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The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

The European Food Safety Authority (EFSA) carried out a consultation to collect input from the scientific community and all interested parties for the risk assessment of the low level (LL) presence of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003. A two-step approach was followed. The draft LL Scientific Opinion was prepared by the ad hoc Working Group of the EFSA Panel on Genetically Modified Organisms (GMO Panel) and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 21 September 2016. EFSA received approximately 100 comments on the draft LL Scientific Opinion from 11 Member States. Based on the outcome of the dedicated consultation, a second draft LL Scientific Opinion was prepared and endorsed by the Panel for a dedicated consultation with European Member States at its plenary meeting on 5 April 2017. EFSA received approximately 60 comments on the draft LL Scientific Opinion from 7 interested parties. The current report summarises the outcome of the two-step consultation, and includes a brief description of the comments received and how the comments were addressed. Comments related to policy or risk management aspects were considered out of the remit of the GMO Panel and outside the scope of these consultations; therefore these are not addressed in this document. The GMO Panel prepared an updated version of the LL Scientific Opinion taking into account the comments under its remit received. EFSA and its GMO Panel wish to thank European Member States, all stakeholders and the general public for their contributions. The LL Scientific

Efsa Panel On Genetically Modified Organisms (gmo) StatementRequestor: European CommissionQuestion number: EFSA-Q-2016-00506 ; This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.

This document provides guidance for the risk assessment under Regulation (EC) No 1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of Annex II of Regulation (EU) No 503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed.

Requestor: European CommissionQuestion number: EFSA-Q-2015-00126 ; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

Requestor: European CommissionQuestion number: EFSA-Q-2015-00126 ; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

Requestor: European CommissionQuestion number: EFSA-Q-2015-00126 ; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

Requestor: European CommissionQuestion number: EFSA-Q-2015-00126 ; The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

In January 2014, an international meeting sponsored by the International Life Sciences Institute/Health and Environmental Sciences Institute and the Canadian Food Inspection Agency titled "Genetic Basis of Unintended Effects in Modified Plants" was held in Ottawa, Canada, bringing together over 75 scientists from academia, government, and the agro-biotech industry. The objectives of the meeting were to explore current knowledge and identify areas requiring further study on unintended effects in plants and to discuss how this information can inform and improve genetically modified (GM) crop risk assessments. The meeting featured presentations on the molecular basis of plant genome variability in general, unintended changes at the molecular and phenotypic levels, and the development and use of hypothesis-driven evaluations of unintended effects in assessing conventional and GM crops. The development and role of emerging "omics" technologies in the assessment of unintended effects was also discussed. Several themes recurred in a number of talks; for example, a common observation was that no system for genetic modification, including conventional methods of plant breeding, is without unintended effects. Another common observation was that "unintended" does not necessarily mean "harmful". This paper summarizes key points from the information presented at the meeting to provide readers with current viewpoints on these topics.