The European Food Safety Authority (EFSA) asked the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) to establish a Working Group with the aim of updating the Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use. The aim encompasses providing updated guidance for the preparation and presentation of applications involving genetically modified microorganisms (GMMs).
The Working Group: i) reviewed the existing Guidance Document in the light of experience gained, technological progress and scientific developments, ii) considered input received from the Member States and applicants on the existing Guidance Document, and iii) completed a public consultation of the draft Guidance.
Guidance for the preparation of applications is given throughout the different chapters of the document. Chapter I clarifies the scope of the document. This guidance covers GMMs and their products falling under Regulation (EC) No 1829/2003 on GM food and feed, as well as those falling under Regulations 1332/2008 (on food enzymes), 1333/2008 (on food additives), 1334/2008 (on food flavourings), and 1831/2003 (on feed additives) when GMMs are involved. Chapter II describes the strategy, the steps to be taken, and the issues to be considered when carrying out a comprehensive risk characterisation. GMMs and their products are divided in four categories, depending on their nature and the level of scientific information required for their risk assessment. Depending on the category to which a product is allocated, its use, and the legislations applicable to the product, it is specified which Sections of this guidance document must be followed, and what other guidelines and guidance are also applicable. Chapter III describes the scientific information that should be provided in applications, and which is required for the risk assessment by the EFSA GMO Panel. This should include a comprehensive characterisation of the GMM and cover the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. Data on composition, toxicity, allergenicity, nutritional value and environmental impact provide, on a case-by-case basis, the cornerstones of the risk assessment process. The characterisation of risk may give rise to the need for further specific activities including post-market monitoring of the GMM and derived food and feed and/or for the environmental monitoring of the GMM.