Archive for the ‘EFSA’ Category

Call for tender: Scientific support, literature review and data collection and analysis for risk assessment on microbial organisms used as active substances in plant protection products (CFT/EFSA/PRAS/2012/02)

Monday, April 30th, 2012

Published on:

11 April 2012

Published in the Official Journal of the European Union of 07/04/2012 – 2012/S 69-112896 the call for tender is open until 31/05/2012. Please note that the documentation for this call for tender is only available in English language.

Text of publication in the Official Journal of the European Union

Call for tender: Scientific support, literature review and data collection and analysis for risk assessment on microbial organisms used as active substances in plant protection products (CFT/EFSA/PRAS/2012/02)


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Call for tender: Collection of pesticide application data in view of performing environmental risk assessments for pesticides (CFT/EFSA/PRAS/2012/05)

Monday, April 30th, 2012

Published on:

11 April 2012

Published in the Official Journal of the European Union of 07/04/2012 – 2012/S 69-112893 the call for tender is open until 31/05/2012. Please note that the documentation for this call for tender is only available in English language.

Text of publication in the Official Journal of the European Union

Call for tender: Collection of pesticide application data in view of performing environmental risk assessments for pesticides (CFT/EFSA/PRAS/2012/05)


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Scientific Opinion on the re-evaluation of vegetable carbon (E 153) as a food additive

Friday, April 27th, 2012

Published on:

27 April 2012

The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of vegetable carbon (E 153). Vegetable carbon has been evaluated previously by the SCF (1977, 1983) and by JECFA (1970, 1977, 1987). Neither Committee established an ADI for vegetable carbon, but the SCF concluded that vegetable carbon could be used in food. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and additional literature. The Panel considered the available toxicological data too limited to establish an ADI for vegetable carbon. The Panel noted that data on the genotoxicity and carcinogenicity of carbon blacks of hydrocarbon origin has been related to the PAHs content of these substances. However, the Panel noted that the margins of exposure for benzo[a]pyrene exposure from vegetable carbon were considerably higher than those estimated from the dietary benzo[a]pyrene exposure.The Panel concluded that at the reported use levels vegetable carbon (E 153) containing less than 1.0 µg/kg of residual carcinogenic PAHs expressed as benzo[a]pyrene is not of safety concern. This was also based on the long history of safe use as a medicinal substance and the knowledge that vegetable carbon is an inert substance which is essentially not absorbed from the gastrointestinal tract following oral administration. The Panel considered that it may be appropriate to introduce in the specifications for vegetable carbon a requirement for residual carcinogenic PAHs expressed as benzo[a]pyrene using a validated analytical method of appropriate sensitivity (e.g. LOD of 0.1 µg/kg). The estimated dietary exposure of European children to vegetable carbon ranged from 3 to 29.7 mg/kg bw/day at the mean, and from 15.3 to 79.1 mg/kg bw/day at the 95th/97.5th percentile. The dietary exposure of UK adults was 3.8 mg/kg bw/day at the mean, and 28.1 mg/kg bw/day for high level (97.5th percentile) consumers.

© European Food Safety Authority, 2012

Scientific Opinion on the re-evaluation of vegetable carbon (E 153) as a food additive


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Revised exposure assessment for ethyl lauroyl arginate for the proposed uses as a food additive

Thursday, April 26th, 2012

Published on:

26 April 2012

Following a request from the European Commission, the European Food Safety Authority (EFSA), carried out a revised exposure assessment of ethyl lauroyl arginate (LAE) from its use as a food additive, for children and adults, based on the revised proposed uses presented in the terms of reference. Revised exposure estimates have been calculated with revised proposed use levels and individual food consumption data from the EFSA Comprehensive Database. When considering consumers only, the anticipated dietary exposure to LAE ranges from 0.06 to 0.50 mg/kg bw/day at the mean, and from 0.15 to 0.91 mg/kg bw/day at the 95th percentile. For high consumers (95th percentile), all population groups except the elderly, have an exposure above the ADI. The main contributor to the total anticipated dietary exposure to LAE is the category of heat-treated meat products. In 2011 by the SCCS estimated the systemic exposure to LAE resulting from its use in cosmetics around 0.0322 mg/kg bw/d. With the assumptions that oral exposure results in a corresponding systemic exposure to all released metabolites and that following dermal absorption and uptake into the circulation LAE will be rapidly and completely converted to the same metabolites as those generated following oral exposure, a comparison between the dietary exposure and the systemic exposure resulting from cosmetic products was made. This exposure is similar to the lowest range of the mean estimates from diet for the total population. For all populations, the additional exposure resulting from the use of LAE in cosmetics could be considered as minor compared to high level dietary exposure and would not change the status of the different population groups regarding the exceedance of the ADI.

© European Food Safety Authority, 2012

Revised exposure assessment for ethyl lauroyl arginate for the proposed uses as a food additive


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Guidance on Dermal Absorption

Wednesday, April 25th, 2012

Published on:

25 April 2012

This guidance on the assessment of dermal absorption has been developed to assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of chemical plant protection products. It is based on the opinion on the science behind the revision of the guidance document on dermal absorption (EFSA, 2011) to which the guidance refers to in many instances. Basic details of experimental design, available elsewhere, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with plant protection products are given. Issues discussed include a brief description of the skin and its properties affecting dermal absorption. To facilitate use of the guidance, flow charts are included. Guidance is also provided, for example, when there are no data on dermal absorption for the product under evaluation. Elements for a tiered approach are presented including use of default values, data on closely related products, in vitro studies with human skin, data from experimental animals (rats) in vitro and in vivo and the so called “Triple pack” approach. Various elements of study design and reporting, that reduce experimental variation and aid consistent interpretation, are presented. A proposal for reporting data for Draft Assessment Reports and Registration Reports is also provided. The issue of nanoparticles in plant protection products is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of plant protection products.

© European Food Safety Authority, 2012

Guidance on Dermal Absorption


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Reasoned opinion on the modification of the existing MRLs for methoxyfenozide in various leafy vegetables

Monday, April 23rd, 2012

Published on:

23 April 2012

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State (EMS), received an application from the company Dow AgroSciences to modify the existing MRLs for the active substance methoxyfenozide in leafy vegetables and fresh herbs (except vine leaves, water cress and witloof). In order to accommodate for the intended use of methoxyfenozide in the SEU, the EMS proposed to raise the existing MRLs in these crops (except in scarole) from the limit of quantification (LOQ) of 0.02 mg/kg to 4 mg/kg. Spain drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA.

EFSA considers that the submitted supervised residue trials are sufficient to support the proposed residue data extrapolation from lettuce to other crops under consideration and to derive a MRL proposal of 4 mg/kg for the proposed use on lettuce and other salad plants including Brassicaceae, the whole group of spinach and similar leaves and the whole group of herbs. Adequate analytical enforcement methods are available to control the residues of methoxyfenozide in the commodities under consideration.

EFSA concludes that the intended uses on the leafy vegetables under consideration (except on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. EFSA confirms the conclusion of the EMS that the intended use of methoxyfenozide on scarole is not acceptable due to acute consumer intake concerns identified.

© European Food Safety Authority, 2012

Reasoned opinion on the modification of the existing MRLs for methoxyfenozide in various leafy vegetables


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Conclusion on the peer review of the pesticide risk assessment of the active substance Adoxophyes orana granulovirus

Monday, April 23rd, 2012

Published on:

23 April 2012

Conclusion on the peer review of the pesticide risk assessment of the active substance Adoxophyes orana granulovirus


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Conclusion on the peer review of the pesticide risk assessment of the active substance Cydia pomonella granulovirus (CpGV)

Monday, April 23rd, 2012

Published on:

23 April 2012

Conclusion on the peer review of the pesticide risk assessment of the active substance Cydia pomonella granulovirus (CpGV)


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Extensive literature search on the PCN and PCN-host interaction

Thursday, April 19th, 2012

This external report is not produced by EFSA. It is published here to help keep the public informed of developments related to EFSA’s scientific work. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

19 April 2012

Extensive literature search on the PCN and PCN-host interaction


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Scientific Opinion on Flavouring Group Evaluation 51, Revision 1 (FGE.51Rev1): Consideration of alicyclic ketones and secondary alcohols and related esters evaluated by the JECFA (59th meeting) structurally related to alicyclic ketones secondary alcohols and related esters in FGE.09Rev3 (2011)

Wednesday, April 18th, 2012

Published on:

18 April 2012

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 20 alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting) in 2002. This revision is made due to inclusion of seven additional substances cleared for genotoxicity concern compared to the previous version. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 20 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 20 substances, the information is adequate.

© European Food Safety Authority, 2012

Scientific Opinion on Flavouring Group Evaluation 51, Revision 1 (FGE.51Rev1): Consideration of alicyclic ketones and secondary alcohols and related esters evaluated by the JECFA (59th meeting) structurally related to alicyclic ketones secondary alcohols and related esters in FGE.09Rev3 (2011)


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Assessment of different monitoring strategies for early detection of FMD incursion in a free wild boar population area: a simulation modelling approach

Tuesday, April 17th, 2012

Published on:

17 April 2012

Foot-and-mouth disease (FMD) is a viral disease primarily of cloven-hoofed animals that can profoundly affect animal husbandry by evolving into severe epidemics that reduce the productivity of susceptible livestock.. Hunting activities are considered valuable for surveillance in the hunting areas, especially at the forest edges, and are a possible option for surveillance. To assess the performance, in terms of early detection, of different monitoring and sampling schemes in case of an incursion of FMD virus in a disease free wild boar population area a simulation model was developed. The findings from this simulation show that a sampling strategy based on hunting alone needs a long time (13 to 39 weeks) before the first sero-positive animal is detected. On the contrary, a sampling strategy based on regular weekly sampling performs relevantly better (maximum number of weeks needed to detect the first sero-positive animal is 5). The simulation results show that in the investigated sensitivity range (i.e. 85% – 100%), the sensitivity of the surveillance system has almost no impact on the number of weeks needed to detect the first case. On the contrary, the specificity of the testing system must be 100% in order to avoid the reporting of false-positive results.

© European Food Safety Authority, 2012

Assessment of different monitoring strategies for early detection of FMD incursion in a free wild boar population area: a simulation modelling approach


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Scientific Opinion on the risks to plant health posed by European versus non-European populations of the potato cyst nematodes Globodera pallida and Globodera rostochiensis

Monday, April 16th, 2012

Published on:

16 April 2012

The Panel on Plant Health has delivered a scientific opinion on the different risks posed by European and non-European populations of the potato cyst nematodes (PCN) Globodera pallida and Globodera rostochiensis to solanaceous plants in the EU and on the effectiveness of current control measures. Although PCN, particularly G. rostochiensis, are widespread in the EU, crop damage is limited because breeders have been able to develop varieties that are resistant to the small number of genotypes that are present. These genotypes represent a minor subset of the gene pool and virulence that is present in South America. As new South American genotypes are very likely to have a similar potential for establishment and spread as existing European genotypes, the potato varieties currently grown in Europe will not be resistant to new virulent genotypes. As resistant varieties take a very long time to develop, the consequences of a new introduction of South American PCN would be major. The Panel therefore concluded that it is very important to maintain the current phytosanitary measures to prevent the entry of South American PCN. However, uncertainties over the effectiveness of the measures in Annex IVAI relating to place of production freedom and soil origin were noted, and the Panel identified additional risk reduction options for certain plants for planting (e.g. bulbs) and additional requirements to confirm the absence of PCN in places of production. The Panel also identified some problems with the existing control measures to reduce the spread of PCN within the EU. A thorough and well-coordinated EU-wide survey using standardized methods would be necessary to evaluate the need to maintain these measures. The monitoring of PCN populations should exploit new diagnostic techniques (e.g. mitochondrial DNA sequences) to ensure that the resistance available is deployed appropriately.

© European Food Safety Authority, 2012

Scientific Opinion on the risks to plant health posed by European versus non-European populations of the potato cyst nematodes Globodera pallida and Globodera rostochiensis


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Focal Point Activities 2011

Friday, April 13th, 2012

Published on:

12 April 2012

Focal Point Activities 2011


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Identification of Cumulative Assessment Groups of Pesticides

Friday, April 13th, 2012

The present document has been produced and adopted by the bodies identified above as author(s). In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the author(s) in the context of a grant agreement between the European Food Safety Authority and the author(s). The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the
conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

13 April 2012

The objective of the project was to identify common assessment groups (CAGs) for the pesticide active substances included in Annex I of Council Directive 91/414/EEC (up to 31st of May 2009). Initially, 120 substances were excluded for further consideration using objective criteria. For the remaining 224 substances information regarding e.g. name, chemical identity, pesticidal mode of action, and toxicological effects was collected. The establishment of CAGs was based on a tiered approach comprising up to four CAG levels spanning from grouping of all compounds having effects on a given target organ or tissue at CAG Level 1 to grouping at CAG Level 4 only those compounds for which a common mechanism of action could been established. Draft Assessment Reports (DARs) prepared for the “European Commission Programme for inclusion of Active Substances in Annex I of Council Directive 91/414/EEC (Articles 5 and 6 of Council Directive 91/414/EEC)” were used to identify the relevant target organs and tissues (end-points) for the toxicological effects of the active substances. For each relevant target all compounds exerting a toxicological effect were allocated to CAG Level 1. In the next step detailed toxicological information was scrutinized and compounds showing a common toxic effect on a phenomenological/specific effect basis in each target organ and tissue were grouped into CAGs at Level 2. Refined CAGs were established when it could be demonstrated that the compounds actually possess the same mode of action (CAG Level 3) or mechanism of action (CAG Level 4). All chemical and toxicological information that formed the basis for the establishment of CAGs was included in a searchable database.

Identification of Cumulative Assessment Groups of Pesticides


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Annual Report of the EFSA Journal

Thursday, April 12th, 2012

Published on:

12 April 2012

With more than 7500 citations of EFSA scientific outputs in bibliographic databases relevant to EFSA’s remit, indexation significantly increased since the re-launch of the EFSA Journal in December 2009. By the end of 2011 the EFSA Journal was included in the following bibliographic databases and repositories: (a) Food Science and Technology Abstracts (FSTA), (b) CABI, (c) SciFinder, (d) ISI Web of Science, (e) International Portal on Food Safety, (f) Animal and Plant Health (IPFSAPH), (g) DTU Libraries, (h) Google Scholar and (i) EBSCO. To meet the requirements of the databases, several features of the EFSA Journal were further developed and improved, e.g. the XML-dataset was expanded, and the IT project to ensure readers are timely informed about an erratum in previously published articles was initiated. Further bibliographic databases have been contacted to investigate application criteria for indexing the EFSA Journal. Two editorials (one in the area of pesticides, one on BSE) were published and attracted increasing attention of the readers. The EFSA Journal continued to be promoted at scientific conferences and national and international meetings as well as in articles on EFSA matters. Looking ahead, EFSA will continue to apply to and negotiate with relevant bibliographic databases and library catalogues to index the EFSA Journal in order to increase EFSA’s scientific visibility. A newly created section for “Special Issues” will allow the publication of special issues whenever deemed appropriate. The first special issue will be about EFSA’s scientific achievements since its inception in 2002 and is intended to be published in 2012 in the context of EFSA’s 10th anniversary.

© European Food Safety Authority, 2012

Annual Report of the EFSA Journal


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Manual for Reporting on Zoonoses, Zoonotic Agents and Antimicrobial Resistance in the framework of Directive 2003/99/EC and of some other pathogenic microbiological agents for information derived from the year 2011

Wednesday, April 11th, 2012

Published on:

11 April 2012

This Reporting Manual provides guidance for reporting on zoonoses, zoonotic agents and antimicrobial resistance in animals, food and feed under the framework of Directive 2003/99/EC. Some advice is also given on reporting on other pathogenic microbiological agents in food. The objective is to harmonise and streamline the reporting made by the Member States in a way that the data collected would be relevant and easy to be analysed at the European Union level. The manual covers all the agents and items included by the current data collection through the web – based reporting system run by the European Food Safety Authority. Detailed guidelines are provided for reporting of the data in the tables and text forms. This guidance typically applies to the agents, animal species and food categories to be reported on. Instructions are given on description of the sampling and monitoring schemes as well as analyses of the results in the national reports. Special reference is made to fields were following of trends would be desirable. This manual is specifically aimed to guide the reporting of information deriving from the year 2011.

© European Food Safety Authority, 2012

Manual for Reporting on Zoonoses, Zoonotic Agents and Antimicrobial Resistance in the framework of Directive 2003/99/EC and of some other pathogenic microbiological agents for information derived from the year 2011


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Manual for reporting of food-borne outbreaks in accordance with Directive 2003/99/EC from the year 2011

Wednesday, April 11th, 2012

Published on:

11 April 2012

This manual provides specific guidance for reporting on food-borne outbreaks under the framework of Directive 2003/99/EC and it is based on the reporting format described in the EFSA Report onUpdated technical specifications for harmonised reporting of food-borne outbreaks through the European Union reporting system in accordance with Directive 2003/99/EC. The objective is to harmonise and streamline the reporting made by the Member States. The manual includes the description of the structure and scope of the reporting system for food-borne outbreaks, the definitions used in the system as well as the variables to be reported on. It gives detailed advice, often through examples, how to report and classify the causative agents, food vehicles implicated, settings, places of origin of problem and the contributory factors.

© European Food Safety Authority, 2012

Manual for reporting of food-borne outbreaks in accordance with Directive 2003/99/EC from the year 2011


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Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010

Wednesday, April 11th, 2012

Published on:

11 April 2012

Following the request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 growing season of maize MON810 provided by Monsanto Europe S.A. On 7 September 2011, the EFSA GMO Panel already adopted a scientifc opinion on the 2009 monitoring report of maize MON 810. The EFSA GMO Panel followed the same approach as for the assessment of the 2009 monitoring report and assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the Case-Specific Monitoring and General Surveillance of maize MON 810 in 2010. Concerning the Case- Specific Monitoring (CSM), the EFSA GMO Panel considered the plan for Insect-Resistant Management mainly based on the “high dose/refuge strategy”, monitoring of target pest resistance and education of farmers. Concerning General Surveillance (GS), the EFSA GMO Panel paid particular attention to the design and analysis of the farmer questionnaires. The EFSA GMO Panel notes similar shortcomings in the methodology for CSM and GS as in the 2009 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of maize MON 810 as in its scientific opinion on the 2009 monitoring report of maize MON 810. However, from the data submitted by the applicant in its 2010 monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season. The outcomes of the 2010 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.

© European Food Safety Authority, 2012

Scientific Opinion on the annual Post-Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2010


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Scientific Opinion on the safety evaluation of the substance, N-(2-aminoethyl)ethanolamine, CAS No. 111-41-1, for use in food contact materials

Tuesday, April 10th, 2012

Published on:

10 April 2012

This scientific opinion of EFSA deals with the risk assessment of the co-monomer N-(2-aminoethyl)ethanolamine (CAS No 111-41-1, Ref. No 35284 and FCM substance No 262). The CEF Panel concluded that the use of N-(2-aminoethylamino)ethanol in manufacturing of can coatings in direct contact with food does not raise a safety concern for the substance itself if migration does not exceed 0.05 mg/kg food. The Panel, however, noted that many oligomers are formed during the manufacturing process which may migrate into the food. Only limited information was provided on the identities of the oligomers in the fraction below 1000 Da. Further structural and quantitative information is needed for a conclusion to be drawn concerning genotoxicity or other toxicity end points of the oligomeric fraction. The toxicological data needed will depend on the identity and level of migration of the oligomers in the food.

© European Food Safety Authority, 2012

Scientific Opinion on the safety evaluation of the substance, N-(2-aminoethyl)ethanolamine, CAS No. 111-41-1, for use in food contact materials


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Statement on a heat treatment to control Agrilus planipennis

Wednesday, April 4th, 2012

Published on:

4 April 2012

In 2011, the EFSA Panel on Plant Health was asked by the European Commission to provide an opinion on a technical file submitted by the US Authorities to support a request to list a new heat treatment (60 °C/60 min) among the EU import requirements for wood of Agrilus planipennis host plants. After a thorough analysis of the documents provided the Panel concluded that, with a low uncertainty, A. planipennis is likely to survive the proposed heat treatment of 60 °C/60 min, and that, to ensure a control level of 99 % the temperature of the heat treatment of 60 min should be higher than 70 °C. Following the publication of this scientific opinion, the US Authorities submitted a new proposal to the European Commission, consisting in a new heat treatment (71.1 °C/60 min). The EFSA Panel on Plant Health was asked to consider whether this new proposal was within the scope of the published opinion and, if not, to clarify its conclusion and indicate what data would be needed to assess the effectiveness of the new treatment. The Panel concluded that the new proposal is not within the scope of the opinion as the data provided by the US Authorities cannot be used to evaluate the effectiveness of the new proposed heat treatment. An accurate assessment of the new proposed heat treatment (71.1 °C/60 min) would require an experiment including several temperatures higher than 70 °C (one corresponding to the proposed treatment). Regarding the data requirements for assessing the effectiveness of the new treatment, the Panel lists the information required in the checklist presented in the Panel’s draft guidance document on methodology for evaluation of the effectiveness of options to reduce the risk of introduction and spread of organisms harmful to plant health in the EU territory, currently under public consultation on EFSA website.

© European Food Safety Authority, 2012

Statement on a heat treatment to control Agrilus planipennis


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Statement on the identity of apple snails

Wednesday, April 4th, 2012

Published on:

4 April 2012

Following a request by the European Commission, EFSA’s Panel on Plant Health was asked to deliver a statement to clarify the current scientific knowledge regarding the identity of the apple snails in the context of the evaluation of the pest risk analysis prepared by the Spanish Ministry of Environment and Rural and Marine Affairs (EFSA Panel on Plant Health (PLH), 2012). The Panel concludes on the risk to plant health posed by Pomacea species in the ‘canaliculata complex’, that out of the around 50 species in the genus of Pomacea, four species P. canaliculata, P. insularum, P. lineata and P. maculata belong to the ‘canaliculata complex’, where P. insularum and P. maculata are recently considered to be synonyms. Current methods of identification imply high uncertainty if risk reduction options are applied at the Pomacea single species level. The Spanish pest risk analysis identifies important plant health risks connected to Pomacea species. The available scientific evidence indicates that other Pomacea species may pose similar risks to plant health as identified for P. insularum.
The Panel clarifies that risk reduction options should not be targeted to single species of the genus Pomacea considering: (i) the dynamical situation in the current study on the systematics of the Ampullariidae species and the genus Pomacea in particular; (ii) the uncertainties and the possible unexpected evolution of the invasive potential of species of Pomacea other than P. insularum and P. canaliculata; (iii) the poor knowledge on the trophic habits of many species of the genus Pomacea, with possible overlaps in the trophic niche (macrophytes); (iv) the high uncertainty on the identification of the different Pomacea species.

© European Food Safety Authority, 2012

Statement on the identity of apple snails


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Preliminary Annual Management Plan 2013

Tuesday, April 3rd, 2012

Published on:

3 April 2012

Preliminary Annual Management Plan 2013


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Preliminary Budget and Establishment Plan 2013

Tuesday, April 3rd, 2012

Published on:

3 April 2012

Preliminary Budget and Establishment Plan 2013


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Annual Activity Report 2011

Tuesday, April 3rd, 2012

Published on:

3 April 2012

Annual Activity Report 2011


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Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2011

Monday, April 2nd, 2012

Published on:

2 April 2012

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2011


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Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance glufosinate

Friday, March 30th, 2012

Published on:

30 March 2012

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance glufosinate


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Scientific Opinion on DL-methionine, DL-methionine sodium salt, the hydroxy analogue of methionine and the calcium salt of methionine hydroxy analogue in all animal species; on the isopropyl ester of methionine hydroxy analogue and DL-methionine technically pure protected with copolymer vinylpyridine/styrene in dairy cows; and on DL-methionine technically pure protected with ethylcellulose in ruminants

Friday, March 30th, 2012

Published on:

30 March 2012

Methionine is an essential amino acid in all animal species. Supplementation of appropriate amounts of methionine and analogues to meet requirements is safe for the target species. The use of methionine-based additives will not result in an increased content in tissues and products. Residues present in animal tissues and products resulting from the extremely small quantities of free styrene and 2-vinylpyridine found in DL-methionine copolymer (DL-Met-cop) are very unlikely to raise concerns about consumer safety. None of the products are considered to present a significant inhalation risk. DL-Methionine (DL-Met), DL-Met-cop and DL-methionine protected with ethylcellulose (DL-Met-ec) are non-irritant to skin and eyes, and the lack of sensitisation potential demonstrated for DL-Met is considered relevant to DL-Met-cop and DL-Met-ec. DL-Methionine sodium salt (DL-Met-Na) is considered to be corrosive to skin and eyes. The hydroxy analogue of methionine (HMTBa) is an irritant to the skin and corrosive to the eyes. The calcium salt of HMTBa, HMTBa-Ca, is irritant to the eyes. The absence of dermal sensitation potential demonstrated for HMTBa is considered relevant for HMTBa-Ca. The isopropyl ester of HMTBa, HMTB-i, is non-irritant to skin/eyes, and is not a dermal sensitiser. The use of these products as feed additives does not represent a risk to the environment. DL-Met, DL-Met-Na, HMTBa and HMTBa-Ca are effective dietary sources of methionine for protein synthesis in monogastric animals (including fish). The hydroxy analogues show a somewhat lower bioefficacy than the DL-methionine forms. They can all be used in ruminants, particularly when protected against ruminal degradation by specific formulations. DL-Met-cop, HMTB-i and DL-Met-ec escape ruminal degradation to a certain extent, the remainder being available for gastrointestinal absorption. The FEEDAP Panel does not support the use of the additives under application in water for drinking because of concerns about target animal safety and the maintenance of optimum performance.

© European Food Safety Authority, 2012

Scientific Opinion on DL-methionine, DL-methionine sodium salt, the hydroxy analogue of methionine and the calcium salt of methionine hydroxy analogue in all animal species; on the isopropyl ester of methionine hydroxy analogue and DL-methionine technically pure protected with copolymer vinylpyridine/styrene in dairy cows; and on DL-methionine technically pure protected with ethylcellulose in ruminants


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Conclusion on the peer review of the pesticide risk assessment of the active substance isopyrazam

Thursday, March 29th, 2012

Published on:

29 March 2012

Conclusion on the peer review of the pesticide risk assessment of the active substance isopyrazam


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Scientific Opinion on Flavouring Group Evaluation 47, Revision 1 (FGE.47Rev1): Bi- and tricyclic secondary alcohols, ketones and related esters from chemical group 8

Wednesday, March 28th, 2012

Published on:

28 March 2012

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate six flavouring substances in the Flavouring Group Evaluation 47, including an additional two substances in this Revision 1, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the six substances [FL-no: 02.119, 07.171, 07.196, 09.584, 09.848 and 09.888] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all six candidate substances.

© European Food Safety Authority, 2012

Scientific Opinion on Flavouring Group Evaluation 47, Revision 1 (FGE.47Rev1): Bi- and tricyclic secondary alcohols, ketones and related esters from chemical group 8


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Scientific Opinion on applications EFSA-GMO-UK-2005-09 and EFSA-GMO-RX-MON531×MON1445 for the placing on the market of food and feed produced from or containing ingredients produced from insect-resistant and herbicide-tolerant genetically modified cotton MON 531 × MON 1445, and for the renewal of authorisation of existing products produced from cotton MON 531 × MON 1445, both under Regulation (EC) No 1829/2003 from Monsanto

Wednesday, March 28th, 2012

Published on:

28 March 2012

This scientific opinion evaluates the risk assessment for the authorisation for (continued) marketing of genetically modified insect-resistant and herbicide-tolerant cotton MON 531 × MON 1445 for food and feed produced from it. Cotton MON 531 × MON 1445 was produced by conventional crossing methods, and the stack is homozygous for the newly introduced traits. The integrity and the stable co-inheritance of the parental events were demonstrated in the stack. Molecular characterisation did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 531 × MON 1445 in comparison with its conventional counterpart and its composition fell within the range of non-GM cotton varieties, except for the Cry1Ac, CP4 EPSPS and NPTII proteins. No safety issues were identified with regard to toxicity and allergenicity of food and feed produced from cotton MON 531 × MON 1445. A feeding study in catfish confirmed that toasted cottonseed meal from MON 531 × MON 1445 is as nutritious as toasted cottonseed meal from its conventional counterpart and four commercial non-GM cotton varieties. Products from cotton MON 531 × MON 1445 do not contain viable plant parts. The insert structure in cotton MON 531 × MON 1445 may facilitate the stabilisation of the nptII gene in plasmids of environmental bacteria through double homologous recombination. However, considering the overall limited occurrence of horizontal transfer of DNA in plant material to bacteria, and the very low exposure to DNA from cotton MON 531 × MON 1445, the EFSA GMO Panel concludes that it is highly unlikely that cotton MON 531 × MON 1445 will contribute to the environmental prevalence of nptII genes. Potential interactions of cotton MON 531 × MON 1445 with non-target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post-market environmental monitoring plan is not required.

© European Food Safety Authority, 2012

Scientific Opinion on applications EFSA-GMO-UK-2005-09 and EFSA-GMO-RX-MON531×MON1445 for the placing on the market of food and feed produced from or containing ingredients produced from insect-resistant and herbicide-tolerant genetically modified cotton MON 531 × MON 1445, and for the renewal of authorisation of existing products produced from cotton MON 531 × MON 1445, both under Regulation (EC) No 1829/2003 from Monsanto


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Statement on a request from the European Commission for the assessment of the scientific elements supporting the prohibition for the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria

Wednesday, March 28th, 2012

Published on:

28 March 2012

Austria notified to the European Commission its ordinance implementing a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria, after which the European Commission asked the European Food Safety Authority to assess the scientific elements supporting the prohibition. Having considered the information package provided by Austria and all relevant scientific publications, the GMO and BIOHAZ Panels concluded that: i) no new data specific to the safety of the nptII gene have been provided; ii) the risk posed by the formation of mosaic structures of aminoglycoside phosphotransferase genes could not be assessed without data documenting the existence of such structures among the existing gene variants and such data were not provided; iii) the therapeutic relevance of kanamycin and neomycin was already addressed in the EFSA’s opinion on ARM genes and as of yet there is no evidence to indicate that resistance to these antibiotics in clinically-relevant bacteria has developed as a result of acquisition of the nptII gene; iv) the knowledge gaps and uncertainties highlighted in the Austrian document have already been considered in the EFSA’s opinion on ARM genes. Austria did not provide any new or additional information on the molecular characterisation or PMEM of potato EH92-527-1 after the date of consent for this GM event that would require the reassessment of existing information. The EFSA GMO Panel reiterates its scientific opinion on the 2010 monitoring report of GM potato EH92-527-1 in which it provides specific recommendations to improve the methodology of the PMEM of the GM potato. Further, the EFSA GMO Panel concludes that no grounds exist to date that would lead to reconsideration of its opinion on GM potato EH92-527-1.

© European Food Safety Authority, 2012

Statement on a request from the European Commission for the assessment of the scientific elements supporting the prohibition for the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria


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Scientific Opinion on the safety and efficacy of Lactobacillus brevis (DSMZ 21982) as a silage additive for all species

Monday, March 26th, 2012

Published on:

26 March 2012

The strain of Lactobacillus brevis under application is intended for use as a technological additive to improve the ensiling process at a proposed dose of 1×108 to 1×109 CFU/kg fresh material. The bacterial species L. brevis is considered by EFSA to be suitable for the Qualified Presumption of Safety approach. Therefore, the strain does not require any specific demonstration of safety other than confirming the absence of any determinants of resistance to antibiotics of human and veterinary clinical significance. As the identity of the strain has been clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is considered safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Given the lack of information and its proteinaceous nature, the active agent should be considered as a potential skin and respiratory sensitiser. Five studies with laboratory-scale silos are described, each lasting at least 90 days, made using samples of forage covering a range of dry matter content (19 to 52 %) with differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared to silos containing the same untreated forage. The results showed that the additive has the potential to improve the production of silage from forages by increasing acetic acid production resulting in an extended aerobic stability of the treated silage.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of Lactobacillus brevis (DSMZ 21982) as a silage additive for all species


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Inventory of available data and data sources and proposal for data collection on vector-borne zoonoses in animals

Monday, March 26th, 2012

The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

26 March 2012

An inventory of data collected from animals was carried out on the following agents of vector borne zoonoses: Borrelia burgdorferi sensu lato (sl), West Nile virus (WNV), Francisella tularensis, Leptospira, Hantavirus, Leishmania infantum, tick borne encephalitis virus (TBEV) and Crimean Congo hemorrhagic fever virus (CCHFV). The role of animals in transmission cycles of these agents is described through a narrative literature review. Information on data collection carried out by competent authorities of European Union Member States, Norway, and Switzerland was gathered using questionnaires. Ecological and epidemiological research was analysed through a systematic literature review. Fourteen out of 29 countries replied to the questionnaires.  Results show that, up to 2009, data collection by competent authorities was relatively frequent on Leptospira, F. tularensis, and WNV. Conversely, data collection on B. burgdorferi sl in animals was less frequent, in spite of a widespread and expanding distribution of this agent. Based on information gathered in the data inventory, proposals were developed for data collection within the framework of Directive 2003/99/EC. The following animal species were proposed in data collection on one or more agent: dogs (which were proposed in data collection on B. burgdorferi sl, L. infantum, Leptospira, TBEV, F. tularensis, and Hantavirus), domestic ruminants (B. burgdorferi sl, TBEV, F. tularensis, CCHFV, and Leptospira), horses (B. burgdorferi sl, F. tularensis, WNV, and Leptospira), pigs (F. tularensis and Leptospira), wild boars and foxes (F. tularensis and Leptospira), wild and synanthropic rodents (Leptospira, Hantavirus, TBEV, and F. tularensis), hares (F. tularensis and CCHFV), wild and synanthropic birds (WNV), and farmed ostriches (CCHFV).

Inventory of available data and data sources and proposal for data collection on vector-borne zoonoses in animals


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Statement on List of Representative Substances for Testing

Friday, March 23rd, 2012

Published on:

23 March 2012

EFSA is requested to carry out a risk assessment on groups of flavouring substances listed in a Register prior to their authorisation and inclusion in a Union list according to Commission Regulation (EC) No 1565/2000.

The current Statement lays down a list of substances in sub-groups with representative substances for which additional data are required prior to their evaluation through the Procedure (Regulation (EC) No 1565/2000).

© European Food Safety Authority, 2012

Statement on List of Representative Substances for Testing


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Scientific Opinion on the safety and efficacy of Urea for ruminants

Friday, March 23rd, 2012

Published on:

23 March 2012

Urea supplementation to feed for ruminants provides non-protein nitrogen for microbial protein synthesis in the rumen and thus in part replaces other dietary protein sources. Urea supplementation of feed for ruminants at doses up to 1 % of complete feed DM (corresponding to 0.3 g/kg bw/day) is considered safe when given to animals with a well adapted ruminal microbiota and fed diets rich in easily digestible carbohydrates. Based on the metabolic fate of urea in ruminants, the use of urea in ruminant nutrition does not raise any concern for consumers’ safety. Urea is considered to be non irritant to skin and eyes and its topical use suggests that it is not a dermal sensitiser. The risk of exposure by inhalation would be low. The substitution of protein by urea in well balanced feed for ruminants would not result in an increased environmental nitrogen load. Urea is an effective source of non-protein nitrogen substituting for dietary protein in ruminants.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of Urea for ruminants


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Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additives for all animal species: Zinc chelate of amino acids hydrate, based on a dossier submitted by Zinpro Animal Nutrition Inc.

Friday, March 23rd, 2012

Published on:

23 March 2012

Zinc from zinc chelate of amino acids hydrate would not exert additional or different adverse effects in target species than those observed for zinc from authorised inorganic sources. Consequently it is concluded that the zinc chelate of amino acids hydrate is a safe source of zinc for all animal species, considering the maximum authorised contents for total zinc in feedingstuffs. The use of zinc chelate of amino acids hydrate as feed additive is not expected to modify the current consumer exposure to zinc. Therefore, no concerns for consumer safety are expected from the use of zinc chelate of amino acids hydrate in animal nutrition up to the maximum authorised levels of total zinc in feedingstuffs. The additive should be considered as a skin and eye irritant and, due to its amino acid/peptide component, as a skin sensitiser. The risk of exposure by inhalation would be low. The use of zinc as a feed additive does not pose a direct concern for the soil compartment. However, there is a potential environmental concern related to drainage and run-off of zinc to surface water. Most vulnerable for these processes are acid sandy soils. In order to draw a final conclusion, some further refinement to the assessment of zinc-based feed additives in livestock needs to be considered, for which additional data would be required. The use of zinc-containing feed additives in aquaculture up to maximum authorised zinc level in feeds is not expected to pose an appreciable risk to the environment. Zinc chelate of amino acids hydrate is recognised as an efficacious source of zinc in meeting animal requirements.

© European Food Safety Authority, 2012

Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additives for all animal species: Zinc chelate of amino acids hydrate, based on a dossier submitted by Zinpro Animal Nutrition Inc.


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Scientific Opinion on safety and efficacy of CRINA® Poultry Plus (preparation of benzoic acid and essential oil compounds) as feed additive for chickens for fattening

Friday, March 23rd, 2012

Published on:

23 March 2012

CRINA® Poultry Plus (CPP) is a feed additive consisting on seven active substances: benzoic acid (83 %), thymol (1.9 %), eugenol (1 %), benzylsalicylate (0.3 %), piperine (0.1 %), isoamylsalicylate (0.1 %) and trans-anethole (0.1 %). It is intended to be used as a zootechnical additive in complete feed for chickens for fattening (300-450 mg CPP/kg feed) to favourably affect their performance. Given the inconsistency of the data and the suggestion of adverse effects, albeit not dose-related, the FEEDAP Panel is unable to conclude on the safety of the additive at the dose range proposed. None of the components of CPP are genotoxic and in vitro assays made with the additive gave no indication of a genotoxic potential. No metabolism/residue data are available for eugenol and piperine in chickens for fattening. Consequently, the FEEDAP Panel cannot draw any final conclusion on the safety for the consumer of CPP used as feed additive in chickens for fattening. CPP should be considered as irritant for the skin and eyes, as well as skin sensitiser; no adverse effects upon inhalation are to be expected. In the absence of data on the environmental fate of piperine, isoamylsalicylate and benzylsalicylate, or the additive itself, the safety for the environment cannot be assessed. A significant effect relative to performance was shown in only one of the eight studies taken for the demonstration of efficacy. There is insufficient evidence that CPP at the recommended dose can improve the zootechnical performance of chickens. The sensory properties of the meat from chickens fed CPP are not affected.

© European Food Safety Authority, 2012

Scientific Opinion on safety and efficacy of CRINA® Poultry Plus (preparation of benzoic acid and essential oil compounds) as feed additive for chickens for fattening


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Scientific Opinion on the risks for public and animal health related to the presence of citrinin in food and feed

Friday, March 23rd, 2012

Published on:

23 March 2012

The European Food Safety Authority (EFSA) was asked by the European Commission to deliver a scientific opinion on the health risks from citrinin in food and feed. Citrinin is a mycotoxin produced by several species of the genera Aspergillus, Penicillium and Monascus and occurs mainly in stored grains. The available occurrence data were not adequate to carry out a dietary exposure assessment. Citrinin is nephrotoxic and a no-observed-adverse-effect level (NOAEL) of 20 µg/kg body weight (b.w.) per day was identified from a 90-day study in rats. Due to the limitations and uncertainties in the database, the derivation of a health-based guidance value was not considered appropriate but a level of no concern for nephrotoxicity of 0.2 µg/kg b.w. per day was determined. Based on the available data a concern for genotoxicity and carcinogenicity could not be excluded at the level of no concern for nephrotoxicity. In the absence of adequate exposure data, characterisation of the risk of citrinin as a food contaminant was based on the estimate of the citrinin concentrations in grains and grain-based products that would result in an exposure equal to the level of no concern for nephrotoxicity. For high consuming toddlers, other children and adults this citrinin concentration is between 9 and 53 µg citrinin/kg and between 19 and 100 µg citrinin/kg for average consumers, respectively. For animals, risk characterisation was based on the estimate of the citrinin concentration in grains that would result in exceedance of the NOAEL of 20 µg/kg b.w. per day for pigs, which ranged between 640 and 1 173 µg/kg. The CONTAM Panel concluded that the impact of uncertainties on the risk assessment is large, and more data regarding the toxicity and the occurrence of citrinin in food and feed in Europe are needed to enable refinement of the risk assessment.

© European Food Safety Authority, 2012

Scientific Opinion on the risks for public and animal health related to the presence of citrinin in food and feed


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Scientific Opinion on the safety and efficacy of Phyzyme XP (6-phytase) as a feed additive for minor poultry species

Thursday, March 22nd, 2012

Published on:

22 March 2012

Phyzyme XP is a feed additive that contains 6-phytase, produced by a genetically modified strain of Schizosaccharomyces pombe (ATCC 5233) and is authorised for use in feed for chickens and turkeys for fattening, laying hens, ducks, piglets, pigs for fattening and sows. The applicant requested for an extension of use of the additive to all minor poultry species. Safety for chickens and turkeys for fattening and for laying hens was previously established at 750, 1000 and 1500 U/kg feed, respectively. Given the margin of safety established for the major poultry species, a maximum dose of 1000 U/kg feed was considered safe for all minor poultry species. Since the mode of action of phytases can be reasonably assumed to be the same in all avian species the minimum effective dose authorised for fattening birds (250 U/kg feed) and for laying birds (150 U/kg feed) was considered efficacious for minor poultry species.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of Phyzyme XP (6-phytase) as a feed additive for minor poultry species


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Scientific Opinion on the safety and efficacy of phenyl ethyl alcohols, phenylacetic acids, related esters, phenoxyacetic acids and related esters (chemical group 15) when used as flavourings for all animal species

Thursday, March 22nd, 2012

Published on:

22 March 2012

Chemical group 15 (CG 15) consists of phenyl ethyl alcohols, phenylacetic acids, related esters, phenoxyacetic acids and related esters, of which 18 are currently authorised for use as flavours in food. For all 18 compounds belonging to CG 15 the maximum safe concentration was calculated and rounded to be 1 mg/kg feed for poultry and pigs and 1.5 mg/kg feed for cattle, salmonids and non food-producing animals. Safe concentrations should be appropriately reduced if used in water for drinking. The absence of a margin of safety would not allow the simultaneous administration of the compounds under consideration in feed and water for drinking. No residues of safety concern derived from the compounds of CG 15 are expected in animal tissues or products when used up to 1–1.5 mg/kg feed. The FEEDAP Panel considered it prudent to treat all compounds under assessment as irritant to skin, eyes and respiratory tract, skin sensitiser and harmful if swallowed. At a concentration of 1–1.5 mg/kg complete feed, the compounds included in CG 15 are not expected to pose a risk for the environment. Since all 18 compounds are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy was considered necessary.

© European Food Safety Authority, 2012

Scientific Opinion on the safety and efficacy of phenyl ethyl alcohols, phenylacetic acids, related esters, phenoxyacetic acids and related esters (chemical group 15) when used as flavourings for all animal species


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Reasoned opinion on the modification of the existing MRLs for teflubenzuron in various fruiting vegetables

Thursday, March 22nd, 2012

Published on:

22 March 2012

Reasoned opinion on the modification of the existing MRLs for teflubenzuron in various fruiting vegetables


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Reasoned opinion on the modification of the existing MRL for acibenzolar-S-methyl in lettuce and other salad plants including Brassicaceae

Wednesday, March 21st, 2012

Published on:

21 March 2012

Reasoned opinion on the modification of the existing MRL for acibenzolar-S-methyl in lettuce and other salad plants including Brassicaceae


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Scientific Opinion on the ‘Biomation’ application for an alternative method for the treatment of animal-by-products

Tuesday, March 20th, 2012

Published on:

20 March 2012

A method alternative to the ones already approved in the current legislation, called ‘Biomation’ process, for the treatment of Category (Cat.) 2 and 3 Animal By-Products (ABP) was assessed. The process consists of an alkaline treatment. The target parameters are: particle size ≤ 5mm, temperature 70 °C, pH 12.5, exposure time 20 minutes. According to the application received also Cat. 1 ABP can enter the processing plant and it has then to be removed from the rest of the ABP material and treated according to current legislation. The end product generated by the ‘Biomation’ process is intended to be used as an organic fertiliser and soil improver. According to the legislation in force, before being used as an organic fertiliser, Cat. 2 (and mixes of Cat. 2 and 3) material should be treated with a sterilisation process (i.e. 133 °C / 20 min / 3 bars / 50 mm particle size). The hazard identification provided by the applicant was not adequately addressed, since the most resistant organisms (including TSE agents) were not properly identified, and an experimental validation with representative test-organisms under practical conditions was not performed. A laboratory experiment was performed but its results were not clear and did not allow a proper assessment of the level of risk reduction of the relevant biological hazards achieved by the process. Moreover, it was noticed that it is not certain that the values of the parameters used in the laboratory experiment would be homogenously reached in all the material under real scale conditions. Major deficiencies were noticed in the HACCP plan provided. It was concluded that there is no evidence that the proposed alternative method is equivalent to the sterilization process defined in the current legislation.

© European Food Safety Authority, 2012

Scientific Opinion on the ‘Biomation’ application for an alternative method for the treatment of animal-by-products


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Scientific Opinion on the evaluation of the safety and efficacy of Listex(TM) P100 for the removal of Listeria monocytogenes surface contamination of raw fish

Tuesday, March 20th, 2012

Published on:

20 March 2012

Studies evaluating the safety and efficacy of Listex™ P100 to reduce Listeria monocytogenes contamination on raw fish were assessed. The material should not present human toxicological problems because the bacteriophage P100, used as active principle, is not regarded as harmful to consumers nor to organisms other than Listeria spp., and because the fabrication parameters do not include anything obvious that might compromise safety. Data of studies considered indicate that Listex™ P100 is listericidal on inoculated catfish and salmon samples, but do not allow definitive conclusions on efficacy in reducing L. monocytogenes counts on raw fish nor on its impact on L. monocytogenes contamination levels in finished product. It was not possible to estimate the potential listeriosis risk reduction by treating raw fish with Listex™ P100. The data were not adequate to allow firm conclusions on persistence or activity of P100 in stored fish. The proposed use of Listex™ P100 is unlikely to result in emergence of reduced susceptibility to biocides and/or resistance to key therapeutic antimicrobials: however, this conclusion may need verification. No information was provided on survival of P100 in processing wastewater or the environment, or on the potential accumulation of naturally P100 resistant L. monocytogenes variants. Pilot and industrial scale studies should consider parameters affecting decontaminating efficacy, and should verify that application on raw fish has an impact on reduction of L. monocytogenes contamination on the final product. The persistence or activity of P100 as well as potential changes in L. monocytogenes counts should be evaluated during fish storage. Tests to investigate potential development of resistance or reduced susceptibility to biocides and key therapeutic antimicrobials, following use of Listex™ P100, are recommended. The continuous effectiveness of Listex™ P100 against L. monocytogenes and the potential for selection and dominance of strains naturally-resistant to P100 should be monitored.

© European Food Safety Authority, 2012

Scientific Opinion on the evaluation of the safety and efficacy of Listex(TM) P100 for the removal of Listeria monocytogenes surface contamination of raw fish


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Reasoned opinion on the review of the existing maximum residue levels (MRLs) for milbemectin according to Article 12 of Regulation (EC) No 396/2005

Tuesday, March 20th, 2012

Published on:

20 March 2012

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for milbemectin according to Article 12 of Regulation (EC) No 396/2005


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Reasoned opinion on the review of the existing maximum residue levels (MRLs) for spinosad according to Article 12 of Regulation (EC) No 396/2005

Tuesday, March 20th, 2012

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20 March 2012

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for spinosad according to Article 12 of Regulation (EC) No 396/2005


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

Thursday, March 15th, 2012

Published on:

15 March 2012

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.

© European Food Safety Authority, 2012

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


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Literature search and review related to specific preparatory work in the establishment of Dietary Reference Values Preparation of an evidence report identifying health outcomes upon which Dietary Reference Values could potentially be based for vitamins A, C, E, and K

Thursday, March 15th, 2012

This external report is not produced by EFSA. It is published here to help keep the public informed of developments related to EFSA’s scientific work. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

15 March 2012

Literature search and review related to specific preparatory work in the establishment of Dietary Reference Values Preparation of an evidence report identifying health outcomes upon which Dietary Reference Values could potentially be based for vitamins A, C, E, and K


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The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010

Wednesday, March 14th, 2012

Published on:

14 March 2012

The antimicrobial resistance data on zoonotic and indicator bacteria in 2010, submitted by 26 European Union Member States, were jointly analysed by the European Food Safety Authority and the European Centre for Disease Prevention and Control. Data covered resistance in zoonotic Salmonella and Campylobacter from humans, food and animals, and in indicator Escherichia coli and enterococci from animals and food. Some data on meticillin-resistant Staphylococcus aureus in animals and food were also included. In isolates from humans, resistance was mainly interpreted using clinical breakpoints, whereas in animal and food isolates, microbiological resistance was defined using epidemiological cut-off values. No major changes in resistance in monitored bacteria were observed compared with previous years. Resistance was commonly found in isolates from humans, animals and food, although disparities in resistance were frequently observed between Member States. High resistance levels were recorded to ampicillin, tetracyclines and sulfonamides in Salmonella isolates from humans, whereas resistance to third-generation cephalosporins and fluoroquinolones remained low. In Salmonella and indicator E. coli isolates from fowl, pigs, cattle and meat thereof, resistance to tetracyclines, ampicillin and sulfonamides was also commonly detected, whereas resistance to third-generation cephalosporins was low. Moderate to high levels of ciprofloxacin (a fluoroquinolone) resistance were observed in Salmonella isolates from turkeys, fowl and broiler meat. In Campylobacter isolates from human cases, resistance to ampicillin, ciprofloxacin, nalidixic acid and tetracyclines was high, while resistance to erythromycin was recorded at low to moderate levels. High resistance to ciprofloxacin, nalidixic acid and tetracyclines was also observed in Campylobacter isolates from fowl, broiler meat, pigs and cattle, whereas much lower levels were observed for erythromycin and gentamicin. Among the indicator enterococci isolates from animals and food, resistance to tetracyclines and erythromycin was commonly detected. Meticillin-resistant Staphylococcus aureus was detected in some animal species and food of animal origin.

© European Food Safety Authority, 2012

The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010


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Collection, collation and analysis of data in relation to reference heights and reference weights for female and male children and adolescents (0-18 years) in the EU, as well as in relation to the age of onset of puberty and the age at which different stages of puberty are reached in adolescents in the EU

Monday, March 12th, 2012

This external report is not produced by EFSA. It is published here to help keep the public informed of developments related to EFSA’s scientific work. EFSA reserves its rights, view and position as regards the issues addressed and conclusions reached in the present document, without prejudice to the rights of the authors.

Published on:

12 March 2012

Collection, collation and analysis of data in relation to reference heights and reference weights for female and male children and adolescents (0-18 years) in the EU, as well as in relation to the age of onset of puberty and the age at which different stages of puberty are reached in adolescents in the EU


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