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The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that required by the European Commission in accordance with Article 23 of Regulation (EC) No 1107/2009 following the submission of an application for approval of milk as a basic substance for use in plant protection as elicitor and barrier mechanism. The current report summarises the outcome of the consultation process organised by EFSA and presents EFSA's scientific views on the individual comments received.© European Food Safety Authority, 2018 [ABSTRACT FROM AUTHOR]

The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the procedures implemented at country level for the investigation of, and response to, multi‐country foodborne outbreaks. On this occasion, the tools available at European Union level for early signal detection of and response to multi‐country foodborne events were presented, including the Epidemic Intelligence and Information System for food‐ and waterborne diseases (EPIS‐FWD), Early Warning and Response System (EWRS) platform, Rapid Alert System for Food and Feed (RASFF) platform and the FoodChain‐Lab tool. The topics discussed included examples of recent multi‐country outbreaks in the EU: an event of Salmonella Enteritidis linked to contaminated eggs originating from Poland and an outbreak caused by a new, previously unknown Salmonella serotype and linked to imported contaminated sesame seeds. The countries involved, ECDC and EFSA, as well as the European Commission gave an overview of their contribution to the investigation and management of these outbreaks. Several EU‐wide projects were presented in the meeting, including ENGAGE, INNUENDO, COMPARE, Swiss One Health project and EuroCigua project. The inter‐active session at the end of the meeting offered the opportunity to identify and prioritize the gaps in the collaborative efforts to better responding to foodborne outbreaks at the national and EU level. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for copper (I), and copper (II) variants (formerly referred to as copper compounds) are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State France and presents EFSA's scientific views and conclusions on the individual comments received. It is noted that EFSA finalised in January 2018 a conclusion on the peer review of the pesticide risk assessment of this active substance, in the context of the renewal of the approval. [ABSTRACT FROM AUTHOR]

Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The approach of EFSA for the evaluation of TF notifications is based on the EFSA guidance for stakeholders on notifications and applications for authorisations of TF and on the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. Based on the available data and provided that the TF is produced in compliance with the steps described in the Organisation for Economic Co‐operation and Development (OECD) consensus document on S. bicolor and with the requirements and specifications set by the Food and Drug Administration (FDA) (i.e. heat treatment applied and minimum sugar content of 74%), EFSA does not raise safety objections to the placing on the market within the European Union of syrup from Sorghum bicolor (L.) Moench as a TF [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for sulfoxaflor are presented. The current report summarises the outcome of the consultation process organised by the co‐rapporteur Member State Czech Republic and presents EFSA's scientific views and conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 2018. The written public consultation for this document was open from 18 April 2018 to 23 May 2018. EFSA received comments from 4 interested parties. EFSA and its NDA Panel wish to thank all stakeholders for their contributions. The current report summarises the outcome of the public consultation, and includes a brief summary of the comments received and how the comments were addressed. The NDA Panel prepared an updated version of the Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants taking into account the comments received. The Scientific Opinion was discussed and adopted at the NDA Plenary meeting on 28 June 2018, and is published in the EFSA Journal. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeting on 12 December 2017. The written public consultation was open from 9 January to 4 March 2018. A technical meeting with stakeholders was held in Brussels on 13 February 2018, during the consultation period. Stakeholders were encouraged to submit their comments in writing within the consultation deadline. EFSA received comments from 46 interested parties. EFSA and its NDA Panel wish to thank all stakeholders for their contributions. The present report summarises the outcome of the public consultation, and includes a brief summary of the comments received and how they were addressed. In particular, the report describes the revisions of the draft protocol that have been applied in light of the comments received. The protocol will be implemented in order to draft a Scientific Opinion on the Tolerable Upper Intake Level of dietary sugars. Another public consultation will be organised on the draft scientific opinion, which is foreseen to be endorsed by the NDA Panel at the end of 2019. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for iodosulfuron and prosulfuron are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Sweden and co‐rapporteur Member State France and presents EFSA's scientific views and conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

Abstract: Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any DNA sequence inserted in the GM plant genome. When a GM plant is designed to produce one or more newly expressed proteins, an aspect of the risk assessment process is to characterise these proteins and to reliably determine their levels in the GM plant tissues. A number of methods to measure protein expression levels are used and several experimental factors within these methods are of critical importance in order to obtain reliable results. This explanatory note provides details on key methodological aspects for the determination of newly expressed protein levels that should be considered and reported by applicants in order to harmonise the information in GM plant applications submitted to EFSA. [ABSTRACT FROM AUTHOR]

In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilation of the contributions of the reporting countries. [ABSTRACT FROM AUTHOR]

EFSA has carried out a public consultation on the draft Guidance of the EFSA Scientific Panel on Plant Health (PLH Panel) on quantitative pest risk assessment with the aim of collecting input from the scientific community and all interested parties. The draft Guidance was prepared by the dedicated Working Group of the PLH Panel. It provides guidance on the methodology to conduct quantitative pest risk assessment and the evaluation of risk reduction options. The methodology consists of a two‐phase approach. Phase one consists of pest categorisation to determine whether the pest has the characteristics of a quarantine pest or those of a regulated non‐quarantine pest for the area of the EU. Phase two consists of pest risk assessment and is a more detailed assessment to inform phytosanitary decision making. Following the endorsement of the draft Guidance by the PLH Panel, the public consultation was launched on 12 February 2018 and closed on 25 March 2018. EFSA received 178 comments on the draft Guidance from 11 interested parties. This technical report on the outcome of the public consultation on the draft Guidance summarises the comments received through the public consultation and presents the responses of the PLH Panel to the comments. The PLH Panel prepared an updated version of the draft Guidance taking into account the comments received. The Guidance was adopted at the PLH Panel plenary meeting on 21 June 2018, and is published in the EFSA Journal. [ABSTRACT FROM AUTHOR]

This document describes the lifecycle of cross‐cutting guidance documents in EFSA. Cross‐cutting guidance documents deal with matters of a horizontal nature in fields that affect scientific areas covered by more than one Panel. The main objective of developing cross‐cutting guidance documents is to harmonise food and feed safety risk assessment in EFSA. The document outlines the procedures for the identification of needs for cross‐cutting guidance documents, their development, implementation, their review and revision. [ABSTRACT FROM AUTHOR]

The analytical data on the presence of chemical contaminants in food and feed used in dietary exposure assessments in EFSA scientific outputs often contain a high number of left‐censored data, i.e. non‐quantified/non‐detected data; EFSA usually uses the so‐called substitution method to make use of this type of data in its assessments. However, the presence of left‐censored data together with a wide range of detection and/or quantification limits is often an important source of uncertainty associated with the dietary exposure estimates. This Technical Report describes a step‐wise approach to select the most appropriate cut‐off values on the provided censoring limits based on: 1) legal requirements; 2) typical expanded uncertainty levels; or 3) distributions of the quantified values and reported limits of quantification. This approach is intended to minimise the influence of left‐censored data on the uncertainty associated with the dietary exposure estimates. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) were asked by the European Commission to develop a common Guidance Document for the implementation of the hazard‐based criteria to identify endocrine disruptors (ED) in the context of Regulations (EC) No. 1107/2009 and (EU) No. 528/2012. The requested technical and scientific assistance is provided for under Article 31 of Regulation (EC) No. 178/2002 (for EFSA) and Article 76 (1) (d) of Regulation (EU) No. 528/2012 (for ECHA). During the drafting process, several targeted consultations have been organised by EFSA and ECHA to support the drafting procedure and to provide a sound revision of the Guidance. A public consultation on the draft Guidance was also launched, to ensure the opportunity for the public and all relevant stakeholders to comment and get involved in the development of the Guidance. Immediately after the closure of the public consultation, the European Commission organised a specific workshop in Brussels with Member States' experts risk assessors and other stakeholders. Finally, two last consultation rounds have been organised with the relevant EFSA/ECHA scientific risk assessment bodies and risk management bodies. The current report summarises the outcome of the different consultation processes organised by both Agencies. [ABSTRACT FROM AUTHOR]

Following a notification from Soloberry Ltd, submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market berries of Lonicera caerulea L. as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The approach of EFSA for the evaluation of TF notifications is based on the EFSA guidance for stakeholders on notifications and applications for authorisations of TF and on the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. EFSA considers that the available data on composition and history of use of berries from three L. caerulea varieties (Lonicera caerulea var. emphyllocalix, Lonicera caerulea var. kamtschatica, Lonicera caerulea var. edulis) do not raise safety concerns. Considering the available data, EFSA does not raise safety objections to the placing on the market of the requested TF (i.e. berries from Lonicera caerulea var. edulis) within the European Union. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a Draft Scientific Guidance of the EFSA Panel on Animal Health and Welfare (AHAW Panel) on the assessment criteria for applications for new or modified stunning methods regarding animal protection at the time of killing. The Draft Guidance proposed three main sections i) guidance for handling applications on stunning methods, ii) suitability check of data for risk assessment and iii) risk assessment of the stunning method. Applicants could submit comments related to each of the three sections. The draft was discussed and endorsed for public consultation by the AHAW Panel at its plenary meeting on 06‐07 March 2018. The consultation was carried out via the internet and was open from 13 March 2018 till 24 April 2018. Interested parties were invited to submit comments and to refer to the line and page numbers. All eligible comments were recorded and assessed by the ad‐hoc Working Group on “Revision of the stunning guidance” of the AHAW Panel. The AHAW Panel prepared an updated version of the guidance taking into account the relevant comments received. The Scientific Opinion was discussed and adopted at the AHAW Plenary meeting on the 11th of June 2018, and is published in the EFSA Journal (EFSA AHAW Panel, 2018). [ABSTRACT FROM AUTHOR]

Following a notification from Obà Food Srl, submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market decorticated grains of Digitaria exilis (Kippist) Stapf as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing of the TF on the market within the European Union. The approach of EFSA for the evaluation of TF notifications is based on the EFSA guidance for stakeholders on notifications and applications for authorisations of TF and on the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. EFSA considers that the available data on composition on wholegrain and decorticated (bran removed) grains of Digitaria exilis (Kippist) Stapf do not raise safety concerns. Considering the available data, EFSA does not raise safety objections to the placing on the market of the requested TF (i.e. decorticated grains of Digitaria exilis (Kippist) Stapf) within the European Union. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. The draft Guidance was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its plenary meeting of 15‐15 November 2017. The public consultation for this document was open from 12 January to 4 March 2018. EFSA received about 400 comments from 30 interested parties. EFSA's Scientific Committee wishes to thank all stakeholders for their contributions. This report presents statistics on the comments received and provides a summarised description of how the comments were addressed in the finalisation of the document. The stakeholders valuable and detailed comments were taken into account by the Scientific Committee to prepare an updated version of the guidance. The draft guidance was discussed and endorsed at the Scientific Committee plenary meeting on 28‐29 May 2018. This draft is published in the EFSA Journal to enter a pilot phase within EFSA. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for tebufenozide are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Germany and presents EFSA's scientific views and conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for oxathiapiprolin are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Ireland and presents EFSA's scientific views and conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]