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In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Document introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs on non-target organisms is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resulting from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.

In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Docuinent introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs tin non-target organislns is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resultihg from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.

In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Docuinent introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs tin non-target organislns is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resultihg from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.

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.