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WEEE introduction
WEEE treatment
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European Union's WEEE Directive 2002/96/EC on Waste of Electronic and Electrical Equipment has now been transposed in national laws and has become effective. The manufacturers became financially responsible for the compliance to the directive since 13 August 2005. Failure to comply with the directive will lead the manufacturers to prosecution.
This symbol must be printed visibly, legibly and indelibly.
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Besides the requirements for selective treatment for materials and components of WEEE- Waste of Electronic and Electrical Equipment, the WEEE Directive obligates member states to establish and maintain a registry of producers putting electrical and electronic equipment onto the market. So far, there does not exist a centralized European registration office.
Producers must register in every individual EU country. Without the WEEE registration a product can not be placed on in the EU market!
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Producers will be expected to pay an annual registration fee to the appropriate Agency.
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Producers, or compliance schemes acting on their behalf, will be required to report data on the amount of EEE which they put onto the market.
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Producers will be required to report this data annually to the Agencies. It will be an offence not to do so.
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The Directive aims to:
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reduce the waste arising from electrical and electronic equipment; and
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improve the environmental performance of all those involved in the life cycle of electrical and electronic products.
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The Directive covers WEEE used by consumers and for professional purposes.
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Private householders will be able to return their WEEE to collection facilities free of charge;
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Producers (manufacturers, sellers, distributors) will be responsible for taking back and recycling electrical and electronic equipment.
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Producers will be required to achieve a series of demanding recycling and recovery targets for different categories of appliance
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Who does it affect?
Those involved in manufacturing, selling, distributing, recycling or treating electrical and electronic equipment. This includes 10 Categories of products
- Large household appliances
- Small household appliances
- IT and telecommunications equipment
- Consumer equipment
- Lighting equipment
- Electrical and electronic tools (with the exception of large-scale stationary industrial tools)
- Toys, leisure and sports equipment
- Medical devices (with the exception of all implanted and infected products)
- Monitoring and control instruments
- Automatic dispensers
(For any other information, please refer to Environment Directorate-General of the European Commission)
Documents:
| 出口欧盟医疗器械要交回收费
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中国工业设备网 发表时间:2005-9-19
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欧 盟委员会《报废电子电气设备指令》(下称“WEEE指令”)即于今年8月13日施行。该指令将为我国医疗器械出口设置新技术壁垒,未来企业出口成本可能会 因此提高15%左右。而值得注意的是,与其他行业积极应对不同,针对WEEE指令实施后可能带来的影响,众多国内医药企业相关人士却很无奈地表示:“我们 只有被动地接受。
WEEE指令提高出口门槛
WEEE指令要求,电子电气设备生产商、进口商、经销商于今年8月13日以后,负责回收、处理进入欧盟市场的废弃电气和电子产品,并在今年8月 13日后投放欧盟市场的电气和电子产品上加贴回收标志。其中所涉及到的医疗器械设备主要包括放射治疗设备、心脏病透析设备、肺部通气机、放射医学设备等, 涉及范围非常广。
“欧盟设置的这个壁垒可能会使企业的出口成本增加5%~15%左右。”欧盟最权威的认证机构“德国莱茵TUV公司”广东分公司产品安全及质量部经 理黄力坤表示。他告诉记者,在以往,医疗设备只要符合欧盟的CE标准就可以进入欧盟市场,产品在报废后企业和经销商也不用负责回收、处理,但WEEE指令 实施后,生产企业和经销商必须面对回收成本与责任,需要付出很大的精力和资金,这对中国医疗器械出口行业必定产生较大影响。
中国医疗器械行业协会会长姜峰表示,欧盟出台WEEE指令,一方面是因为环保,一方面也是为了提高外来企业进入欧盟市场的门槛。
而记者刚从中国医药保健品进出口商会获取的数据显示,中国医疗器械产品2004年出口欧盟的总额为5亿多美元,比2003年增加了31.72%。 今年1~5月份,出口欧盟总额为2.59亿美元,比去年同期增长了34.76%。由此可见,欧盟已经成为我国医疗器械出口非常重要的市场。
黄力坤称,目前全球的医疗器械生产基地正在向中国转移,上世纪90年代,中国开放最早的家电产业所走过的路,将在医疗器械产业重演,随着国际医疗 器械生产不断向中国转移,将会有越来越多的医疗设备通过中国出口欧盟,这一趋势只会加强而不会削弱。因此,WEEE指令设置的新技术壁垒对中国医疗设备出 口的影响将是深远的。
国内企业被动接受?
但遗憾的是,虽然WEEE指令公布已两年之久,但国内企业对此条款的知晓程度却非常低,对其可能带来的影响也后知后觉。上海医药保健品进出口公司 总经理蒋震伟告诉记者,虽然他们公司也有出口到欧盟市场的医疗器械,但他并不了解WEEE指令,因此无法估计出具体影响。通用电器中国医疗器械系统公司、 沈阳东软数字医疗系统股份有限公司等也给了记者同样的答案。
上海医疗器械进出口公司有关人士告诉记者,他们听说过WEEE指令,但由于还未开始实施,因此对方客户还没有开始向他们收取这部分费用。该人士同时告诉记 者,从WEEE指令设定的范围看,主要为大型医疗器械设备,而我国许多本土医疗器械生产商出口较多为消耗类的简单设备,因此可能受限范围不会很大。
和其他行业积极应对不同的是,针对WEEE指令实施后可能受到的影响,该人士很无奈地表示:“我们只有被动地接受。”他告诉记者,即使要提起诉讼,也需要很长时间,“没有一两年时间是搞不定的。”
国内相关条款有望出台
而从莱茵TUV公司同时获悉,目前欧盟有说法表示,WEEE指令对医疗设备的实施将推迟到2008年之后,国内企业可以暂时喘口气。
但与此同时,我国标准委员会等7部委,目前也在制定类似欧盟WEEE和ROHS(《限制使用有害物质指令》)的相关法规,前者称之为《废旧家电及 电子产品回收处理体系》,后者为《电子信息产品污染防治管理办法》,以针对WEEE和ROHS,并有望在今年底或明年初颁布。
如果上述两个政策强制性实施的话,国内电子医疗设备生产企业将会面临更为巨大的压力,为自己销售的每一个产品的回收“埋单”,由此带来的生产成本的增加和产品价格的上涨,将不再仅局限于出口企业。
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