第58条 国の水準でリスクをもたらす包装に対処するための手続

1. Without prejudice to Article 19 of Regulation (EU) 2019/1020, where the market surveillance authorities of a Member State have sufficient reason to believe that packaging covered by this Regulation presents a risk to the environment or human health, they shall, without undue delay, carry out an evaluation in relation to the packaging concerned covering all requirements laid down in this Regulation that are relevant to that risk. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

For the purposes of the first subparagraph, the authorities responsible for the enforcement of this Regulation shall follow up on complaints or reports related to alleged non-compliance of packaging with this Regulation, and verify that the appropriate corrective action has been taken.

Where, in the course of the evaluation carried out pursuant to the first subparagraph, the market surveillance authorities find that the packaging does not comply with the requirements laid down in this Regulation, they shall, without delay, require the relevant economic operator to take appropriate and proportionate corrective measures, within a period prescribed by the market surveillance authorities which is reasonable and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the packaging into compliance with those requirements.

2. By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the market surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for evaluating such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.

3. Where the market surveillance authorities consider that non-compliance is not restricted to their territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

4. The economic operator shall ensure that all appropriate corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.

5. Where the economic operator does not take adequate corrective measures within the period referred to in paragraph 1, third subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit the making available of the packaging on their territory, to withdraw it or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States of those measures without delay.

6. The information to be sent to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin of the packaging, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator and, where applicable, the information referred to in Article 61(1) of this Regulation. The market surveillance authorities shall also indicate whether the non-compliance is due to either of the following:

(a)failure of the packaging to meet the sustainability requirements laid down in or pursuant to this Regulation;

(b)shortcomings in the harmonised standards or common specifications referred to in Articles 36 and 37 of this Regulation.

7. Member States other than the Member State taking the measures pursuant to paragraph 5 shall, without delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the packaging concerned, and, in the event that Member States object to the measures taken pursuant to paragraph 5, of their objections.

8. Where, within 3months of receipt of the information referred to in paragraph 5 or 7 no objection has been raised either by a Member State or the Commission in respect of provisional measures taken by a Member State, those measures shall be considered justified.

Member States may provide for a longer or shorter period of application for provisional measures than 3months in order to take account of the specificities of the requirements concerned.

9. Member States shall ensure that the packaging is withdrawn from their market or that other appropriate restrictive measures are taken without delay in respect of the packaging or the manufacturer concerned.