2026年7月8日,欧盟委员会发布了指令草案,拟对RoHS 指令(2011/65/EU)附件III(11类电子电气产品通用豁免)和附件 IV(医疗/工业监测设备专用豁免)中涉及铅(Pb)和镉(Cd)的豁免条款实施修订。
本指令于《欧盟官方公报》发布后第二十日生效。
RoHS:Restriction of use of certain Hazardous Substancesin EEE,即2003年由欧洲议会和理事会通过的《欧盟关于在电子电气设备中限制使用某些有害物质指令》。
2024年1月10日,欧盟官方公报发布了指令(EU)2024/232 ,在RoHS指令附件III中新增第46条豁免。RoHS(2011/65/EU)是由欧盟立法制定的一项强制性标准,它的全称是《关于限制在电子电气设备中使用某些有害成分的指令》(Restriction of Hazardous Substances)。2003年1月27日欧盟理事会通过了首版RoHS指令:2002/95/EC; 2011 年7月1日,欧盟公布了新一版的RoHS指令:2011/65/EU,并于2011年7月21日生效,取代了之前的版本2002/95/EC。主要用于规范电子电气产品的材料及工艺标准,使之更加有利于人体健康及环境保护。RoHS禁止的物质是铅(Pb)、汞(Hg)、镉(Cd)、六价铬(CrVI)、多溴联苯(PBB)、多溴二苯醚(PBDE)和四种不同的邻苯二甲酸盐(DEHP、BBP、BBP , DIBP)。
适用产品及地区-欧盟27个成员国:英国(2020年退出欧盟),法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、希腊、西班牙、葡萄牙、奥地利、瑞典、芬兰、塞浦路斯、匈牙利、捷克、爱沙尼亚、拉脱维亚、立陶宛、马耳他、波兰、 斯洛伐克、斯洛文尼亚、保加利亚、罗马尼亚 。
RoHS指令涉及的产品范围相当广泛,几乎涵盖了所有电子、电器、医疗、通信、玩具、安防信息等产品,它不仅包括整机产品,而且包括生产整机所使用的零部件、原材料及包装件,关系到整个生产链。
产品范围:1.大型家用电器;2.小型家用电器;3.信息技术及电讯设备;4.消费类设备;5.照明设备;6.电动工具;7.玩具、娱乐及运动设备;8.医疗设备;9.监视和控制设备;10.自动售货设备;11.不被以上类别涵盖的其它电子电气设备。
对附件III、附件IV作出如下修订:
(1)在附件III中,第5(b)、13(a)、13(b)、13(b)-(I)、13(b)-(II)、13(b)-(III)、18(b)、18(b)-I、24、29、32以及34款替换为如下内容:
条款 | 豁免内容 | 适用范围和有效期 |
5(b) | Lead (not intentionally added) in soda lime glass used in the glass tube of fluorescent lamps, not exceeding 0,2 % by weight | Expires on [same day as date of entry into force plus 30 months] for category 5. |
13(a) | Lead in white glasses used for optical applications (excluding applications falling under any of points 13(b) to 13b-V of this Annex) | Expires on [same day as date of entry into force plus 30 months] for categories 3, 4,6,7,8,9 and 11. |
13(b) | Cadmium and lead used in filter glasses and glasses for reflectance standards | Expires on [same day as date of entry into force plus 12 months] for categories 8,9 and 11. |
13(b)-I | Lead in ion coloured optical filter glass types | Expires on [same day as date of entry into force plus 30 months] for all categories. |
13(b)-II | Cadmium in striking optical filter glass types; excluding applications falling under point 39(a) of this Annex | |
13(b)-III | Cadmium and lead in glazes used for reflectance standards | Expires on [same day as date of entry into force plus 12 months] for categories 1 to 7 and 10. |
13(b)-IV | Cadmium in glazes used for reflectance standards | Expires on [same day as date of entry into force plus 30 months] for categories 8 and 9. |
13(b)-V | Lead compound coatings in infrared interference filters used in infrared gas analysis and mid-far-infrared spectroscopy | Expires on [same day as date of entry into force plus 30 months] for category 9 industrial monitoring and control instruments. |
18(b) | Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb) | Expires on [same day as date of entry into force plus 54 months] for categories 5, 8, 9 and 11. |
18(b)-I | Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment | Applies to category 5 and 8 and expires on [same day as date of entry into force plus 12 months] |
18(b)-II | Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment, including extracorporeal photopheresis lamps | Expires on [same day as date of entry into force plus 54 months] for categories 5, 8 and 9. |
24 | Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors | Expires on [same day as date of entry into force plus 18 months] for all categories. |
24(a) | Lead in alloys used for soldering to through hole discoidal and/or planar array ceramic multilayer capacitors | Expires on [same day as date of entry into force plus 54 months] for all categories. |
29 | Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC (2) | Expires on [same day as date of entry into force plus 30 months] for categories 3, 4, 5 and 11. |
32 | Lead oxide in glass frit used as a sealing material for making window assemblies for argon and/or krypton laser tubes | Expires on [same day as date of entry into force plus 30 months] for categories 6, 8, 9 and 11. |
34 | Lead in cermet-based trimmer potentiometer elements | Expires on [same day as date of entry into force plus 30 months] for all categories. |
(2)对附件IV的1(b)、4、9、11、12、34条款作出如下修订:
条款 | 豁免内容 | 适用范围和有效期 |
1(b) | Lead anodes in electrochemical oxygen sensors. | Expires on [same day as date of entry into force plus 12 months]. |
1(b)-Ⅰ | Lead anodes in electrochemical sensors that measure oxygen concentrations of inhaled and/or exhaled air for patients and that are consumables in medical devices placed on the market before 26 May 2024. | Expires on [same day as date of entry into force plus 54 months] for category 8 medical devices other than in-vitro diagnostic medical devices. |
1(b)-Ⅱ | Lead in galvanic oxygen sensors in instruments that are designed for the measurement of dissolved oxygen in concentrations below 30 ppb. | Expires on [same day as date of entry into force plus 54 months] for category 8 medical devices other than in-vitro diagnostic medical devices. |
1(b)-Ⅲ | Lead anodes in galvanic capillary oxygen sensors in instruments that are designed for the measurement of oxygen in gases. | Expires on [same day as date of entry into force plus 54 months] for category 9 industrial monitoring and control instruments. |
1(b)-Ⅳ | Lead anodes in galvanic Hersch cells for oxygen sensors where sensitivity below 100 ppm is required. | Expires on [same day as date of entry into force plus 54 months] for category 9 industrial monitoring and control instruments. |
1(b)-Ⅴ | Cadmium anodes in Hersch cells for oxygen sensors where sensitivity below 100 ppm is required. | Expires on [same day as date of entry into force plus 78 months] for category 9. |
1(b)- Ⅵ | Lead anodes in galvanic permeable membrane oxygen sensors in instruments that are designed for the measurement of oxygen in gases. | Expires on [same day as date of entry into force plus 54 months] for category 9 industrial monitoring and control instruments.’; |
4 | Lead in glass frit of X-ray tubes and image intensifiers and lead in glass frit binder for assembly of gas lasers and for vacuum tubes that convert electromagnetic radiation into electrons. | Expires on [same day as date of entry into force plus 12 months] for categories 8 and 9. |
4(a) | Lead in glass frit binders for assembly of HeNe gas lasers used in heterodyne interferometry calibration and heterodyne interferometry positioning applications. | Expires on [same day as date of entry into force plus 30 months] for category 9 industrial monitoring and control instruments.’; |
9 | Cadmium in helium-cadmium lasers. | Expires on [same day as date of entry into force plus 12 months] for category 9. |
9(a) | Cadmium in helium-cadmium lasers of Raman spectrometers for stress measurement in semiconductors. | Expires on [same day as date of entry into force plus 30 months] for category 9 industrial monitoring and control instruments.’; |
11 | Lead in alloys as a superconductor and thermal conductor in magnetic resonance imaging (MRI). | Expires on [same day as date of entry into force plus 12 months]. |
11(a) | Lead in alloys as a superconductor in MRI devices and nuclear magnetic resonance (NMR) devices.' | Expires on [same day as date of entry into force plus 78 months].’; |
12 | Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. | Expires on [same day as date of entry into force plus 12 months].' |
12(a) | Lead in metallic bonds creating superconducting electric circuits in superconducting quantum interference device (SQUID) detectors. | Expires on [same day as date of entry into force plus 78 months].’; |
34 | Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. | Expires on [same day as date of entry into force plus 12 months].’. |
来源:欧盟委员会
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