2020-2021年度化学品法规展望

2020-2021年度化学品法规展望 Prospects of Chemical Regulations for2020-2021 2020-2021年度，许多国家的法规在持续更新中，也有更多的新的法规预计将出台，包括欧盟REACH评估，英国脱欧，纳米材料法规实施都将影响众多企业。 In 2020-2021, many countries are continuously updating their laws and regulations. More newlaws and regulations are expected to be issued in the future which may affect many enterprises inevery aspect, including the implementation of EU REACH evaluation,Brexit, nanomaterialsregulations, etc. 除这些法规外，还有一些特别的法规，也将在接下来的1-2年实施，需要引起企业极大关注。以下将对这些法规进行逐一分析。 Inaddition to these regulations, enterprises also need give prominence to some special regulationswhich will be implemented in the next 1-2 years. We will analyze these regulations one by one inthe following sections. 1.REACH法规最新进展以及纳米材料法规 Updating development of REACH and nanomaterials regulation 作为REACH法规的重要组成部分E（Evaluation）,在过去的一年中深刻影响到了多家注册企业。根据ECHA官方提供2019年的评估数据，80%以上要求补充额外的数据。根据CIRS 2019年度收到的欧盟注册Draft Decision(DD)中，注册吨位为100-1000吨/年，相当高的比例需要补充OECD 408和OECD 414第一个物种；注册吨位为1000+吨/年，相当高的比例需要补充OECD414第二个物种以及OECD 443。尤其是OECD 443,单个实验室报价通常为100万欧元附近，即使分摊后，注册企业也需要分摊到20-30万欧元以上，造成企业无力应对卷宗或者物质评估，只能选择放弃注册号的方式。 Evaluation, as an important part of REACH Regulation, has deeply influenced many registeredenterprises in the lastyear. In accordance with theevaluationdata provided by ECHA in 2019,more than 80% of the substances require supplemental data. According to the draft decision (DD)of EU registration received by CIRS in 2019, a considerable proportion of substances in volumes of100-1000 t/y need to supplement the data of OECD 408 and OECD 414with first species; aconsiderable proportion of substances in volumes of 1000+ t/y need to supplement the data of thesecond species of OECD 414 and OECD 443. It is noteworthy that the quotation on OECD 443 is usuallyaround 1 million euros. Even after cost sharing, each registrant (enterprise) need to bearmore than 200,000-300,000 euros. As a result, enterprisescan’t bear the cost ofdossier orsubstance evaluation, and finally have to revokethe registration number. 在上述这些物质的注册卷宗里，大部分不合规的数据是因为采用了非测试方法比如read-across, QSAR或者一些公开文献数据，但缺乏相关细节。对于生殖/发育毒性以及重复剂量毒性这几个节点而言，ECHA公布的数据，具有可靠的GLP测试报告的比例仅仅占30%左右，意味着大部分高吨位的注册卷宗存在数据缺口，在后续评估过程中要求补充数据的可能性极大，而这几个节点测试的费用也是相当高，对已经完成注册的企业而言，是个巨大的负担。 In the registration dossiers of abovementioned substances, most of the data are not compliantdue to the adoption of non-test methods such as read-across, QSAR. Forpublic literatures,relevant detailsare not provided. According tothe data published byECHA, in terms of thereproductive anddevelopmental toxicity and repeated dose toxicity, the proportion of data withreliable GLP test reports only accounts for about 30%, which means that most of the high tonnageregistered dossiers are not completedenough and may be required for supplementaldata in thesubsequent evaluation process. However, the expensive test cost ofthoseendpoints is a hugeburden for the enterprises that have completed the registration. 2018年12月，欧盟委员会通过了(EU) 2018/1881号法规，称之为纳米材料法规，该法规自2020年1月1日起正式实施。法规主要是针对REACH法规的数据要求进行了更新，要求具有纳米形态的产品补充更多与纳米材料相关的信息。 The European Commission released Regulation (EU) No. 2018 / 1881 in December，2018, which isalso known as the nanomaterial regulation. It comes into force since January 1, 2020. Theregulation mainly updates the data requirements of REACH regulation, requiring products withnanoforms to supplement more information related to nanomaterials. 自2020年1月1日起，如果客户向欧盟出口纳米材料物质，必须事先更新注册卷宗，添加和纳米材料有关的信息后，方能出口。对于通过联合提交方式完成REACH注册的企业而 言，其他新增加的数据要求主要是领头注册人LR的责任，其主要责任是及时更新和纳米材料有关的物质识别信息。企业也可以事先在该网站查询自己的产品是否可能具有纳米形式： https://euon.echa.europa.eu/search-for-nanomaterials From January 1, 2020, before exporting nanomaterialsto the EU, the companies must update theregistration dossier in advance and add information related to nanomaterials. For enterprises thatcomplete REACH registration via joint submission, their main responsibility is to timely update thesubstance identification information related to nanomaterials. Enterprises can also check whethertheir products may have nanoforms on the website in advance: https://euon.echa.europa.eu/search-for-nanomaterials 除了已经在之前注册卷宗中包括的通用物质识别信息外，对于纳米材料的物质识别信息具体规定有如下增加： 1、物质的纳米形态或类似的纳米形态组的名称或其他标识符；2、基于数量的粒度分布，指示尺寸在1 nm-100 nm范围内组成颗粒的分布；3、表面功能化或处理的描述以及每种处理剂的标识，包括IUPAC名称和CAS或EC号；4、形状，长宽比和其他形态特征：结晶度，组合结构信息，例如壳状结构或中空结构（如果适用）；5、表面积（体积比表面积，质量比表面积，或两者兼有）；6、本小节中信息的分析方法或适当的参考文献说明。 In addition to the general substance identification information already included in the previousregistration dossier, the specific provisions for substance identification information ofnanomaterials are added as follows: 1. Namesor other identifiers of the nanoforms or sets of similar nanoforms of the substance;2. Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm–100 nm; 3. Description of surface functionalisation or treatment and identification of each agent includingIUPAC name and CAS or EC number; 4. Shape, aspect ratio and o