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      歐洲認證
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      REACH是歐盟規章《化學品注冊、評估、許可和限制》(REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals)的簡稱,是歐盟建立的,并于2007年6月1日起實施的化學品監管體系。

        這是一個涉及化學品生產、貿易、使用安全的法規提案,法規旨在保護人類健康和環境安全,保持和提高歐盟化學工業的競爭力,以及研發無毒無害化合物的創新能力,防止市場分裂,增加化學品使用透明度,促進非動物實驗,追求社會可持續發展等。REACH指令要求凡進口和在歐洲境內生產的化學品必須通過注冊、評估、授權和限制等一組綜合程序,以更好更簡單地識別化學品的成分來達到確保環境和人體安全的目的。該指令主要有注冊、評估、授權、限制等幾大項內容。任何商品都必須有一個列明化學成分的登記檔案,并說明制造商如何使用這些化學成分以及毒性評估報告。所有信息將會輸入到一個正在建設的數據庫中,數據庫由位于芬蘭赫爾辛基的一個歐盟新機構———歐洲化學品局來管理。該機構將評估每一個檔案,如果發現化學品對人體健康或環境有影響,他們就可能會采取更加嚴格的措施。根據對幾個因素的評估結果,化學品可能會被禁止使用或者需要經過批準后才能使用。

        據介紹,與RoHS指令不同,REACH涉及的范圍要寬得多,事實上它會影響從采礦業到紡織服裝、輕工、機電等幾乎所有行業的產品及制造工序。REACH要求制造商注冊產品中的每一種化學成分,大約共有3萬種--并要衡量其對公眾健康的潛在危害。REACH建立了這樣的理念:社會不應該引入新的材料、產品或技術,如果它們的潛在危害是不確知的。

        機電產品一直是寧波地區外貿的重頭之一。作為化工產業的下游用戶,沒有一家對歐貿易的機電企業可以不受REACH制度的限制。REACH法規草案規定進入歐盟市場化學品和其它有形產品的生產商和進口商負有以下義務:

        (一)整理并提交包括產品所含每種化學物質測試數據在內的詳細報告(即“注冊”)。

        REACH法規中,化學物質的注冊范圍主要包括:

        1. 數量≥1噸/年/人的獨立存在的物質或配制品中的物質;

        2. 上游供應商中未注冊的含量(重量比)≥2%且總量≥1噸/年/人的以單體單元(monomericunits)或化合物(chemically bound substances)形式存在于聚合物中的單體或其他物質;

        3. 總量>1噸/年/人且正常或可合理預見使用狀態下會有意釋放的物品中物質(substances in articles);

        4. 總量>1噸/年/人,化學品局有理由懷疑會從物品中釋放且這種釋放對人體或環境有害的物品中物質,化學品局可要求注冊。

        REACH法規中,豁免注冊物質有:

        1. 1噸/年/人的物質

        2. 放射性物質

        3. 海關監管下的不做任何處理或加工的:(1)為再出口而暫存的,或保稅區或保稅倉庫中的;或(2)過境的

        4. 非分離中間體

        5. 運輸危險物質的運輸工具

        6. 廢棄物

        7. 成員國因國防之因而豁免的

        8. 醫藥或獸藥

        9. 食品或飼料中的添加劑、食品調味劑和動物營養劑

        10. 附件 IV中的物質(已知風險很低)

        11. 附件V中的物質

        12. 再次進口已注冊的物質本身或制品中的物質

        13. 已注冊的物質本身、制品或物品中的物質再次加工時(recovery process)

        14. 聚合物(聚合物本身)(但上游供應商中未注冊的含量[重量比]≥2%且總量≥1噸/年的以單體單元(monomericunits)或化合物(chemically bound substances)形式存在于聚合物中的單體或其他物質除外)

        15. 僅用于產品或研發的化學物質(PPORD)(5+5/10年)

        16. 只用于植保產品中的活性成分和輔料(co-formulants)(視為已注冊)

        17. 只用于生物殺滅劑中的活性成分(視為已注冊)

        18. 根據79/831/EEC指令,已做過新化學物質申報的物質(視為已注冊)

        (二)評估產品所含每種化學物質的安全系數(“化學品安全評估”)。

        評估的內容有:

        1,檔案評估是核查企業提交注冊卷宗的完整性和一致性。

        2,物質評估是核查該種物質是否需要企業提供進一步的信息。

        3,評估主要包括檔案評估(Dossier Evaluation)和物質評估(substance Evaluation)。

        檔案評估(Dossier Evaluation)包括:

        --. 歐洲化學品管理局須于登記后3周內,將注冊人的登記資料與完整性檢查報告提供給成員國(Member State)主管機關。但在分階段注冊截至日期前2個月內收到的注冊卷宗,需3個月時間進行審核;

        --. 非分階段注冊物質以及過了注冊截止日期的分階段注冊物質,在審核未通過前,禁止在歐盟國家生產、銷售使用和進口(成員國主管機關對技術檔案進行審查:評估登記的技術文件是否符合法規的規定,并檢查動物試驗計劃,以避免不必要動物試驗);

       
       
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