CHAPTER IVGENERAL AND FINAL PROVISIONS
Article 9Community Register
1
The Commission shall establish and maintain a Community Register on the addition of vitamins and minerals and of certain other substances to foods, hereinafter referred to as ‘the Register’.
2
The Register shall include the following:
a
the vitamins and minerals which may be added to foods as listed in Annex I;
b
the vitamin formulations and mineral substances which may be added to foods as listed in Annex II;
c
the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6;
d
the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11;
e
any restrictions on the addition of vitamins and minerals as set out in Article 4;
f
the substances for which dossiers have been submitted as provided for in Article 17(1)(b);
g
information about the substances referred to in Annex III and the reasons for their inclusion therein;
h
information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).
3
The Register shall be made available to the public.
Article 10Free movement of goods
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in foods which comply with this Regulation and Community acts adopted for its implementation by the application of non-harmonised national provisions governing the addition of vitamins and minerals to foods.
Article 11National provisions
1
By 19 July 2007, Member States shall inform the Commission of existing national provisions on the mandatory addition of vitamins and minerals and of products covered by the derogation provided for in Article 4(b).
2
If a Member State, in the absence of Community provisions, considers it necessary to adopt new legislation:
a
on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or
b
on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods,
it shall notify the Commission in accordance with the procedure laid down in Article 12.
Article 12Notification procedure
1
If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.
2
The Commission shall consult the Committee referred to in Article 14(1), if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
3
The Member State concerned may take the envisaged measures only six months after the notification referred to in paragraph 1, and provided that the Commission's opinion is not negative.
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 14(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented. The Commission may require certain amendments to be made to the envisaged measures.
Article 13Safeguard measures
1
Where a Member State has serious grounds for considering that a product endangers human health despite complying with this Regulation, that Member State may temporarily suspend or restrict application of the provisions in question within its territory.
It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.
2
In accordance with the procedure referred to in Article 14(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
The Commission may initiate this procedure on its own initiative.
3
The Member State referred to in paragraph 1 may maintain the suspension or restriction until the decision referred to in paragraph 2 has been notified to it.
Article 14F1Committee procedure
1
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002.
2
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3
Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4
Where reference is made to this paragraph, Article 5a(1), (2) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 15Monitoring
To facilitate efficient monitoring of foods to which vitamins and minerals have been added, and of foods containing substances listed in Annex III, Parts B and C, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by providing a model of the label used for the product. In such cases, information on the withdrawal of the product from the market may also be required.
Article 16Evaluation
By 1 July 2013, the Commission shall submit to the European Parliament and the Council a report on the effects of implementing this Regulation, in particular concerning the evolution of the market in foods to which vitamins and minerals have been added, their consumption, nutrient intakes for the population and changes in dietary habits, and the addition of certain other substances, accompanied by any proposals for amendment of this Regulation which the Commission deems necessary. In this context Member States shall provide the necessary relevant information to the Commission by 1 July 2012. Rules for implementing this Article shall be specified in accordance with the procedure referred to in Article 14(2).
Article 17Transitional measures
1
By way of derogation from Article 3(1) and until 19 January 2014, Member States may allow in their territory the use of vitamins and minerals not listed in Annex I, or in forms not listed in Annex II, provided that:
a
the substance in question is used for addition to foods marketed in the Community on 19 January 2007; and
b
the Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 19 January 2010.
2
Until 19 January 2014, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on trade in foods to which vitamins and minerals not included in the list in Annex I or in the forms not listed in Annex II are added.
3
Member States may, in compliance with the rules of the Treaty, continue to apply existing national provisions on maximum and minimum amounts of vitamins and minerals listed in Annex I added to foods and on the conditions applicable to this addition until the adoption of corresponding Community measures in accordance with Article 6 or under other specific Community provisions.
Article 18Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2007.
Foods placed on the market or labelled prior to 1 July 2007 which do not comply with this Regulation may be marketed until their expiry date, but not later than 31 December 2009.