Article 12
1
Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive or one of the implementing Community acts was adopted, has detailed grounds for establishing that a product referred to in Article 1 endangers human health though it complies with the said Directive or said acts, 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
The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Standing Committee on the Food Chain and Animal Health, and shall then deliver its opinion without delay and take appropriate measures.
3
In order to remedy the difficulties described in paragraph 1 and to ensure the protection of human health, adaptations of this Directive or of its implementing measures shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive,
inter alia
, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 13(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 13(4) in order to adopt those adaptations. The Member State that has adopted safeguard measures may in that event retain such measures until the adoption of the adaptations.
Substituted by Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part One.