The European Parliament and the Council appear to have reached agreement, in principle, on the text of a draft Regulation on food intended for infants and young children and food for special medical purposes. The Regulation would repeal current rules applicable in this field, the so-called PARNUTS Directive (Directive 2009/39/EC on foodstuffs intended for particular nutritional uses). The Council is expected to formally publish its position on the proposed Regulation following which, should the European Commission not object, the Regulation would be adopted.
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 2009/39/EC has in recent years been completed by several specific directives:
- Foods for infants and young children (infant formulae and follow on formulae, and processed cereal-based foods and baby foods);
- Foods for energy restricted diets for weight reduction;
- Foods for medical purposes; and
- Foods for people with gluten intolerance (gluten-free foods).
In June 2011, the European Commission proposed a new measure that would abolish the concept of 'dietetic foods' and that would 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. The new Regulation aims to clarify, simplify and improve the legal framework on specific food for vulnerable people, as well as aims to ensure that the adequate level of information is provided to consumers together with appropriate labelling requirements.
The review of the proposal by the European Parliament resulted in many amendments that were not necessarily in line with the objectives of the European Commission (see our update of 1 March 2012). In order to accelerate the adoption process, the European Parliament and the Council engaged in negotiations early on with the aim of aligning their positions prior to the adoption of a final position by the Council.
As a result of these negotiations, the scope of the new draft Regulation was further clarified. According to the EP and the Council it should include compositional and informational requirements for the following categories of foods: infant formula (0-6 months), follow-on formula (6-12 months), processed cereal-based and baby food, food for special medical purposes and total diet replacement for weight control. With this approach the European Parliament and Council, by extending the list of categories covered, clearly go beyond what the European Commission suggested. The amended draft Regulation also provides rules for establishing and updating a common list of substances (“Union list”) that may be added to one or more categories of food. In addition, the amended draft Regulation contains provisions for information on labelling to avoid parents being misled by attractive and inappropriate labelling. As regards the information for certain groups with specific dietary requirements (such as intolerance to gluten) current provisions would be maintained to guarantee protection by ensuring appropriate labelling.
The formal adoption of a so-called common position by the Council of the EU is the next necessary step in the decision-making process. The Council is expected to publish this "common position" by the end of 2012. It remains to be seen what exactly will happen once the final draft text is examined by the European Commission. If the Commission concludes that the measures agreed between the European Parliament and the Council diverge too much from its original proposal, it may decide to withdraw the measure. In its communication following the European Parliament's first reading in June 2012, the Commission rejected one-third of all the amendments proposed. These included, inter alia, the extension of the scope to gluten free food. The Commission also rejected the possibility to establish the EU list of permitted substances via delegated acts instead of implementing acts. However, in principle it agreed to cover total diet replacement for weight control as well as prohibition of baby pictures on follow-on formulae. It remains to be seen how the Commission will react.
The new rules would be laid down in a Regulation which would enter into force twenty days following publication and be directly applicable throughout the EU to all dietetic foods within its scope. This will assist in ensuring harmonised implementation throughout the EU. Furthermore, the existence of a single list of substances that may be added to different types of special foods covered by the Regulation will assist in compliance with these rules.
According to the current draft of the proposed Regulation, the food industry would benefit from a two-year transition period from the date of entry into force of the measure in order to adapt food labels where required. This will allow manufacturers of dietetic foods that currently place their products on the EU market 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, labelling and notification obligations.