At a "conciliation" meeting on March 28, the European Parliament, the Council of the European Union and the European Commission – the EU's key decision-making bodies – failed in a last ditch attempt to reach a consensus on whether the revamped regulation should contain a provision outlawing the production of food from cloned animals and their offspring.
In one corner was the Parliament, arguing for an outright ban. In the other was the Council and the Commission, contending that offspring bred from usual and traditional methods (even if their parents had been clones) did not constitute a "novel food" and should be covered by alternative, specific legislation.
The Parliament refused to budge, and after three separate – and doomed – attempts to arrive at a compromise the reform process was abandoned altogether.
Europe's failure to thrash out a deal on this contentious issue means moves to amend the Novel Food Regulation have been put on ice indefinitely. For companies developing and marketing functional ingredients, this is a bitter blow.
History of the regulation
The regulation dictates that, to be marketed legally within the EU's borders, a food component must have a history of use in the region prior to May 15, 1997. If it hasn't, any company wishing to market such an ingredient must first prove it does not pose a danger to health.
Despite the good intentions behind the regulation, it has proved to be a bureaucratic nightmare for companies engaging in the process of attempting to gain permission to market a novel ingredient in the EU. It can take up to three years before a decision is reached on a single application, a fact critics say is a deterrent to innovation and a barrier to trade.
The European Commission agreed in 2008 to simplify the application process in an effort to cut this waiting time – a move that was greeted positively by industry. However, three years on, and the push by the European Parliament to bring the regulation of food from cloned farm animals and their offspring under the remit of the regulation has derailed the entire process, prompting strong feelings in some quarters.
Moral opposition to cloning
Nigel Baldwin, director of scientific and regulatory consulting at Cantox Health Sciences International, said Members of the European Parliament (MEPs) have used the Novel Food Regulation as a "political football" to make a point about their moral opposition to the cloning of farm animals.
"In a way, it's disrespectful to industry," he said. "If you asked 100 people in the food ingredient sector whether they had any use for cloned animals or offspring of cloned animals, you'd have to say none of them would.
"In effect, this regulation is there to regulate the functional food and supplements industry. It's not there for commodity products like meat. For meat products, there's meat products legislation, so why don't they deal with it through that? It's something that's totally out of context in the Novel Food Regulation. The Regulation has been held hostage by the Parliament to get what they want."
According to Xavier Lavigne, food law manager at Brussels-based consultancy EAS, the European Commission is unlikely to want to revisit reform of the Novel Food Regulation until politicians have reached some kind of deal on how to police the production of food from cloned animals and their offspring.
This will probably delay any changes to the novel food regime by at least two years, he said, which will constitute a major disappointment for the functional ingredients sector.
Lack of decision stifles innovation
"The industry had hoped that the revision would accelerate the authorization procedure, thereby providing a good incentive for research and innovation," he explained. "The impact on the sector will be significant since many issues will remain unclear for the foreseeable future."
CIAA, the federation representing Europe's food and beverage manufacturers, argues that the collapse of the reform process will hit innovation and mean consumers missing out on new ingredients that might improve their health.
CIAA president Jesús Serafín Pérez said: "We regret the failure to reach an agreement. It would have encouraged innovation in the food and drink industry, engendering greater consumer choice and facilitating market access for novel foods. This impacts Europe's 500 million consumers and Europe's largest manufacturing sector, made up of 288,000 companies, 99 percent of which are small and medium-sized enterprises."
So, as far as reform of the Novel Food Regulation is concerned, it's a case of back to the drawing board. Much needed change to this important but unwieldy legislation is now years away. For Europe's functional ingredients industry, already reeling from impact of the controversial Nutrition & Health Claims Regulation, it is another major setback.