欧盟 RoHS 指令修订版（2011/65/EU），即《电子电气设备中特定有害物质禁用指令》，于2011 年7 月1 日在
欧盟官方期刊（OJ）上正式公布，将于公布后20 天 (2011 年7 月21 日) 生效。成员国需要在2013 年1 月2 日
前将其转化为本国法律，即新指令将在2013 年1 月3 日正式实施，旧指令2002/95/EC 同时废止。
The Directive 2011/65/EU, on the restriction of the use of certain hazardous substances in electrical and
electronic equipment was publicized in the Official Journal of the European unio at 1 Jul 2011, and will be enter into
force at 21 Jul 2011. Member States shall adopt and publish, by 2 January 2013, the laws, regulations and the
administrative provisions necessary to comply with this Directive, at the same time the Directive 2002/95/EC is
repealed.

2011/65/EU 主要内容如下：
Ⅰ 范围 Scope
1. 大型家用电器 Large household appliances.
2. 小型家用电器 Small household appliances.
3. 信息技术和通信设备 IT and telecommunications equipment.
4. 消费类设备 Consumer equipment.
5. 照明设备Lighting equipment.
6. 电器和电子工具 Electrical and electronic tools.
7. 玩具、休闲和运动设备Toys, leisure and sports equipment.
8. 医疗器械 Medical devices.
9. 监控设备(包括大型的工业监控设备) Monitoring and control instruments including industrial monitoring and
control instruments.
10. 自动售货机Automatic dispensers.
11. 不被1~10 类产品涵盖的其它电子电器设备，包括线材及其他零部件Other EEE not covered by any of the
categories above.
以下材料不在指令管控范围之内 This Directive does not apply to:
(a) 涉及国家安全的军事设备，武器装备，军需物品；
Equipment for the protection of the security of Member States, including arms, munitions and war materialintended for specifically military purposes;
(b) 航空，航天设备 Equipment designed to be sent into space;
(c) 大型固定工业工具 Large-scale stationary industrial tools;
(d) 大型固定装置Large-scale fixed installations;
(e) 有源植入设备 Active implantable medical devices;
(f) 光伏电池板Photovoltaic panels;
(g) 用于科研的设备Equipment specifically designed solely for the purposes of research.

Ⅱ 限制物质 Restricted Substances
铅 (Lead, Pb) 0.1% （1000ppm）
镉 (Cadmium, Cd) 0.01% （100ppm）
汞 (Mercury, Hg) 0.1% （1000ppm）
六价铬（Hexavalent chromium, Cr(Ⅵ) ） 0.1% （1000ppm）
多溴联苯(Polybrominated biphenyls, PBBs) 0.1% （1000ppm）
多溴联苯醚(Polybrominated diphenyl ethers, PBDEs) 0.1% （1000ppm）
新指令并没有增加新的限制物质，但选定六溴环十二烷(HBCCD)、邻苯二甲酸二(2-乙基己基)酯（DEHP）、邻苯
二甲酸丁苄酯（DBP）和邻苯二甲酸二丁酯（BBP）4 种有害物质作为限制物质的候选。
The risks to human health and the environment arising from the use of Hexabromocyclododecane (HBCDD), Bis
(2- ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl phthalate (DBP) should be considered as
a priority.
新增物质需要考虑REACH 法规，特别是授权清单ANNEX XIV 及限制清单ANNEX ⅩⅩ。
The review and amendment of the list of restricted substances shall be coherent with other legislation related to
chemicals, in particular Regulation (EC) No 1907/2006,and shall take into account, inter alia, Annexes XIV and XVII
to that Regulation.

Ⅲ CE 标志 CE Marking
产品投放于市场之前，制造商/进口商/分销商需确保已依据768/2008/EC 附录II 模组A 的符合性评估程序（自我声明）进行了相关评估，并且必须在最终产品贴上加贴CE 标识。其相关技术文件及欧盟符合性声明书需至少保留10
年。
When placing EEE on the market, the manufacturers should draw up the required technical documentation and
carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC; and
manufacturers draw up an EU declaration of conformity and affix the CE marking on the finished product. The
technical documentation and the EU declaration of conformity should be kept for 10 years.

Ⅳ 过渡期 Transition
为使新纳入ROHS 2011 管控产品的生产商有充分时间来符合指令要求，ROHS 2011 为相关产品设定了管控过渡
期：
—医疗设备和监控设备及其零部件自2014 年7 月22 日起应符合ROHS 2011;
—体外诊疗设备及其零部件自2016 年7 月22 日起应符合ROHS 2011;
—工业监控设备及其零部件自2017 年7 月22 日起应符合ROHS 2011;
—其它未纳入ROHS 2011 管控的产品自2019 年7 月22 日起应符合ROHS 2011.
The Directive shall apply to the medical devices, monitoring and control instruments, as well as cables or spare parts
which are placed on the market from 22 July 2014; to in vitro diagnostic medical devices and its cables or spare parts
which are placed on the market from 22 July 2016; to industrial monitoring and control instruments and its cables or
spare parts which are placed on the market from 22 July 2017; The EEE that was outside the scope of Directive
2002/95/EC, but which would not comply with this Directive, may nevertheless continue to be made available on the
market until 22 July 2019.

Ⅴ 豁免机制Exempted
新指令采纳了现有的39 条豁免；同时对医疗器械和监控设备提出了20 项新豁免。
The Directive have adopted the existing 39 exemptions of applications; at the same time 20 applications
exempted from medical devices and monitoring and control instruments are proposed.

39 条豁免清单
The existing 39 exemptions of applications
序号NO                                  豁免Exemption                                       范围和应用日期Scope and dates of applicability

1 单端（紧凑）荧光灯中的汞含量不得超过（每灯）：
Mercury in single capped (compact) fluorescent
lamps not exceeding (per burner):

1(a) 一般照明用途小于30 W：5 毫克
For general lighting purposes < 30 W: 5 mg
2011 年12 月31 日到期；2011 年 12 月
31 日至2012 年12 月 31 日按照 3.5 毫克
/灯；之后每盏可用2.5 毫克
Expires on 31 December 2011; 3.5 mg
may be used per burner after 31
December 2011 until 31 December 2012;
2.5 mg shall be used per burner after 31
December 2012

1(b) 一般照明用途大于 30 W 和小于 50 W：5 毫克
For general lighting purposes >30 W and < 50 W: 5
mg
2011 年12 月31 日到期；之后每盏灯可用
3. 5 毫克/灯
Expires on 31 December 2011; 3.5 mg
may be used per burner after 31
December 2011

1(c) 一般照明用途大于50 W 和小于150 W：5 毫克
For general lighting purposes > 50 W and < 150 W: 5
mg

1(d) 一般照明用途大于150 W：15 毫克
For general lighting purposes >150 W: 15 mg

1(e) 圆形或者方形结极和直径小于 17 mm 的一般照明用
途
For general lighting purposes with circular or square
structural shape and tube diameter <17 mm
2011 年12 月31 日前没有使用限制；之后
每盏灯可用 7 毫克
No limitation of use until 31 December
2011; 7 mg may be used per burner after
31 December 2011

1(f) 特殊用途：5 毫克For special purposes: 5 mg

2(a) 用于一般照明用途的双端线性荧光灯中汞的含量不超
过（每灯）：
Mercury in double-capped linear fluorescent lamps for