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    歐盟經濟運營者

    什么是歐盟經濟運營者

    根據歐盟2019/1020號條例(關于產品的市場監管法規),在2021年7月16號以后,某些指令/法規覆蓋的產品必須在歐盟內有一個經濟運營者(economic operator),才能投放市場。即歐盟外的制造商,必須授權一個經濟運營者,在歐盟內代表其處理相關市場監管事務。


    哪些指令或者法規需要歐盟經濟運營者

    建筑產品法規
    Regulation (EU) No 305/2011 - Construction products(CPR)
    個人防護產品法規
    Regulation (EU) 2016/425 Personal protective equipment(PPE)
    燃氣法規
    Regulation (EU) 2016/426 Appliances burning gaseous fuels(GAR)
    戶外噪音指令
    2000/14/EC Noise emission in the environment by equipment for use outdoors
    機械指令
    2006/42/EC Machinery(MD)
    玩具指令
    2009/48/EC Safety of toys
    能效指令
    2009/125/EC Energy-related Products(ErP)
    電子電器有害物質指令
    2011/65/EU Restriction of the use of certain hazardous substances (RoHS)
    煙火產品指令
    2013/29/EU Pyrotechnic articles
    娛樂游艇指令
    2013/53/EU Recreational craft and personal watercraft(RCD)
    簡單壓力容器指令
    2014/29/EU Simple pressure vessels(SPVD)
    電磁兼容指令
    2014/30/EU Electromagnetic compatibility(EMC)
    非自動衡器指令
    2014/31/EU Non-automatic weighing instruments(NAWI)
    計量器具指令
    2014/32/EU Measuring Instruments Directive(MID)
    防爆產品指令
    2014/34/EU Equipment for explosive atmospheres (ATEX)
    低電壓指令
    2014/35/EU Low Voltage (LVD)
    無線指令
    2014/53/EU Radio equipment(RED)
    承壓設備指令
    2014/68/EU Pressure equipment(PED)


    哪些可以做歐盟經濟運營者

    (a)a manufacturer established in the Union; 

    歐盟內的制造商

    (b) an importer, where the manufacturer is not established in the Union; 

    進口商(制造商不在歐盟內的) 

    (c)an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf; 

    歐盟授權代表

    (d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.

    履行服務提供商(如果沒有上面三種),履約服務提供商是至少提供以下兩項服務的個人或公司:倉儲,包裝,地址分配和派送,但不擁有相關產品的所有權;快遞和郵政公司除外


    經濟運營者(economic operator)的責任

    (a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request; 

    確保符合性聲明DOC或者性能聲明DOP和技術文檔TCF的可用性

    (b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority; 

    根據市場監督機構的合理要求,向該機構提供所有必要的信息和文件;

    (c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof; 

    有理由認為產品存在風險時,通知市場監督機構;

    (d) cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.

    與市場監督機構合作,整改不符合法規規定的問題。


    制造商對于經濟運營者(economic operator)的標記

    Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

    經濟運營者(economic operator)的相關信息,應標記下產品或包裝或隨貨文件上。


    如何獲得一個歐盟經濟運營者

    沃證可提供專業的第三方歐盟授權代表(歐代),協助您的產品滿足歐盟相關指令/法規的要求,順利進入歐盟市場,歡迎咨詢交流。

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