Food Safety/Risk Management/Nutrition Security/Foods for specific groups/Questions and answers on the application of Regulation (UE) No 609/2013
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Questions and answers on the application of Regulation (UE) No 609/2013

 

  1. What happens after 20 July 2016 with products that were previously considered as food intended for a particular nutritional use and are not considered in Regulation (EU) No 609/2013?
  2. Is it possible to adopt national measures for products classified as “dietetic” under Directive 2009/39/CE and which are now outside the scope of Regulation (EU) No 609/2013?
  3. What occurs with the national laws already adopted in Member States for products which are outside the scope of Regulation (EU) No 609/2013?

What happens after 20 July 2016 with products that were previously considered as food intended for a particular nutritional use and are not considered in Regulation (EU) No 609/2013?

  • Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013, on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, repeals from 20 July 2016 the concept of food intended for a particular nutritional use, also called “dietetic” or “dietary”, previously established in Directive 2009/39/EC.

    Under the new law, foods considered as “dietetic” but which are not already included under the new scope of Regulation (EU) No 609/2013, from 20 July 2016 shall be regulated by other currently applicable legislation of the horizontal law, including, for example:

    • Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers.
    • Regulation (EC) No 1924/2006 of the European Parliament and of the Council, of 20 December, on nutrition and health claims made on foods.
    • Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins, minerals and of certain other substances to foods;
    • Royal Decree 1487/2009, of 26 September, on food supplements;
    • Regulation (EC) No 258/97, of 27 January 1997, on novel foods and novel food ingredients. From 1 January 2018, Regulation 2015/2283 on novel food will be applicable.

    Therefore, these products, in general terms:

    • Cannot be placed on the market indicating “dietetic” or “dietary” on the label, nevertheless please refer to the transition periods for the particular cases listed in this document.
    • Cannot be placed on the market indicating that they are intended for certain types of people or a particular population group, for example diabetics, unless this is expressly authorised in any of the afore-mentioned horizontal laws. For example, Commission Implementing Regulation (EU) No 828/2014, of 30 July 2014, on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food.
    • Claims appearing in the labelling, presentation or advertising of the product shall satisfy Regulation (EC) No 1924/2006 on nutrition and health claims made on food.
      • Nutrition claims must be those listed in the Annex of Regulation (EC) No 1924/2006 and its amendments, and satisfy the conditions of use established in this Regulation.
      • The health claims that may be used in the labelling, presentation and advertising must be authorised and included in the implementing Regulations of this Regulation and also satisfy the conditions of use and restrictions where applicable.
    • The use of a food product shall never refer to the property of preventing, treating or curing a human disease, as established in article 7, point 3 of Regulation (EU) No 1169/2011 on the provision of food information to consumers.
    • As regards the composition, this shall satisfy the provisions regulating food for everyday consumption.

Is it possible to adopt national measures for products classified as “dietetic” under Directive 2009/39/CE and which are now outside the scope of Regulation (EU) No 609/2013?

The Commission has explained to Member States with the right to adopt legislation at national level about non-harmonised aspects in the European legislation. Nevertheless, such measures shall be proportioned, justified and compatible with the rules of the Treaty on the Functioning of the European Union. These national measures shall be notified to the Commission under the procedure of Directive 1535/2015/EU and assessed case by case.

It also reminded Member States that the European Parliament and the Council agreed in 2013, that food not covered by Regulation (EU) No 609/2013 may be suitably regulated with the horizontal legislation of the European Union food law.

What occurs with the national laws already adopted in Member States for products which are outside the scope of Regulation (EU) No 609/2013?

The Commission has indicated that the Member States are responsible for ensuring that from 20 July 2016 their legislation is compatible with European legislation. Therefore, food such as, for example, “low calorie snacks for weight control”, which were considered as dietary food in the national laws of some Member States, and which were placed on the interior market in Spain, are not required to give notification of their placing on the market after 20 July 2016.

From 20 July 2016, food which is not within the scope of Regulation (EU) No 609/2013 may not bear the indication “dietetic” or “dietary” in its labelling.

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