1. All packaging placed on the market shall be recyclable.
1. 所有投放市场的包装均应具备可回收性。
2. Packaging shall be considered to be recyclable if it fulfils the following conditions:
(a) it is designed for material recycling, which enables the use of resulting secondary raw materials that are of sufficient quality when compared to the original material that they can be used to substitute primary raw materials, in accordance with paragraph 4; and
(b) when it becomes waste, it can be collected separately in accordance with Article 48(1) and (5), sorted into specific waste streams without affecting the recyclability of other waste streams and recycled at scale, on the basis of the methodology set out in accordance with paragraph 5 of this Article.
Packaging that is in compliance with the delegated acts adopted pursuant to paragraph 4 shall be deemed to comply with the condition set out in point (a) of the first subparagraph of this paragraph.
Packaging that is in compliance with the delegated acts adopted pursuant to paragraph 4 and the implementing acts adopted pursuant to paragraph 5 shall be deemed to comply with the conditions set out in the first subparagraph of this paragraph.
Point (a) of the first subparagraph of this paragraphshall apply from 1 January 2030 or 24 months from the date of entry into force of the delegated acts adopted pursuant to the first subparagraph of paragraph 4, whichever is the latest.
Point (b) of the first subparagraph of this paragraphshall apply from 1 January 2035 or, as regards the recycled-at-scale requirement, from 1 January 2035 or five years from the date of entry into force of the implementing acts adopted pursuant to paragraph 5, whichever is the latest.
2. 包装应满足以下条件，方可视为可回收：
(a) 其设计符合材料回收要求，使所产生的二次原材料质量足以与原始材料相当，能够替代初级原材料，符合第 4款规定；且
（b）当其成为废弃物时，应根据第48条第（1）款和第（5）款的规定单独收集，分类进入特定废物流，且不 得影响其他废物流的可回收性，并应依据本条第5款所述方法论进行大规模回收。
符合根据第4款通过的授权条例的包装，应视为符合本款第一段第一项（a）点所规定的条件。
符合根据第4款通过的授权条例及根据第5款通过的实施条例的包装，应视为符合本款第一段所规定的条件。
本款第一段（a）点自2030年1月1日起生效，或自根据第4款第一段通过的授权条例生效之日起24个月后生效 ,以较晚者为准。
本段第一款第(b)点自2035年1月1日起适用，或就规模化回收要求而言，自根据第5款通过的实施条例生效之日 起五年或2035年1月1日，以较晚者为准。
3. The manufacturer shall assess packaging recyclability on the basis of the delegated acts adopted pursuant to in paragraph 4 of this Article and the implementing acts adopted pursuant to paragraph 5 of this Article. Packaging recyclability shall be expressed in the recyclability performance grades A, B or C as described in Table 3 of Annex II.
Without prejudice to paragraph 10, from 1 January 2030 or 24 months from the entry into force of the delegated acts adopted pursuant to paragraph 4 of this Article, whichever is the latest, packaging shall not be placed on the market unless it is recyclable within grades A, B or C as described in Table 3 of Annex II.
Without prejudice to paragraph 10 of this Article, from 1 January 2038 packaging shall not be placed on the market unless it is recyclable within grades A or B as described in Table 3 of Annex II.
3. 制造商应依据本条第4款通过的授权条例及第5款通过的实施条例评估包装可回收性。包装可回收性应以附件 II表3所列的可回收性能等级A、B或C表示。
在不影响第10款规定的前提下，自2030年1月1日或根据本条第4款通过的授权条例生效之日起24个月，以较晚 者为准，包装不得投放市场，除非其可回收性能等级符合附件II表3所述的A、B或C级。
在不影响本条第10款规定的前提下，自2038年1月1日起，除非包装符合附件II表3所述的A或B等级的可回收性 ,否则不得投放市场。
4. By 1 January 2028, the Commission shall, after taking into consideration standards developed by the European standardisation organisations, adopt delegated acts in accordance with Article 64 to supplement this Regulation by establishing:
(a) design for recycling criteria and recyclability performance grades based on Table 3 of Annex II and the parameters listed in Table 4 of Annex II for packaging categories listed in Table 1 of Annex II; design for recycling criteria and recyclability performance grades shall be developed on the basis of the predominant material and shall:
(i) take into account the ability of packaging waste to be separated into different material streams for recycling, sorted and recycled, so that the resulting secondary raw materials are of sufficient quality compared to the original material and can be used to substitute primary raw materials for packaging or other applications where the quality of the recycled material is retained, where feasible;
(ii) consider established collection and sorting processes proven in an operational environment and cover all packaging components;
(iii) take into account available recycling technologies, their economic and environmental performance, including the
quality of the output, the availability of the waste, the energy needed and the emissions of greenhouse gases;
(iv) where appropriate,identify substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present;
(v) where appropriate, impose restrictions on the presence of substances of concern, or of groups of such substances, in packaging or packaging components for reasons not relating primarily to chemical safety; such restrictions may also serve to reduce unacceptable risks to human health or the environment, without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004;
(b) how to perform recyclability performance assessment and express its result in recyclability performance grades per packaging unit, in terms of weighting, including material-specific criteria and sorting efficiency, to determine whether packaging is to be considered recyclable under paragraph 2;
(c) a description, for each packaging category listed in Table 1 of Annex II, of the conditions for compliance with their respective recyclability performance grades;
(d) a framework concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 45(1), based on the packaging recyclability performance grades.
When adopting the delegated acts referred to in the first subparagraph of this paragraph, the Commission shall take into account the results of the assessment, if any, carried out pursuant to Article 5(2).
The Commission is empowered to adopt delegated acts in accordance with Article 64 to amend Table 1 of Annex II in order to adapt it to the scientific and technical developments in material and product design, and in collection, sorting and recycling infrastructure. In those delegated acts, the Commission may lay down design for recycling criteria for additional packaging categories or create sub-categories within the categories listed in Table 1 of Annex II.
Economic operators shall comply with new or updated design for recycling criteria within 3 years of the date of entry into force of the relevant delegated act.
4. 委员会应于2028年1月1日前，在考虑欧洲标准化组织制定的标准后，依据第64条通过授权法案，补充本条 例，建立：
(a) 针对附件II表1所列包装类别，依据附件II表3及附件II表4中列明的参数，制定可回收设计标准和可回收性能 等级；可回收设计标准及可回收性能等级应基于主要材料制定，并应当：
(i) 考虑包装废弃物被分离为不同材料流进行回收、分类和再利用的能力，确保所产生的二次原材料质量足 以媲美原始材料，并在可行情况下，可用于替代包装或其他应用中的初级原材料，同时保持再生材料的 质量；
(ii) 考虑在运行环境中已被证明有效的既定收集和分拣流程，并涵盖所有包装组成部分；
(iii) 考虑现有的回收技术及其经济和环境绩效，包括产出质量、废弃物的可获得性、所需能源及温室气体排 放；
(iv) 在适当情况下，识别对包装中材料的再利用和回收产生负面影响的关注物质；
(v) 在适当情况下，基于非主要化学安全原因，对包装或包装组成部分中关注物质或其类别的存在施加限制 ;此类限制亦可用于降低对人体健康或环境的不可接受风险，且不影响《条例》（EC）第1907/2006号 附录XVII中关于化学品的限制，或在适用情况下，《条例》（EC）第1935/2004号中关于食品接触材料 和物品的限制及具体措施。
(b) 如何对每个包装单位的可回收性能进行评估，并以可回收性能等级表示其结果，包括加权、材料特定标准 及分拣效率，以确定包装是否应根据第2款被视为可回收；
(c) 对附件II表1中列出的每个包装类别，说明其各自可回收性能等级的合规条件；
(d) 关于根据包装可回收性能等级调整生产者为履行第45条第1款规定的生产者延伸责任义务而应支付的财务贡 献的框架。
在采纳本款第一段所述的授权法案时，委员会应考虑根据第5条第2款进行的评估结果（如有）。
委员会有权根据第64条采纳授权法案，以修订附件II表1，使其适应材料和产品设计以及收集、分拣和回收基础 设施的科学技术发展。在该等授权条例中，委员会可为附录II表1所列的包装类别设定额外的可回收设计标准， 或在该类别内设立子类别。
经济运营者应自相关授权条例生效之日起三年内，遵守新的或更新的可回收设计标准。
5. By 1 January 2030, the Commission shall adopt implementing acts establishing:
(a) the methodology for the recycled-at-scale assessment per packaging category listed in Table 2 of Annex II, supplementing Table 3 of Annex II with thresholds for the recycled-at-scale assessment and, if necessary, updating the overall recyclability performance grades described in Table 3 of Annex II; that methodology shall be based on at least the following elements:
(i) quantities of packaging per packaging category listed in Table 2 of Annex II placed on the market in the Union as a whole and in each Member State;
(ii) quantities of recycled packaging waste, as calculated at the calculation point in accordance with the implementing act adopted under Article 56(7), point (a), per packaging category listed in Table 2 of Annex II, in the Union as a whole and in each Member State;
(b) the chain of custody mechanism ensuring that packaging is recycled at scale.
The chain of custody mechanism referred to in point (b) shall be based on at least the following elements:
(i) technical documentation referring to the quantity of collected packaging waste that is sent to sorting and recycling facilities;
(ii) a verification process that allows manufacturers to obtain the necessary data from the downstream operators ensuring that packaging is recycled at scale.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2). The data referred to in the first subparagraph of this paragraphshall be available and easily accessible by the public.
5. 委员会应于2030年1月1日前通过实施条例，确立：
(a) 针对附录II表2所列各包装类别的规模化回收评估方法，补充附录II表3中关于规模化回收评估的阈值，并在 必要时更新附录II表3所述的整体可回收性能等级；该方法应至少基于以下要素：
(i) 附录II表2所列各包装类别在整个联盟及各成员国投放市场的包装数量；
(ii) 根据第56条第7款(a)项通过的实施条例，在计算点计算的附录II表2所列各包装类别的回收包装废弃物数 量，涵盖整个联盟及各成员国；
(b) 确保包装实现大规模回收的监管链机制。
第(b)点所述的监管链机制应至少包括以下要素：
(i) 说明送往分拣和回收设施的收集包装废弃物数量的技术文件；
(ii) 一项验证程序，允许制造商从下游运营商处获取必要数据，以确保包装实现大规模回收。
该等实施条例应依据第65条第2款所述的审查程序予以采纳。 本款第一段所述的数据应向公众公开且易于获取。
6. The Commission shall assess the granularity of data that need to be reported for the recycled-at-scale methodology. Where appropriate, the Commission shall adopt delegated acts in accordance with Article 64 to amend Table 2 of Annex II and Table 3 of Annex XII to adapt them to technical and scientific development.
6. 委员会应评估回收大规模方法论所需报告数据的细化程度。
在适当情况下，委员会应依据第64条采纳授权条例，修订附件II表2和附件XII表3，以适应技术和科学的发展。
7. By 2035, the Commission, on the basis of developments in sorting and recycling technologies, may review the minimum thresholds for packaging to be considered recycled at scale and, where appropriate, present a legislative proposal to revise the thresholds.
7. 至2035年，委员会可根据分拣和回收技术的发展，审查被视为大规模回收的包装最低门槛，并在适当情 况下提出修订门槛的立法建议。
8. In order to increase the level of recyclability of packaging, 18 months from the date of entry into force of the delegated acts adopted pursuant to paragraph 4 of this Article and implementing acts adopted pursuant to paragraph 5 of this Article, the financial contributions paid by producers in order to comply with their extended producer responsibility obligations as laid down in Article 45 shall be modulated in accordance with therecyclability performance grades, as set out in detail in the delegated acts adopted pursuant to paragraph 4 of this Article and the implementing acts adopted pursuant to paragraph 5 of this Article.
Regarding financial contributions paid by producers in order to comply with their extended producer responsibility obligations as laid down in Article 45 in respect of packaging referred to in paragraph 11, point (g), of this Article, Member States shall take into account the technical feasibility and economic viability of recycling of that packaging.
8. 为提高包装的可回收性水平，自根据本条第4款通过的授权条例及根据本条第5款通过的实施条例生效之 日起18个月内，生产者为履行第45条规定的延伸生产者责任义务而支付的财务贡献，应依据授权条例和实施条 例中详细规定的可回收性能等级进行调节。
关于生产者为履行本条第11款(g)项所述包装的第45条规定的延伸生产者责任义务而支付的财务贡献，成员国应 考虑该包装回收的技术可行性及经济可行性。
9. Compliance with the requirements set out in paragraphs 2 and 3 of this Articleshall be demonstrated in the technical documentation concerning the packaging as set out in Annex VII.
Where a unit of packaging includes integrated components, the assessment of compliance with the design for recycling criteria and with the recycled-at-scale requirements shall include all integrated components. A separate assessment shall be carried out for integrated components that can become separated from each other as a result of mechanical stress during transportation or sorting.
Where a unit of packaging includes separate components, the assessment of compliance with the design for recycling requirements and with the recycled-at-scale requirements shall be carried out separately for each separate component.
All components of a unit of packaging shall be compatible with the established collection, sorting and recycling processes proven in an operational environment and shall not hinder the recyclability of the main body of the packaging unit.
9. 应通过本条第2款和第3款规定的技术文件证明包装的合规性，技术文件内容详见附件七。
当包装单元包含集成组件时，关于符合可回收设计标准及规模化回收要求的评估，应涵盖所有集成组件。对于 因运输或分拣过程中的机械应力可能导致相互分离的集成组件，应进行单独评估。
当包装单元包含分离组件时，关于符合可回收设计标准及规模化回收要求的评估，应分别对每个分离组件进行
包装单元的所有组件应与已在运行环境中验证的既定收集、分拣及回收工艺兼容，且不得妨碍包装单元主体的 可回收性。
10. By way of derogation from paragraphs 2 and 3, from 1 January 2030, innovative packaging that does not comply with the requirements under paragraph 2 may be made available on the market up to 5 years from the end of the calendar year in which it was placed on the market.
Where use is made of this derogation, the economic operator shall notify the competent authority before the innovative packaging is placed on the market and shall include all technical details demonstrating that the packaging is innovative packaging. That notificationshall include a timeline for reaching the recycled-at-scale requirements in terms of collection and recycling of the innovative packaging. The information shall be made available to the Commission and the national authorities carrying out market surveillance.
If the competent authority considers that the packaging is not innovative packaging, the economic operator shall comply with the existing design for recycling criteria.
If the competent authority considers that the packaging is innovative packaging, it shall inform the Commission accordingly.
The Commission shall assess requests by competent authorities in relation to innovative nature of packaging and update or adopt new delegated acts under paragraph 4 of this Article, as appropriate.
The Commission shall monitor the impact of the derogation referred to in the first subparagraph on the quantity of packaging placed on the market. The Commission shall, where appropriate, present a legislative proposal with a view to amending that subparagraph.
Member States shall continuously aim to improve collection and sorting infrastructures for innovative packaging with expected environmental benefits.
10. 根据第2款和第3款的例外，自2030年1月1日起，不符合第2款要求的创新包装可在投放市场当年年底起计 的5年内继续投放市场。
在使用本豁免时，经济运营者应在创新包装投放市场前通知主管当局，并提供所有证明该包装为创新包装的技 术细节。该通知应包含实现创新包装收集和回收规模化要求的时间表。该信息应向委员会及负责市场监管的国 家主管当局提供。
如主管当局认定该包装非创新包装，经济运营者应遵守现行的可回收设计标准。
如主管当局认定该包装为创新包装，应及时通知委员会。
委员会应对主管当局关于包装创新性质的请求进行评估，并根据本条第4款的规定，适时更新或采纳新的授权 法案。
委员会应监测第一款所述豁免对投放市场包装数量的影响。委员会应在适当情况下，提出旨在修订该小款的立 法提案。
成员国应持续致力于提升具有预期环境效益的创新包装的收集与分类基础设施。
11. This Articleshall not apply to the following:
(a) immediate packaging as defined in Article 1, point (23), of Directive 2001/83/EC and in Article 4, point (25), of Regulation (EU) 2019/6;
(b) contact-sensitive packaging of medical devices covered by Regulation (EU) 2017/745;
(c) contact-sensitive packaging of in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
(d) outer packaging as defined in Article 1, point (24),of Directive 2001/83/EC and in Article 4, point (26),of Regulation (EU) 2019/6 in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product;
(e) contact-sensitive packaging for infant formula and follow-on formula, processed cereal-based food and baby food, and
food for special medical purposes as defined in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013; (f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC;
(g) sales packaging made from lightweight wood, cork, textile, rubber, ceramic, porcelain or wax; however, paragraph 8 shall apply to such packaging.
。
11. 本条款不适用于以下情形：
(a) 指令2001/83/EC第1条第(23)款及条例(EU) 2019/6第4条第(25)款所定义的即时包装；
(b) 受条例(EU) 2017/745涵盖的医疗器械接触敏感包装；
(c) 受条例(EU) 2017/746涵盖的体外诊断医疗器械接触敏感包装；
(d) 指令2001/83/EC第1条第(24)款及条例(EU) 2019/6第4条第(26)款所定义的外包装，且该包装为遵守特定要求以 保持药品质量所必需；
(e) 用于婴儿配方奶粉、后续配方奶粉、基于谷物的加工食品、婴儿食品及根据条例（欧盟） 2013年第609/201
3号第1条第(a)、(b)和(c)款定义的特殊医学用途食品的接触敏感包装； (f) 根据指令2008/68/EC用于危险货物运输的包装；
(g) 由轻质木材、软木、纺织品、橡胶、陶瓷、瓷器或蜡制成的销售用包装；但第8款应适用于此类包装。
12. By 1 January 2035, the Commission shall review the exceptions under paragraph 11, taking into account at least the evolution of sorting and recycling technologies and practical experience gained by the economic operators and Member States. On that basis,the Commission shall assess the appropriateness of the continuation of those exceptions and, where appropriate, present a legislative proposal.
12. 委员会应于2035年1月1日前审查第11款所列例外，至少考虑分拣和回收技术的发展以及经济运营者和成员 国积累的实际经验。在此基础上，委员会应评估继续适用这些例外的适当性，并在适当情况下提出立法建议。