Animal-based measures, identified on the basis of scientific evidence, can be effectively used in the evaluation of the welfare of dairy cattle on farm in relation to laws, codes of practice, quality assurance schemes and management. Some of these measures are also appropriate for ante-mortem inspection and there are additional post-mortem animal-based measures which can be taken at the slaughterhouse. The validity and reliability of the measures should be known. There do not seem to be any animal welfare issues that can not be addressed using animal-based measures, but there may be practical constraints that make it difficult to use some animal-based measures or which make the use of non-animal-based measures preferable in some situations. Non-animal-based measures can be used when the association between them and the welfare outcome is strong and when they are more efficient than animal-based measures as a means to safeguard welfare. Some animal-based measures are early indicators and can be used to predict those animals at risk of poor welfare. Others can only be used for welfare assessment if collected over a long period, in which case they are best taken from historical records or recording systems. For an overall classification of welfare, a wide range of measures is needed. However, it is unnecessary to use all animal-based measures on every occasion. The choice of animal-based measures will depend upon the specific objectives of the assessment. The full list is comparable to a ‘toolbox’, from which the appropriate range of measures can be selected. The Welfare Quality^® protocol provides information on the majority of the welfare outcomes of the main hazards identified in the EFSA Scientific Opinions but not those where time limitation prevents it. The extent to which short-term management can prevent the negative effects of hazards arising from genetic selection, and of most housing-related problems, is extremely limited. Herd monitoring and surveillance programmes should be implemented within the dairy industry using a range of appropriate animal-based measures in order to document welfare changes over time. There should be both initial and ongoing training of assessors to ensure valid and reliable welfare measurement.

Animal-based measures, identified on the basis of scientific evidence, can be used effectively in the evaluation of the welfare of on-farm pigs in relation to laws, codes of practice, quality assurance schemes and management. Some of these measures are also appropriate for ante-mortem inspection and there are additional post-mortem animal-based measures which can be taken at the slaughterhouse. Non-animal-based measures can be used when the association between them and the welfare outcome is strong and when they are more efficient than animal-based measures as a means to safeguard welfare. Both animal-based and non-animal-based measures can be useful predictors of welfare in pigs. In order to assess welfare, a wide range of measures is needed. However, to assess aspects of welfare it is unnecessary to use all animal-based measures on every occasion. The choice of animal-based measures will depend upon the specific objectives of the assessment. The full list is comparable to a ‘toolbox’, from which the appropriate range of measures can be selected. The Welfare Quality^® protocol provides information on the majority of the welfare outcomes of the main hazards identified in the EFSA Scientific Opinions but not those where time limitation prevents it. There are currently insufficient animal-based measures to use as welfare outcome indicators on-farm or in the slaughterhouse to assess the issues of pain, frustration and other positive and negative emotional states. The extent to which short-term management can prevent the negative effects of hazards arising from genetic selection, and of most housing-related problems, is extremely limited. Herd monitoring and surveillance programmes should be implemented within the pig industry using a range of appropriate animal-based measures to document welfare changes over time. There should be both initial and ongoing training of assessors to ensure valid and reliable welfare measurement.

The European Commission requested the Panel on Plant Health to deliver a scientific opinion on the phytosanitary risk of plants (other than fruits and seeds) of Pinus pinea and of the genera Chamaecyparis, Cryptomeria and Juniperus for the spread of pine wood nematode (PWN) via movement of infested plants or untreated plant products or by supporting natural spread of PWN in conjunction with European species of the vector. The Panel analysed the data submitted by Portugal regarding surveys on the Tróia Peninsula where P. pinaster and P. pinea co-occur, and the related laboratory results of Naves et al. (2006) on feeding and oviposition preferences of Monochamus galloprovincialis. The Panel also undertook a comprehensive review of the literature. The zero infestation of PWN recorded on P. pinea on the Tróia Peninsula was not significantly different from the result for P. pinaster, because of the small P. pinea sample. Hence, the conclusion that P. pinea is not a host plant for PWN is not supported by the data submitted, principally because of low statistical confidence arising from the few P. pinea trees present. Moreover, the limited presence of P. pinea in the study areas means that the results are representative neither of the Tróia Peninsula nor of other parts of Portugal. Naves et al. (2006) recorded some oviposition by M. galloprovincialis on P. pinea, but less than on other hosts. No differences in feeding of M. galloprovincialis on P. pinaster and P. pinea were detected, thus potentially allowing PWN transmission to trees by this route. The available information regarding the genera Chamaecyparis, Cryptomeria and Juniperus as potential hosts of Monochamus spp. and PWN suggests overall a low susceptibility to PWN or its vectors; the uncertainty concerning PWN is high and would require supplementary research.

The Panel considers the Spanish pest risk analysis (PRA) to be clear and to provide appropriate supporting evidence. However, (i) the environmental impact assessment is incomplete and (ii) the estimates for the potentially endangered area are too limited. The Panel points out that large areas of the European Union have climatic conditions, that are very similar to those of the areas of native distribution of Pomacea spp. snails, and suitable host plants are available. The Panel agrees with the Spanish PRA on the following points with regard to the risk assessment area: (i) the potential consequences of the organism for rice crops are major; (ii) the probability for establishment of the organism is very likely and (iii) the probability of spread is estimated as likely. The Panel disagrees with the Spanish PRA on the following points and considers (i) the effects on the environment to be massive under suitable environmental conditions in the PRA area and (ii) the probability of entry of the organism to be high. Regarding risk reduction options the Panel agrees with the Spanish PRA that no single risk reduction method is sufficient to halt the introduction and spread of Pomacea spp. snails in the PRA area. However, a legislative ban on import of Pomacea spp. is the only risk reduction option identified that can reduce the probability of entry. The many other risk reduction options listed will help to reduce the probability of spread within the PRA area. The Panel considers that the risk reduction options should target the canaliculata complex, as Pomacea insularum and P. canaliculata, as well as other species from the complex, are almost indistinguishable. This is of particular importance for risk reduction options addressing both breeding and trade of the organism.

NoV is highly infectious, and there is no threshold infectivity limit for NoV detected by PCR. The probability of becoming infected increases with the dose but depends also on the characteristics of the organism, the food matrix and the host factors. The relationship between the number of infectious virus particles and the number of virus genome copies detected by quantitative PCR is not a constant, and it is important to realise that the infectious risk associated with low level positive oysters as determined by real-time PCR may be overestimated.

Quantitative data on viral load from areas compliant with current EU legislative requirements (E. coli standards) during January-March 2010 in 3 selected member states, show that a viral limit of 100, 200, 500, 1000 or 10.000 NoV PCR copies would result in 33.6-88.9%, 24.4-83.3%, 10.0-72.2%, 7.7-44.4% or 0-11.1% of non-compliant batches, respectively. Compliance with any of the above NoV limits would reduce the number of contaminated oysters placed on the market and therefore the risk for consumers to become infected. It is currently not possible to quantify the public health impact of different limits.

Microbiological criteria for NoV in oysters are useful for validation and verification of HACCP-based processes and procedures, and can also be used by competent authorities as an additional control to improve risk management in production areas, during processing and retail. The Panel recommended that risk managers should consider establishing an acceptable limit for NoV in oysters to be harvested and placed on the market. NoV testing of oysters (standardized CEN method) should be used to verify compliance with the acceptable NoV limit established.

The most effective public health measure to control human NoV infection from oyster consumption is to produce oysters from areas which are not faecally contaminated, particularly given the ineffectiveness of current depuration and relaying procedures.

The additive Ronozyme^® HiPhos M/L is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. It is intended to be used as a zootechnical feed additive for poultry and pigs. The final enzyme preparation contains no cultivable production organisms or recombinant DNA, given the limits of detection. Based on the trials provided, it was concluded that Ronozyme^® HiPhos is safe for chickens for fattening, turkeys for fattening, laying hens, weaned piglets and sows when used at the maximum recommended dose. This conclusion can be extended to all poultry species and pigs for fattening. The fermentation product is non-genotoxic and there are no concerns for consumer safety. It is not an irritant to skin or eye but in the absence of data should be treated as a skin sensitiser. Since the additive is practically dust free, respiratory exposure from the solid preparation is unlikely. The liquid formulation is only used in contained environments. The active substance of Ronozyme^® HiPhos M/L is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risks for the environment are expected and no further environmental risk assessment is required. The additive has the potential to improve phosphorus utilization in all poultry at the minimum dose of 500 FYT/kg complete feed, as demonstrated in short-term trials with chickens and turkeys for fattening, and laying hens. Improved phosphorus utilization was also seen in weaned piglets and pigs for fattening at the minimum dose of 500 FYT/kg complete feed, and at the minimum dose of 1000 FYT/kg complete feed for sows. The use of the additive allows the use of diets with a lower level of inorganic phosphorus, which may in turn reduce the excretion of phosphorus.

Isoeugenol is a flavouring compound belonging to chemical group 17, defined as ‘propenylhydroxybenzenes’. The additive is currently authorised for use as flavour in food and is naturally found in various herbs and plants. The use of isoeugenol as a flavour in feed for fish and other aquatic species is contra-indicated. The range of use levels of 1 to 5 mg/kg feed proposed by the applicant for isoeugenol is safe for all animal species (except fish) with a margin of safety in the range of 1 to 4. Considering the low margin of safety, the simultaneous administration of isoeugenol in feed and water for drinking for poultry should be avoided. The use of isoeugenol as flavour in non-dairy mammals up to the highest use levels proposed in feed is safe for the consumer. However, the lack of data on metabolism and residues in all other species and categories precludes an assessment of consumer exposure from these sources. No data on the safety for the user was provided. Based on the information available in the literature, the FEEDAP Panel considered isoeugenol as an irritant to the respiratory system, skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal nutrition at the levels proposed is expected to be safe for the environment. Since isoeugenol is used in food as flavouring, and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

The additive Quantum^TM is an enzyme preparation containing 6-phytase produced by fermentation of a genetically modified strain of the yeast Pichia pastoris. The efficacy and safety of this product for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned), including the assessment of the safety for the consumer, the user and the environment as well as the safety aspects of the genetic modification, have already been previously assessed by EFSA. The applicant is now asking for a modification of the terms of authorisation of the feed additive when used in turkeys for fattening, by reducing the minimum recommended dose from 1000 FTU/kg to 500 FTU/kg. Based on the results obtained in three studies, the FEEDAP Panel concluded that the additive Quantum^TM has the potential to improve phosphorus utilisation in turkeys for fattening at the minimum dose of 500 FTU/kg.

Potassium diformate (KDF preservative) is currently authorised as preservative for raw fish for feed use in all animal species. EFSA already issued an opinion on the safety and efficacy of potassium diformate when used as a preservative for raw fish and fish by-products for feed use in all animal species. The FEEDAP Panel concluded that the additive (i) is safe for the target species, the consumer and the environment when used under the proposed conditions, (ii) is an eye irritant and (iii) has the potential to increase the storage time of raw fish and fish by-products for feed use, in a dose-dependent manner at low temperature. The FEEDAP Panel is not aware of any new information that would lead it to reconsider its former position.

The additive Actisaf Sc47 is a microbiological feed additive consisting only of dried cells of Saccharomyces cerevisiae. The applicant has requested the re-evaluation of the product when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for rabbits for fattening and the extension of use in diets for non food-producing rabbits at the inclusion rate of 5 x 10⁹ CFU/kg feedingstuffs. S. cerevisiae is a species which is considered by EFSA to be suitable for the QPS approach to safety assessment. As the identity of the active agent has been established, the use of Actisaf Sc47 can be presumed safe for the target species, consumers and the environment. Actisaf Sc47 is non-irritant to skin. Given the absence of particles of inhalable size and the virtual absence of dust, exposure and therefore sensitisation via a respiratory route is not to be expected. Three trials performed with weaned rabbits showed the potential of Actisaf Sc47 to reduce mortality when used in diets at a dose of 5 x 10⁹ CFU/kg feed. A similar effect can be expected in non food-producing rabbits.

The additive rosemary extract liquid of natural origin is intended to be used as a technological additive (antioxidant) in feed for dogs and cats. The FEEDAP Panel assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered several aspects of the characterisation of the additive, the safety of the additive for the target species and its efficacy. The applicant has failed to provide the additional information even after several requests by EFSA. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive rosemary extract liquid of natural origin as a technological additive for dogs and cats.

The two strains of Lactobacillus plantarum are each intended for use as technological additives to improve the ensiling process at a proposed dose of 1 x 10⁹ CFU/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the QPS approach to safety assessment. As the identity of the strains have been established and no antibiotic resistance detected, the use of the strains in the production of silage is considered safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Given the proteinaceous nature of the active agents and its high dusting potential, the additives should be considered to have the potential to be skin and respiratory sensitisers. Three studies with laboratory-scale silos are described, each lasting 90 days, involving both strains of L. plantarum used individually and made with tall fescue, red clover and lucerne with different water-soluble carbohydrate content, representing material easy to ensile, moderately difficult to ensile and difficult to ensile. In each case, replicate silos containing treated forage were compared to identical silos containing the same untreated forage. Both additives consistently showed the potential to improve the production of silage by increasing the preservation of dry matter and reducing the loss of protein.

This document provides guidance for the risk assessment of food and feed containing, consisting of or produced from genetically modified (GM) animals, as well as for the health and welfare assessment of these animals, within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The assessment strategy seeks to deploy appropriate approaches to compare GM animals and derived food and feed with their respective comparators. The health status of a food/feed producing animal has traditionally been considered as an important indicator of the safety of derived foods/feed and therefore comparative analysis of the phenotypic characteristics of the GM animal with the traditionally-bred animal, including health and physiological parameters, is considered an important component in the risk assessment. The document addresses the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the possible impact of biologically relevant change(s) in the GM animal and/or derived food and feed, the allergenicity assessment of the novel protein(s), as well as of the whole food derived from the GM animal; and the nutritional assessment to evaluate whether food and feed derived from a GM animal is as nutritious to humans and/or animals as food and feed derived from traditionally-bred animals. This guidance document also addresses the scientific requirements for the assessment of health and welfare of GM animals bred for food and feed use. The assessment is made in terms of the effective functioning of their body systems in a given environment. The document does not cover the environmental risk assessment of GM animals, which will be addressed in stand-alone guidance under development by the EFSA GMO Panel.

The document provides methodological guidance to assess risks for animal welfare, considering the various husbandry systems, management procedures and the different animal welfare issues. The terminology for the risk assessment of animal welfare is described. Risk assessment should not be carried out unless the relevant welfare problem is clearly specified and formulated. The major components of the problem formulation are the description of the exposure scenario, the target population and the conceptual model linking the relevant factors of animal welfare concern. The formal risk assessment consists of exposure assessment, consequence characterisation, and risk characterisation. The systematic evaluation of the various aspects and components of the assessment procedure aims at ensuring its consistency. All assumptions used in problem formulation and risk assessment need to be clear. This also applies to uncertainty and variability in the various steps of the risk assessment. The choice between qualitative, semi-qualitative or quantitative approaches should be made based on the purpose or the type of questions to be answered, data, and resource availability for a specific risk assessment. Quantitative data should be used whenever possible. Positive effects on welfare (benefit) could be handled within the framework of risk assessment if the analysis considers factors as having both positive and negative effects on animal welfare. The last section details the main components of risk assessment documentation.

Cadmium can cause kidney failure and has been statistically associated with an increased risk of cancer. Food is the dominating source of human exposure in the non-smoking population. The Joint FAO/WHO Expert Committee on Food Additives established a provisional tolerable monthly intake of 25 µg/kg body weight, whereas the EFSA Panel on Contaminants in the Food Chain nominated a tolerable weekly intake of 2.5 µg/kg body weight to ensure sufficient protection of all consumers. To better identify major dietary sources, cadmium levels in food on the European market were reviewed and exposure estimated using detailed individual food consumption data. High levels of cadmium were found in algal formulations, cocoa-based products, crustaceans, edible offal, fungi, oilseeds, seaweeds and water molluscs. In an attempt to calculate lifetime cadmium dietary exposure, a middle bound overall weekly average was estimated at 2.04 µg/kg body weight and a potential 95^th percentile at 3.66 µg/kg body weight. Individual dietary survey results varied between a weekly minimum lower bound average of 1.15 to a maximum upper bound average of 7.84 µg/kg body weight and a minimum lower bound 95^th percentile of 2.01 and a maximum upper bound 95^th percentile of 12.1 µg/kg body weight reflecting different dietary habits and survey methodologies. Food consumed in larger quantities had the greatest impact on dietary exposure to cadmium. This was true for the broad food categories of grains and grain products (26.9%), vegetables and vegetable products (16.0%) and starchy roots and tubers (13.2%). Looking at the food categories in more detail, potatoes (13.2%), bread and rolls (11.7%), fine bakery wares (5.1%), chocolate products (4.3%), leafy vegetables (3.9%) and water molluscs (3.2%) contributed the most to cadmium dietary exposure across age groups. The current review confirmed that children and adults at the 95^th percentile exposure could exceed health-based guidance values.

European scenarios for exposure of soil organisms to Plant Protection Products are currently not available (EFSA Panel on Plant Protection Products and their Residues (PPR), 2010). In this document, the parameterisation of realistic worst-case scenarios for Tier-1 and Tier-2A simulations is described which are part of a tiered approach. The aim of this scheme is to assess such Predicted Environmental Concentrations (PEC), chosen to be the 90th spatial percentile, resulting from the use of the plant protection product. In order to account for the uncertainty in substance and soil properties, the Tier-2A scenarios are combinations of soil and climatic properties within a zone, for which the predicted concentration is equal to the 95th percentile of all concentrations within the area of annual crops. The selected soil profiles are based on digitised information from topsoil (organic matter and texture) combined with calculated average soil profiles available in the SPADE-1 database. The daily weather information for the scenarios is taken from the MARS database using the period 1990-2009. In order to have a sufficient overview on the differences between simulations performed with the analytical Tier-1 model and the numerical Tier-2A models, PEARL and PELMO test runs are performed covering all relevant substance properties and all evaluation depths. For each of the total-soil scenarios, both models simulate nearly the same concentration. Small differences between PEARL and PELMO can be found for the pore-water scenarios due to differences in the calculation of soil moisture contents. The comparison with the analytical model shows that Tier-1 concentrations are usually above the respective Tier-2A concentrations in accordance with the philosophy of the tiered assessment scheme. However, due to the different handling of soil moisture, Tier-1 simulations may occasionally give concentrations below those of Tier 2A, which occurrence necessitates additional calibration using special model-adjustment factors.