歐盟REACH是什么?歐盟REACH檢測

“Registration，Evaluation， Authorization and Restriction of Chemicals，化學(xué)品注冊、評估、許可和限制”，是歐盟對進入其市場的所有化學(xué)品進行預(yù)防性管理的法規(guī)。己于2008年6月1日正式實施。法規(guī)長達849頁，歷時7年才完成，被譽為歐盟史上最為復(fù)雜的法規(guī)，同時也是過去20年最為重要的一項法規(guī)。

目的

保護人類健康和環(huán)境;保持和提高歐盟化學(xué)工業(yè)的競爭力;增加化學(xué)品信息的透明度;減少脊椎動物試驗;與歐盟在WTO框架下的國際義務(wù)相一致。

從實質(zhì)意義上講，REACH法規(guī)將促進化學(xué)工業(yè)的革新，使其生產(chǎn)更安全的產(chǎn)品，刺激競爭和增長。與現(xiàn)行復(fù)雜的法規(guī)體系不同， REACH將在歐盟范圍內(nèi)創(chuàng)建一個統(tǒng)一的化學(xué)品管理體系，使企業(yè)能夠遵循同一原則生產(chǎn)新的化學(xué)品及其產(chǎn)品。

主要內(nèi)容

注冊(Registration) 年產(chǎn)量或進口量超過1噸的所有化學(xué)物質(zhì)需要注冊，年產(chǎn)量或進口量10噸以上的化學(xué)物質(zhì)還應(yīng)提交化學(xué)安全報告。

評估(Evaluation) 包括檔案評估和物質(zhì)評估。檔案評估是核查企業(yè)提交注冊卷宗的完整性和一致性。物質(zhì)評估是指確認化學(xué)物質(zhì)危害人體健康與環(huán)境的風(fēng)險性。

許可(Authorization) 對具有一定危險特性并引起人們高度重視的化學(xué)物質(zhì)的生產(chǎn)和進口進行授權(quán)，包括CMR，PBT ，vPvB等。

限制(Restriction) 如果認為某種物質(zhì)或其配置品、制品的制造、投放市場或使用導(dǎo)致對人類健康和環(huán)境的風(fēng)險不能被充分控制，將限制其在歐盟境內(nèi)生產(chǎn)或進口。

注：PBT 持久性、生物富積和毒性化學(xué)物質(zhì)

vPvB 高持久性、高度生物富積化學(xué)物質(zhì)

CMR 致癌性、誘變性和生物毒性物質(zhì)

注冊

Registration

要求年產(chǎn)量超過1噸的所有現(xiàn)有化學(xué)品和新化學(xué)品及應(yīng)用于各種產(chǎn)品中的化學(xué)物質(zhì)注冊其基本信息。只有通過注冊的物質(zhì)才能在歐盟內(nèi)生產(chǎn)或進口。

每一個物質(zhì)的生產(chǎn)商和進口商須向化學(xué)管理署提交該物質(zhì)的注冊檔案，并繳納相應(yīng)的費用。但是要求聯(lián)合提交同一個物質(zhì)的注冊信息，即遵循“一個物質(zhì)，一次注冊”原則。作為聯(lián)合注冊的成員，可以與其他成員共同分攤注冊的費用。

為了易于管理、接受大量注冊檔案的提交，提交給化學(xué)署的注冊檔案需電子化處理?；瘜W(xué)管理署會給每一個收到的注冊檔案一個注冊編號和注冊日期，并立刻把這些信息傳遞給注冊人。

在提交注冊文檔后的三周內(nèi)，化學(xué)署會對提交的注冊文檔作一個完整性確認，以確定該檔案符合Reach檢測的要求。如果注冊檔案不完整，化學(xué)署將在注冊提交之日起的三周內(nèi)，通知注冊人在規(guī)定的期限內(nèi)提交進一步信息，把注冊檔案補充完整。

對于分階段物質(zhì)，提供了預(yù)注冊程序。通過預(yù)注冊的物質(zhì)，就可以繼續(xù)在歐盟內(nèi)生產(chǎn)和銷售，只須在規(guī)定的最后期限前通過正式注冊。

對于分階段物質(zhì)，在期限內(nèi)有大量的注冊需要完成。因此，化學(xué)署對于每個提交的注冊，需要在在3周內(nèi)檢查注冊的資料是否完整;但是對于在截止日期前2個月內(nèi)提交的每個注冊，歐盟將在3個月內(nèi)來檢查注冊是否完整。

注冊人需要在設(shè)定的期限內(nèi)向化學(xué)署提交更新的檔案，要求提交缺少的信息。然后化學(xué)署確定這些信息的提交日期，在3個星期內(nèi)對更新的檔案再進一步檢查其完整性。

如果注冊人沒在期限內(nèi)能完成注冊，注冊將被化學(xué)署拒絕，制造商或進口商將不能開始或繼續(xù)物質(zhì)的制造或進口。

如果有必要，化學(xué)署將會轉(zhuǎn)送注冊檔案、注冊號和日期、完整性檢查的結(jié)果給成員國當(dāng)局，制造商和進口商確立能夠?qū)嵤┬袆?。為不完整的檔案提交的補充信息，連同第二次完整性檢查的結(jié)果提交給主管機關(guān)。

All the exisiting, new chemical substances itself and which applied to every manufacture need to registrate basic information when the output in quantities of 1 tonne or more per year.Only registered substances are allowed to be manufactured or imported.

Each manufacturer or importer of a substance shall submit his registration dossier for the substance to the Agency, accompanied by a fee.But they should submit the information of the same substance jointly,that is”one subject,one registration”.As a consortium member he only has to pay one third of the registration fee.

The registration dossiers submitted to the Agency will be handled electronically to facilitate the management of the expected amount of registrations that will be submitted. The Agency assigns a registration number and a registration date to each registration dossier received and immediately communicates this information to the registrant.

Within 3 weeks of the registration date, the Agency performs an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date about which further information is needed and will set a deadline for completion of the dossier.

For phase in substances, a considerable number of registrations are expected to arrive just before the deadlines for the registrations. Therefore, the Agency is given 3 months from each registration deadline to check the completeness of those registrations that have been submitted within 2 months of the deadlines. However, the Agency will have to check the completeness of registrations submitted more than 2 months before the deadlines, within 3 weeks of receipt.

The registrant needs to submit the requested missing information in an updated dossier to the Agency within the set deadline. The Agency then confirms the submission date of this information and makes a further completeness check within 3 weeks of receipt of the updated dossier.

If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the Agency and the manufacturer or importer is not allowed to start or continue manufacture or import of the substance.

The Agency will forward the registration dossier, the registration number and date, and the result of the completeness check to the authorities of the Member States in which the manufacturers and importers are established to enable enforcement action, if necessary. Also the further information that is submitted for completion of the dossier will be forwarded to the competent authority together with the result of the second completeness check.