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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.

Following the submission of application EFSA‐GMO‐RX‐017 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant and herbicide‐tolerant genetically modified maize MON 88017 × MON 810, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, and updated bioinformatic analysis. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 88017 × MON 810 considered for renewal are identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐017 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017 × MON 810.

Following the submission of application EFSA–GMO–RX–018 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified cotton GHB614, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. The GMO Panel concludes that there is no evidence in renewal application EFSA–GMO–RX–018 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614.