REACH冲击我国化工等行业

即将于2007年6月1日正式实施的欧盟化学品注册、评估、授权和限制法规（REACH），将对我国化工、纺织、机电等行业造成冲击。欧盟REACH制度的实施，一方面有利于人类健康和环境保护以及化学品生产与使用的规范，但同时也会给我国相关行业产品出口带来严重负面影响。     

日本版REACH将在2010年实施

日本政府将在2010年以法律形式要求从事化学品业务的相关企业就化学品产量、进口量以及用途等每年向政府报告一次,目的是对可能造成环境和健康危害的化学品进行严格管理。这项制度被称为“日本版REACH”。日本《经济新闻》也报道称,新制度将在对现有的“化学物质审查规制法”修改的基础上引入。目前,经济产业省、环境省、厚生劳动省已草拟了相关方案,并将在来年提交国会审议。日本版REACH将对两万多种化学品规定报告义务。政府通过对企业报告资料的汇总分析来把握化学物质总量,并监督其不会对环境和国民健康造成损害。同时,政府还将公布危险性较高的“优先评价物质”,并把有害化学品由354种增加到462种,对危险化学品将实行从供货商到生产的全过程管理。估计这项制度的实施将涉及日本包括化学品生产、汽车、电器等数千家企业。(中国分析计量网)日本版REACH将在2010年实施     

欧盟化学品分类及标签法案即将出台

随着欧盟即将对欧盟的化学物质及制剂贸易商实施《化学品注册、评估及许可法规》（简称REACH法规）,有关化学品分类及标签方法的法规将会出台。新法规将与联合国的全球化学品分类及标签协调制度一致。欧委会已通过一项关于化学物质和混合剂分类、标签及包装的法规议案,并已纳入了联合国认可的分类准则及标签规则。     

针对欧盟禁用APEO想到的几个问题

针对欧盟禁用APEO类表面活性荆问题,对APEO及各国关于APEO的政策法规进行了介绍,简述了APEO的毒性、生产和使用现状,APEO替代品的研究及检测状况;结合欧盟化学品新法规REACH制度,展望了我国APEO方面的工作.     

微波消解-电感耦合等离子体质谱法测定橡胶制品中铬、钴、砷、溴、钼、镉、锡和铅北大核心CSCD

欧盟议会和理事会关于《化学品注册、评估、许可和限制》的（EC）1907/2006法规即欧盟REACH法规已于2007年6月1日实施。REACH法规提出了高度关注物质（SVHCs）清单,规定SVHCs在物品中的总含量超过1吨/年或是SVHCs在物品中的总含量以质量分数计超过0.1%,任何欧洲制造商或进口商应向欧盟化学品管理署进行通报。SVHCs具有致癌、致畸及生殖毒性、     

微波消解-电感耦合等离子体质谱法测定橡胶制品中铬、钴、砷、溴、钼、镉、锡和铅

正欧盟议会和理事会关于《化学品注册、评估、许可和限制》的(EC)1907/2006法规即欧盟REACH法规已于2007年6月1日实施。REACH法规提出了高度关注物质(SVHCs)清单,规定SVHCs在物品中的总含量超过1吨/年或是SVHCs在物品中的总含量以质量分数计超过0.1%,任何欧洲制造商或进口商应向欧盟化学品管理署进行通报。SVHCs具有致癌、致畸及生殖毒性、持久累积毒性     

欧盟或将限制纺织品中的壬基酚

欧洲化学品管理局最新消息称,前不久,瑞典递交了一份关于壬基酚(直链和支链)和壬基酚聚氧乙烯醚(直链和支链)的新限制提案(REACH法规附件XVII提案)。就在2012年7月,德国提议将壬基酚纳入REACH法规高度关注物质清单,同年12月,在第8批高度关注物质清单中,出现了壬基酚,并定义为可能对环境有严重危害。     

上海化工研究院检测中心成为首家化学品安全评价GLP

不久前,国家认监委正式批准上海化工研究院检测中心通过良好实验室规范(英文简称GLP)评价,该实验室成为认监委批准的首家化学品安全评价GLP实验室,标志着国家认监委GLP监控体系取得重大进展。中国合格评定国家认可中心为该实验室颁发了全国首张化学品安全评价GLP实验室技术评价合格证书。GLP是英文Good Laboratory Practice的缩写,最早产生于美国药品行业,后扩大到化学品,在国际上已开展了近30年。GLP主要针对医药、农药、食品添加剂、化妆品、兽药等进行的安全性评价实验而制定的规范,主要目的是严格控制化学品安全性评价试验的各个环节,即严格控制可能影响实验结果准确性的各种主客观因素,降低试验误差,确保实验结果的真实性。根据2008年6月1日开始实施的欧盟REACH法规的相关规定,进入欧盟市场的所有化学品必须在规定的时间内凭GLP实验室出具的安全性评价数据到相关部门登记注册,方可在欧洲市场销售。我国化学品对欧贸易量逐年递增,REACH法规的实施对我国的化学品贸易造成了严重影响。目前国内还没有获得有关国际组织认可的GLP实验室,相关的产品安全性评价工作只能依靠国外的GLP实验室,检测费用高昂,企业为此...     

欧盟化学品分类标签议案通过 出口面临考验

继欧盟化学品新规REACH之后,我国产品出口又将面临新一波“绿色考验”。不久前,欧盟已通过一项关于化学物质和混合剂分类、标签及包装的法规议案,并已纳入了联合国认可的分类准则及标签规则。新法规对化学物质的分类及标签的准则或责任做出规定,填补了REACH法规具体化学物质分类及标签内容的缺失,并与其相辅相成,共同构筑欧盟抵御危险化学品的绿色壁垒。为此,输欧化学物质或混合剂制造商和贸易商须引起特别注意。新法令重点对化学品分类的方法、要求及时间限定等进行了解读。据悉,议案法规旨在为企业设立一个自行分类制度,要求输入物质或混合剂的贸易商必须按照以下方法进行分类:(1)识别及阐述其危害;(2)评估有关危害的资料;(3)将有关资料与法规议案所载的危害准则进行比较。标签方面,须提供供应商的名称、地址和电话,可以识别物质或混合剂的资料、危害标志、危害声明、提防声明,以及有关危害的补充资料。议案生效后,物质重新分类的限期为2010年11月30日,混合剂为2015年5月31日。现时有关分类、标签及包装的指令将于2015年6月1日撤销。欧委会希望法规议案可于今年底获欧洲议会和理事会最后通过,并会就议案的应用拟定指南。可见,欧盟次调整化...     

REACH限制名单草案再添7种物质

日前,欧洲化学品管理署(ECHA)继2008年将15种物质被列入首批REACH高关注名单(SVHC)后,公布了首批需ECHA授权才能使用的物质名单草案。根据该草案,7种物质首先被列入了清单(附件XIV)。被列入清单的7种物质分别为:5-叔丁基-2,4,6-三硝基间二甲苯(二甲苯麝香)、短链氯化石蜡(SCCPs,C10～C13)、六溴环十二烷(HBCDD)和所有有关联的主要非对应异构体、邻苯二甲酸双(2-乙基己)酯(DEHP)、邻苯二甲酸丁苄酯(BBP)、邻苯二甲酸二丁酯(DBP)以及4,4‘-二氨基二苯甲烷(MDA)。根据REACH法规,企业如果要使用进入授权名单的物质,就必须申请许可。申请者必须论证物质使用风险可以充分控制,或是社会经济利益超过使用风险,且没有替代物和相应的替代技术。ECHA表示,他们是根据产品的固有特性、用途和批准用量来评估是否将这些化学品列入REACH限制清单的。各利益相关方必须于2009年4月14日对磋商作出回应,ECHA将于2009年6月1日之前确定优先列表。ECHA还建议,授权申请应当在以上物质进入REACH附件XIV后24～30个月期间提交。这些物质进入名单之后,42～48个月后...     

Liquid chromatography-tandem mass spectrometric analysis and regulatory issues of polar pesticides in natural and treated waters

Pesticides are among the most detected contaminants in the aquatic environment. This is mainly due to their use in agriculture and their physico-chemical properties that enable transportation and a persistent or pseudo-persistent existence in the water media. Several directives and guidelines set maximum levels of pesticides in water in order to protect the human and environmental health. A brief discussion of the existing directives and guidelines concerning pesticides in water is presented, e.g., the new regulatory framework for the Registration, Evaluation and Authorisation of Chemicals (REACH), and the Directive 91/414/EEC concerning the placing of plant protection products on the market. Up-to-date analytical tools to support the REACH program are of prime importance to ensure its complete implementation. Since liquid chromatography (LC) coupled to mass spectrometry (MS) is considered the most appropriate technique for determination of most modern pesticides in environmental waters, the most recent developments and applications in this field are discussed in detail in this review.     

环保型乳聚丁苯橡胶的研发进展

介绍了国内外关于乳聚丁苯橡胶的欧盟REACH法规、轮胎燃料标签法和美国国家燃油效率政策等环保法规;概述了乳聚丁苯橡胶的结构特征,进而说明了橡胶填充油对乳聚丁苯橡胶的作用及环保机理;详细介绍了引发剂、终止剂、硫化促进剂和防老剂等助剂的作用及其环保化的研发进展,并阐述了橡胶填充油的种类及其研发进展;综述了环保型乳聚丁苯橡胶产品的基本牌号及研发现状,并从助剂、填充油和橡胶产品等方面对环保型乳聚丁苯橡胶的发展提出了建议。     

CATALOGIC 301C model – validation and improvement

In Europe, REACH legislation encourages the use of alternative in silico methods such as (Q)SAR models. According to the recent progress of Chemical Substances Control Law (CSCL) in Japan, (Q)SAR predictions are also utilized as supporting evidence for the assessment of bioaccumulation potential of chemicals along with read across. Currently, the effective use of read across and QSARs is examined for other hazards, including biodegradability. This paper describes the results of external validation and improvement of CATALOGIC 301C model based on more than 1000 tested new chemical substances of the publication schedule under CSCL. CATALOGIC 301C model meets all REACH requirements to be used for biodegradability assessment. The model formalism built on scientific understanding for the microbial degradation of chemicals has a well-defined and transparent applicability domain. The model predictions are adequate for the evaluation of the ready degradability of chemicals.     

电感耦合等离子体发射光谱法测定REACH法规涉及产品中铅、铬、钴、砷、锡、铝、锆、钼和硼

采用电感耦合等离子体原子发射光谱法对REACH法规涉及产品中铅、铬、钴、砷、锡、铝、锆、钼和硼的含量进行测定。0.2g样品经微波消解处理,聚合物材质试样以8mL硝酸和2mL过氧化氢为消解试剂;无机非金属材质试样以6mL硝酸、2mL过氧化氢和2mL氢氟酸为消解试剂。各元素的方法检出限均低于15mg·kg-1。方法的加标回收率在82.4%～108%之间,测定值的相对标准偏差(n=7)在3%～6%之间。     

Predicting toxicity through computers: a changing world

The computational approaches used to predict toxicity are evolving rapidly, a process hastened on by the emergence of new ways of describing chemical information. Although this trend offers many opportunities, new regulations, such as the European Community's 'Registration, Evaluation, Authorisation and Restriction of Chemicals' (REACH), demand that models be ever more robust.     

Comparative PBT screening using (Q)SAR tools within REACH legislation

Small to medium sized enterprises (SMEs) in the EU are facing challenges due to the introduction of new legislation designed to protect consumers and the environment, REACH (Registration, Evaluation, Authorisation and Restriction of CHemicals). There can be high costs associated with implementing REACH because data on mammalian toxicity, environmental toxicity and environmental fate properties is required and if this data is obtained experimentally the cost is significant. These costs can be reduced if reliable quantitative structure–activity relationships ((Q)SAR) models are instead used to obtain the required information. In this paper we investigate how easily freely available (Q)SAR models can be applied for persistent, bioaccumulative and toxic (PBT) screening of 17 chemicals of interest to SMEs. In this study the PBT predictions obtained from the more user-friendly PBT Profiler and the Danish(Q)SAR database for the chemicals were compared with the results taken directly from the EPI Suite software. It was found that these widely used (Q)SAR databases might have some errors and examples are provided. It was concluded that extra care must be taken when considering the use of these databases for PBT screening. In addition, to increase the likelihood of a correct prediction, data estimates from various (Q)SAR models relevant to the PBT endpoints must be compared.     

Updated “Onion Skin” Model for Temperature Rising Elution Fractionation

Recent developments on the temperature rising elution fractionation (TREF) technique, understanding the impact strength of polyethylene blends based on their chemical structure, as well as ongoing discussions on REACH legislation regarding the oligomer fraction of polymers, are all reasons for better comprehension of the separation mechanism in TREF. To achieve this goal, two carefully chosen blends of linear metallocene polyethylene were analyzed by TREF over a large domain of crystallization rates. The results allowed updating the “onion skin” model for the crystallization kinetics during the cooling step of TREF. The advantages and limitations of the TREF technique for different applications are discussed.     

气相色谱/质谱测定皮革及其制品中乙二醇醚类有机溶剂的残留量

建立了同时测定皮革及其制品中12种乙二醇醚类有机溶剂残留量的气相色谱/质谱-选择离子监测方法。以乙酸乙酯为萃取溶剂,在45℃下超声萃取皮革及其制品中的乙二醇醚类有机溶剂,萃取液经固相萃取柱净化后进行气相色谱/质谱-选择离子监测法测定,外标法定量。在信噪比（S/N）=3的条件下,乙二醇单乙醚（EGEE）的检出限为0.10 mg/kg,其余11种乙二醇醚类有机溶剂的检出限均小于0.05 mg/kg。在3个加标水平下,该方法的平均加标回收率为81.2%~95.5%,相对标准偏差（RSD）为1.4%~6.6%（n=9）。该方法简便快捷,灵敏度高,检出限远远低于欧盟法规《化学品的注册、评估、授权和限制》（REACH）的限量要求,适用于皮革及其制品中乙二醇醚类有机溶剂残留量的测定,为制定相关检测标准提供了参考。     

CAESAR models for developmental toxicity

Background

The new REACH legislation requires assessment of a large number of chemicals in the European market for several endpoints. Developmental toxicity is one of the most difficult endpoints to assess, on account of the complexity, length and costs of experiments. Following the encouragement of QSAR (in silico) methods provided in the REACH itself, the CAESAR project has developed several models.

Results

Two QSAR models for developmental toxicity have been developed, using different statistical/mathematical methods. Both models performed well. The first makes a classification based on a random forest algorithm, while the second is based on an adaptive fuzzy partition algorithm. The first model has been implemented and inserted into the CAESAR on-line application, which is java-based software that allows everyone to freely use the models.

Conclusions

The CAESAR QSAR models have been developed with the aim to minimize false negatives in order to make them more usable for REACH. The CAESAR on-line application ensures that both industry and regulators can easily access and use the developmental toxicity model (as well as the models for the other four endpoints).

     

The prospects for using (Q)SARs in a changing political environment--high expectations and a key role for the European Commission's joint research centre

Recent policy developments in the European union (EU) and within the Organisation for Economic Cooperation and Development (OECD) have placed increased emphasis on the use of structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs), collectively referred to as (Q)SARs, within various regulatory programmes for the assessment of chemicals and products. The most significant example within the EU is the European commission's proposal (of 29 October 2003) to introduce a new system for managing chemicals (called REACH), which calls for an increased use of (Q)SARs and other non-animal methods, especially for the assessment of low production volume chemicals. Another development within the EU is the Seventh Amendment to the Cosmetics Directive, which foresees the phasing out of animal testing on cosmetics, combined with the imposition of marketing bans on cosmetics that have been tested on animals after certain deadlines. At the same time, the Existing Chemicals programme within the OECD is investigating ways of increasing the use of chemical category approaches, which depend heavily on the use of (Q)SARs, activity-activity relationships and read-across. Such developments are placing an enormous challenge on industry, regulatory bodies, and on the European commission's Joint Research Centre (JRC), which is responsible for providing independent scientific advice to policy makers in the European Commission and the Member States. This paper reviews the different scientific and regulatory purposes for which reliable (Q)SARs could be used, and describes the current work of the JRC in providing scientific support for the development, validation and implementation of (Q)SARs.