‘Novel foods’ regulation returns to the EU’s agenda


Food from cloned animals comes under the EU's novel foods regulation. [Shutterstock]

The European Commission and Parliament are renewing their attempt to update the EU’s regulation on novel foods, which was rejected three years ago over ethical and safety concerns related to animal cloning for food production.

The EU regulation on novel foods, which dates back to 1997, is up for a review again, after a last-chance conciliation in March 2011 failed to reach agreement on the use of cloned animals’ offspring for food production.

While the two institutions agreed to ban the use of cloning in animal reproduction for food production, and to ban comestible products from cloned animals altogether, they clashed on allowing onto the EU market food obtained from clones’ offspring.


The Commission was sent back to the drawing board and tabled a revised proposal in December 2013, which included a ban on the use and import of cloned animal as well as the marketing of food derived from them.

The new proposal is limited to the safety of novel foods and is based on the overall agreement achieved in 2011.

For those, the Commission wants a simpler, clearer and more efficient authorisation procedure, which it believes should be centralised at European level.

“The regulation aims at facilitating market authorisation of new foods, while at the same time ensuring safety and helping innovation, especially for SMEs,” explained Chantal Bruetschy, an official who heads the biotechnology unit at the European Commission’s health and consumer directorate (DG Sanco).

“Today, the legislation is not efficient, because the procedures are long and everyone agrees that there is room for improvement,” she told a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI).

“We are keen to speed up the approval system by facilitating market access,” Bruetschy told the Committee MEPs who were meeting for the first time since the European elections were held in May this year.

Definitions matter

The Commission defines novel food as a type of food which was not consumed in the EU to a significant degree before May 1997, when the current regulation was adopted.

They include GMOs, food produced with nanomaterials, meat from cloned animals, as well as traditional foods from third countries (see full catalogue).

To market a novel food or ingredient, companies must apply to an EU country authority for authorisation, presenting the relevant scientific information. The national authority may allow the company to market its product if no additional assessment is necessary, and if the Commission and other EU countries do not object.

Before approval, however, the Commission will also ask the European Food Safety Authority’s (EFSA) Standing Committee on Food Chain and Animal Health for an opinion.

New categories

James Nicholson, the European Parliament’s newly-appointed Rapporteur on the novel foods review, is from the European Conservatives and Reformist (ECR) group.

For him, the key issue is how to categorise novel food. “We also want to address the industry’s concern over coordination, data protection and health claims,” Nicholson told MEPs at the ENVI committee, adding that better cooperation between industry and universities was “hugely important” in this regard.

Steven Tompkins, a farming systems consultant at consultancy ADAS UK, cautioned EU legislators about changing categories for novel food, saying it could potentially mean that hundreds of thousands of products would come under the ‘novel foods’ definition.

For example, some varieties of fruit could suddenly be considered novel, Tompkins said.

Pilar Ayuso, a Spanish member of the European people’s Party (EPP) who is a shadow rapporteur on the novel foods proposal, acknowledged that the Commission and Parliament need to be clear with the new definitions and approval procedures.

“We also need to take into account that requirements on foods from third countries aren’t necessarily going to be the same as other requirements for foods, as there can be other procedures for production,” Ayuso said.

A new regulation would mean more work for EFSA, she warned, saying this was an issue that needed to be addressed.

“If they are going to have more work, and if their budget is going to be reduced, that seems to me to be creating a situation where it’s going to be difficult to even scratch the surface, and it has to be tackled,” the Spanish MEP said.

An EU proposal for a regulation on novel foods was rejected in 2011 over concerns related to animal cloning.

The discussions mainly focused on the provisions applicable to nanomaterials, the cloning of animals for food production, traditional foods from third countries, the criteria to be examined for the risk assessment and risk management, and to the procedure for the authorisation of novel foods.

>> Read: Novel foods review stumbles over cloning

A new proposal was tabled in December 2013, which is limited to the safety of novel foods and is based on the overall agreement achieved in Conciliation.

The general criteria for novel food definition remain unchanged: novel foods are foods and food ingredients which were not consumed in the EU to a significant degree before the entry into force (15 May 1997) of the current Novel Food Regulation.

  • 2016: The earliest year draft legislation can enter into force.

European Commission

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