Guidance Of The Gmo Panel

"Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The marketing of these products within the European Union falls under different legislative instruments, which establish the requirement for a risk assessment for the authorisation of the product. The present guidance describes the principles to be followed when conducting such a risk assessment, as well as the scientific information required in applications for authorisation to be evaluated by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel). Products form four categories, depending on their nature and the level of scientific information required for their evaluation by the EFSA GMO Panel. The guidance details the data to be provided for the assessment of products of each category, providing reference to other guidance that is also applicable. This document draws on the experience gained by the EFSA GMO Panel in assessing applications for marketing food and feed involving GMMs and takes into account the input received from different stakeholders, and updates the "Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed", adopted by the EFSA GMO Panel in 2006."--Editor.

The Scientific Panel on Genetically Modified Organisms (GMO Panel) adopted its guidance document for the risk assessment of genetically modified (GM) plants and derived food and feed on 24 September 2004. The European Food Safety Authority (EFSA) and the GMO Panel have consulted stakeholders prior to the final adoption of this document. This document provides guidance for the preparation and presentation of applications submitted within the framework of Regulation (EC) 1829/2003 on GM food and feed, and of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document therefore covers the full risk assessment of GM plants and derived food and feed. Issues related to risk management of GMOs (traceability, labelling, co-existence) are outside the scope of the guidance document. Guidance for the preparation of applications is given throughout the different chapters of the document. The first chapter of the guidance document clarifies the scope of the document and the legal background for the risk assessment of GMOs, GM food and feed at Community level. Chapter II describes the overall risk assessment strategy. Chapter III describes the issues to be considered when carrying out a comprehensive risk characterisation. These include molecular characterisation of the inserts, assessment of modification to the agronomic characteristics of the GM plant and evaluation of food/feed safety aspects of the GM plant and/or derived food and feed. 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 GM food/feed and/or for the environmental monitoring of GM plants. Finally, Chapter IV summaries the overall risk characterisation process.

This document provides updated guidance for the risk assessment of food and feed containing, consisting or produced from genetically modified (GM) plants, submitted within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The risk assessment strategy for GM plants and derived food and feed proposed seeks to deploy appropriate approaches to compare GM plants and derived food and feed with their respective comparators. The underlying assumption of this comparative approach is that traditionally cultivated crops have gained a history of safe use for consumers and/or domesticated animals. The document provides guidance on how to perform the comparative analysis of the relevant characteristics of the GM plant. The document addresses the details of the different components of the risk assessment: the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the impact of biologically relevant change(s) in the GM plant and/or derived food and feed resulting from the genetic modification; the assessment of potential allergenicity, of the novel protein(s) as well as of the whole food derived from the GM plant; the nutritional assessment to evaluate whether food and feed derived from a GM plant is not nutritionally disadvantageous to humans and/or animals. In addition every section of the document addresses specifically the requirements for GM plants containing a combination of transformation events, providing guidance on how to establish that the combination is stable and that no interactions occurs between the events that may raise safety concerns. The document does not cover the environmental risk assessment of GM plants which is addressed in a stand-alone environmental risk assessment (ERA) guidance document developed by the EFSA GMO Panel.

The European Commission asked the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to update its 2006 scientific opinion on Post-Market Environmental Monitoring (PMEM) of Genetically Modified Plants (GMPs). For doing so, the EFSA GMO Panel made use of the experience gained from its assessment of applications on GMPs for cultivation and considered different sources of information such as the PMEM reports on cultivated GMPs, relevant scientific literature and stakeholders comments. This scientific opinion aims to clarify the objectives, tasks, tools and requirements for PMEM. Firsly, the present document explains the scientific rationale for PMEM, including the concept of developing management and monitoring strategies based on the overall conclusions and assumptions of the Environmental Risk Assessment. Secondly, it provides examples and guidance to applicants on how to develop and implement their plans for Case-Specific Monitoring (CSM), taking into account the case-by-case character of CSM. In addition, it provides guidance to applicants on the strategy, methodology and reporting of General Surveillance (GS). Different tools and approaches to implement a plan for GS are considered. The EFSA GMO Panel proposes a holistic and integrative approach for monitoring GMPs in the EU that considers GS within a framework of general environmental protection monitoring. Finally, the EFSA GMO Panel makes proposals to risk managers for the future conduct of PMEM in the EU and suggests that access to PMEM data could be facilitated by setting-up standardised and centralised reporting centres. This scientific opinion repeals the former 2006 scientific opinion of the EFSA GMO Panel on PMEM of GMPs.

This document provides guidance for the risk assessment of food and feed containing, consisting of or produced from genetically modified (GM) animals, as well as for the health and welfare assessment of these animals, within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The assessment strategy seeks to deploy appropriate approaches to compare GM animals and derived food and feed with their respective comparators. The health status of a food/feed producing animal has traditionally been considered as an important indicator of the safety of derived foods/feed and therefore comparative analysis of the phenotypic characteristics of the GM animal with the traditionally-bred animal, including health and physiological parameters, is considered an important component in the risk assessment. The document addresses the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the possible impact of biologically relevant change(s) in the GM animal and/or derived food and feed, the allergenicity assessment of the novel protein(s), as well as of the whole food derived from the GM animal; and the nutritional assessment to evaluate whether food and feed derived from a GM animal is as nutritious to humans and/or animals as food and feed derived from traditionally-bred animals. This guidance document also addresses the scientific requirements for the assessment of health and welfare of GM animals bred for food and feed use. The assessment is made in terms of the effective functioning of their body systems in a given environment. The document does not cover the environmental risk assessment of GM animals, which will be addressed in stand-alone guidance under development by the EFSA GMO Panel.

This document provides guidance on how to estimate measurement uncertainty (MU) and supports the enforcement of EU food and feed labelling legislation in the GMO sector. Measurement uncertainty is a parameter which is always associated with the result of a measurement, and characterises the dispersion of values attributed to that result. This measurement uncertainty needs to be estimated when compliance is investigated. The first version of this guidance document was written on request of the European Network of GMO Laboratories (ENGL) as a follow-up to a workshop on MU in the GMO sector organised by the European Commission, Joint Research Centre and was published in 2007. It was updated in 2009. The current version takes into account current EU legislation, availability of certified reference materials (CRMs) and validated quantification methods and the need for control laboratories which carry out measurements for the enforcement of EU legislation to be accredited according to ISO/IEC 17025. This guidance document contributes towards a harmonised approach for how EU Member States check compliance of food and feed samples with EU legislation. Other documents, e.g. the flexible scope accreditation document refer to this document concerning aspects related to MU.

This Brief describes in three concise chapters one of the newest ‘hot topics’ under EU Food Law and Policy: the new Regulation (EU) No 2015/2283 from the European Parliament and by the Council, November 25, 2015, on novel foods, applicable from January 2018. In this work, the Authors discuss the long-time criticized EU Regulation on novel foods ((EC) No 258/1997) and how it has been significantly altered by the adoption of the new regulation. In the first chapter, the Authors provide a comprehensive analysis of the genesis of the new Regulation, its rationale and the policy’s goals. In particular, they describe what food business operators shall do in order to get a new product allowed on the EU market, providing updated information on the regulatory developments from the European Food Safety Authority in nanofoods, cloned animals and insect foods. The role of the European Food Safety Authority is also discussed. The second Chapter summarizes the current toxicological studies used to evaluate novel foods safety, which are an extremely important pillar when speaking of food safety and commercial introduction of new products. Finally, the third Chapter discusses the ‘history of safe use’ approach to the problem of novel foods, and factors such as consumption period analysis, preparation advices and processes, intake levels, nutritional composition, and results of animal studies. Food lawyers, professionals and auditors working in the area of official inspections, quality assurance, food traceability, and international regulation, both in academia and industry, will find this Brief an important account.

This guide has been prepared by the IUCN Environmental Law Programme and the Foundation for International Environmental Law and Development (FIELD), in cooperation with the World Resources Institute (WRI). The main goal of the guide is to facilitate the understanding of the obligations of Parties to the Protocol, by providing an information base on the content and origin of the Protocol provisions, accessible to the non-specialist and useful for those who will be involved in the development and implementation of national safety frameworks.