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Brussels, 20 June 2011

Questions and Answers on Commission proposal replacing current framework legislation on dietetic foods

Why did the Commission decide to revise the legislation on dietetic foods?

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.

What are foods for particular nutritional uses or dietetic foods?

Dietetic foods are especially manufactured products intended to satisfy the particular nutritional requirements of specific groups of the population, such as foods for infants and children up to three years old, for people intolerant to gluten, meal replacements foods for weight control, foods intended for athletes, etc.

Why is it proposed to abolish the concept of dietetic foods?

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.

What happens to special foods, such as sports foods, energy drinks, foods for elderly, certain slimming products, etc.?

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.

Why were specific rules for sports foods never adopted as it was foreseen in the framework legislation?

The Framework Directive on dietetic foods indicates since 1989 that specific provisions will be laid down to cover "foods intended to meet the expenditure of intense muscular effort, especially for sportsmen." Despite extensive discussions, minimal progress was achieved and no successful conclusion could be reached. This was due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation, the number of sub-categories of the foods to be included, the criteria for establishing composition requirements and the potential impact on innovation in product development.

Will products disappear from the market?

No products will have to be withdrawn from the market as a result of the new rules. Those used to be covered by the dietetic legislation –such as foods for sports people, for weight management, gluten-free food, etc.– can remain on the market but will be legislated fully by the other pieces of food legislation. Some re-labelling may be necessary but in order to reduce possible costs for operators, a two-year transition period is foreseen.

Why does the draft Regulation cover only foods intended for infants and children up to three years old and medical foods?

These categories of food are the sole, or partial, source of nourishment of these vulnerable groups of the population. Such categories of foods are vital for the nutritional management of certain conditions (e.g. renal failure, cancer) and/or are essential to maintain adequate nutrition of the group for which they are intended (e.g. foods for infants not being breastfed).

The general rules on safety and labelling applying to all foods should be complemented to ensure adequate nutritional composition and consumer information for the aforementioned categories of food to protect the vulnerable groups of consumers.

What will the benefits of these changes be?

Having no general rules on dietetic foods and clearer rules for foods for specific groups of the population will provide clarity and legal certainty. Food products will be covered by the same rules in the EU. This will ensure that the same high level of consumer protection is applied in all Member States and that consumers will be able to compare food products more easily. The reduction in legal confusion will also facilitate market access for the Small and Medium-sized Enterprises (SMEs), support innovation and make it easier for controlling authorities to check that a food is correctly labelled when considering its nutritional composition and target audience.

What about foods intended for people suffering from diabetes?

Like sports foods, foods for diabetic people are treated differently in the Member States. The Framework Directive on dietetic foods required the Commission to draft a report on the advisability of establishing harmonised EU rules on foods intended for people suffering from diabetes. However, the Commission report1 on diabetic foods concludes that there is no scientific basis on which to develop specific compositional requirements for this group of foods. People with diabetes should be able to meet their dietary needs by choosing appropriate foods intended for the general population.

When will the new rules apply?

The proposal will follow the ordinary legislative procedure. It will be discussed by the European Parliament and the Council. Realistically, rules could be adopted by the end of 2012.


1 :

COM (2008) 392 Report from the Commission to the European Parliament and the Council on foods for persons suffering from carbohydrate metabolism disorders (diabetes), Brussels, 26.6.2008

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