European Commission Proposes Repealing Specialized Foods Labeling

The draft regulation strengthens and clarifies provisions for foods intended for vulnerable groups of the population who need particular protection – namely infants and children up to three years old, and people with specific medical conditions, such as cancer patients or individuals with metabolism disorders.

6/21/2011 --- The European Commission has adopted a draft regulation that will “better inform consumers across the EU and achieving the aim of better and clearer legislation.”

For example, lactose-free food, slimming products or protein bars could be covered by the dietetic food legislation (Directive 2009/39/EC). The proposal repeals this directive and abolishes the concept of dietetic foods because its application differs significantly between Member States and creates distortions in the internal market. Dietetic foods will be solely covered by other already existing legislation, such as, for instance, the one on nutrition and health claims (Regulation 1924/2006) and/or the regulation on the addition of vitamins, minerals and other substances to foods.

The draft regulation strengthens and clarifies provisions for foods intended for vulnerable groups of the population who need particular protection – namely infants and children up to three years old, and people with specific medical conditions, such as cancer patients or individuals with metabolism disorders.

It does so 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. Further, the proposal establishes a single EU list of substances, instead of the existing three, that can be added to these foods. The substances covered in the list include, among others, minerals and vitamins.

"Thanks to our new approach, consumers will be able to compare food products more easily as the foods concerned will be covered by the same rules in the 27 Member States providing the same high level of protection for all European citizens and fair and accurate information," John Dalli, Health and Consumer Policy Commissioner, said. "The abolishing of general rules on dietetic foods that have become unnecessary or confusing should also contribute to fair competition between similar products, allow SMEs to gain easier access to the market and support innovation," he added.

The new framework will result in less administrative burden, more clarity and consistency within the EU and consequently allow for more flexibility for the evolving, innovative food market.

No products will have to be withdrawn from the market as a result of the new rules. Those covered by the dietetic food legislation can remain on the market but will be legislated fully by the other pieces of existing food legislation. In order to facilitate the adaptation of products and reduce costs for operators, mainly in terms of re-labelling, a two-year transitional period is foreseen.

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 should be in force by the end of 2012.

Foods for particular nutritional uses are defined by the existing framework legislation on dietetic foods, as foods that are different from foods for normal consumption and are specially manufactured products intended to satisfy the particular nutritional requirements of specific groups of the population.

The designation under which a dietetic food is sold is accompanied by a suitability statement for the particular nutritional use and the specific group of the population to whom the food is intended (e.g.: gluten-free food for celiac people, processed cereal-based food for young children, infant formulae for infants from birth, food for sports people etc).

After more than 30 years of application, and given the evolution of food products and the evolution of EU food legislation, a review of the dietetic food legislation became necessary. Specialised "normal" foods have increasingly been targeting sub-groups of the general population (e.g. protein bar supporting muscle building for sportspeople, food supplements for pregnant women, fortified food in calcium and vitamin D suitable for older adults, slimming products etc).

Consequently, the difference between "dietetic foods" for specific groups of the population and "specialised foods" for the general population or sub-groups is no longer clear for citizens, stakeholders and enforcement authorities. Therefore, it became clear that the existence of a specific EU framework for "dietetic foods" existing in parallel with other, more recent, pieces of legislation was no longer justified.  

Accoridng to the Commission, discussions with Member States and stakeholders highlighted the increasing difficulties related to the implementation of the legislation on dietetic foods, in particular in parallel with more recent pieces of Union legislation, such as the legislation on food supplements, on fortified foods and on the use of nutrition and health claims.

A study pointed out that the type of foods regulated under the dietetic food legislation differs significantly between Member States: similar foods could be marketed in some member States as dietetic foods while in others as food for normal consumption addressed to the population in general or certain sub-groups, such as pregnant women, active individuals, older adults etc.

The interaction of the dietetic food legislation with the more recent pieces of EU legislation, potentially covering similar products, and occasionally conflicting, has often created trade distortions in the internal market due to different interpretations and enforcement across Member States.

These more recently adopted Union acts would adequately cover products addressing nutritional benefits for the general population and certain sub-group with less administrative burden and more clarity.

It was necessary to remove the concept of dietetic foods to close loopholes in the existing EU legislation to limit the possibility for companies to do "legislative shopping" –i.e. select the piece of legislation they prefer– thus circumventing important rules.

Nowadays, due to the diversification and specialisation of foods, the concept of dietetic foods (i.e. foods that are different from "normal" foods for the general population and are especially manufactured to satisfy the particular nutritional requirements of specific groups of the population) does not correspond with the reality of the food market. A vast number of food products on the market today, without necessarily being "dietetic foods," target certain groups of the population with alleged specific nutritional needs e.g. a food supplement concentrated in caffeine to enhance performance or fortified cereals in vitamins B for growing children

Consequently, the difference between "dietetic foods" for specific groups of the population and "specialised foods" for the general population or sub-groups is no longer clear and useful.

In cases of dietetic foods for which no further rules have been set in specific pieces of legislation, the presence on food labels of "dietetic" suitability statements on one hand and nutrition and health claims on the other creates increasing confusion for consumers and enforcement authorities. Furthermore, given that the use of a suitability statement and of a nutrition or health claim are not subject to the same rules –a national notification system is required for the former, a centralised EU prior-authorisation procedure for the latter– the same high-level of food information might not be ensured in the different Member States. For all these reasons, keeping the broad concept of dietetic foods is no longer justified. Other food rules would be adequate to regulate these foods with minor administrative burden and increased clarity, according to the Commission.