通报条件
根据(REACH法规)第7(2)条,如果同时满足以下两个条件,生产商和进口商必须向ECHA通报其产品中存在的候选清单所列物质:
• 在他们的相关物品中,该物质的质量百分比高于0.1%。
• 这种物质存在于这些相关物品中,每年的总量超过一吨。
Producers and importers have to notify to ECHA the substances listed on the Candidate list which are present in their articles, if both the following conditions are met:
• The substance is present in their relevant articles above a concentration of 0.1% weight by weight.
• The substance is present in these relevant articles in quantities totalling over one tonne per year.
截止日期
截止日期:公司必须在将物质列入候选名单后六个月内通知。
Companies have to notify no later than six months after the inclusion of the substance in the Candidate List.
豁免
有两种情况不需要通报。
• 物品的生产商或进口商可以在正常或合理可预见的物品使用条件下,包括物品的处置条件下,排除人类和环境接触该物质。在这种情况下,生产商和进口商将向物品的接受者发出适当的指示。
• 该物质已经由欧盟的制造商或进口商注册用于该用途。
Exemptions
There are two cases when a notification will not need to be required.
• The producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article, including its disposal. In these cases, the producers and importers will give appropriate instructions to the recipient of the article.
• The substance has already been registered by a manufacturer or importer in the EU for that use.
准备信息
通报需要提交的信息包括:
• 生产商信息和联系方式
• 物质信息及其注册号(如果有)
• 通知物品中物质的吨位范围
• 物品中物质的用途和物品用途的简要说明
• 物质的分类信息
如果之前通知的信息发生了变化,建议您更新通知。这种变化的例子可以是:吨位范围的变化、不同物品的生产/进口等。
欧盟市场上可供消费者使用的物品中候选列表物质的非机密数据发布在ECHA网站上。
• The information you need to submit consists of the identity and contact details of your company
• the identity of the substance and its registration number, if available the tonnage range of the substance in the notified article(s)
• a brief description of the use(s) of the substance in the article(s) and of the uses of the article(s)
You are advised to update your notification if the information previously notified has undergone changes. Examples of such changes could be: change in tonnage range, production/import of different articles, etc.
Non-confidential data on candidate list substances in articles which are available for consumer use on the EU market are published on the ECHA website.
通报方式
物品中的物质通报通过REACH-IT提交。
在提交之前,有两种可能来准备您的通知:
• 在REACH-IT中在线准备您的通知
建议所有通知提交者使用此方法,特别是不熟悉IUCLID的用户。
• 准备并上传IUCLID档案到REACH-IT
这种方法推荐给已经使用IUCLID的通知提交者,以及那些也想报告不同的物质识别、成分或分类和标签信息的人。除了一直被视为机密的信息(见REACH第118条)之外,如果您希望声明部分通报信息为机密信息,请使用此方法。要准备你的IUCLID档案,你可以在《手册-如何制备物质》中找到详细的描述。
您必须拥有一个活跃的REACH-IT帐户才能提交您的通知。
1. 登录到REACH-IT,选择“提交档案”(登录页面或菜单)
2. 从档案类型列表中选择“物品中的物质”
3. 选择上传IUCLID档案,或者在REACH-IT中在线准备通知
4. 按照向导的说明提交通知
一旦您的通报在REACH-IT中提交,您可以使用REACH-IT中的提交或物质页面来跟踪其提交状态。您需要从REACH-IT中的参考编号页获得通报的更新信息。
Submitting your notification
The substance in articles notifications are submitted via REACH-IT.
Before submission, there are two possibilities to prepare your notification:
• Preparing your notification online in REACH-IT
This method is recommended for all notification submitters, especially those who are not familiar with IUCLID.
• Preparing and uploading a IUCLID dossier to REACH-IT
This method is recommended for notification submitters who are already users of IUCLID, as well as for those who also want to report a different substance identification, composition, or classification and labelling information. Please use this method, if you wish to claim some of the notified information as confidential, in addition to information which is always treated as confidential (see Article 118 of REACH). To prepare your IUCLID dossier, you can find a detailed description in the Manual - How to prepare a substance in articles notification.
You must have an active REACH-IT account to be able to submit your notification.
1. Log in to REACH-IT and select “Submit a dossier” (landing page or menu)
2. Select from the list of dossier types “Substance in articles”
3. Select either to upload a IUCLID dossier, or to prepare your notification online in REACH-IT
4. Submit your notification by following the wizard instructions
Once your notification has been submitted in REACH-IT, you can follow its submission status using the submissions or substances pages in REACH-IT. The update of your notification needs to be initiated from the reference number page in REACH-IT.
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