EFSA consults on the risk assessment of ‘hybrids’GM plants and publishes guidance on the risk assessment of GM microorganisms

In line with its commitment to openness and transparency and encouraging scientific input from all interested parties, the European Food Safety Authority (EFSA) will today launch an open consultation on the approach of its Panel on Genetically Modified Organisms (GMO Panel) in assessing ‘hybrid’[1] genetically modified (GM) plants. At the same time, EFSA will also publish its final guidance document for the risk assessment of GM microorganisms which has also been subject to an extensive public consultation process.

EFSA will today launch a new public consultation on the approach of its GMO Panel in carrying out risk assessments on ‘hybrid’ GM plants. The Authority will publish a draft guidance document explaining how its GMO Panel evaluates the potential human health and environmental effects of ‘hybrid’ GM plants. This concerns ‘hybrids’ obtained by combining two GM plants which have been previously assessed. The document informs applicants how its Panel evaluates the potential interactions between the combined GM plants of the ‘hybrids’ in terms of their toxicity, allergenicity, nutritional value and environmental impact and describes what type of information and test results it expects applicants to deliver. EFSA is interested in receiving input and comments on this guidance document from potential applicants, national authorities and other regulatory bodies, key stakeholders and all interested parties. In line with its recently published GMO strategy[2], EFSA would particularly encourage Member States to contribute.

EFSA will also publish today its guidance for the risk assessment of GM microorganisms (GMMs) which is an aid to applicants requesting authorizations for GMMs and their derived products intended for food and feed use. During the consultation, a significant number of detailed comments were received from national institutions, industry, research institutions and NGOs amongst others. The document provides guidance for the risk assessment of a broad spectrum of GMMs and derived products ranging from single compounds used in food and feed (e.g. amino acids and vitamins) to products containing viable GMMs (e.g. probiotics and starter cultures for dairy products or beverages). Typical GMMs covered by the guidance document are various non-harmful bacteria, yeasts, fungi and microalgae used in food or feed.

[1] ‘Hybrid’ GM plants are created through genetically crossing or combining two different types of GM plants. EFSA has already evaluated GMO hybrids, such as MON 863 X MON 810 hybrid maize.
[2] EFSA’s on-going strategy in relation to the assessment of GMOs and its initiatives to build closer collaboration with the Member States

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