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Just Published: February, 2016

Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel

Chemical group 14 for all animal species

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
EFSA Journal 2016;14(2):4389 [19 pp.].
doi
10.2903/j.efsa.2016.4389
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 18 compounds belonging to chemical group 14 (furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms). They are currently authorised as flavours in food. This opinion concerns 13 compounds from this group. The FEEDAP Panel concludes that all compounds except 5‑methylfurfural are safe at the proposed maximum use level for all animal species: furfural and furfuryl alcohol at 5 mg/kg complete feed; methyl 2‑furoate and furfuryl acetate at 0.5 mg/kg complete feed; bis‑(2-methyl-3-furyl) disulfide, furanmethanethiol, S‑furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2‑methylfuran-3-thiol, methyl furfuryl disulfide and methyl 2‑methyl-3-furyl disulfide at 0.05 mg/kg complete feed. 5‑Methylfurfural is safe at the proposed use level of 0.5 mg/kg complete feed for cattle, salmonids and non-food producing animals and at the use level of 0.3 mg/kg complete feed for pigs and poultry. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and freshwater environments. Since all the compounds under assessment 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. In the absence of data on the stability in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

Copper complexes of chlorophylls and copper complexes of chlorophyllins for several animal species

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
EFSA Journal 2016;14(2):4391 [17 pp.].
doi
10.2903/j.efsa.2016.4391
Abstract

Copper complexes of chlorophylls are applied as colourants used for ornamental fish, grain-eating ornamental birds and small rodents (subgroup: substances which favourably affect the colour of ornamental fish or birds). Copper complexes of chlorophyllins are applied as a colourant to add colour to feedingstuffs of cats and dogs and all animal species and for all animal species for use in certain groups of feed materials. In the absence of adequate data on absorption, distribution, metabolism and excretion, genotoxicity, subchronic and chronic toxicity, carcinogenicity, and reproductive and developmental toxicity of copper  complexes of chlorophyllins, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of this additive for the consumer. No data on the tolerance of target animals were provided. In the absence of adequate toxicological data that would allow deriving a no observed adverse effect level (NOAEL) and to exclude the genotoxic potential, the FEEDAP Panel could not conclude on the safety of copper complex of chlorophylls and copper complex of chlorophyllins for the target animals. In the absence of data the FEEDAP Panel cannot conclude on the safety for the user of the additives. No risks to the environment are expected from the use of copper complexes of chlorophylls or copper complexes of chlorophyllins in animal nutrition. The FEEDAP Panel is not in the position to conclude (i) on the efficacy of copper complexes of chlorophylls to colour ornamental fish, grain-eating ornamental birds and small rodents, and (ii) on the concentrations of copper complexes of chlorophylls and of chlorophyllins necessary to visibly colour feed of cats and dogs, ornamental birds, small rodents and certain feed materials for all animal species.

Pyridine, pyrrole and quinoline derivatives (CG 28) for all animal species

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
EFSA Journal 2016;14(2):4390 [19 pp.].
doi
10.2903/j.efsa.2016.4390
Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of nine compounds belonging to chemical group 28 (pyridine, pyrrole and quinoline derivatives). They are currently authorised as flavours in food. The FEEDAP Panel concludes that piperine, 3-methylindole, indole, 2-acetylpyridine and 2-acetylpyrrole are safe at the proposed maximum use level of 0.5 mg/kg complete feed for all animal species; trimethyloxazole, 3‑ethylpyridine, pyrrolidine and 2,6-dimethylpyridine are safe at the proposed use level of 0.5 mg/kg complete feed for cattle, salmonids and non-food-producing animals, and at the use level of 0.3 mg/kg complete feed for pigs and poultry. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact, and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and fresh water environments. As all the compounds under assessment 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. In the absence of data on the stability in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

RONOZYME® NP for pigs for fattening

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
EFSA Journal 2016;14(2):4392 [10 pp.].
doi
10.2903/j.efsa.2016.4392
Abstract

The additive RONOZYME® NP is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. This product is authorised in the European Union as a feed additive for poultry, weaned piglets, pigs for fattening and sows. The authorisation of RONOZYME® NP for use in pigs for fattening is at a minimum dose of 1,500 FYT/kg feed (recommended range 1,500–3,000 FYT/kg feed). The applicant requested to modify the terms of the authorisation for this species/category of animals, by lowering the minimum recommended dose from 1,500 to 1,000 FYT/kg feed. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded in previous assessments that the additive is safe for the target species, the consumers and the environment, and that the solid forms of the additive are regarded as dermal and eye irritants and all forms are assumed to be respiratory sensitisers. The reduction in the dose proposed would not change the previous conclusions regarding the safety for the target animals, consumer, user and environment. Three trials carried out with growing pigs were submitted in order to support the efficacy at the new recommended dose. In all the trials faecal apparent digestibility of phosphorus was measured, retention was measured only in one trial. The demonstration of efficacy for a phytase requires three studies showing positive and significant effects on the retention of phosphorus. In the trials submitted, the phosphorus retention was studied only in one trial; consequently the efficacy at the newly recommended dose was not demonstrated.

Ecological recovery in ERA

EFSA Scientific Committee
Simon More, Alicja Mortensen, Antonia Ricci, Vittorio Silano, Katrine Helle Knutsen, Guido Rychen, Hanspeter Naegeli, Dominique Turck, Michael John Jeger, Colin Ockleford, Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Hubert Noteborn, Josef R. Schlatter, Roland Solecki
EFSA Journal 2016;14(2):4313 [85 pp.].
doi
10.2903/j.efsa.2016.4313
Abstract

EFSA performs environmental risk assessments (ERAs) for single potential stressors such as plant protection products, genetically modified organisms and feed additives and for invasive alien species that are harmful for plant health. In this risk assessment domain, the EFSA Scientific Committee recognises the importance of more integrated ERAs considering both the local and landscape scales, as well as the possible co-occurrence of multiple potential stressors that fall under the remit of EFSA, which are important when addressing ecological recovery. In this scientific opinion, the Scientific Committee gathered scientific knowledge on the potential for the recovery of non-target organisms for the further development of ERA. Current EFSA guidance documents and opinions were reviewed on how ecological recovery is addressed in ERA schemes. In addition, this scientific opinion is based on expert knowledge and data retrieved from the literature. Finally, the information presented in this opinion was reviewed by experts from the relevant EFSA Panels, European risk assessment bodies and through an open consultation requesting input from stakeholders. A conceptual framework was developed to address ecological recovery for any assessed products, and invasive alien species that are harmful for plant health. This framework proposes an integrative approach based on well-defined specific protection goals, scientific knowledge derived by means of experimentation, modelling and monitoring, and the selection of focal taxa, communities, processes and landscapes to develop environmental scenarios to allow the assessment of recovery of organisms and ecological processes at relevant spatial and temporal scales.

Endangered species in ERA

EFSA Scientific Committee
Simon More, Alicja Mortensen, Antonia Ricci, Vittorio Silano, Katrine Helle Knutsen, Guido Rychen, Hanspeter Naegeli, Dominique Turck, Michael John Jeger, Colin Ockleford, Diane Benford, Thorhallur Halldorsson, Anthony Hardy, Hubert Noteborn, Josef R. Schlatter, Roland Solecki
EFSA Journal 2016; 14(2):4312 [124 pp.].
doi
10.2903/j.efsa.2016.4312
Abstract

The EFSA performs environmental risk assessment (ERA) for single potential stressors such as plant protection products, genetically modified organisms and feed additives, and for invasive alien species that are harmful to plant health. This ERA focusses primarily on the use or spread of such potential stressors in an agricultural context, but also considers the impact on the wider environment. It is important to realise that the above potential stressors in most cases contribute a minor proportion of the total integrated pressure that ecosystems experience. The World Wildlife Fund listed the relative attribution of threats contributing to the declines in animal populations as follows: 37% from exploitation (fishing, hunting, etc.), 31% habitat degradation and change, 13% from habitat loss, 7% from climate change, and only 5% from invasive species, 4% from pollution and 2% from disease. In this scientific opinion, the Scientific Committee gathered scientific knowledge on the extent of coverage of endangered species in current ERA schemes that fall under the remit of EFSA. The legal basis and the relevant ecological and biological features used to classify a species as endangered are investigated. The characteristics that determine vulnerability of endangered species are reviewed. Whether endangered species are more at risk from exposure to potential stressors than other nontarget species is discussed, but specific protection goals for endangered species are not given. Due to a lack of effect and exposure data for the vast majority of endangered species, the reliability of using data from other species is a key issue for their ERA. This issue and other uncertainties are discussed when reviewing the coverage of endangered species in current ERA schemes. Potential tools, such as population and landscape modelling and trait-based approaches, for extending the coverage of endangered species in current ERA schemes, are explored and reported.

Reasoned Opinions

Setting of import tolerances for fenpyrazamine in cane fruits and blueberries

European Food Safety Authority
EFSA Journal 2016;14(2):4384 [20 pp.].
doi
10.2903/j.efsa.2016.4384
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Austria received an application from the company Sumitomo Chemical Agro Europa S.A.S. to set maximum residue limits (MRLs) for fenpyrazamine in blueberries and cane fruits in support of the import of these berries from the United States. Austria drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the submitted supervised residue trials are sufficient to derive a MRL proposal of 4 mg/kg in blueberries. From a combined residue data set on blackberries and raspberries a MRL of 5 mg/kg is derived for the whole group of cane fruits. Adequate analytical enforcement methods are available. Based on the risk assessment results, EFSA concludes that the authorized use of fenpyrazamine in the United States on blueberries and cane fruits will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of the existing maximum residue level for pyriproxyfen in bananas

European Food Safety Authority
EFSA Journal 2016;14(1):4387 [18 pp.].
doi
10.2903/j.efsa.2016.4387
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Spain, received an application from Cheminova Agro S.A. to modify the existing maximum residue level (MRL) for the active substance pyriproxyfen in bananas. In order to accommodate for the intended use of pyriproxyfen, Spain proposed to raise the existing MRL from the limit of quantification of 0.05 mg/kg to 0.5 mg/kg. According to EFSA the data are sufficient to derive a MRL proposal of 0.7 mg/kg for the proposed use on bananas. Adequate analytical enforcement methods are available to control the residues of pyriproxyfen in banana. Based on the risk assessment results, EFSA concludes that the proposed use of pyriproxyfen on banana will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Review of the existing MRLs for bitertanol

European Food Safety Authority
EFSA Journal 2016;14(2):4386 [15 pp.].
doi
10.2903/j.efsa.2016.4386
Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance bitertanol. Although this active substance is no longer authorised within the European Union due to certain impurities of unknown toxicological relevance, MRLs established by the Codex Alimentarius Commission (CXLs) are still in place. Based on lacking toxicological characterisation of the impurities, it was not possible for EFSA to perform an assessment of these CXLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses. 

Scientific Reports of EFSA

EUSR on AMR in zoonotic and indicator bacteria from humans, animals and food 2014

European Food Safety Authority
EFSA Journal 2016;14(2):4380 [207 pp.].
doi
10.2903/j.efsa.2016.4380
Abstract

The data on antimicrobial resistance in zoonotic and indicator bacteria in 2014, submitted by 28 EU Member States (MSs), were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter species from humans, animals and food, and resistance in indicator Escherichia coli as well as meticillin-resistant Staphylococcus aureus in animals and food was assessed. ‘Microbiological’ resistance was assessed using epidemiological cut-off (ECOFF) values; for some countries, quantitative data on human isolates were interpreted in a way which corresponds closely to the ECOFF-defined ‘microbiological’ resistance. In Salmonella from humans, high proportions of isolates were resistant to ampicillin, sulfonamides and tetracyclines, whereas resistance to third-generation cephalosporins and to fluoroquinolones remained generally low, although it was markedly higher in some serovars commonly associated with broilers and turkeys. In Salmonella and Escherichia coli isolates from broilers, fattening turkeys and meat thereof, resistance to ampicillin, (fluoro)quinolones, tetracyclines and sulfonamides was frequently detected, whereas resistance to third-generation cephalosporins was uncommon. For the first time, presumptive extended spectrum beta-lactamase (ESBL)-/AmpC-/carbapenemase production in Salmonella and Escherichia coli was monitored in poultry. The occurrence of ESBL-/AmpC-producers was low, and carbapenemase-producers were not detected. Resistance to colistin was observed at low levels in Salmonella and Escherichia coli from poultry and meat thereof. In Campylobacter from humans, a high to very high proportion of isolates were resistant to ciprofloxacin and tetracyclines, whereas resistance to erythromycin was low to moderate. Resistance to fluoroquinolones in some MSs was extremely high; in such settings, the effective treatment options for human enteric Campylobacter infection may be significantly reduced. High resistance to ciprofloxacin and tetracyclines was observed in Campylobacter isolates from broilers and broiler meat, whereas much lower levels were recorded for erythromycin. Co-resistance to critically important antimicrobials in both human and animal isolates was generally uncommon, but very high to extremely high MDR levels were observed in some Salmonella serovars. A minority of Salmonella isolates from animals belonging to a few serovars (notably Kentucky and Infantis) exhibited high-level resistance to ciprofloxacin. 

Update of a database of host plants of Xylella fastidiosa: 20 November 2015

European Food Safety Authority
EFSA Journal 2016;14(2):4378 [40 pp.].
doi
10.2903/j.efsa.2016.4378
Abstract

Following a request from the European Commission, EFSA was tasked to periodically update its database of host plants of Xylella fastidiosa which was published in April 2015. An extensive literature search approach was used for updating the database in order to catch all new scientific developments published on the topic. Furthermore, the outputs of investigations conducted on host plants affected by X. fastidiosa in the Italian and French outbreaks were included. Literature screening and data extraction were performed using the Distiller platform. The protocol and the guideline applied for the Extensive Literature Search and for the update of the database are described in this report. The current version of the database includes reports of hosts of X. fastidiosa published up to 20 November 2015. The current list of X. fastidiosa host plant species consists of 359 plant species (including hybrids) from 204 genera and 75 different botanical families. Compared to the previous database, 44 new species and 2 new hybrids, 15 new genera and 5 new families were found. The majority of the additional species (70%) were reported in Apulia, Corsica and southern France.

BSE monitoring Croatia

European Food Safety Authority
Ana Allende, Declan Bolton, Marianne Chemaly, Robert Davies, Pablo Salvador Fernández Escámez, Rosina Gironés, Lieve Herman, Kostas Koutsoumanis, Roland Lindqvist, Birgit Nørrung, Antonia Ricci, Lucy Robertson, Giuseppe Ru, Moez Sanaa, Marion Simmons, Panagiotis Skandamis, Emma Snary, Niko Speybroeck, Benno Ter Kuile, John Threlfall, and Helene Wahlström.
EFSA Journal 2016;14(2):4399
doi
10.2903/j.efsa.2016.4399
Abstract

On 22 January 2015, Croatia submitted to the European Commission (EC) a request to revise its bovine spongiform encephalopathy (BSE) monitoring programme. The EC requested the European Food Safety Authority (EFSA) to provide scientific and technical assistance on an assessment of the capacity of the proposed revised monitoring programme in Croatia to allow the detection of BSE, both classical and atypical strains, with a design prevalence of at least one case per 100,000 animals in the adult cattle population of the EU26 group (EU25 and Croatia). Under this revision Croatia would stop testing all healthy slaughtered cattle and would test all ‘at risk’ cattle of active surveillance above 36 months of age. The EC resolved that the EU26 should be considered as a unique epidemiological unit for this assessment. Data related to the EU26 were updated to run the Cattle Transmissible Spongiform Encephalopathies Monitoring Model (C-TSEMM), previously applied to similar assessments. This model allows the estimation of the design prevalence of the same surveillance regime applied by a group of countries. Using data up to 2014, the current EU25 surveillance regime would allow the detection of BSE in the EU25 with a design prevalence of at least 1 per 3,769,555 of the cattle adult population, lower (i.e. more sensitive) than the minimum requirement of 1 case per 100,000. The addition of Croatia to the EU25 epidemiological unit (EU26) assuming the current EU25 surveillance regime resulted in an ability in EU26 to detect BSE with a design prevalence of at least 1 per 3,789,838 of the adult cattle population. It is recommended: [1] to run the C-TSEMM model on an annual basis with updated data; [2] to monitor MS data in order to evaluate the surveillance coverage and [3] to identify any shortcomings affecting the overall sensitivity of the surveillance system.