Commission Memo (MEMO/13/528), 11 June 2013
What does this Regulation change?
The Regulation amends the legislation that applies to foods for particular nutritional uses ('dietetic foods'). For example, the Regulation:
What are foods for particular nutritional uses (or dietetic foods) and why was there a need to revise the rules?
Dietetic foods are foods that are different from food for normal consumption and that, owing to their special composition or manufacturing, are intended to meet the particular nutritional requirements of specific groups of the population (e.g. foods for infants and young children, food for people intolerant to gluten, meal replacements foods for weight control, foods intended for athletes, etc.).
A study confirmed the increasing difficulties related to the application of the complex legislation on dietetic foods and pointed out that the type of foods regulated under the dietetic food legislation differs significantly between Member States. For example, similar foods could be marketed in some Member States as dietetic foods while in others as food for normal consumption by the general public or specific groups of consumers.
The interaction of the dietetic food legislation with the more recent EU legislation1, 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. Consequently, the Commission decided in 2011 to completely revise the legislation on dietetic foods.
Why is it necessary to abolish the concept of “dietetic food”?
It was necessary to remove the concept of dietetic food in order to reduce the legal uncertainty on product classification; close loopholes in the existing EU legislation; and limit the possibility for businesses to do "legislative shopping" – i.e. select the piece of legislation they prefer– thus by-passing important EU rules.
Nowadays, due to the range of specialist food available, the concept of dietetic food no longer corresponds to market reality. A vast number of food products on the market today, without necessarily being dietetic foods, target the specific nutritional needs of certain groups of the population (e.g. a food supplement concentrated in caffeine to enhance performance or fortified cereals in vitamins B for growing children). This has caused a problem for consumers, stakeholders and enforcement authorities in distinguishing between 'dietetic food' and 'normal food'.
An additional problem was related to the difference between the rules applying to 'dietetic food' and 'normal food'. This problem became worse over the last decade, in parallel with the development of legislation to better regulate the EU food market and in particular 'normal foods' targeting specific groups of the population (e.g. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods that sets specific rules on how food manufacturers can inform consumers about the beneficial nutritional or health properties of food).
For example, the dietetic food legislation requires food manufacturers to include a suitability statement on the dietetic food to inform consumers about the particular nutritional use and the specific group of the population to whom a dietetic food is intended (e.g.: gluten-free food for celiac people, infant formulae for infants from birth).
In certain cases this suitability statement can be very similar to a health claim (e.g. branched chain amino-acids for growth in muscle mass for body builders). This similarity provides an incentive for some food manufacturers to notify under the dietetic food legislation a 'normal' food in order to be able to use a 'dietetic' suitability statement instead of the equivalent voluntary claim. This would mean that they would avoid the rules on health claims and could lead to consumers being confused and even misled. In addition, this would lead to market distortion and unfair competition.
Why were the rules on food for coeliacs not included?
In 2009, the Commission adopted a Regulation2 on the composition and labelling of foodstuffs suitable for people intolerant to gluten. This Regulation sets rules and conditions for the use of the statements 'gluten-free' and 'very low gluten'. These rules will continue to exist, but will be transferred under a more appropriate legal framework: Regulation (EU) No 1169/2011 on the provision of food information to consumers.
The transfer under this Regulation increases the level of protection for coeliacs because not only the existing rules are maintained, but they are also extended to non-pre-packed food. Indeed, while the Food Information Regulation applies both to pre-packed and non-pre-packed food, the existing rules in Regulation (EC) No 41/2009 apply only to pre-packed food.
In addition, the transfer under the Food Information Regulation will increase the coherence of EU food law since all the rules related to gluten will be covered by the same legislation. Indeed, the same Regulation already sets rules on the mandatory labelling of allergens and substances causing intolerance (including gluten containing ingredients) in the list of ingredients.
What about food intended for diabetics?
A Commission report [See Note 3 below] on diabetic food concluded that there is no scientific basis on which to develop specific compositional requirements for this food group. People with diabetes should be able to meet their dietary needs by choosing an appropriate diet made of food intended for the general population.
What happens to all the food that is today considered as dietetic food but will not be covered by the new rules?
Keeping the broad concept of dietetic foods is no longer justified. However, these products will continue to be on the market and will be regulated by more recent EU legislation [See Note 4 below].
What about growing-up milk and food for sports people?
The Commission proposed that no specific rules should be set for growing-up milk and food for sports people on the basis that these products should be covered by other EU legislation. However, during negotiations, the European Parliament and Council asked the Commission to further assess and report back on these aspects.
The Commission will analyse these two issues in separate reports. The Commission's report on growing-up milk will be based on the scientific advice of the European Food Safety Authority and will analyse the nutritional needs of young children; the role of these products in the diet of young children; whether these products are necessary or beneficial to young children; and whether specific rules are needed.
The Commission will also adopt a similar approach for food aimed at sports people: the European Food Safety Authority will be consulted and the report will analyse whether specific rules are needed.
Both reports should be presented to the European Parliament and the Council for further discussion by 2015.
Who will benefit from these changes?
Having no general rules on dietetic foods and clearer rules for foods for specific groups of the population will provide increased clarity and legal certainty. Clearer rules will be better enforced by national authorities and will lead to an overall increase in consumer protection. It will be easier for consumers to compare different food products. At the same time, the fact that food products will be covered by the same rules in the EU will also create a better environment for businesses, in particular SMEs.
When will the new rules apply?
The new Regulation will apply from mid-2016. In the meantime, the existing legislation will continue to apply. Over the next two years, the Commission will adopt specific rules for the different categories of products covered by the Regulation via delegated acts. The Commission will also transfer existing rules on the use of the statements 'gluten-free' and 'very low gluten'. By 2016 the entire new Framework will be in place. Businesses between now and then will be able to adjust to the new rules They will also have time to run down the stocks produced before the entry into application of these new rules.
1 : E.g. Regulation (EC) No 1924/2006 on nutrition and health claims made on food, Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and Directive 2002/46/EC on food supplements
2 : Regulation (EC) No 41/2009
3 : 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
4 : E.g.; Regulation (EC) No 1924/2006 on nutrition and health claims made on food, Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and Directive 2002/46/EC on food supplements