On 29 February 2012, the European Parliament ENVI Committee (Committee on the Environment, Public Health and Food Safety) voted on a draft European Commission Regulation concerning food intended for infants and young children and food intended for special medical purposes. The proposed Regulation was adopted with significant amendments. The amended text will now be put to a vote during the European Parliament's plenary session in May 2012. The Council of EU Member States is working on the text in parallel.


    In June 2011, the European Commission proposed a new Regulation that would repeal the existing foods for particular nutrition uses ('PARNUTS') Directive 2009/39/EC. The proposed measure would abolish the concept of 'dietetic foods' and provide for a new general framework for a limited number of food categories, focusing specifically on foods for infants and children up to three years old and on foods for people with specific medical conditions. The proposed Regulation merges into one list, the three existing lists of substances which may be added to the food categories covered (e.g., vitamins and minerals and other substances). In addition, the new measure would establish an EU-wide notification obligation.

Foods for particular nutritional uses (PARNUTS), generally referred to as "dietetic foods", are currently governed by EU Framework Directive 2009/39/EC that establishes general rules for dietetic foods aimed at ensuring product safety, suitability and appropriate consumer information. The Framework Directive was first adopted in 1989 and last amended in 2009. Specific Directives have been adopted for targeted food groups, such as:

  1. Foods for infants and young children (infant formulae and follow on formulae, and processed cereal-based foods and baby foods);
  2. Foods for energy restricted diets for weight reduction;
  3. Foods for medical purposes; and
  4. Foods for people with gluten intolerance (gluten-free foods).

The main objective of the original Framework Directive was to remove the differences between national laws relating to foodstuffs for particular nutritional uses, thus allowing their free movement and creating fair conditions of competition. Discussions with Member States and stakeholders however, highlighted increasing difficulties for implementing the Framework Directive, in particular in relation to more recent pieces of Union legislation such as the legislation on food supplements (Directive 2002/46/EC), on the addition of vitamins and minerals and other substances to foods (Regulation (EC) No 1925/2006) and nutrition and health claims (Regulation (EC) No 1924/2006). It appeared that these more recently adopted EU measures could adequately cover all products addressing nutritional benefits for the general population and certain sub-groups thereof with less administrative burden and more clarity as to their scope (click here for details of the proposal).


EP ENVI Committee position

On 29 February 2012, the EP ENVI Committee voted to amend the European Commission's proposal significantly. The Committee members decided to keep foods for weight loss within the scope of the proposed Regulation. Therefore, the new rules should also cover energy restricted diets including 'low calorie diets' (800-1200 calories per day) and 'very low calorie diets' (400-800 calories). Statements on diet foods aimed at the general population should, according to the ENVI Committee, be regulated by the nutrition and health claims Regulation.

Another key amendment consists of the inclusion of special gluten labelling rules within the scope of the proposed Regulation rather than have these covered by the nutrition and health claims Regulation as proposed by the European Commission. According to the EP ENVI Committee, food products intended for people with gluten intolerance should contain less than 100 mg gluten per kg to be labelled as having "very low gluten content"; they should contain less than 20 mg of gluten per kg where labelled "gluten free".

Other amendments proposed by the EP ENVI Committee include the following:

  • Labels of infant formulae products should not show pictures of babies or images promoting the use of infant formulae;
  • The European Commission should review the regulatory framework for so-called 'growing-up milks' (aimed at children between 12-36 months);
  • The European Commission should prepare a study regarding the need for specific rules for lactose intolerance; and
  • There should be post market monitoring of food products that have been notified under the new Regulation by Member States authorities.


EU Council's position

The EU Council of Member States has not yet issued an official position on the proposal. However, according to a progress report published in November 2011, some of the debated provisions include the scope of the proposal, the scope of the delegated acts that may be adopted by the European Commission and clarification of information requirements concerning special foods.


Next steps

The text of the proposed Regulation as amended by the EP ENVI Committee is scheduled to be voted upon by the European Parliament during the May plenary session. Should the European Parliament agree in plenary with the amendments put forward by the ENVI Committee, it will be interesting to see whether, and to what extent, the European Commission would be willing to agree to the changes proposed by the European Parliament. Likewise, it will be important to follow the discussion that will take place within the EU Council to determine whether the Council would be inclined to agree with the changes proposed by the European Parliament.

Should all three EU Institutions succeed in agreeing on the final wording, the earliest by which the proposal could be adopted would be towards the end of 2012.

According to the current draft of the proposed Regulation, the food industry would have two years from the entry into force date of the measure to adapt food labels where required.



Since it is, as a result of the discussions in the European Parliament, not entirely sure at this stage what the scope of the final Regulation will be (beyond infant formulae, foods for young children and foods for special medical purposes, as proposed by the European Commission), dietetic food producers would certainly have an interest in following the discussions at EU-level closely.

The new rules would be laid down in a Regulation which would be directly applicable throughout the EU. This will assist in ensuring harmonised implementation throughout the EU. Furthermore, the existence of a single list of substances that may be added to the different types of special foods covered by the Regulation will assist in compliance with these rules.

Manufacturers of dietetic foods that currently place their products on the EU market would need to prepare well in advance for upcoming changes. They should verify whether their foods would likely fall within the food categories to be regulated by the new proposed EU measure. If so, they would need to check compliance with regard to, among other, product composition, and labelling and notification obligations.  

Dietetic food manufacturers that produce foods that will fall outside the scope of the future Regulation, would have an interest in understanding the likely impact of other EU food legislation on product composition and labelling of their food products which have hitherto been marketed in the EU as 'dietetic foods'. Relevant legislation could include EU rules on food supplements, on the addition of vitamins and minerals and other substances to food, and nutrition and health claims.