The European Food Safety Authority (EFSA) has published guidance for the risk assessment of food and feed derived from GM animals and on related animal health and welfare aspects. The document outlines specific data requirements and the methodology to be followed for risk assessment should applications for food and feed derived from GM animals be submitted for market authorisation in the European Union (EU). The risk assessment approach compares GM animals and derived food and feed with their respective conventional counterparts, integrating food and feed safety as well as animal health and welfare aspects. Prior to its finalisation, stakeholders and interested parties provided comments on a draft of the guidance document through an online public consultation that ran over the summer 2011.
At present, 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. In this context and as a proactive measure in anticipation of potential future applications, the European Commission requested EFSA to develop comprehensive guidance for the risk assessment of food and feed derived from GM animals and on related aspects of animal health and welfare. A separate EFSA guidance document, due to be launched for public consultation in 2012, will address the environmental risk assessment of GM animals.
The current 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, which is required under current EU legislation for all GMOs submitted for market authorisation, 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 also outlines the methodology required for the comparative assessment of health and welfare aspects of GM animals. This assessment is applied in two ways: firstly, in relation to the GM animal itself; and secondly, in relation to the food and feed risk assessment, as the health and welfare status of animals is seen as an important indicator of the safety of animal-derived products.
In the final chapter, the document gives recommendations for the post-market monitoring and surveillance (PMM) of GM animals and derived food and feed. PMM seeks to identify any potential unintended effects related to the genetic modification which might arise after the product has been authorised for placement on the market.
As with all EFSA guidance documents on GMOs, the Authority engaged in consultation during its development allowing Member States and a broad range of stakeholders to comment on the work in progress. Feedback received during the online public consultation to the draft guidance document was assessed by the EFSA Panel on Genetically Modified Organisms and the EFSA Panel on Animal Health and Welfare and, where scientifically relevant, incorporated into the current final version of the guidance.
The full consultation report for the guidance on GM animals will be published shortly on the EFSA website.
The risk assessment of GM animals proposed in the guidance follows a comparative approach similar to that recommended by EFSA for the risk assessment of GM plants and required under current EU legislation.
Although no applications for market approval of GM animals have been submitted in the EU, in the US, the Food and Drug Administration (FDA) is currently considering an application from industry for placement on the market of a GM salmon.
The development of EFSA’s guidance on food and feed risk assessment of GM animals and animal health and welfare aspects followed a programme of work that began in 2009. At the beginning of that year, EFSA set up a Working Group of its GMO Panel to address the molecular characterisation and food and feed safety assessment of products derived from GM animals. In 2010, EFSA set up a Working Group of the AHAW Panel to address animal health and welfare aspects. Prior to commencing work on the EFSA guidance on GM animals, in 2008, the Authority provided scientific and technical advice to the European Commission related to existing guidelines on GM animals by Codex Alimentarius (“Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals”). EFSA’s guidance was, in part, informed by the Codex Alimentarius guidelines although these did not consider aspects of animal health and welfare.