EFSA Journal最新文献

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Quillaja saponaria powder and Yucca schidigera powder (Magni-Phi®) for all avian species (to slaughter age/weight, or to the point of lay) and ornamental birds, as a zootechnical additive (digestibility enhancer and other zootechnical additives). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening at the level of 250 mg/kg complete feed with a margin of safety of 20 assuming that the additive contains 3.58% of saponins. This conclusion was extrapolated to all growing poultry species and ornamental birds. The Panel concluded that the use of the feed additive in animal nutrition at 250 mg/kg complete feed is of no concern for the safety for the consumer and the environment. The Panel also concluded that the additive is not irritant to skin, but irritant to the eyes and to the respiratory system. Due to the lack of data, the FEEDAP Panel could not conclude on the skin sensitisation potential of the additive. The FEEDAP Panel was not in the position to conclude on the efficacy of the additive for all poultry species and ornamental birds.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l-tyrosine as a nutritional feed additive. The additive is authorised for use in all animal species (3c401). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, consumers, and the environment. As regards the safety for the user, l-tyrosine is not an irritant to skin or eyes. In the absence of data, the potential of l-tyrosine to be a dermal and respiratory sensitiser cannot be excluded. Exposure by inhalation of persons handling the additive is likely. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and, therefore, there is no need for re-assessing the efficacy.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I-1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 10⁹ CFU per kg of complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non-food-producing animals, an assessment of the safety for the consumer and the environment is not needed. The non-coated form of the additive was shown to be non-irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I-1079 at the proposed conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium ferrocyanide and potassium ferrocyanide as technological feed additives for all animal species. In its previous opinion on the safety and efficacy of the additives, the FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anions (anhydrous)/kg for turkeys for fattening and laying hens and other laying/breeding birds, all porcine species and categories, all ruminant species and categories, rabbits, horses, salmonids and other minor fin fish, dogs and cats. However, the Panel could not conclude on the safety of the additives for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys, and for all species/categories other than the above listed. In the current assessment, the applicant is proposing a maximum content of 60 mg ferrocyanide anions (anhydrous)/kg sodium chloride for chickens for fattening and other poultry species (except turkeys) for fattening or reared for laying/breeding and for all species/categories other than the listed above. The FEEDAP Panel concluded that sodium ferrocyanide and potassium ferrocyanide are safe at a maximum content of 80 mg ferrocyanide anions (anhydrous)/kg sodium chloride for: turkeys for fattening and reared for breeding, laying hens and other laying/breeding birds, all porcine species, all ruminant species, rabbits, equines, salmonids and minor fin fish, dogs and cats. The Panel concluded also that a maximum content of 60 mg ferrocyanide anions (anhydrous)/kg sodium chloride is safe for chickens for fattening and minor poultry species for fattening or reared for laying/breeding and all other animal species.

The food enzyme laccase (benzenediol:oxygen oxidoreductase, i.e. EC 1.10.3.2) is produced with the non-genetically modified Trametes hirsuta strain AE-OR by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in six food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.030 mg TOS/kg body weight (bw) per day in European populations. Using the no observed adverse effect level previously reported (862 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 28,733. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

EFSA performs dietary exposure assessments for food-producing and non-food-producing animals to deliver risk assessment for mandates on the presence of contaminants in feed. The CONTAM and FEEDAP Panels identified the need to update the animal dietary exposure assessment model used in those assessments in CONTAM Scientific Opinions since 2011 in cases where insufficient occurrence data are available on species specific compound feeds. The Panels proposed in this statement a series of model diets based on groups of feed materials with the possibility to use different feed materials in their formulation. The Panels considered that the currently proposed model diets cover the need of the CONTAM Panel to assess the dietary exposure of animals to contaminants in feed.

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation ‘on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625’. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.

The European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of Ceroplastes rubens Maskell (Hemiptera: Coccidae), following the commodity risk assessments of Acer palmatum plants grafted on A. davidii and Pinus parviflora bonsai plants grafted on P. thunbergii from China, in which C. rubens was identified as a pest of possible concern to the European Union (EU). The pest, which is commonly known as the pink, red or ruby wax scale, originates in Africa and is highly polyphagous attacking plants from more than 193 genera in 84 families. It has been present in Germany since 2010 in a single tropical glasshouse. It is known to attack primarily tropical and subtropical plants, but also other host plants commonly found in the EU, such as Malus sylvestris, Prunus spp., Pyrus spp. and ornamentals. It is considered an important pest of Citrus spp. The pink wax scale reproduces mainly parthenogenetically, and it has one or two generations per year. Fecundity ranges from 5 to 1178 eggs. Crawlers settle usually on young twigs and later stages are sessile. All life stages of C. rubens egest honeydew on which sooty mould grows. Host availability and climate suitability suggest that parts of the EU would be suitable for establishment. Plants for planting and cut branches provide the main pathways for entry. Crawlers could spread over short distances naturally through wind, animals, humans or machinery. C. rubens could be dispersed more rapidly and over long distances via infested plants for planting for trade. The introduction of C. rubens into the EU could lead to outbreaks causing damage to orchards, amenity ornamental trees and shrubs. Phytosanitary measures are available to inhibit the entry and spread of this species. C. rubens satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest.

The EFSA Panel on Plant Health performed a pest categorisation of Monema flavescens (Lepidoptera, Limacodidae), following the commodity risk assessment of Acer palmatum plants grafted on A. davidii from China, in which M. flavescens was identified as a pest of possible concern to the European Union. This species can be identified by morphological taxonomic keys and by barcoding. The adults of the overwintering generation emerge from late June to late August. The eggs are laid in groups on the underside of the host-plant leaves, on which the larvae feed throughout their six to eight larval instars. Pupation occurs in ovoid cocoons at the junction between twigs and branches, or on the trunk. Overwintering occurs as fully grown larvae or prepupae in their cocoon. There are one or two generations per year. M. flavescens is polyphagous and feeds on broadleaves; it has been reported on 51 plant species belonging to 24 families. It mainly occurs in Asia (Bhutan, China, the Democratic People's Republic of Korea, Japan, Nepal, the Republic of Korea), Russia (Eastern Siberia) and Taiwan. It is also present in the USA (Massachusetts). The pest's flight capacities are unknown. The main pathway for entry and spread is plants for planting with cocoons attached. This is partially closed by prohibition of some hosts. In several EU member states climatic conditions are conducive for establishment and many host plants are widespread. Introduction of M. flavescens may result in defoliations influencing tree health and forest diversity. The caterpillars also have urticating spines affecting human health. Phytosanitary measures are available to reduce the likelihood of entry, establishment and spread, and there is a definite potential for classical biological control. Recognising that natural enemies prevent M. flavescens being regarded as a pest in Asia, there is uncertainty regarding the magnitude of potential impact in EU depending on the influence of natural enemies. All criteria assessed by EFSA for consideration as a potential quarantine pest are met.

The European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of Coniella castaneicola (Ellis & Everh) Sutton, following commodity risk assessments of Acer campestre, A. palmatum, A. platanoides, A. pseudoplatanus, Quercus petraea and Q. robur plants from the UK, in which C. castaneicola was identified as a pest of possible concern to the EU. When first described, Coniella castaneicola was a clearly defined fungus of the family Schizoparmaceae, but due to lack of a curated type-derived DNA sequence, current identification based only on DNA sequence is uncertain and taxa previously reported to be this fungus based on molecular identification must be confirmed. The uncertainty on the reported identification of this species translates into uncertainty on all the sections of this categorisation. The fungus has been reported on several plant species associated with leaf spots, leaf blights and fruit rots, and as an endophyte in asymptomatic plants. The species is reported from North and South America, Africa, Asia, non-EU Europe and Oceania. Coniella castaneicola is not known to occur in the EU. However, there is a key uncertainty on its presence and geographical distribution worldwide and in the EU due to its endophytic nature, the lack of systematic surveys and possible misidentifications. Coniella castaneicola is not included in Commission Implementing Regulation (EU) 2019/2072 and there are no interceptions in the EU. Plants for planting, fresh fruits and soil and other growing media associated with infected plant debris are the main pathways for its entry into the EU. Host availability and climate suitability in parts of the EU are favourable for the establishment and spread of the fungus. Based on the scarce information available, the introduction and spread of C. castaneicola in the EU is not expected to cause substantial impacts, with a key uncertainty. Phytosanitary measures are available to prevent its introduction and spread in the EU. Because of lack of documented impacts, Coniella castaneicola does not satisfy all the criteria that are within the remit of EFSA to assess for this species to be regarded as potential Union quarantine pest.