The term 'cloned farm animal' is understood to refer to a creature which has been borne naturally by a dam, but whose fertilisation took place in vitro. Its defining characteristic consists in the fact that the cloned animal has nearly or completely the same genetic material as the previously selected donor individual. That individual’s genome is isolated and introduced into an empty, unfertilised ovum. The genetic material of the donor individual and the cloned individual is identical if the ovum is taken from the same dam. Otherwise, the genetic material differs only with regard to the egg cell’s mitochondria. By means of biotechnological techniques, the two components are then brought together and activated so that as a result the now fertilised egg can be implanted and a 'twin' of the donor animal can develop. A reproductively cloned animal is not declared as being a genetically modified organism (GMO), since no genetic engineering techniques have been employed in its production.

As it is still very expensive to clone animals, they are not simply used for consumption, but only as particularly valuable breeding animals whose characteristics are to be passed on to a large number of offspring by using their germ cells.

For some years there has been an ongoing discussion as to whether the offspring of cloned animals should be specially labelled, whether at all they should be available for sale and whether the consumption of such individuals may be associated with any kind of risk. The type of debate and the public view of the matter are in part very reminiscent of the controversies regarding GMO.

Meanwhile and based on corresponding safety studies, a range of research communities and regulating authorities came to the conclusion that the consumption of foods obtained from cloned animals and their offspring represents no health risks. To begin with, a committee of the National Academy of Science in the USA published recommendations in 2004 for risk assessment studies in this field. Four years later and as a result of an evaluation of corresponding studies, the American admission authority Food and Drug Administration (FDA) concluded that in terms of their composition foods obtained from cloned cattle, pigs or goats are indistinguishable from animal products gained from conventional breeding and that consequently their consumption entails no particular risks. Likewise, the European Food Safety Authority (EFSA) addressed the topic several times over the last few years and confirmed in its latest opinion of July 2012 that foods such as meat and milk obtained from healthy cloned animals involve no particular health risks for humans.

Even though it seems that foods gained from cloned farm animals are scientifically proven to entail no health risks, other concerns have been expressed regarding the ethical acceptability of using animal clones for food production. For animal welfare reasons, the EFSA considers the cloning of animals problematic, especially because cloning technology is associated with considerable health risks for the animal clones – in particular in early developmental stages before and after birth. The European Group on Ethics in Science and New Technologies (EGE) arrived at similar results in an opinion submitted in 2008. Considering the suffering and the health problems of both the surrogate dams and the animal clones, the experts find no convincing arguments for justifying the use of animal clones and their offspring for food production.

Within the scope of EU law, food obtained from animal clones is regarded as "novel food" which requires licensing according to the "Novel Food Regulation" (EC No. 258/97). After a failed draft initiative filed in 2008 with which animal cloning, i.a., was to be generally banned, Regulation (EU) 2015/2283 was passed in 2015. As in the previous legislation, food gained from cloned animals still needs to be approved and marked. As of yet there has been no proposal to approve such food. Hence, food gained from cloned animals cannot currently be sold in the EU.

The EU Member States have not yet reached an agreement concerning the legality of animal cloning nor the marking process of descendants of animal clones or of food imported from third countries gained from animal clones.