PARMA, Italy – Specific data requirements and the methodology that should be followed for risk assessment should applications for food and feed derived from genetically modified (GM) animals be submitted for market authorization in the European Union (EU) is outlined in a new guidance document from the European Food Safety Authority (EFSA).

This risk-assessment approach compares GM animals and derived food and feed with their respective conventional counterparts integrating both food and feed safety as well as animal health and welfare aspects. Stakeholders and interested parties are invited to provide comments through an online public consultation that runs until Sept. 30.

To date, no applications for market approval of food and feed derived from GM animals have been submitted in the EU. The technology has advanced rapidly in recent years and in some countries outside the EU regulators are already evaluating the safety of GM animal products developed for food and feed purposes.

The European Commission requested EFSA in 2007 to develop comprehensive guidance for the risk assessment of food and feed derived from GM animals and in 2010 requested the inclusion of related aspects of animal health and welfare as a proactive measure in anticipation of potential future applications.

Developed by scientific experts from EFSA’s Panel on Genetically Modified Organisms (GMO) and Panel on Animal Health and Welfare (AHAW), the draft guidance document integrates the risk assessment of food and feed from GM animals with related aspects of animal health and welfare. Set to launch for public consultation in 2012, a separate EFSA guidance document will address the environmental risk assessment of GM animals.

The present draft guidance document outlines a risk assessment approach to compare GM animals and derived food and feed with their respective conventional counterparts. The basic assumption of this type of comparative assessment is that food and feed from conventionally-bred animals have a history of safe use and therefore can serve as a baseline for the risk assessment of food and feed derived from GM animals.

The document outlines specific data requirements for the comparative analysis of different components of the food and feed risk assessment. Important components of the risk assessment include molecular characterization, compositional analysis and assessment of toxicity, nutritional aspects and potential allergenicity. Experts can assess whether food and feed from GM animals are as nutritious to humans and animals as those from conventionally-bred animals.

The draft guidance document also outlines the methodology required for the comparative assessment of health and welfare aspects of GM animals.

In the final chapter of the draft guidance document, recommendations are made for the post-market monitoring and surveillance (PMM) of GM animals and derived food and feed, which seeks to identify any potential unintended effects related to the genetic modification which might arise after the product has been authorized for placement on the market.

In regard to animal health and welfare, PMM is required to determine possible long-term unexpected effects with low incidence. The monitoring takes into account the breeding of large numbers of GM animals for food and feed purposes in more varied commercial conditions than those established during stage three of the proposed assessment strategy for animal health and welfare (i.e. trials carried out in a commercial setting).

Following public consultation, EFSA will assess all comments made and, where relevant, these will be incorporated in a revised guidance document to be adopted by EFSA’s GMO and AHAW Panels at the end of 2011.