REGULATION (EU) 2025/40 · ARTICLE 58

第 58 条 · 处理在国家层面构成风险的包装的程序

Procedure for dealing with packaging presenting a risk at national level

ENGLISH · SOURCE READING COPY中文 · 参考译文
§ 1

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 Regulationshall 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.

第 1 款

1. 在不影响(欧盟) 2019/1020号条例第19条规定的前提下,若成员国市场监管机构有充分理由相信本条例涵 盖的包装对环境或人体健康构成风险,应当毫不拖延地对相关包装进行评估,涵盖本条例中与该风险相关的所 有要求。相关经济运营者应根据需要与市场监管当局合作。

为实现第一款之目的,负责执行本条例的当局应跟进与涉嫌包装不符合本条例有关的投诉或报告,并核实已采 取适当的纠正措施。

在根据第一款进行的评估过程中,若市场监管当局发现包装不符合本条例规定的要求,应立即要求相关经济运 营者在市场监管当局规定的合理且与不合规性质及程度相称的期限内,采取适当且相称的纠正措施,使包装符 合该等要求。

§ 2

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.

第 2 款

2. 根据第1款的例外规定,若涉及接触敏感包装且受旨在保护人体健康的特定法律管辖的风险,该风险转移 至包装材料的包装内容物,市场监管当局不得对包装材料引起的人体或动物健康风险进行评估。相反,应将此 类风险评估的职责通知相关主管当局,即《条例》(EU) 2017/625、(EU) 2017/745、(EU) 2017/746、(E U) 2019/6或指令2001/83/EC中所指的主管当局。

§ 3

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.

第 3 款

3. 当市场监管当局认为不合规行为不限于其辖区时,应将评估结果及其要求经济运营者采取的措施通知委 员会及其他成员国。

§ 4

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.

第 4 款

4. 经济运营者应确保对其在整个联盟市场上提供的所有不合规包装采取所有适当的纠正措施。

§ 5

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.

第 5 款

5. 若经济运营者未能在第1款第三段规定的期限内采取适当纠正措施,或不合规情况持续存在,市场监管当 局应采取一切适当的临时措施,禁止该包装在其辖区内提供、撤回或召回。

市场监管当局应立即将上述措施通知委员会及其他成员国。

§ 6

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.

第 6 款

6. 根据本条第5款应向委员会及其他成员国发送的信息,应通过《条例》(欧盟) 2019/1020第34条所述的 信息与通信系统传达,并应包括所有可用细节,特别是识别不合规包装所需的数据、包装来源、涉嫌不合规的 性质及涉及的风险、采取的国家措施的性质和期限、经济运营者提出的理由,以及适用时本条例第61条第1款 所述的信息。市场监管当局还应指出不合规是否由于以下任一原因:

(a) 包装未能符合本条例或依据本条例规定的可持续性要求;

(b) 本条例第36条和第37条所述的协调标准或通用规范存在缺陷。

§ 7

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.

第 7 款

7. 除根据第5款采取措施的成员国外,其他成员国应立即将所采取的任何措施及其掌握的有关相关包装不合 规的任何补充信息通知委员会和其他成员国;若成员国对根据第5款采取的措施提出异议,应同时通报其异议

§ 8

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.

第 8 款

8. 若在收到第5款或第7款所述信息后三个月内,成员国或委员会均未对成员国采取的临时措施提出异议, 则该等措施应视为合理。

成员国可根据相关要求的具体情况,规定临时措施的适用期限长于或短于三个月。

§ 9

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.

第 9 款

9. 成员国应确保相关包装或制造商的包装被及时从其市场撤回,或采取其他适当的限制性措施。