FAQ on genetically modified animals
1. What are genetically modified (GM) animals?
2. What is EFSA’s remit regarding GM animals?
3. Which aspects does EFSA’s guidance cover?
4. Is there any food or feed from GM animals currently authorised for placement on the market in the EU?
5. How will EFSA evaluate the safety of food and feed derived from GM animals should applications be received?
6. Does EFSA take into account the health and welfare of GM animals in its guidance?
7. Does EFSA consider the environmental aspects of GM animals bred for food and feed purposes?
8. What about the ethical concerns surrounding GM animals?
9. What is the difference between GM animals and cloned animals?
10. When will EFSA’s guidance documents be adopted and what are the next steps?
1. What are genetically modified (GM) animals?
Genetic modification of an animal involves the modification of its genetic material by adding, changing or removing certain DNA sequences to modify the characteristics of the animal or introduce a new trait, such as disease resistance or enhanced growth, in a predetermined way. DNA is the genetic material of an organism and carries the instructions for all the characteristics that an organism inherits. Changes introduced in an animal’s genetic make-up can therefore be transmitted to the next generation.
2. What is EFSA’s remit regarding GM animals?
The European Commission asked EFSA to develop comprehensive guidance for the risk assessment of food and feed derived from GM animals, taking into account food and feed safety, animal health and welfare and environmental safety.
EFSA’s role is to independently assess and provide scientific advice to risk managers on any possible risks that GMOs pose for human and animal health and the environment. In Europe, it is the role of risk managers such as the European Commission and the Member States to decide whether a GMO or a derived product can be placed on the EU market.
3. Which aspects does EFSA’s guidance cover?
EFSA’s guidance documents outline specific data requirements and the methodology for the risk assessment of GM animals and derived products should applications for food and feed be submitted for market authorisation in the European Union (EU).
EFSA will deliver two guidance documents for the risk assessment of food and feed derived from GM animals. The first, an integrated guidance covering food and feed safety and related aspects of animal health and welfare, was launched in draft format for public consultation in August 2011 and a final version was adopted by EFSA’s Panel on GMOs in December 2011.
The second guidance document will address the environmental risk assessment (ERA) of GM animals bred for food and feed purposes, due to be published in 2012. The guidance takes a species-by-species approach to ERA, focusing on GM fish, GM insects, and GM birds and mammals. To help define the criteria for ERA of GM animals, EFSA launched external calls for data for the three categories. The information received is being considered by EFSA’s Working Group preparing the guidance document.
4. Is there any food or feed from GM animals currently authorised for placement on the market in the EU?
No food or feed from GM animals has been authorised for placement on the market in the EU, nor have any applications been made by industry for approval. EFSA’s guidance on GM animals is a proactive measure and should be used by industry, if applications for market approval are made in the future. Risk assessment is a prerequisite for the possible market authorisation of GMOs which is why EFSA’s guidance has been prepared.
In some countries outside the EU, regulators are already assessing the safety of GM animal products developed for food and feed purposes. For example, in the US the Food and Drug Administration (FDA) is considering an application from industry for placement on the market of a GM salmon.
5. How will EFSA evaluate the safety of food and feed derived from GM animals should applications be received?
The 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. Important components of the risk assessment include molecular characterisation, compositional analysis and assessment of toxicity, nutritional aspects and potential allergenicity. For example, experts can assess whether food and feed from GM animals are as nutritious to humans and animals as those from conventionally-bred animals.
The guidance 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, where the assessment should focus on the effective functioning of the animal’s body systems (e.g. disease resistance); 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. For further information on animal health and welfare aspects, see question 6.
The guidance also includes recommendations for the post-market monitoring and surveillance of food and feed derived from GM animals on a case-by case basis.
6. Does EFSA take into account the health and welfare of GM animals in its guidance?
EFSA recognises that there are potential concerns about animal health and welfare related to the development of GM animals for food and feed purposes. Requirements for the assessment of animal health and welfare are integrated in its guidance on the risk assessment of food and feed from GM animals.
The guidance highlights the need for extensive comparative analysis of the characteristics and traits of GM animals, including physiological parameters, with those of their conventional counterparts. It also proposes that health and welfare should be assessed at all stages of development of the GM animal, up to the point at which it would receive authorisation, should this be granted. The recommended assessment strategy covers the laboratory setting where the GM animal is initially developed, experimental field trials outside the laboratory involving a higher number of animals and trials with large numbers of animals carried out in a commercial setting (prior to authorisation).
Post-market monitoring and surveillance is also considered necessary to identify infrequent, unintended effects of the genetic modification on the health and welfare of the GM animal arising after it has been authorised for placement on the market.
7. Does EFSA consider the environmental aspects of GM animals bred for food and feed purposes?
Yes. EFSA is currently developing a guidance document on the environmental risk assessment of GM animals bred for food and feed purposes. For further information, see answer to question 3 above.
8. What about the ethical concerns surrounding GM animals?
EFSA is only responsible for evaluating the food and feed safety, environmental safety and animal health and welfare aspects of food and feed derived from GM animals. While EFSA acknowledges the broader societal, political and economic debates about GMOs and GM animals, these considerations are not taken into account in the scientific process of risk assessment.
9. What is the difference between GM animals and cloned animals?
Genetic modification involves the modification of the genetic material of an animal. In a genetically modified animal, DNA sequences have been inserted, removed or modified in order to introduce a new trait or change a characteristic such as the disease resistance of an animal. The technology used is known as recombinant-DNA technology and was first applied in the 1970s.
Animal cloning results in the production of an animal that is a genetically identical copy of the original.
10. When will EFSA’s guidance documents be adopted and what are the next steps?
EFSA’s guidance on the risk assessment of food and feed from GM animals and on animal health and welfare aspects was adopted in December 2011 and is available on the EFSA website:
The guidance document on the environmental risk assessment of GM animals bred for food and feed purposes is expected to be launched for public consultation and adopted in 2012.
