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In November 2017, EFSA published new guidance for assessing, under Regulation EC 1829/2003, risks from the "unintended, adventitious or technically unavoidable presence" in food and feed of a low level of genetically-modified plant material intended for markets other than Europe. The presence at low level is defined by the European Commission to be a maximum of 0.9% of genetically modified plant material per ingredient (e.g. grain, flour, syrup).

EFSA is carrying out an increasing number of assessments on the safety of plants containing more than one genetic modification. electricity dance moms The combination of two or more modifications within one plant is called a stack. Such a plant does not represent a new genetic modification. The plant contains several existing genetic modifications that have been combined through conventional breeding techniques. The aim is to benefit from the combination in one single plant of several properties created by the individual genetic modifications, such as insect resistance and herbicide tolerance.

EFSA adopted its first opinion on a GM plant containing stacked properties in June 2005. As of August 2016, EFSA has adopted 28 opinions involving stacks. electricity and magnetism review game While most initial applications involved lower stacks with two or three genetic modifications, EFSA now assesses the safety also of higher stacks with four, five or six modifications combined in one plant.

When assessing the safety of a stack for humans, animals and the environment, EFSA considers the quality and quantity of all available information and draws on the existing risk assessments of each of the individual genetic modifications that form the stack. EFSA also takes into account the data for the stack, focusing on the levels of newly expressed proteins, the stability of the modifications and on potential interactions between individual modifications combined in the stack.

The safety assessment of the GM stack plant includes all possible sub-combinations of the individual modifications. Some may have been assessed previously as separate stacks; others do not exist and data are therefore not available. In such cases, EFSA performs its assessment on a weight-of-evidence approach, using available information from risk assessments of the high stack, the single genetic modifications and existing sub-combinations to conclude on its safety.

EFSA clearly identifies any uncertainties stemming from the lack of data and, if relevant, recommends mitigation measures. For example, such measures could require applicants to provide relevant data for a risk assessment of the respective sub-combination should they produce plants with previously non-existent sub-combinations through conventional breeding.

EFSA is currently updating guidance on allergenicity to reflect scientific advances in the field. The update is based in part on extensive literature reviews, which revealed new methodologies that could be applied in allergenicity assessment. It also reflects recent EU legislation on GM food and feed by addressing new requirements for the authorisation of GM plants for the European market.

The draft guidance on allergenicity assessment of GM plants is a milestone in EFSA’s efforts to engage stakeholders in its scientific processes. electricity production by state An eight-member stakeholder focus group acted as a consultative body and contributed to the development of the document from the start. The involvement of stakeholders allowed EFSA to benefit from relevant expertise throughout the development of the guidance.

In June 2015, EFSA published new guidance clarifying the data needs for the agronomic and phenotypic characterisation of GM plants. The document complements existing guidance on data requirements for the risk assessment of GM plants. It gives applicants seeking market approval for a GM plant in the European Union recommendations on how to generate, analyse and interpret agronomic and phenotypic data of the GM plant.

In June 2018, EFSA adopted a technical note that provides recommendations and requirements on the sequencing information to be submitted when Sanger sequencing or Next generation sequencing (NGS) is used as part of GMO applications for EU market authorisation. From 1 October 2018, this note will replace the European Commission’s Joint Research Centre guideline of 2016. electricity videos for 4th grade EFSA will be responsible for the verification and quality assessment of sequencing data for all GMO applications received after that date.

Following a request from the Commission, EFSA launched a project in 2011 to evaluate eight new plant breeding techniques. The GMO Panel was asked to assess whether the current guidance documents would still be applicable to plants developed using these novel methods. The techniques earmarked for evaluation included intragenesis, cisgenesis and zinc finger nuclease technique (ZFN).

EFSA delivered the first of these opinions on cisgenesis and intragenesis in January 2012 followed by a second opinion on zinc finger nuclease 3 (ZFN-3) in October 2012. gas laws worksheet pdf The GMO Panel concluded in both opinions that current risk assessment guidance (including environmental risk assessment guidance) was applicable to evaluate food and feed derived from these new techniques. In 2013, the European Commission requested that EFSA put further assessments of new plant breeding techniques on hold to allow the GMO Panel to focus on the evaluation of GMO applications and the development of guidance documents.

EFSA evaluates the safety of new GMO products before a market authorisation decision is taken by risk managers. This evaluation encompasses the assessment of the potential impact of GMOs on human health, animal health and the environment. EFSA’s assessments are based on scientific dossiers presented by applicants and any other relevant scientific information.

• Comparative analysis: comparison of the GM plant with its conventional counterpart. The aim is to detect differences in the plant’s observable appearance such as height and colour – phenotypic characteristics – and its agronomic characteristics such as yield. The analysis also compares the nutritional values of the GM plant and its conventional counterpart.

Under EU legislation, applications for import and processing as well as for cultivation of GM plants must contain a plan for detailed post-market environmental monitoring (PMEM). This plan should describe how the GM plant will be monitored for possible adverse effects on the environment. EFSA assesses the results of PMEM for cultivated GM plants annually. gas bubble in back It makes recommendations to the European Commission when necessary.

In some cases, EFSA recommends the post-market monitoring of GM plants for possible adverse effects on animal or human health. This is usually done when the GM food or feed has an altered nutritional composition, when the nutritional value of the GM food or feed differs from the conventional varieties, or when there is a likelihood of increased allergenicity due to the genetic modification. The aim of post-market monitoring is to ensure the continued safety of the new GMO.

EFSA assesses any possible risks from GMOs to human and animal health, and the environment in Europe. EFSA’s role is to give scientific advice on the safety of GMOs to Europe’s risk managers, i.e. the European Commission and EU Member States. It is their responsibility as risk managers to decide on the authorisation of GMOs for the European market.

EFSA applies the strict criteria laid down in the European Union regulatory framework when evaluating the safety of GMOs before they can be authorised for use as food or feed or for cultivation in the EU. static electricity online games The GMO Panel has developed guidance documents describing application procedures and the data applicants must include in their application dossiers. The required information includes all necessary studies on human and animal safety, as well as on environmental impact. This approach ensures that the Panel’s evaluations meet the highest scientific standards.

EFSA works closely with Member States during the GMO assessment process through a network of over 100 organisations and authorities across Europe including over 250 experts. gas prices going up 2016 Member States are able to give input to EFSA on its GMO assessments during a commenting period. To ensure transparency, EFSA provides a summary of how comments and input from Member States are followed up in each of its GMO opinions.

EFSA’s GMO risk assessment work is carried out by the GMO Panel of up to 21 scientific experts, supported by a team of EFSA scientists, with experience in a wide range of scientific disciplines: biochemistry, food and environmental food microbiology, soil microbiology, molecular biology, genetics, toxicology, animal pathology, immunology, biotechnology, food sciences, ecology, plant biology, agronomy, entomology and statistics. In addition, over 40 external scientific experts with additional expertise contribute to the work of the Panel as members of its working groups, which are created to deal with specific areas of GMO risk assessment.

Members of the GMO Panel and its working groups, as well as other external experts contributing to the work of EFSA, are selected based on their scientific competence and expertise, and according to objective and transparent criteria. All scientific experts selected to contribute to the work of the Panel or any of the working groups have to make Declarations of Interests (DoIs) which are published on the EFSA website. This policy helps EFSA to ensure the independence of its scientific advice.