EU Commission Tables Proposals on Animal Cloning and Novel Food

19 Dec 2013 --- The European Commission has adopted three draft laws on animal cloning and on novel food which will provide legal certainty in this field. Two proposals will ban the use of the cloning technique in the EU for farm animals1 and the imports of these animal clones.

The marketing of food from animal clones will also be prohibited. These proposals intend to address animal welfare and other ethical concerns related to the use of the technique. The draft law on novel food revises the existing Novel Food Regulation with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.

EU Commissioner in charge of Health Tonio Borg said "Today's initiatives on animal cloning respond to animal welfare concerns as well as consumer perceptions on food from animal clones in a realistic and workable way. The changes on novel food will create a more efficient system. It will offer EU consumers the benefit of a broad choice of foodstuffs and provides a favourable environment for Europe's food industry."

No cloning for farming purposes will be carried out in the EU and no such clone will be imported as long animal welfare concerns persist.

A temporary ban on using the cloning technique on farmed animals as well as on the placing on the market live animal clones and embryo clones is foreseen in the first draft Directive. The second draft Directive ensures that food such as meat or milk from animal clones is not placed on the EU market.

Cloning will however not be prohibited for purposes such as research, conservation of rare breeds and endangered species or use of animals for the production of pharmaceuticals and medical devices, where the use of the technique can be justified.

Under the draft Regulation, novel food would be subject to a simpler, clearer and more efficient authorisation procedure centralised at EU level, which should enable safe and innovative food to reach the EU market faster.

Novel food generally refers to food which was not consumed in the EU to a significant degree before May 1997, i.e. before the current Regulation entered into force and in particular to food produced using new techniques and technologies, such as nanomaterials.

Special provisions are also made for food which has not been marketed in the EU but which has a history of safe use in non-EU countries. This creates a more balanced system and a positive environment for trade.

Protecting innovation is also a feature of the draft law. Under the new system, in case of innovation supported by new scientific developments, the food company which submitted the application, would be given the authorisation to market the food for 5 years before it can be produced by others.

Other EU institutions, including the European Parliament and the Council will consider the Commission's draft legislation and will adopt their positions in due course. At this stage, it can be estimated that the draft legislation will enter into force in 2016 at the earliest.

Animal cloning is a relatively new technique to reproduce animals. Cloning does not involve any genetic modification. A clone is not a GMO. Cloning technique does not improve an animal's performance. Yet breeders may consider cloning to increase the quantity of reproductive material (semen or embryos) of a particularly valuable animal.

Today, cloning is not used for food production. Currently, in the EU the marketing of food from clones would require pre-market approval under the Novel Food Regulation based on a scientific food safety assessment by the European Food Safety Authority (EFSA). So far, no European or foreign food business operator has applied for an authorisation to market food produced by using the cloning technique.

EFSA carried out a scientific risk assessment in 2008 on cloning and concluded that there is no indication of any difference for food safety on meat and milk of clones and their offspring compared with those of conventionally bred animals. This opinion was confirmed in 2009, 2010 and 2012.

Researcher use cloning for certain investigations. The reproductive material (semen and embryos) and the food (meat, milk) from these clones are not placed on the market.