The proposed regulation will repeal directive 2009/39/EC, the legislative framework currently in place for dietetic foods and which the Commission claims has become ‘unnecessary and confusing’.
Under the current law, dietetic foods are defined as ‘specially manufactured products intended to satisfy the particular nutritional requirements of specific groups of the population’.
If a manufacturer wishes to place a new dietetic food on the market, they are required to notify the relevant national authority, for example, in the UK, the Food Standards Agency.
However, according to Ariane Vander Stappen, administrator with the EU Commission’s unit of nutrition, food composition and information, this broad definition of dietetic foods has led to application differences between member states and created distortions in the EU market.
In addition, she says that the framework does not co-exist well in parallel with other, more recent, pieces of legislation, such as the 2006 health and nutrition claims regulation (NHCR).
“Today the definition of dietetic foods is far too broad for it to be understood exactly what foods it refers to,” she told NutraIngredients. “In 1977, when the definition was first adopted, dietetic foods were easy to identify, but with the evolution of the food market, there are special foods for virtually every consumer group which could potentially fall within the framework.”
The Commission says the draft regulation ‘strengthens and clarifies’ provisions for foods intended for vulnerable groups of the population by maintaining the existing compositional and labelling rules applicable to infant and follow-on formulae, processed cereal-based foods and other baby foods and foods for special medical purposes.
Other legislation
Foods that fall outside these categories will be covered by other existing legislation.
“In other words, foods other than infant and baby foods and foods for special medical purposes that would previously have been classed as dietetic will be treated as normal foods, unless they make a health or nutrition claim, in which case they would have to submit a dossier to EFSA,” explains Vander Stappen.
She adds that this shouldn’t be a problem, as, under the notification system, manufacturers are required to provide supporting evidence for their products.
“What it should do is close the loophole that may have been exploited by products that made spurious or unfounded claims,” she says.
However, the European Dietetic Food Industry Association (IDACE), which represents manufacturers of foods for particular nutritional uses, has expressed concerns that the ‘deregulation of the dietetic foods sector is a threat to vulnerable consumers’.
Speaking today at the Annual General Assembly of IDACE in Lisbon, President Ferdinand Haschke said:
“There is no justification for dismantling the existing legislation. General food law alone is not adequate to provide food safety and health protection for the vulnerable and fragile part of the EU population. Many of our consumers have very special and unique nutritional needs.”
IDACE members from 18 countries confirmed today that they will do all they can to significantly amend this proposal.
The proposal will be now submitted to the European Parliament and the Council. If these institutions reach an agreement on the proposal the new regulation could be in force by the end of 2012.