Showing papers in "EFSA Journal in 2012"

Scientific Opinion on Dietary Reference Values for protein.

Abstract: This opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) deals with the setting of Dietary Reference Values (DRVs) for protein. The Panel concludes that a Population Reference Intake (PRI) can be derived from nitrogen balance studies. Several health outcomes possibly associated with protein intake were also considered but data were found to be insufficient to establish DRVs. For healthy adults of both sexes, the average requirement (AR) is 0.66 g protein/kg body weight per day based on nitrogen balance data. Considering the 97.5th percentile of the distribution of the requirement and assuming an efficiency of utilisation of dietary protein for maintenance of 47 %, the PRI for adults of all ages was estimated to be 0.83 g protein/kg body weight per day and is applicable both to high quality protein and to protein in mixed diets. For children from six months onwards, age-dependent requirements for growth estimated from average daily rates of protein deposition and adjusted by a protein efficiency for growth of 58 % were added to the requirement for maintenance of 0.66 g/kg body weight per day. The PRI was estimated based on the average requirement plus 1.96 SD using a combined SD for growth and maintenance. For pregnancy, an intake of 1, 9 and 28 g/d in the first, second and third trimesters, respectively, is proposed in addition to the PRI for non-pregnant women. For lactation, a protein intake of 19 g/d during the first six months, and of 13 g/d after six months, is proposed in addition to the PRI for non-lactating women. Data are insufficient to establish a Tolerable Upper Intake Level (UL) for protein. Intakes up to twice the PRI are regularly consumed from mixed diets by some physically active and healthy adults in Europe and are considered safe.

Scientific Opinion on the Tolerable Upper Intake Level of vitamin D

Abstract: Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to re-evaluate the safety in use of vitamin D and to provide, if necessary, revised Tolerable Upper Intake Levels (ULs) of vitamin D for all relevant population groups. The ULs for adults including pregnant and lactating women, children and adolescents were revised. For adults, hypercalcaemia was selected as the indicator of toxicity. In two studies in men, intakes between 234 and 275 μg/day were not associated with hypercalcaemia, and a no observed adverse effect level (NOAEL) of 250 μg/day was established. Taking into account uncertainties associated with these studies, the UL for adults including pregnant and lactating women was set at 100 μg/day. Despite a continuing paucity of data for high vitamin D intakes in children and adolescents, the UL was adapted to 100 μg/day for ages 11-17 years, considering that owing to phases of rapid bone formation and growth this age group is unlikely to have a lower tolerance for vitamin D compared to adults. The same applies also to children aged 1-10 years, but taking into account their smaller body size, a UL of 50 μg/day is proposed. For infants, the UL of 25 μg/day based on previously available data relating high vitamin D intakes to impaired growth and hypercalcaemia was retained as limited additional evidence has emerged since the previous risk assessment. Data on vitamin D intakes from surveys in 14 European countries indicate that intakes in high consumers are below the revised ULs for vitamin D for all population groups. © European Food Safety Authority, 2012

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)

Abstract: 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.

Guidance on the use of probabilistic methodology for modelling dietary exposure to pesticide residues

Abstract: The European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues to provide guidance on methodology for performing probabilistic dietary exposure assessment of single or multiple active substances, as a potential additional tool to supplement or complement the standard deterministic methodologies which are currently used in the EU for conducting dietary exposure assessments for pesticides. Specific guidance is provided for basic assessments but not for refined assessments, where specialised expertise is required to select methods appropriate to the assessment in hand. The guidance includes probabilistic methods for quantifying some of the major sources of variability and uncertainty affecting dietary exposure to pesticides. Other important sources of variability and uncertainty might be quantified probabilistically in refined assessments but are addressed more simply in basic assessments by conducting alternative model runs with optimistic and pessimistic assumptions. Guidance is provided on problem formulation, including definition of appropriate scenarios for acute and chronic exposure assessment in the differing contexts of approval of new substances, MRL setting, authorisation of products, evaluation of residues found above the MRL, and annual reviews of residue monitoring data.

Scientific Opinion on Ergot alkaloids in food and feed

Abstract: The European Food Safety Authority (EFSA) was asked by the European Commission to deliver a scientific opinion on ergot alkaloids (EAs) in food and feed. EAs are produced by several members within the fungal orders of Hypocreales and Eurotiales. In Europe, Claviceps purpurea is the most widespread Claviceps species within the Hypocreales. A total of 20 558 analytical results for EAs in 1 716 food, 496 feed and 67 unprocessed grain samples were considered in this opinion. Based on the EAs identified in sclerotia of C. purpurea, and recent literature data, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) based its risk assessment on the main C. purpurea EAs, namely ergometrine, ergotamine, ergosine, ergocristine, ergocryptine (which is a mixture of a- and s- isomers), ergocornine, and the corresponding –inine epimers. The CONTAM Panel performed estimates of both chronic and acute exposure for various age groups across European countries. A BMDL10 of 0.33 mg/kg b.w. per day was calculated for the incidence of tail muscular atrophy in a 13-week rat feeding study of ergotamine. This effect was considered representative of the vasoconstrictive effects of EAs and provided a suitable reference point for establishment of a group acute reference dose of 1 µg/kg body weight (b.w.) and a group tolerable daily intake of 0.6 µg/kg b.w. per day. The Panel concluded that whilst the available data do not indicate a concern for any population subgroup, the dietary exposure estimates relate to a limited number of food groups and a possible unknown contribution from other foods cannot be discounted. Estimates of exposure for livestock based on example diets and levels of EAs in cereal grains reported suggest that under normal conditions the risk of toxicosis is low.

Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis

Abstract: The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of cisgenic and intragenic plants. The EFSA GMO Panel considers that the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are applicable for the evaluation of food and feed products derived from cisgenic and intragenic plants and for performing an environmental risk assessment and do not need to be developed further. It can be envisaged that on a case-by-case basis lesser amounts of eventspecific data are needed for the risk assessment. The EFSA GMO Panel compared the hazards associated with plants produced by cisgenesis and intragenesis with those obtained either by conventional plant breeding techniques or by transgenesis. The Panel concludes that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants. The Panel is of the opinion that all of these breeding methods can produce variable frequencies and severities of unintended effects. The frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case. Independent of the breeding method, undesirable phenotypes are generally removed during selection and testing programmes by breeders. The risks to human and animal health and the environment will depend on exposure factors such as the extent to which the plant is cultivated and consumed.

Scientific opinion on the substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Abstract: Following an application from Barry Callebaut Belgium nv, 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 (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. Cocoa flavanols are sufficiently characterised. The claimed effect is “help maintain endothelium-dependent vasodilation which contributes to healthy blood flow”. The target population proposed by the applicant is the general healthy adult population. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. In weighing the evidence, the Panel took into account that cocoa flavanols consumed for 12 weeks have been shown to increase fasting ED-FMD significantly in the target population in one human intervention study, that in another study the effect was dose-dependent and occurred after one week of consumption, that the effect was supported by two additional studies, and that it was also observed in two out of three studies in patients under pharmacological treatment for coronary artery disease, although the mechanisms by which regular consumption of cocoa flavanols may induce a sustained effect on fasting ED-FMD are unknown. The Panel concludes that a cause and effect relationship has been established between the consumption of cocoa flavanols and maintenance of normal endothelium-dependent vasodilation. The following wording reflects the scientific evidence: “Cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow”. In order to obtain the claimed effect, 200 mg of cocoa flavanols should be consumed daily. This amount could be provided by 2.5 g of high-flavanol cocoa powder or 10 g of high-flavanol dark chocolate, both of which can be consumed in the context of a balanced diet. The target population is the general population.

Risk assessment of genetically modified organisms (GMOs).

Abstract: EFSA’s remit in the risk assessment of GMOs is very broad encompassing genetically modified plants, microorganisms and animals and assessing their safety for humans, animals and the environment. The legal frame for GMOs is set by Directive 2001/18/EC on their release into the environment, and Regulation (EC) No 1829/2003 on GM food and feed. The main focus of EFSA’s GMO Panel and GMO Unit lies in the evaluation of the scientific risk assessment of new applications for market authorisation of GMOs, and in the development of corresponding guidelines for the applicants. The EFSA GMO Panel has elaborated comprehensive guidance documents on GM plants, GM microorganisms and GM animals, as well as on specific aspects of risk assessment such as the selection of comparators. EFSA also provides special scientific advice upon request of the European Commission; examples are post-market environmental monitoring of GMOs, and consideration of potential risks of new plant breeding techniques. The GMO Panel regularly reviews its guidance documents in the light of experience gained with the evaluation of applications, technological progress in breeding technologies and scientific developments in the diverse areas of risk assessment.

Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other site-directed Nucleases with similar function

Abstract: The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of plants developed using the zinc finger nuclease 3 technique (ZFN-3) which allows the integration of gene(s) in a predefined insertion site in the genome of the recipient species. Since other nucleases with a similar function to ZFN are considered in this opinion the term site-directed nuclease 3 (SDN-3) is used to describe the technique rather than ZFN-3 specifically. The EFSA GMO Panel considers that its guidance documents are applicable for the evaluation of food and feed products derived from plants developed using the SDN-3 technique and for performing an environmental risk assessment. However, on a case-by-case basis lesser amounts of event specific data may be needed for the risk assessment of plants developed using the SDN-3 technique. The EFSA GMO Panel compared the hazards associated with plants produced by the SDN-3 technique with those obtained by conventional plant breeding techniques and by currently used transgenesis. With respect to the genes introduced, the SDN-3 technique does not differ from transgenesis or from the other genetic modification techniques currently used, and can be used to introduce transgenes, intragenes or cisgenes. The main difference between the SDN-3 technique and transgenesis is that the insertion of DNA is targeted to a predefined region of the genome. Therefore, the SDN-3 technique can minimise hazards associated with the disruption of genes and/or regulatory elements in the recipient genome. Whilst the SDN-3 technique can induce off-target changes in the genome of the recipient plant these would be fewer than those occurring with most mutagenesis techniques. Furthermore, where such changes occur they would be of the same types as those produced by conventional breeding techniques.

"Schmallenberg" virus: Analysis of the Epidemiological Data and Assessment of Impact: EFSA-Q-2012-00305

Abstract: This scientific report provides an overall assessment of the impact of the infection on animal health, animal production and animal welfare of the provisionally named “Schmallenberg” virus (SBV) first detected in Germany. In Europe, 3745 holdings have been reported with SBV cases confirmed by laboratory testing across several Member States, mid May 2012. EFSA reviewed the epidemiological reports noting that SBV has been detected in cattle, sheep, goats and a bison. SBV antibodies have been detected in deer and no other species are known to be affected. EFSA also confirms that new studies support the initial assessment undertaken by the European Center for Disease Control and Prevention, that it is very unlikely that SBV poses a risk to humans. In terms of transmission routes, recent entomological investigations have identified SBV in field samples of biting midges of the Culicoides obsoletus group. Currently there is no evidence of any other route of transmission other than transplacental or vector borne routes. EFSA coordinated the collation of SBV epidemiological data during 2011–2012 in order to obtain comparable data for Europe. The maximum proportion of reported sheep holdings with SBV confirmed was 4% per country and 7.6% per region while for cattle less than 1.3 % of holdings were reported as SBV confirmed at both country and regional level. In order to assess the impact of SBV(spatial and temporal spread, proportion of affected holding and potential projection of arthrogryposis hydranencephaly syndrome cases) three models were used. In regions with SBV confirmed holdings, assuming a high prevalence of infection and post infection immunity, impact in the 2012–2013 calving and lambing season should be low. However, assuming SBV survived the winter of 2011, the models suggest that in unaffected regions with suitable temperatures for within herd transmission by vectors and high density of susceptible species (cattle and sheep) SBV infection is likely to spread. EFSA puts forward a number of recommendations to fill the knowledge gaps, these include but are not limited to: continuing serological investigations in affected regions and regions neighbouring affected areas, within herd and animal level impact investigation, monitoring putative vector population, setting SBV host vector transmission parameters, investigating other routes of transmission, host susceptibility, virulence and vulnerable period during gestation. Furthermore, the possible origins of the virus should be investigated as more information becomes available on the virus characteristics and infection epidemiology.

Risk assessment of biological hazards for consumer protection

Abstract: EFSA's scientific Panel on Biological Hazards (BIOHAZ Panel) provides independent scientific advice on biological hazards in relation to food safety and food-borne diseases. This covers food-borne zoonoses, food microbiology, food hygiene, antimicrobial resistance (AMR), transmissible spongiform encephalopathies (BSE/TSEs) and associated waste management issues. Most of the activities of the BIOHAZ Panel focus on human health and the whole food chain and on science-based interventions to lower the risk to consumers. In the future, food-borne disease burden estimations are foreseen to become increasingly relevant. The risk assessments done by the BIOHAZ Panel are in line with the EU (European Union) strategy of one health, include a farm to fork approach and in many cases have a high multidisciplinary component. Whenever possible, the Panel applies this risk assessment framework developed by Codex Alimentarius as a basis for their work on food safety. The outcomes of some of the activities during the last three to four years are presented. From these examples of recent BIOHAZ opinions it can be seen that the work covers different approaches, ranging from quantitative risk assessments over structured qualitative risk assessment/risk ranking to opinions with short deadlines summarising existence knowledge from scientific literature. The approach taken depends on both the terms of reference (ToR) as received from the EC (European Commission), the available data and resources, and last but not least the time frame for the work following the risk managers’ needs.

Scientific Opinion on the substantiation of a health claim related to 3 g/day plant sterols/stanols and lowering blood LDL-cholesterol and reduced risk of (coronary) heart disease pursuant to Article 19 of Regulation (EC) No 1924/2006

Abstract: 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.

Risk assessment of contaminants in food and feed.

Abstract: The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) carries out risk assessment on contaminants in food and feed. The presence of hazardous chemical contaminants or undesirable substances in food and feed is often unavoidable as these substances may occur ubiquitously or are of natural origin. Therefore, human and animal exposure to such substances is also unavoidable. The task of the CONTAM Panel is to assess whether or not exposure to a chemical contaminant in food is likely to be associated with adverse health effects in the European population. Similarly, the Panel assesses if the exposure to a contaminant in feed is likely to be associated with adverse health effects in farm animals, fish and pets in Europe, or to represent a risk to the consumer of foods of animal origin. In contrast to EFSA Panels dealing with regulated substances where inter alia applications are taken into account, the CONTAM Panel relies on scientific information that is in the public domain. EFSA often launches calls for data on occurrence of contaminants in food and feedstuffs where Member States and other interested stakeholders are invited to submit data. Whenever possible and required the CONTAM Panel establishes for a substance a health-based guidance value such as tolerable daily intake. For substances that are both genotoxic and carcinogenic, or for which the data are inadequate to establish a health-based guidance value, the margin of exposure approach is used. Recently the CONTAM Panel also used the threshold of toxicological concern approach. In addition, the CONTAM Panel considers inherent uncertainties in relation to objectives, exposure and hazard characterisation in its risk assessments. During 2003–2012, the CONTAM Panel published 107 scientific outputs (55 on food, 43 on feed, 9 on food and feed).

Scientific Opinion on the use of animal-based measures to assess welfare in pigs

Abstract: 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 animalbased 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.

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on bovine lactoferrin: EFSA-Q-2010-01269

Abstract: Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out the additional assessment of „lactoferrin‟ as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Bovine lactoferrin (bLF) is a protein that occurs naturally in cow‟s milk. The applicant intends to market bLF as an ingredient for food supplements, infant and follow-on formulae, dietetic food for special medical purposes and sports nutrition, and for a variety of foods. For infants with an age of 0 6 months, the applicant has estimated an intake of approximately 200 mg per kg bodyweight and 1.2 g bLF per day at the proposed use level. For adults, the mean and 95 th percentile daily intakes were calculated to be about 1.4 g and 3.4 g for an adult person. The toxicological information provided by the applicant included information from an in vitro genotoxicity study, a single dose study, a four week and a thirteen week oral repeated dose study in rats. The Panel notes that the estimated intake of \"lactoferrin\" for infants up to the age of one year of approximately 210 mg/kg bw per day would be around ten times lower than the highest dose (2,000 mg/kg bw per day) tested in the subchronic thirteen week rat study, which did not show adverse effects related to bLF. For adults above 19 years of age the proposed intake is approximately 100 times lower. This level of anticipated intake is considered a high intake scenario as opposed to a worst-case situation. The data provided suggest the absence of adverse effects of lactoferrin at the proposed levels of consumption. The Panel concludes that the novel food ingredient bLF is safe under the proposed uses and use levels. © European Food Safety Authority, 2012

Scientific Opinion on the safety evaluation of the substance, titanium nitride, nanoparticles, for use in food contact materials

Abstract: This scientific opinion of EFSA deals with the safety evaluation of titanium nitride, nanoparticles with the European Commission REF. No 93485 and FCM substance No 807, for use as additive in PET plastics. A request has been submitted for an extension of use in thermoformed PET sheets/films in addition to the use in PET bottles, evaluated by the EFSA in 2008. Under the intended conditions of use, no migration of the substance into food is expected and therefore no exposure of the consumer via food is expected. Based on this, the CEF Panel concluded that there is no safety concern for the consumer if the substance is used up to 20 mg/kg in only PET plastics intended for contact with all types of foodstuffs under conditions of any duration of time and at temperatures up to and including hot-fill.

Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects

Abstract: 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.

Scientific Opinion on the safety and efficacy of aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers (chemical group 6) when used as flavourings for all animal species

Abstract: 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.

Scientific Opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae

Abstract: On request from the European Commission following an application by Dairy Goat Co-operative (NZ) Ltd, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on the suitability of goat milk protein as a source of protein in infant and follow-on formulae. The Panel considered compositional data of an infant and a follow-on formula made from whole goat milk that retained the natural whey-to-casein ratio of goat milk, data from a double-blind, randomised, controlled, three-centre trial, and a re-analysis of the data of the trial which formed the basis of a previous evaluation of the Panel. A study in 200 Australian infants, randomised to receive an infant formula with unmodified goat milk protein or a cow milk formula exclusively for at least four months and thereafter in addition to complementary food until 12 months did not show statistically significant or clinically relevant differences in weight, length or head circumference development. The growth pattern of formula-fed infants differed, as expected, from that of the WHO growth standard in particular with respect to weight-for-length. The results of this study were supported by the results of the trial considered in the Panel's earlier assessment, in which, however, the sample size was insufficient to draw conclusions. The Panel concludes that protein from goat milk can be suitable as a protein source for infant and follow-on formulae, provided the final product complies with the compositional criteria laid down in Directive 2006/141/EC.

Scientific opinion on public health risks represented by certain composite products containing food of animal origin

Abstract: 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. © European Food Safety Authority, 2012

Scientific Opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of plant protection products in soil

Abstract: Based on consultation with Member States, EFSA asked the Panel to prepare a revision of the Guidance Document on the persistence of plant protection products in soil (SANCO/9188VI/1997 of 12 July 2000) as scientific knowledge in this field has evolved in recent years. Therefore the Panel developed a revised methodology for the assessment of exposure of soil organisms to such products. Based on a previous Opinion of the Panel, this methodology has been developed both for the concentration in total soil and the concentration in the soil pore water. The goal of the exposure assessment has been chosen to be the 90th percentile of the exposure concentration in the intended area of use in each of the three regulatory geographical zones (North, Centre, South). The exposure-assessment methodology is restricted to spray applications to annual crops under conventional or reduced tillage (excluding tillage systems with ridges and furrows). The Panel proposes a tiered approach. Tier 1 is based on a simple analytical model. Tier 2A is based on simulations with numerical models. To keep the approach as simple as possible, the Panel based Tiers 1 and 2A for each regulatory zone on only one scenario each for the concentration in total soil and for that in pore water. These scenarios are to be used for all these annual crops and for all plant protection products in each regulatory zone. Tiers 2B and 2C are also based on the simple analytical model but in these tiers a specific crop or crop group and an individual plant protection product are considered. Tier 3 is based on simulations with numerical models but, as in Tiers 2B and 2C, a specific crop or crop group and a specific plant protection product are considered. All tiers aim to assess the same exposure assessment goal. Given the complexity of the calculations in the different tiers, efficient use of this tiered approach in the regulatory process is impossible without software tools. Therefore the Panel recommends developing user-friendly software tools for the calculation of the exposure concentrations in the different tiers

Scientific Opinion on the evaluation of the pest risk analysis on Pomacea insularum, the island apple snail, prepared by the Spanish Ministry of Environment and Rural and Marine Affairs

Abstract: 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. © European Food Safety Authority, 2012