1. Packaging placed on the market shall be so manufactured that the presence and concentration of substances of concern as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal, and to the adverse impact on the environment due to microplastics.
1. 投放市场的包装应当制造得使关注物质作为包装材料或任何包装组成部分的含量及浓度降至最低，包括 其在排放物及废弃物管理结果（如二次原材料、灰烬或其他最终处置材料）中的存在，以及因微塑料对环境造 成的不利影响。
2. The Commission shall monitor the presence of substances of concern in packaging and packaging components and shall take, where appropriate, the relevant follow-up measures.
By 31 December 2026, the Commission, assisted by the European Chemicals Agency, shall prepare a report on the presence of substances of concern in packaging and packaging components, to determine the extent to which they negatively affect the re-use and recycling of materials or impact chemical safety. That report may list the substances of concern present in packaging and packaging components and indicate the extent to which they could present an unacceptable risk to human health and the environment.
The Commission shall submit the report to the European Parliament, to the Council and to the committee referred to in Article 65 of this Regulation setting out its findings and shall consider appropriate follow-up measures, including:
(a) for substances of concern in packaging materials which primarily affect human health or the environment, the use of the procedures referred to in Article 68(1) and (2) of Regulation (EC) No 1907/2006 to adopt new restrictions;
(b) for substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, the establishment of restrictions as a part of design for recycling criteria in accordance with Article 6(4) of this Regulation.
If a Member State considers that a substance negatively affects the re-use and recycling of materials in the packaging in which it is present, it shall, by 31 December 2025, supply such information to the Commission and the European Chemicals Agency and, where available, refer to the relevant risk assessments or other relevant data.
2. 委员会应监测包装及包装组成部分中关注物质的存在情况，并在适当情况下采取相关后续措施。
委员会应于2026年12月31日前，在欧洲化学品管理局协助下，编制关于包装及包装组成部分中关注物质存在 情况的报告，以确定其在多大程度上对材料的再使用和回收产生负面影响或影响化学品安全。该报告可能列明 包装及包装组成部分中存在的关注物质，并指出其对人体健康和环境可能构成不可接受风险的程度。
委员会应将报告提交欧洲议会、理事会及本条例第65条所述委员会，陈述其调查结果，并应考虑适当的后续措 施，包括：
（a）对于主要影响人体健康或环境的包装材料中的关注物质，依据条例（EC）第1907/2006号第68条第1款和 第2款所述程序，制定新的限制措施；
（b）对于负面影响其所存在包装中材料的再使用和回收的关注物质，根据本条例第6条第4款，作为可回收设 计标准的一部分，建立限制措施。
若成员国认为某种物质负面影响其所存在包装中材料的再使用和回收，应于2025年12月31日前向委员会和欧 洲化学品管理局提供相关信息，并在可行情况下引用相关风险评估或其他相关数据。
3. Member States may request the Commission to consider restricting, pursuant to Article 6(4), point (a), the use of substances of concern that potentially negatively affect the re-use and recycling of materials in packaging in which they are present, for reasons other than those related primarily to the chemical safety of those substances. Member States shall accompany such requests with a report documenting the identity and uses of the substances and a description of how the use of the substances in packaging hinders recycling, for reasons other than those related primarily to chemical safety. The Commission shall evaluate the request and present the results of that evaluation to the committee referred to in Article 65.
3. 成员国可根据第6条第4款(a)项的规定，要求委员会考虑限制关注物质的使用，这些关注物质可能对其存 在的包装材料的再利用和回收产生负面影响，且限制理由主要不涉及该等物质的化学安全性。成员国应随同此 类请求提交一份报告，说明关注物质的身份及用途，并描述该物质在包装中使用如何妨碍回收，且理由主要不 涉及化学安全性。委员会应对该请求进行评估，并将评估结果提交第65条所述的委员会。
4. Without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004, the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
4. 在不影响《(EC) No 1907/2006条例》第XVII附录关于化学品限制的规定，或在适用情况下不影响《(EC) No 1935/2004条例》中关于食品接触材料和物品的限制及具体措施的前提下，包装或包装组成部分中存在的物质 所导致的铅、镉、汞和六价铬浓度总和不得超过100mg/kg。
5. From 12 August 2026, food-contact packaging shall not be placed on the market if it contains per- and polyfluorinated alkyl substances (PFAS) in a concentration equal to or above the following limit values to the extent that the placing on the market of packaging containing such a concentration of PFAS is not prohibited pursuant to another Union legal act:
(a) 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);
(b) 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors (polymeric PFAS excluded from quantification); and
(c) 50 ppm for PFASs (including polymeric PFAS); if total fluorine exceeds 50 mg/kg the manufacturer, importer or downstream user as defined respectively in Article 3, points (9), (11) and (13) of Regulation (EC) No 1907/2006 shall, upon request, provide to the manufacturer or the importer as defined respectively in Article 3(1), points (13) and (17), of this Regulation proof of the quantity of fluorine measured as content of either PFAS or non-PFAS in order for them to draw up the technical documentation as referred to in Annex VII to this Regulation.
‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it), except substances that only contain the following structural elements: CF3-X or X-CF2-X′, where X = -OR or -NRR′ and X′ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C (O)-), -OR′′, -SR′′ or –NR′′R′′′; and where R/R′/R′′/R′′′ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).
By 12 August 2030, the Commission shall carry out an evaluation to assess the need to amend or repeal this paragraph in order to avoid overlaps with restrictions or prohibitions on the use of PFAS laid down in accordance with Regulations (EC) No 1935/2004, (EC) No 1907/2006, or (EU) 2019/1021.
5. 自2026年8月12日起，若食品接触包装中含有全氟烷基物质（PFAS）的浓度达到或超过以下限值，且根据 其他欧盟法律文件未禁止该浓度的包装投放市场，则不得将该包装投放市场：
(a) 任何PFAS的靶向PFAS分析测定浓度为25ppb（不包括聚合型PFAS的定量）；
(b) PFAS总和的靶向PFAS分析测定浓度为250ppb，如适用，先对前体物进行降解处理（不包括聚合型PFAS的定 量）；
(c) PFAS（包括聚合型PFAS）为50 ppm； 若总氟含量超过50mg/kg，根据条例（EC）第1907/2006号第3条第（9 )、（11）及（13）款定义的制造商、进口商或下游用户，应根据请求，向本条例第3条第1款第（13）及
（17）款定义的制造商或进口商提供以PFAS或非PFAS形式测定的氟含量证明，以便其编制本条例附件七所 述的技术文件。
‘全氟烷基物质’指任何含有至少一个全氟甲基（CF3-）或亚甲基（-CF2-）碳原子（且该碳原子未连接任何H、Cl 、Br或I）的物质，但不包括仅含有以下结构单元的物质： CF3-X或X-CF2-X′，其中X为-OR或-NRR′ ，X′为甲基（- CH3）、亚甲基（-CH2-）、芳香基、羰基（-C(O)-）、-OR′′、-SR′′或–NR′′R′′′； 且R、R′、R′′或R′′′为氢（-H） 、甲基（-CH3）、亚甲基（-CH2-）、芳香基或羰基（-C(O)-）。
委员会应于2030年8月12日前开展评估，以确定是否有必要修订或废止本款，以避免与依据条例（EC）第1935 /2004号、第1907/2006号或（EU） 2019/1021号规定的全氟烷基物质使用限制或禁令产生重叠。
6. Compliance with the requirements set out in paragraphs 4 and 5 of this Articleshall be demonstrated in the technical documentation drawn up in accordance with Annex VII.
6. 应当按照附件七编制的技术文件，证明符合本条第4款和第5款规定的要求。
7. In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to amend this Regulation in order to lower the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components referred to in paragraph 4 of this Article.
7. 为适应科学和技术进步，委员会可依据第64条采用授权法案，修订本条例，以降低因本条第4款所述包装或 包装组成部分中存在的物质所致的铅、镉、汞和六价铬浓度总和。
8. In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to supplement this Regulation in order to determine the conditions under which the sum of the concentrations referred to in paragraph 4 of this Articleshall not apply to recycled materials or to product loops which are in a closed and controlled chain, as well as to determine the packaging types or formats of packaging, based on the packaging categories listed in Table 1 of Annex II to this Regulation, which shall be exempted from the requirements laid down in that paragraph. Such delegated acts shall be justified on the basis of a case by case analysis, time-limited, provide for appropriate marking and information requirements, and contain requirements for regular reporting in order to ensure that the exemption is regularly reviewed. Delegated acts adopted in accordance with this paragraphshall only be adopted to amend derogations established in Decisions 2001/171/EC and 2009/292/EC.
8. 为适应科学和技术进步，委员会可依据第64条采用授权法案，补充本条例，以确定本条第4款所述浓度总和 不适用于再生材料或处于封闭且受控链条中的产品循环的条件，并确定基于本条例附件二表1所列包装类别的 包装类型或包装格式，可免于遵守该款规定的要求。此类授权法案应基于逐案分析予以说明，具有时限性，规 定适当的标识和信息要求，并包含定期报告的要求，以确保对豁免进行定期审查。根据本款通过的授权法案仅 可用于修改决议2001/171/EC和2009/292/EC中确立的例外情况。
9. By 12 August 2033, the Commission shall carry out an evaluation to assess whether this Article and the design for recycling criteria set out in accordance with Article 6(4) have contributed sufficiently to minimising the presence and concentration of substances of concern as constituents of packaging materials.
9. 委员会应于2033年8月12日前开展评估，以判断本条款及根据第6条第4款制定的可回收设计标准是否已充分 促进减少关注物质作为包装材料成分的存在及浓度。