13.2.2008 EN Official Journal of the European Union L 39/11
REGULATION (EC) No 108/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 15 January 2008
amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION
,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1) Regulation (EC) No 1925/2006 of the European Parliament and of the Council (3) provides that the regulatory procedure established by Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4) is to be applied for the adoption of implementing measures concerning that Regulation.
(2) Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.
(3) The Commission should be empowered to adopt modifications to Annexes I and II to Regulation (EC) No 1925/2006; to establish additional foods to which particular vitamins or minerals may not be added; to take decisions to establish and/or amend the lists of authorised, prohibited or restricted other substances; to define the conditions under which vitamins and minerals may be used, such as purity criteria, maximum amounts, minimum amounts and other restrictions or prohibitions on the addition of vitamins and minerals to food; and to establish derogations from certain provisions of that Regulation. Since those measures are of general scope and are designed to amend non-essential elements of that Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(4) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the deletion of certain vitamins or minerals listed in the annexes and for the inclusion and amendment of certain other substances in Annex III to Regulation (EC) No 1925/2006.
(5) Regulation (EC) No 1925/2006 should therefore be amended accordingly,
Regulation (EC) No 1925/2006 is hereby amended as follows:
1. Article 3(3) shall be replaced by the following:
2. in Article 4, the second paragraph shall be replaced by the following:
3. Article 5(1) shall be replaced by the following:
4. Article 6 shall be amended as follows:
(a) paragraph 1 shall be replaced by the following:
(b) paragraph 2 shall be replaced by the following:
(c) paragraph 6 shall be replaced by the following:
5. Article 7(1) shall be replaced by the following:
6. Article 8 shall be amended as follows:
(a) paragraph 2 shall be replaced by the following:
(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:
(i) be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or
(ii) be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.
(b) paragraph 5 shall be replaced by the following:
7. Article 14 shall be replaced by the following:
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.