Article 10

Flexibility provisions 1. The provisions of this Regulation and of rules adopted for its implementation 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. If the safety problem is the result of: an inadequate level of safety resulting from the application of this Regulation; or a shortcoming in this Regulation or its implementing rules; the Member State shall immediately notify to the Agency, the Commission and the other Member States the measures taken and the reasons therefor. 2. The Commission shall decide, in accordance with the procedure referred to in Article 54(3), whether an inadequate level of safety or a shortcoming in this Regulation or its implementing rules justify the continuing application of the measures adopted pursuant to paragraph 1. In that event, it shall also take the necessary steps to amend the related rule. If the Member State's measures are found not to be justified, the Member State shall revoke or amend the measures in question. 3. 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 thereby. 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. 4. Where the measures decided on by a Member State are less restrictive than the applicable Community provisions, the Commission shall examine whether the exemptions comply with the general safety objective of this Regulation or any other rule of Community law. If the exemptions granted do not comply with the general safety objectives of this Regulation or any other rule of Community law, the Commission shall take a decision in accordance with the procedure referred to in Article 54(4). In such a case, the Member State shall revoke the exemption. 5. Where an equivalent level of protection to that attained by the application of the implementing rules for Articles 5 and 6 can be achieved by other means, Member States may, without discrimination on grounds of nationality, grant approval derogating from those implementing rules. In such cases, the Member State concerned shall notify the Commission that it intends to grant such 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. 6. Within three months of being notified by a Member State in accordance with paragraph 5, the Commission shall initiate the procedure referred to in Article 54(3), in order to decide whether an approval proposed in accordance with paragraph 5 fulfils the conditions laid down in that paragraph and can be granted. In such a case, it shall notify its decision to all Member States, which shall also be entitled to apply that measure. The provisions of Article 8 shall apply to the measure in question. The relevant implementing rules may also be amended to reflect such measure, using transparent procedures in accordance with Article 43.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.