Module A
Internal production control
模块 A
内部生产控制
1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 and ensures and declares on his sole responsibility that the packaging concerned satisfies the requirements of Articles 5 to 12 of this Regulation that apply to it.
1. 内部生产控制是制造商履行第2、 3及4点规定的义务，并在其唯一责任下确保并声明相关包装符合本条例第 5至12条适用要求的合格评定程序。
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the packaging’s conformity with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity.
The technical documentation shall specify the applicable requirements and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. The technical documentation shall contain, wherever applicable, at least the following elements:
(a) a general description of the packaging and its intended use;
(b) conceptual design, manufacturing drawings and materials of components;
(c) descriptions and explanations necessary for the understanding of the drawings provided under point (b) and the schemes and operation of the packaging;
(d) a list of:
(i) the harmonised standards, referred to in Article 36, applied in full or in part; (ii) the common specifications, referred to in Article 37, applied in full or in part;
(iii) other relevant technical specifications used for measurement or calculation purposes;
(iv) in the event of partly applied harmonised standards or common specifications, an indication of the parts which have been applied;
(v) in the event of harmonised standards or common specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1;
(e) a qualitative description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and (f) test reports.
2. 技术文件
制造商应编制技术文件。该技术文件应能够评估包装是否符合适用要求，并应包含对不合格风险的充分分 析与评估。
技术文件应明确适用要求，并应涵盖与评估相关的包装设计、制造及操作。技术文件应当在适用情况下至 少包含以下内容：
(a) 包装及其预期用途的一般描述； (b) 概念设计、制造图纸及组件材料；
(c) 为理解第(b)点所提供图纸及包装方案与操作所必需的描述和说明；
(d) 以下清单：
(i) 第36条所述的全部或部分适用的协调标准； (ii) 第37条所述的全部或部分适用的通用规范；
(iii) 用于测量或计算目的的其他相关技术规范；
(iv) 在部分适用协调标准或通用规范的情况下，所适用部分的说明；
(v) 在未适用协调标准或通用规范的情况下，采用的满足第1点所述要求的解决方案说明；
(e) 对第6、 10及11条所规定的评估进行的定性描述；及 (f) 测试报告。
3. Manufacturing
The manufacturershall take all measures necessary so that the manufacturing process and the monitoring thereof ensure compliance of the manufactured packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1.
3. 制造
制造商应采取一切必要措施，确保制造过程及其监控能够保证所制造的包装符合第2点所述的技术文件及第 1点所述的要求。
4. Declaration of conformity
The manufacturer shall draw up a written declaration of conformity for each packaging type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after single-use packaging has been placed on the market, and 10 years after reusable packaging has been placed on the market. The declaration of conformity shall identify the packaging for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
4. 符合性声明
制造商应为每种包装类型编制书面符合性声明，并将其与技术文件一并保存，供国家主管当局查阅。单次 使用包装投放市场后应保存5年，可重复使用包装投放市场后应保存10年。符合性声明应明确其所针对的包 装。
符合性声明的副本应在相关主管当局要求时提供。
5. Authorised representative
The manufacturer’s obligations set out in point 4 as regards keeping the technical documentation may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that those obligations are specified in the mandate.
5. 授权代表
制造商在第4点中关于保存技术文件的义务，可由其授权代表代表其并在其责任范围内履行，前提是该义务 已在授权委托书中明确规定。