評估 Evaluation
***個目的:管理署評估工業(yè)界的測試方法以確保產(chǎn)品的安全性,并保證盡量減少或避免動物試驗。
第二個目的:檢查是否符合注冊的要求。
第三個目的:檢查該物質(zhì)對人類健康和環(huán)境可能造成的危害。
評估為管理當(dāng)局提供了一系列方法去要求注冊人,及其少數(shù)的下游用戶,提供進一步的信息。
評估分兩類:檔案評估和物質(zhì)評估。
檔案評估:管理當(dāng)局檢查測試的目的以避免不必要的動物試驗和花費,同時檢查注冊檔案是否符合注冊的要求。
物質(zhì)評估:當(dāng)懷疑一個物質(zhì)對人類健康和環(huán)境有暴露的風(fēng)險時(比如與另一個物質(zhì)有相似的結(jié)構(gòu)),管理當(dāng)局進行物質(zhì)評估。因此,同一 個物質(zhì)的所有技術(shù)檔案將一起評估,任何有用的信息都將被考慮在內(nèi)。
The evaluation process has three purposes:
The first purpose is for authorities to evaluate the testing proposals made by industry to ensure the safety of their products and thereby ensuring that animal testing is kept to a minimum.
The second purpose is to check compliance with the requirements of the regulation.
The third purpose is to examine any suspicion of risks to human health and the environment arising from substances.
Evaluation provides a means for the authorities to require registrants, and in very limited cases downstream users, to provide further information.
There are two types of evaluation: dossier evaluation and substance evaluation:
Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are ***oided, and to check the compliance of registration dossier with the registration requirements.
Substance evaluation is performed by authorities when there is a reason to suspect that a substance presents a risk to human health or the environment (e.g. because of its structural similarity to another substance). Therefore, all registration dossiers submitted for a substance are examined together and any other ***ailable information is taken into account.