1. Where, having carried out an evaluation under Article 58, a Member State finds that although packaging is in compliance with the applicable requirements laid down in or pursuant to Articles 5 to 12, it nevertheless presents a risk to the environment or human health, it shall, without delay, require the relevant economic operator to:
(a) take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of risk, to ensure that the packaging concerned, when
placed on the market, no longer presents that risk; (b) bring the packaging into conformity;
(c) withdraw the packaging from the market; or
(d) recall the packaging.
1. 当成员国根据第58条进行评估后发现,尽管包装符合第5至第12条规定或依据其规定的适用要求,但仍对环 境或人体健康构成风险时,应立即要求相关经济运营者:
(a) 在市场监管当局规定的合理期限内,采取一切适当措施,该期限应与风险的性质及相关风险程度相称,以确 保相关包装在投放市场时不再构成该风险;
(b) 使包装符合规定;
(c) 从市场上撤回该包装;或
(d) 召回该包装。
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 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 controlling 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.
2. 根据第1款的例外规定,若涉及接触敏感包装且该包装受旨在保护人体健康的特定法律管辖,且该风险转移 至包装材料的包装内容物,监管当局不得对源自包装材料的人体或动物健康风险进行评估。相反,应向负责控 制此类风险的主管当局发出警示,即《条例》(EU) 2017/625、(EU) 2017/745、(EU) 2017/746或(EU) 2 019/6及指令2001/83/EC中所指的主管当局。
3. The economic operator shall ensure that 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.
3. 经济运营者应确保对其在整个联盟市场上投放的所有不合规包装采取纠正措施。
4. The Member State shall immediately inform the Commission and the other Member States of its findings and subsequent actions pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin and the supply chain of the packaging, the nature of the risk involved and the nature and duration of the national measures taken.
4. 成员国应立即根据第1款的规定,将其发现及后续措施通知委员会及其他成员国。该信息应包括所有可用 细节,特别是识别不合规包装所需的数据、包装的来源及供应链、所涉及风险的性质以及所采取国家措施的性 质和持续时间。
5. The Commission shall, without delay, enter into consultation with the Member State and the relevant economic operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified and, where necessary, propose appropriate measures.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).
On duly justified imperative grounds of urgency relating to the protection of the environment or human health, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 65(3).
The Commission shall address the implementing act referred to in this paragraph to all Member States and shall immediately communicate it to them and the relevant economic operator.
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5. 委员会应立即与成员国及相关经济运营者进行磋商,并评估所采取的国家措施。基于该评估结果,委员 会应通过实施法确定国家措施的合理性,并在必要时提出适当措施建议。
该实施条例应按照第65条第(2)款所述的审查程序予以采纳。
基于保护环境或人体健康的正当紧急理由,委员会应根据第65条第3款所述程序,采纳立即生效的实施法。
委员会应将本款所述的实施措施发送给所有成员国,并应立即将其传达给成员国及相关经济经营者。