22/Feb/2011 Exercise 3

In 2002, the European Parliament and the Council adopted a Directive relating to food supplements. The directives aim was to regulate proliferation in the Community of food supplements containing concentrated sources of nutrients and other vitamins that supplemented normal diet. The Directives main objective was to harmonize different Member States regulations of these products. Diverging MS regulations were an obstacle to the free movement of food supplements, created unequal conditions of competition and therefore produced a negative impact on the functioning of the internal market. The directive also sought to ensure a high level of protection for consumers. In this connection, Annex II of the Directive included a list of tradable food supplements. The trading of food supplements not listed in Annex II was prohibited since they could cause serious harm to human health. The directive had to be implemented in 2005. However, Spain failed to implement it.

Questions 1. Does the EU have the competence to adopt a Directive relating to food supplements? Please justify your answer 2. What kind of competence is it? 3. What is the voting procedure according to which the directive was (or should have been) approved?
The Article 115 TFEU according to which the Council unanimously adopted in accordance with a special legislative procedure and after consulting the European Parliament and the Economic and Social Committee, issue directives for the approximation of the laws, regulations and administrative provisions of Member States that have an impact directly in the establishment or functioning of the internal market is deeply conditioned by the rule of art. 114 TFEU no longer speaks of the approach directives but only the establishment of measures for the approximation, and, consistently, is located behind the Article, providing for the ordinary legislative procedure as a procedure natural construction of the internal market. This means, quite simply, that the entry into force of the Treaty of Lisbon on 1 December 2009,

22/Feb/2011
the internal market, as happens with many other policies, will stop evolve by way of unanimity to pass it by way of the majority, which is consistent with an enlarged EU where to get unanimous consensus to develop any policy is normatively impossible.

4. May the directive be applied in Spain? If so, how could it be applied in Spain, taking into account that Spain failed to implement it? The directive can be applied in Spain in accordance with Royal Decree 1275/2003, of October 10 on food supplements, incorporated into national law Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.

In view of the observations made by the European Commission has seen fit to be repealed Royal Decree 1275/2003 and draft a new royal decree fully complying with the requirements of Directive 2002/46/EC. In accordance with current Community legislation, this Royal Decree only establishes specific rules for vitamins and minerals used as ingredients in food supplements, being adjustable in a later stage, once the availability of appropriate scientific data, specific rules relating to other nutrients and ingredients used as ingredients in food supplements such as amino acids, essential fatty acids, fiber and various plants and plant elements.

Pending in the European Union set maximum levels of nutrients or other substances with nutritional or physiological effect, for the purposes of Human food supplements, are taken into account the relevant reports of the Scientific Committee on Food and other international recognized scientifically.

We must emphasize that the implementation of this directive will be marked by these provisions: Transitional provision only. Extension of marketing. As of December 31, 2009, it may permit the use of vitamins and minerals not listed in Annex I or in forms not listed in Annex II, provided that the following conditions: a) That the substances in question are used in one or more food supplements marketed in the EU before July 12, 2002. b) The European Food Safety Authority has not given an unfavorable opinion in respect of the use of these substances or their use in that form, in the manufacture of food supplements on the basis of a dossier supporting use of the substance concerned, and that the Member State concerned shall submit to the Commission no later than July 12, 2005.

22/Feb/2011 Repeal only. Repeal legislation. Is repealed Royal Decree 1275/2003, of October 10 on food supplements. Final provision one. Marketing restrictions. In accordance with the provisions of the Treaty establishing the European Community, will continue to apply existing national restrictions or bans on food supplements containing nutrients are not listed in Annex I or in forms not included in Annex II. Second final provision. Title competence. This royal decree, has the character of basic legislation and issued pursuant to the provisions of Article 149.1.16. Meetings of the Constitution, which grants the state jurisdiction over bases and general coordination of health. Final provision. Incorporation of European Union law. This Royal Decree is incorporated into Spanish law Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Disposal fourth. Power development. It empowers the Ministers of Health and Social Policy and the Environment and Rural and Marine to jointly adopt the measures necessary for the development and implementation of this Royal Decree and in particular to modify or update its annexes to conform to Community legislation or to include nutrients or other substances with a nutritional or physiological effect that has not been regulated in the European Union level.