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The use of genetically modified organisms - their release into the environment, import, and utilisation as food/feed or food/feed ingredients - is regulated in the European Union (EU). For placing onto the market, current legislations require a comprehensive and science-based risk assessment. This risk assessment (RA) is performed by applicants and then evaluated by national authorities in close cooperation with the European Food Safety Authority (EFSA). The EFSA Panel on Genetically Modified Organisms (GMO) has published a comprehensive set of guidance documents for applicants and risk assessors for the RA of GM plants (GMP), their products for food and/or feed use, and their cultivation. In those documents, the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided by the applicant. The assessment starts with the molecular characterisation of the GMP. If the GMP or products derived from it are to be consumed, the evaluation of its composition, potential toxicity and/or allergenicity, and nutritional value constitute further cornerstones of the process. The environmental risk assessment (ERA) considers biotic and abiotic interactions and the impacts of the management of the GM plant when it is intended for cultivation. In the case of GM trees special emphasis would be placed on assessing their characteristic features such as their longevity, ability to disperse and their ecological significance in a range of environments. The outcome of the assessment is reflected in a published opinion from the EFSA GMO panel that indicates whether the GMP and its products raise any safety issues. This scientific opinion constitutes one of the elements taken into account by the different European regulatory authorities prior to a decision regarding authorisation to commercialise the product.

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 postmarket 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.

This document provides guidance for the risk assessment under Regulation (EC) No1829/2003 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 AnnexII of Regulation (EU) No503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.