Genetically modified animals

Genetic modification of an animal involves altering its genetic material by adding, changing or removing certain DNA sequences in a way that does not occur naturally. It aims to modify specific characteristics of an animal or introduce a new trait, such as disease resistance or enhanced growth. 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.

While this technology has so far been used in plants for agriculture and in micro-organisms to produce enzymes, the potential application of genetic modification techniques to animals is also being researched. Several international organisations, including FAO/WHO and the United States Food and Drug Administration, have already published guidelines for the safety assessment of these animals and their derived products.

EU Regulatory Framework

Within the European Union (EU), the application of GM technology is strictly regulated for domestic and imported goods. The EU has established a legal framework regulating GM food and feed derived products as well as the release of living GMOs into the environment in order to ensure a high level of protection of human and animal health, and the environment.

EFSA’s role is to independently assess and provide scientific advice to risk managers on any possible risks of GMOs for human and animal health and the environment and to propose appropriate measures to mitigate the risks. While it acknowledges the broader societal, political and economic concerns over GM animals, EFSA does not consider these aspects when carrying out its scientific assessments. 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.

EFSA’s remit regarding GM animals

Currently, no GM animals or derived products are on the EU market, nor have any applications for GM animals been received in the EU. However, scientific developments suggest submissions may be made in future across a range of species. Therefore, as a proactive measure, the European Commission has asked EFSA to develop comprehensive risk assessment guidelines that would be used by companies and risk assessment bodies to evaluate the possible risks for food and feed safety, the environment as well as related animal health and welfare aspects. These will help possible future applicants when submitting their applications to EFSA.

Acting on the Commission’s request, EFSA has developed two separate guidance documents for the risk assessment of GM animals.

  1. Food, feed and animal welfare risk assessment

This guidance document, published in January 2012, 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 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. 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 guidance 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.

  1. Environmental risk assessment of GM animals

In May 2013, EFSA published its guidance on the environmental risk assessment (ERA) of GM animals. The document  provides guidance to applicants and risk assessors on how to conduct an ERA of living GM animals to be placed on the EU market according to Regulation (EC) No 1829/2003 (EC, 2003) or Directive 2001/18/EC (EC, 2001). This guidance document also includes health and welfare aspects of the GM animals.

Based on the wide range of GM research thought to be currently underway related to several different animal species, the European Commission requested that EFSA develop environmental risk assessment guidance for GM fish, insects, mammals and birds.

EFSA concluded that a risk assessment of GM animals should include three major aspects. Firstly, a six-stage assessment procedure should be completed. This step-by-step process, laid down in EU legislation, should begin with identifying potential hazards and the extent of human, animal and environmental exposure to them. The next three stages are characterising the hazard, exposure and risk. Finally applicants must outline risk management strategies and provide an overall risk evaluation.

Secondly, applicants must address seven areas of potential risk for GM fish, insects, mammals or birds: (1) persistence and invasiveness of the GM animal, including vertical gene transfer; (2) horizontal gene transfer;  (3) interactions of the GM animal with target organisms; (4) interactions of the GM animal with non-target organisms; (5) environmental impacts of the specific techniques used for the management of the GM animal; (6) impacts of the GM animal on biogeochemical processes; and (7) impacts of the GM animal on human and animal health.

Thirdly, the guidance highlights a number of cross-cutting considerations that should be factored into the full ERA process. These include which non-GM animals to use as comparators, the use of appropriate surrogates if necessary, and recommendations on identifying environments into which GM animals are likely to be released.

Cooperation and consultation

EFSA’s Panel on Genetically Modified Organisms (GMO) and Panel on Animal Health and Welfare (AHAW) worked in close co-operation to develop both guidance documents. Separate public consultations were launched on the guidance documents to ensure that the broadest possible range of comments and opinions from consumers, Member States, and stakeholders were taken into account before being finalised. Hundreds of comments made during these consultations by interested parties and stakeholders were assessed by EFSA and, where appropriate, incorporated into the final guidance documents.

All EFSA public consultations are announced on the EFSA website and in EFSA’s weekly email newsletter (EFSA highlights).

EFSA’s work on GM animals builds upon the work carried out thus far at international level, including that of the Codex Alimentarius.

Topics: Completed work

Completed work
E.g., 06/05/2016
E.g., 06/05/2016

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1. What are genetically modified (GM) animals?

A genetically modified animal is one whose genetic material has been altered by adding, changing or removing certain DNA sequences in a way that does not occur naturally. This process is carried out to introduce a new trait or change a characteristic such as the disease resistance of an animal. 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?

EFSA’s role is to independently assess and provide scientific advice to risk managers on any possible risks that genetically modified organisms (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.

Acting on a request from the European Commission, EFSA developed comprehensive guidance for the risk assessment of food and feed derived from GM animals, including an evaluation of animal health and welfare and environmental safety. The Authority has also developed a guidance document on the environmental risk assessment (ERA) of GM animals, which covers GM fish, insects, mammals and birds.

3. Are there GM animals or food and feed from GM animals currently authorised in the EU?

No GM animals, or food or feed from GM animals, have been authorised for placement on the market in the EU, nor have any applications been made by industry for approval.

4. If no such applications have been made, why have these guidance documents been developed?

Scientific developments suggest future submissions for GM animals may be made for a number of species. 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 growth-enhanced GM salmon.

Based on these considerations, and as a proactive measure to assure consumer safety, the European Commission requested that EFSA develop comprehensive risk assessment guidance for GM animals. They provide clear guidance to risk assessors and biotech companies. In the event of making any future application for market approval, applicants would be obliged to use.

5. Which specific areas do EFSA’s guidance documents cover?

EFSA has developed two guidance documents that outline specific data requirements and the methodology for the risk assessment of GM animals.

  • The first relates to the safety assessment of food and feed derived from GM animals and includes considerations on animal health and welfare aspects.
  • The second document provides guidance on how to conduct an environmental risk assessment (ERA) of living GM animals to be placed on the EU market and includes health and welfare aspects.

6. What does EFSA’s guidance on food and feed from GM animals contain?

This guidance document, published in January 2012, relates to the safety assessment of food and feed derived from genetically modified animals and on 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 EU.

7. 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 will 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 10).

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.

8. What is covered in the guidance document on the environmental risk assessment (ERA) of GM animals?

EFSA published guidance on the environmental risk assessment (ERA) of GM animals in May 2013. The document  provides guidance to applicants and risk assessors on how to conduct an ERA of living GM animals to be placed on the EU market according to Regulation (EC) No 1829/2003 (EC, 2003) or Directive 2001/18/EC (EC, 2001).

9. How will EFSA evaluate environmental risk assessments of GM animals should an application be made?

EFSA concluded that a risk assessment of GM animals should include three major aspects. Firstly, a six-stage assessment procedure should be completed. This step-by-step process, laid down in EU legislation, should begin with identifying potential hazards and the extent of human, animal and environmental exposure to them. The next three stages are characterising the hazard and exposure and - from the combination of both - the potential risk. Finally applicants must outline risk management strategies and provide an overall risk evaluation.

Secondly, applicants should address seven areas of potential risk for GM fish, insects, mammals or birds; (1) persistence and invasiveness of the GM animal, including vertical gene transfer; (2) horizontal gene transfer;  (3) interactions of the GM animal with target organisms; (4) interactions of the GM animal with non-target organisms; (5) environmental impacts of the specific techniques used for the management of the GM animal; (6) impacts of the GM animal on biogeochemical processes; and (7) impacts of the GM animal on human and animal health.

The guidance also highlights a number of cross-cutting considerations that should be factored into the full ERA process. These include which non-GM animals to use as comparators, the use of appropriate surrogates if this is considered necessary, and recommendations for the assessment of potential long-term effects of GM animals as well as for the uncertainty analysis.

10. Does EFSA take into account the health and welfare of GM animals in its guidance documents?

EFSA recognises that there are 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 both its guidance documents on GM animals.

The guidance of food and feed derived from GM animals 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. 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).

The ERA guidance also covers GM animals for non-food/feed uses, such as ornamental fish. In these cases, the document provides guidance on data requirements and outlines the obligation for applicants to show the health and welfare of the animals are not significantly affected compared to an appropriate comparator – a non-GM counterpart that is used as a baseline against which to assess the GM animal. Where no comparator can be identified, the health and welfare of the GM animal itself should be considered. If experiments need to be carried out to generate data, these should comply with EU legislation regarding the use of animals for scientific purposes.

Post-market monitoring and surveillance is also considered necessary to identify 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.

11. What about the ethical concerns surrounding GM animals?

EFSA is only responsible for evaluating the food and feed safety, environmental safety and health and welfare aspects of 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.

12. What is the difference between GM animals and cloned animals?

Genetic modification involves the altering of the genetic materialof 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.