SME Chamber

Information Document: On food for infants, children and special medical purposes


The proposal revises the legislation on foodstuffs intended for particular nutritional uses covered by Directive 2009/39/EC the so-called ‘Framework Directive on dietetic foods'. Foodstuffs for particular nutritional uses are foods that are different from foods for normal consumption and are, as currently regulated, specially manufactured products intended to satisfy the particular nutritional requirements of specific categories 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 etc. The evolution of both the food market and food legislation makes an overall revision necessary. The application of the broad concept of "foodstuffs for particular nutritional uses" on which the Framework Directive is based in the evolved market and legal context has led to considerable problems for stakeholders and controlling authorities. The classification of many foods as 'dietetic' foods and the need for such a category of foods has been seriously questioned, although the desirability of maintaining rules on certain specific categories of foods actually addressing nutritional benefits for certain sub-groups of the population is being recognized.


Consequently, in pursuing the objectives of better regulation and simplification, the proposal aims to rectify this situation by simplifying and clarifying the rules that apply to products regulated as 'dietetic' foods, taking into account the evolution of the regulatory measures in relevant areas.

Main changes being proposed

The proposal simplifies and clarifies legal requirements applying to certain categories of foods and establishes a single list of substances that may be added to the foods ('Union list') covered by this proposal. In particular, it:

  • provides a new general Framework legislation applying to well-defined categories of foods that have been identified as essential for certain well-established groups of consumers with specific nutritional needs;
  • establishes a clear and defined scope of application;
  • maintains specific measures for categories of foods that are essential for certain groups of the population;
  • lays down general rules as regards the composition and labelling applying to these categories of foods;
  • removes differences in interpretation and difficulties for Member States and operators in applying different pieces of food legislation by simplifying the regulatory environment;
  • removes the burdens associated with the notification procedure;
  • ensures that similar products are treated in the same way across the Union;
  • removes rules that have become unnecessary, contradictory and potentially conflicting;
  • establishes a single legal measure for substances that can be added to the foods covered by this proposal.

For further detail, you are kindly requested to consult the attached proposal itself.


Your comments regarding this consultation document and the attached proposal are kindly being requested. Comments are to reach the Regulatory Affairs Directorate within the Technical Regulations Division, in writing or via email by Friday 23rdSeptember 2011

Should any further information be required kindly contact the Regulatory Affairs Directorate of the Technical Regulations Division within the Malta Competition and Consumer Affairs Authority, using the following contact details:

Tel no: +(356) 2395 2000 Fax no.: +(356) 21 242406


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