1. Manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.
1. 制造商仅得投放符合第5至第12条规定或依据其规定制定的要求的包装。
2. Before placing packaging on the market, manufacturers shall carry out the conformity assessment procedure referred to in Article 38 or have it carried out on their behalf, and shall draw up the technical documentation referred to in Annex VII.
Where compliance of packaging with the applicable requirements has been demonstrated by the conformity assessment procedure referred to in Article 38, manufacturers shall draw up an EU declaration of conformity in accordance with Article 39.
2. 制造商在投放包装前，应按照第38条规定自行或委托他人进行合格评定程序，并编制附件七所述的技术 文件。
若通过第38条所述的合格评定程序证明包装符合适用要求，制造商应依据第39条编制欧盟合格声明。
3. Manufacturers shall keep the technical documentation referred to in Annex VII and the EU declaration of conformity as follows:
(a) in the case of single-use packaging: for 5 years from the date the packaging was placed on the market; (b) in the case of reusable packaging: for 10 years from the date the packaging was placed on the market.
3. 制造商应保存附件七所述的技术文件及欧盟合格声明，具体如下：
(a) 一次性包装：自包装投放市场之日起保存5年；
(b) 可重复使用的包装：自包装投放市场之日起保存10年。
4. Manufacturers shall ensure that procedures are in place for series production of packaging to remain in conformity with this Regulation. Manufacturers shall adequately take into account changes in packaging design or in characteristics, as well as changes in harmonised standards, common technical specifications or other technical specifications by reference to which conformity is declared or by application of which its conformity is verified. Where the manufacturers find that the packaging’s conformity could be affected, they shall carry out a re-assessment in accordance with the conformity assessment procedure referred to in Article 38, or have it carried out on their behalf.
4. 制造商应确保建立程序，保证包装系列生产持续符合本条例的要求。制造商应充分考虑包装设计或特性 变化，以及协调标准、通用技术规范或其他用于声明合格或验证合格的技术规范的变更。当制造商发现包装的 合格性可能受到影响时，应按照第38条规定的合格评定程序进行重新评估，或委托他人代为进行该评估。
5. Manufacturers shall ensure that the packaging bears a type, batch or serial number or other element allowing its identification or, where the size or nature of the packaging does not so allow, that the required information is provided in a document accompanying the packaged product.
5. 制造商应确保包装上标注类型、批号、序列号或其他可识别其身份的要素；若包装的尺寸或性质不允许 ,则应在随附包装产品的文件中提供所需信息。
6. Manufacturers shall indicate on the packaging or on a QR code or another data carrier their name, registered trade name or registered trademark as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted. Where that is not possible, the required information shall be provided as part of the information through the QR code or other type of standardised, open, digital data carrier as referred to in Article 12(1), (2), (4) or (5) or in a document accompanying the packaged product. The postal address shall indicate a single point at which the manufacturer can be contacted.
6. 制造商应在包装上或通过二维码或其他数据载体标明其名称、注册商号或注册商标，以及其通讯地址，
并在可行情况下提供电子通讯联系方式。在无法实现的情况下，所需信息应通过二维码或第12条第(1)、(2)、(4 )或(5)款所述的其他标准化、开放的数字数据载体提供，或作为随附包装产品的文件内容提供。邮政地址应明 确指示制造商可联系的唯一地点。
7. Manufacturers shall ensure that information provided in accordance with paragraphs 5 and 6 is clear, understandable and legible, and that it does not replace, or obscure nor can be confused with information required by other Union legal acts on the labelling of the packaged product.
7. 制造商应确保根据第5款和第6款提供的信息清晰、易懂且易于辨认，且不得替代、遮盖或与其他欧盟法 律关于包装产品标签的规定混淆。
8. Manufacturers who consider or have reason to believe that packaging which they have placed on the market from the date of entry into force of this Regulation is not in conformity with one or more of the applicable requirements laid down in or pursuant to Articles 5 to 12 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate. Manufacturers shall immediately inform the market surveillance authority of the Member State in which they made the packaging available of the suspected non-compliance and of the corrective measures taken.
8. 制造商如认为或有合理理由相信自本条例生效之日起其投放市场的包装不符合第5至第12条或依据其制定 的适用要求之一项或多项，应立即采取必要的纠正措施，使该包装符合要求，或视情况予以撤回或召回。制造 商应立即将疑似不合规情况及所采取的纠正措施通知其将包装投放市场的成员国市场监管机构。
9. By way of derogation from paragraph 8 of this Article, the obligation to bring into conformity, withdraw or recall packaging which is believed not to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12 shall not apply to reusable packaging placed on the market before 11 February 2025.
9. 根据本条第8款的例外规定，对于2025年2月11日之前投放市场的可重复使用的包装，不适用根据第5至第 12条款或依据其规定的要求进行合规整改、撤回或召回的义务。
10. Manufacturers shall, upon a reasoned request from a national authority, provide all the information and documentation necessary to demonstrate the conformity of the packaging with the requirements laid down in or pursuant to Articles 5 to 12, including the technical documentation, in one or more languages which can be easily understood by that authority. That information and documentation shall be provided in electronic form and, on request, in paper form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority. Manufacturers shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements laid down in or pursuant to Articles 5 to 12.
10. 制造商应根据国家主管机关的合理请求，提供所有必要的信息和文件，以证明包装符合第5至第12条款 或依据其规定的要求，包括技术文件，且应以该主管机关能够轻松理解的一种或多种语言提供。该信息和文件 应以电子形式提供，并应根据要求提供纸质形式。
相关文件应在收到国家主管机关请求之日起10日内提供。
制造商应配合国家主管当局采取的任何措施，以纠正任何不符合第5至12条款或依据其规定设定要求的情况。
11. Paragraphs 2 and 3 shall not apply to custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments.
11. 第2款和第3款不适用于为工业和医疗环境中使用的可配置医疗器械及医疗系统定制的运输包装。
12. Where the natural or legal person that has the packaging designed or manufactured under its own name or trademark falls within the definition of micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person that supplies the packaging to the natural or legal person that has the packaging designed or manufactured under its own name or trademark is located in the Union, the natural or legal person that supplies the packaging shall be considered to be the manufacturer for the purposes of this Article.
12. 若根据2025年2月11日适用的建议2003/361/EC中所定义的微型企业范围内的自然人或法人，以其自身名 称或商标设计或制造包装，且向该自然人或法人供应包装的自然人或法人位于欧盟境内，则该供应包装的自然 人或法人应被视为本条款所指的制造商。