Regulation (EC) No 216/2008 of the European Parliament and of the Council (repealed)Show full title

Article 14 Flexibility provisions

1. The provisions of this Regulation and of its implementing rules shall not prevent a Member State from reacting immediately to a safety problem which involves a product, person or organisation subject to the provisions of this Regulation.

The Member State shall immediately notify the Agency, the Commission and the other Member States of the measures taken and the reasons therefor.

2. (a) The Agency shall assess whether the safety problem can be addressed within the powers conferred on it in accordance with Article 18(d). In this case it shall, within one month of being notified pursuant to paragraph 1, take the appropriate decision.

(b) If the Agency concludes that the safety problem cannot be addressed in accordance with point (a), it shall, within the period referred to in that point, issue a recommendation in accordance with Article 18(b) as to whether this Regulation or its implementing rules should be amended and whether the notified measures should be withdrawn or maintained.

3. The measures designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, and relating to whether an inadequate level of safety or a shortcoming in this Regulation or its implementing rules justify initiating their amendment and whether the measures adopted pursuant to paragraph 1 may be continued, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(6). In such a case the measures shall be implemented as appropriate by all Member States and the provisions of Article 11 shall apply to such measures. If the measures are found not to be justified, they shall be revoked by the Member State concerned.

4. Member States may grant exemptions from the substantive requirements laid down in this Regulation and its implementing rules in the event of unforeseen urgent operational circumstances or operational needs of a limited duration, provided the level of safety is not adversely affected. The Agency, the Commission and the other Member States shall be notified of any such exemptions as soon as they become repetitive or where they are granted for periods of more than two months.

5. The Agency shall assess whether the exemptions notified by a Member State are less restrictive than the applicable Community provisions and, within one month of being notified thereof, shall issue a recommendation in accordance with Article 18(b) on whether these exemptions comply with the general safety objectives of this Regulation or any other rule of Community law.

If an exemption does not comply with the general safety objectives of this Regulation or any other rule of Community law, the Commission shall take a decision not to permit the exemption in accordance with the procedure referred to in Article 65(7). In such a case, the Member State concerned shall revoke the exemption.

6. Where an equivalent level of protection to that attained by the application of the rules implementing this Regulation can be achieved by other means, Member States may, without discrimination on grounds of nationality, grant an approval derogating from those implementing rules.

In such cases, the Member State concerned shall notify the Agency and the Commission that it intends to grant such an approval, and shall give reasons demonstrating the need to derogate from the rule concerned, as well as the conditions laid down to ensure that an equivalent level of protection is achieved.

7. Within two months of being notified in accordance with paragraph 6, the Agency shall issue a recommendation in accordance with Article 18(b) on whether an approval proposed in accordance with paragraph 6 fulfils the conditions laid down in that paragraph.

The measures designed to amend non-essential elements of this Regulation, by supplementing it, relating to whether a proposed approval may be granted shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(6) within one month of receiving the Agency's recommendation. In such a case, the Commission shall notify its decision to all Member States, which shall also be entitled to apply that measure. The provisions of Article 15 shall apply to the measure in question.