phytosterol esters was observed. The Panel concluded that stigmasterol-rich plant sterols are not of concern with respect to genotoxicity. Toxicity studies on phytosterols and phytosterol esters were limited to 90-day subchronic toxicity studies and a 2-generation reproductive toxicity study in rats. No chronic toxicity, carcinogenicity or developmental toxicity studies conducted with phytosterols, phytostanols, and their esters were identified. For adults, mean and 95^th percentile exposures to stigmasterol-rich plant sterols from the proposed uses and use levels were 0.01-0.2 mg/kg bw/day and 0.4-7.4 mg/kg bw/day, respectively. Using the lowest NOAEL values of 1.54 g phytosterols/kg bw/day (335 mg stigmasterol/kg bw/day) the calculated Margin of Safety (MOS) values amount to 7700-154 000 at the mean and 208-3850 at the 95^th percentile for the phytosterols and to 1675-33 500 at the mean and 45-838 at the 95^th percentile for stigmasterol. The Panel considered these MOS values adequate and concluded that the proposed use and use levels of stigmasterol-rich plant sterols in ready-to-freeze alcoholic cocktails as a stabiliser would not be of safety concern.

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucose and “contributes to normal energy-yielding metabolism during exercise”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is glucose, which is sufficiently characterised. The claimed effect is “contributes to normal energy-yielding metabolism during exercise”. The proposed target population is healthy, active, as well as endurance trained, men and women. The Panel notes that the claimed effect refers to the contribution of the food constituent to energy-yielding metabolism in active individuals. Energy-yielding metabolism is needed for all functions and activities of the body, including physical activity and exercise. The Panel considers that contribution to energy-yielding metabolism is a beneficial physiological effect. A claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome.

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucose and “supports normal physical activity”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is glucose, which is sufficiently characterised. The claimed effect is “supports normal physical activity”. The proposed target population is healthy, active, as well as endurance trained, men and women. The Panel notes that the claimed effect refers to the contribution of the food constituent to energy-yielding metabolism in active individuals. Energy-yielding metabolism is needed for all functions and activities of the body, including physical activity and exercise. The Panel considers that contribution to energy-yielding metabolism is a beneficial physiological effect. A claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome.

Chemical group 26 (CG 26) consists of aromatic ethers including anisole derivatives, of which eight are currently authorised for use as flavours in food. These flavouring compounds, excluding 2-methoxyethyl benzene and 2-methoxynaphthalene, were calculated to be safe for all animal species at the proposed use level of 1 mg/kg complete feed. Two compounds, 1,2-dimethoxy-4-(prop-1-enyl)-benzene and 1-methoxy-4-methylbenzene will also be safe at the maximum proposed level of 5 mg/kg complete feed for all target species. The calculated safe use level for 2-methoxyethyl benzene and 2-methoxynaphthalene were 0.5 and 0.08 for cattle, salmonids and non-food producing animals and 0.3 and 0.05 mg/ kg complete feed for pigs and poultry, respectively. Safe concentrations should be appropriately reduced if used in water for drinking. The absence of a margin of safety would not allow their simultaneous administration, except 1,2-dimethoxy-4-(prop-1-enyl)benzene and 1-methoxy-4-methylbenzene, in feed and water for drinking. No residues of safety concern derived from the aromatic ethers and anisole derivatives of CG 26 are expected in animal tissues or products, and the use of these compounds up to the highest doses safe for the target animals would not measurably increase consumer exposure. The Panel considered it prudent to treat all compounds under assessment as irritant to skin, eye and respiratory tract, skin sensitisers, harmful if swallowed. At a dose of 1 mg/kg complete feed these compounds are not expected to pose a risk for the environment. Their environmental consequences when used at a dose of 5 mg/kg complete feed are less certain and may result in PNECs being exceeded in both water and soil compartments. Since these compounds are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucose and “contributes to normal muscle function”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is glucose, which is sufficiently characterised. The claimed effect is “contributes to normal muscle function”. The proposed target population is healthy, active, as well as endurance trained, men and women. The Panel notes that the claimed effect refers to the contribution of the food constituent to energy-yielding metabolism in active individuals. Energy-yielding metabolism is needed for all functions of the body, including normal muscle function. The Panel considers that contribution to energy-yielding metabolism is a beneficial physiological effect. A claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome.

Following an application from Dextro Energy GmbH & Co. KG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucose and “contributes to normal energy-yielding metabolism”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is glucose, which is sufficiently characterised. The claimed effect is “contributes to normal energy-yielding metabolism”. The proposed target population is the general population. Contribution to energy-yielding metabolism is a beneficial physiological effect. A claim on glucose and contribution to energy-yielding metabolism has already been assessed with a favourable outcome.

Following an application from Dextro Energy GmbH & Co. KG submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucose and “it is metabolised within body’s normal energy metabolism”. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is glucose, which is sufficiently characterised. The claimed effect is “it is metabolised within body’s normal energy metabolism”. The proposed target population is the general population. The Panel notes that the claimed effect refers to the contribution of the food constituent to energy-yielding metabolism, which is a beneficial physiological effect. Glucose is used within cells as a source of energy and contributes to energy-yielding metabolism, which is a property inherent to the food constituent. The publications provided by the applicant as being pertinent to the claim do not add new information to the well established role of glucose in energy-yielding metabolism as a source of energy. The Panel concludes that a cause and effect relationship has been established between the intake of glucose and contribution to energy-yielding metabolism. The following wording reflects the scientific evidence: “glucose contributes to energy-yielding metabolism”. In order to bear the claim, a food should be a significant source of glucose. Reference intake values for glycaemic carbohydrates have been established for labelling purposes in Regulation (EU) No. 1169/2011. The target population is the general population.

Following an application from Biocodex, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to citrulline-malate and faster recovery from muscle fatigue after exercise. Citrulline-malate is sufficiently characterised. The claimed effect is “maintenance of ATP levels through reduction of lactates in excess for an improved recovery from muscle fatigue”. The target population proposed by the applicant is healthy children above six years of age and adults. The Panel considers that faster recovery from muscle fatigue after exercise contributing to the restoration of muscle function is a beneficial physiological effect. A total of 33 references were considered as pertinent to the claim by the applicant. A number of studies were provided with hospitalised patients or outpatients who presented with various forms of asthenia or fatigue. No conclusions could be drawn from these studies for the scientific substantiation of the claim. No conclusions could be drawn from one study carried out in athletes, owing to the methodological limitations of the study. A number of mechanistic, animal and in vitro studies were submitted. In the absence of evidence for an effect of consumption of citrulline-malate on a faster recovery from muscle fatigue after exercise in humans, these studies cannot be used as a source of data for the scientific substantiation of the claim as their results cannot predict the occurrence of an effect of citrulline-malate on recovery from muscle fatigue after exercise in vivo in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of citrulline-malate and faster recovery from muscle fatigue after exercise.

The ANS provides a scientific opinion on the exposure assessment of sucrose esters of fatty acids (E 473) taking into account the additional information on its use as surface treatment agent for food and the additional proposed use in flavourings. The Panel previously adopted a scientific opinion (2010) on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings. In that opinion the Panel concluded that, based on the data available, the additional use of the sucrose esters of fatty acids may lead to exposures in excess of the ADI of 40 mg/kg bw/day for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by EFSA in 2004. The Panel further noted that the main contribution to total dietary exposure to sucrose esters of fatty acids was from its use as surface treatment for fruits (on average 40-50%) and suggested that for a more refined estimate of intake, actual data on this use would need to be known. Following this conclusion new data were submitted to EFSA providing actual use levels of sucrose esters of fatty acids as a surface treatment for fresh fruits and the resulting residual levels in fruit. A new exposure assessment was based on this information and taking into account an additional proposed use in flavourings. The Panel noted that the current intake of sucrose esters of fatty acids is considerably lower than previously estimated, but is still above the ADI for children high level consumers. However, an intake resulting from its use as a surface treatment for fruits and the additional proposed use in clear flavoured soft drinks contributes to 0.25% and 0.1% of the ADI, respectively.

Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a single strain of Bacillus subtilis. The additive currently is authorised for use in diets for chickens for fattening, chickens reared for laying, ducks for fattening and other minor avian species. B. subtilis is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to establishing safety for the target species, consumers and the environment. The identity of the active agent in PB6 was established and the absence of toxigenic potential and resistance determinants to antibiotics demonstrated as part of a previous assessment for use with chickens for fattening. Consequently the strain is presumed safe for all animal species, consumers of the products of any animals given the additive and the environment. In the course of the previous assessment, safety for users was also examined. Evidence was provided that the additive is non-irritant to skin and eyes and is not a skin sensitiser. Given the very low dusting potential of the formulation, exposure of users via a respiratory route was also considered unlikely. Bacillus subtilis PB6 appears to have a potential to improve the production of weaned piglets. However, a minimum effective dose could no be established from the data provided. Since a minimum effective dose could not be established for a major porcine species (weaned piglets), it is not possible to extrapolate to weaned minor porcine species.

Chemical group 33 (CD 33) consists of aliphatic and aromatic amines, as 3-methylbutylamine, trimethylamine and trimethylamine hydrochloride currently listed in the European Union database of flavouring substances and as such authorised for use in food. The calculated safe use level for 3-methylbutylamine is 1.5 mg/kg complete feed for cattle, salmonids and non-food producing animals and 1.0 mg/kg for pigs and poultry. For trimethylamine and its salt the proposed high use level of 5 mg/kg complete feedingstuff is safe for all animal species with a margin of safety ranging between 3 and 15. Safe concentrations should be appropriately reduced if the compounds are used in water for drinking. The FEEDAP Panel estimates that the use of these additives would not significantly increase the exposure of the consumer to compounds (and metabolites) already present in or derived from nutrients and endogenous compounds. Consequently, it concludes that 3-methylbutylamine and trimethylamine at the maximum dose considered safe for the target species would not pose safety concerns for the consumer. The compounds under application are well recognised as being corrosive to the eye and strongly irritant or corrosive to the skin and known irritant to the respiratory tract. When used at a dose considered safe for the target animals the compounds under application are not expected to pose a risk to the environment. Since 3-methylbutylamine, trimethylamine and its salt are used in food as flavourings, and their function in feed is essentially the same as that in food no further demonstration of efficacy is necessary. However, the FEEDAP Panel notes that the oral administration of trimethylamine to ‘tainters’ hens could lead to “fishy eggs” depending on the dietary content of rapeseed, choline and betaine.

In order to be approved for use for TSE monitoring in the EU, new TSE rapid tests need to go through a specific evaluation procedure. The first three evaluation programmes were completed in 1999, 2002 and 2004. The present opinion reports the results of the fourth evaluation programme, which was launched by the European Commission in October 2007 and remained open for five consecutive years. The evaluation procedure applied was based on the requirements foreseen by the Commission Call and by the current EFSA protocols for the evaluation of TSE rapid tests in ruminants. By the end of the first application period (1 March 2008), six companies submitted six applications for TSE rapid tests: 1 post-mortem rapid test for the detection of BSE in cattle; 4 post-mortem rapid tests for the detection of TSE in small ruminants; and 1 post-mortem rapid test for the detection of both BSE in cattle and TSE in small ruminants. The only rapid test that went through the whole evaluation and fulfilled all requirements foreseen is the rapid test Prionics^® - Check PrioSTRIP SR (visual reading protocol) for detection of TSE in small ruminants’ central nervous system. This rapid test is considered suitable for approval as rapid test for detection of TSE in small ruminants’ central nervous system.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinions on the safety of the conjugated linoleic acid (CLA)‑rich oils Clarinol® and Tonalin® TG 80 as Novel Food ingredients in the light of additional information provided by Member States to the European Commission. Clarinol® and Tonalin® TG 80 consist of approximately 80 % of the two CLA isomers c‑9,t‑11 and t-10,c-12 (1:1). The applicants suggested a daily intake of CLA of 3 g (3.75 g Clarinol®) and 3.5 g (4.5 g Tonalin® TG 80), respectively. The Panel considers that the additional information provided does not contain evidence thath would modify its previous conclusions regarding the effects of CLA on insulin sensitivity/glucose metabolism, blood lipids, lipid peroxidation, or subclinical inflammation. The Panel also considers that the new studies provided do not address longer-term (> 6 months) effects of CLA intake on insulin sensitivity, the arterial wall or liver steatosis, or the safety of CLA in type‑2 diabetic subjects, under the proposed conditions of use. The Panel concludes that the safety of Clarinol® and Tonalin® TG 80 has been established for the proposed uses and daily doses for up to six months. The safety of CLA consumption for periods longer than six months has not been established under the proposed conditions of use. The safety of CLA consumption by type‑2 diabetic subjects has not been established.

This Guidance document is intended to provide a method to identify Enterococcus faecium strains belonging to a sub-population of bacteria isolated from clinical specimens. Differentiation is based on susceptibility to ampicillin and the absence of three genetic markers associated with the clinical isolates. In the view of the FEEDAP Panel any strain of E. faecium demonstrating a resistance to ampicillin greater than 2 mg/L or possessing any of the three marker genes should not be used as a feed additive.

In accordance with Article 53 of Regulation (EC) No 1107/2009, France has granted an authorisation for spinetoram on cherries, raspberries and blueberries. In order to accommodate for the emergency use of spinetoram, France proposed to raise the existing MRLs for these crops from the limit of quantification (0.05 mg/kg) to 0.2 mg/kg for cherries and blueberries and 0.8 mg/kg for raspberries. In accordance with Article 8 of Regulation (EC) No 396/2005, France submitted to the European Commission an evaluation report summarising the background information, without reporting details on the residue trials supporting the MRL request. France also performed a consumer risk assessment demonstrating that these proposed temporary MRLs are safe. On 14 May 2012 the evaluation report was forwarded to EFSA. The EFSA concludes that the emergency use of spinetoram on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern. In order to verify assumptions on which the EFSA statement is based, France should update the evaluation report as soon as possible providing detailed information on the supervised field trials on the crops under consideration.

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, herewith referred to as the evaluating Member State (EMS), received an application from the company Technology Crops Ltd. to modify the existing MRL for diquat in borage. The actual proposal is made to accommodate the intended use of diquat on echium (Echium plantagineum), but this crop is not listed in Annex I of Regulation (EC) No 396/2005. Since echium (Echium plantagineum) is of the same family (Boraginaceae)as borage, the EMS proposed to consider it under the same food classification code as borage. Consequently, the MRL proposal would refer to borage and echium (Echium plantagineum). In order to accommodate for the intended use of diquat, the EMS proposed to raise the existing MRL for borage from the limit of quantification (LOQ) of 0.1 mg/kg to 2 mg/kg. The EMS drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA.

EFSA concluded that the quality of the available residue trials does not meet the current quality standards. The residue trials showed deficiencies with regard to the validation of the analytical method used to analyse the samples. Furthermore, the samples were not stored under conditions for which the sample integrity was demonstrated. Considering these uncertainties regarding the residue concentrations measured in the residue trials, EFSA did not derive a MRL proposal for borage and echium to support the intended use. Residue trials compliant with the currently applicable EU guidelines have to be submitted to support the intended use on echium (Echium plantagineum) in the NEU.

Given the long-term exposure concerns identified for the existing EU MRLs for diquat, new uses currently cannot be authorized before a comprehensive review of the existing MRLs has been performed. EFSA also notes that for a future MRL application it would be necessary to provide background information on the existing EU MRLs (GAPs, residue trials, processing studies) which would be required to make a more accurate estimation of the long-term exposure resulting from the existing uses and to derive a sound conclusion on the safety of new MRLs for diquat.

In accordance with Article 6 of Regulation (EC) No 396/2005, Greece, herewith referred as the evaluating Member State (EMS), received an application from Cheminova A/S, on behalf of the Dimethoate Task Force, to modify the existing MRLs for the active substance dimethoate in olives for oil production and table olives. In order to accommodate for the intended use of dimethoate, Greece proposed to raise the existing MRLs in olives from the value of 2 mg/kg to 3 mg/kg. Greece drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive a MRL of 4 mg/kg on table olives and olives for oil production for the intended foliar use of dimethoate in Southern Europe according to the enforcement residue definition as sum of dimethoate and omethoate, expressed as dimethoate. Adequate analytical enforcement methods are available to control the residues of dimethoate and omethoate in olives at the validated LOQ of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concludes that the proposed use of dimethoate on olive trees for oil production and table olives will not result in a consumer exposure exceeding the toxicological reference values. However, the risk assessment in the framework of this opinion should be considered as provisional and may underestimate the actual consumer risk. The final evaluation of the toxicological relevance of metabolites III, XII and XX is still to be provided. To perform a more accurate calculation, the confirmation of the supported authorised use pattern and the results from residue trials conducted according to the final agreed residue definition for risk assessment are needed.

In accordance with Article 6 of Regulation (EC) No 396/2005, France, herewith referred to as the evaluating Member State (EMS), received an application from ISK Biosciences Europe N.V. to modify the existing MRL for the active substance fluazinam in apples. In order to accommodate for the intended use of fluazinam in SEU (Italy), France proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.3 mg/kg. The EMS drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA.

The submitted data are sufficient to derive a MRL proposal of 0.3 mg/kg for the proposed use of fluazinam on apples in the SEU (Italy). An adequate analytical enforcement method is available to control fluazinam residues in apples at the LOQ of 0.01 mg/kg.

EFSA concludes that the intended use of fluazinam on apples will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.

In accordance with Article 18(4) of Regulation (EC) No 396/2005 the request from Germany to raise the maximum residue level (MRLs) for fipronil in poultry fat resulting from an emergency authorisation of fipronil on potatoes in accordance with Article 53 of Regulation (EC) No 1107/2009 was submitted to the European Commission who forwarded the request, the evaluation report and the supporting dossier to EFSA. According to EFSA the use on potatoes is sufficiently supported by residue data to derive an MRL proposal of 0.01 mg/kg. From the livestock feeding studies it becomes evident that the use of fipronil on potatoes requires not only the amendment of the existing MRLs for poultry fat but also for ruminant meat, ruminant fat, ruminant liver, pig meat, pig liver, pig kidney, poultry meat and for milk. The results of the risk assessment show that the dietary exposure of consumers might exceed the toxicological reference value for long-term exposure (ADI). Thus, EFSA concludes that for the use of fipronil on potatoes, which requires the amendment of MRLs for food of animal origin, a potential long-term consumer health risk cannot be excluded, resulting from the residues in animal commodities. Further refinements of the chronic consumer risk assessment or application of risk management options to ensure that the consumer exposure is acceptable are proposed.