The European Commission on Dec. 18 adopted three draft laws on animal cloning and on novel food "to provide legal certainty in this field." The proposals seek to prohibit the use of the cloning technique in the European Union (EU) for farm animals, importing of animal clones, and marketing of food from animal clones.

A Commission press release said the three proposals intend to address animal welfare and other ethical concerns related to the use of animal cloning. The draft law on novel food revises the existing Novel Food Regulation with a view to improving access to new and innovative food for the EU market, while still maintaining a high level of consumer protection.

Tonio Borg, EU Commissioner in charge of Health 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."

Regarding next steps, the Commission stated, "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."

The Commission provided the following clarifications regarding the draft laws on cloning:

• No cloning for farming purposes will be carried out in the EU and no such clone will be imported as long as animal welfare concerns persist.
• A temporary ban on using the cloning technique on farmed animals, as well as on the marketing of 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.
• However, cloning will 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.

Regarding Novel Food, the Commission specified that:

• Under the draft Regulation, novel food would be subject to a simpler, clearer and more efficient authorization procedure centralized at the EU level, which should enable safe and innovative food to reach the EU market faster.
• Novel food generally refers to food that 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 that 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 that submitted the application would be given the authorization to market the food for five years before it could be produced by other companies.