歐盟法律法規過多
Ⅰ 歐盟標準的MSDS是什麼法律法規要求
歐盟SDS標准按照的是REACH法規CLP分類!
Ⅱ 歐盟法規對記錄書寫的要求
這個對裡面的記錄書要記載詳細,也具有具體的相應的規定。
Ⅲ 歐洲經濟委員會(E)和 歐盟(e)頒布的所有關於輪胎認證的法律法規有哪些包括基礎法規和新增法規.
UNECE的相關法規,有:
ECE R30 - 乘用車輪胎,
ECE R54 - 商用車輪胎,
ECE R75 - 摩托車版輪胎,
ECE R64 - 備胎及缺氣權行駛輪胎,
ECE R106 - 農用車輪胎,
ECE R108 - 乘用車翻新輪胎,
ECE R109 - 商用車翻新輪胎,
ECE R117 - 輪胎滾動雜訊和濕地附著性,
EU歐盟的相關法規指令有:
92/23/EEC - 車輛的輪胎及安裝, (修訂2001/43/EC和2005/11/EC,被 Reg. (EU) 458/2011替代)
Commission Regulation (EU) No 458/2011 - 輪胎的安裝要求
Ⅳ 要兩篇與歐盟REACH法規相關的英文文獻
Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) is a European Union Regulation of 18 December 2006.[1] REACH addresses the proction and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history[2] and the most important in 20 years.[3] It is the strictest law to date regulating chemical substances and will impact instries throughout the world.[4] REACH entered into force in June 2007, with a phased implementation over the next decade.OverviewWhen REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a new European Chemicals Agency in Helsinki, Finland. Because REACH applies to some substances that are contained in objects ('articles' in REACH terminology), any company importing goods into Europe could be affected.[4]About 143,000 chemical substances marketed in the European Union were pre-registered by the 1 December 2008 deadline. Although pre-registering was not mandatory, it allows potential registrants much more time before they have to fully register. Supply of substances to the European market which have not been pre-registered or registered is illegal (known in REACH as "no data, no market").REACH also addresses the continued use of chemical 'substances of very high concern' (SVHC) because of their potential negative impacts on human health or the environment. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the mass of the object. Some uses of SVHCs may be subject to prior authorisation from the European Chemicals Agency, and applicants for authorisation will have to include plans to replace the use of the SVHC with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as 'substitution'. As of March 2009, there are fifteen SVHCs.[5]REACH applies to all chemicals imported or proced in the EU, in contrast to the US Toxic Substances Control Act which only applies to chemicals newly coming into use. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.The European Commission supports businesses affected by REACH by handing out - free of charge - a software application (IUCLID), which simplifies capturing, managing and submitting of data on chemical properties and effects.HistoryREACH is the proct of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005. The European Parliament approved REACH on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around 5 billion euro over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs.[6] However, there have been different studies on the estimated cost which vary considerably in the outcome.A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive. It came into force on 20 January 2009, and will be fully implemented by 2015.[edit] Reason behind REACH The legislation was proposed under al reasoning: protection of human health and protection of the environment.Using potentially toxic substances (such as phthalates or brominated flame retardants) is deemed undesirable and REACH will force the use of certain of these substances to be phased out. Using potentially toxic substances in procts other than those ingested by humans (such as electronic devices) may seem to be safe, but there are several ways in which chemicals can enter the human body and the environment. Substances can leave articles ring consumer use, for example into the air where they can be inhaled or ingested. Even where they might not do direct harm to humans, they can contaminate the air or water, and can enter the food chain through plants, fish or other animals. According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981.[4] There were 100,106 chemicals in use in the EU in 1981, when the last survey was performed. Of these only 3,000 have been tested and over 800 are known to be carcinogenic, mutagenic or toxic to reproction. These are listed in the Annex 1 of the Dangerous Substances Directive (now Annex 3 of the CLP Regulation)Continued use of many toxic chemicals is sometimes justified because 'at very low levels they are not a concern to health'.[7] However, many of these substances may bioaccumulate in the human body, thus reaching dangerous concentrations. They may also chemically react with one another,[8] procing new substances with new risks.[edit] Controversy Apart from the potential costs to instry and the complexity of the new law, REACH has also attracted concern because of the potential for a very significant increase in animal testing under the proposal.[9] Animal tests on vertebrates are allowed only once per one substance, and where suitable alternatives can't be used. If a company pays for these tests, it must sell the rights to the results for a "reasonable" price (although this is not defined). There are additional concerns that access to the necessary information may prove very costly for potential registrants needing to purchase this.A opinion in Nature in 2009 by Thomas Hartung & Constanza Rovida estimated that 54 million vertebrate animals would be used under REACH and that the costs would amount to 9.5 billion Euros[10]. Hartnung is the former head of European Centre for the Validation of Alternative Methods (ECVAM). ECHA responded by criticising the assumptions made in Hartnung and Rovida's calculations, causing them to overestimate the number of animals used by a factor of 6.[11]On 8 June 2006 the REACH proposal came under criticism from a group of nations including the United States, India and Brazil claiming that the bill would hamper global trade.[12][edit] Fraud Non-EU consultancies offer 「 Representative」 services, though according to REACH it is not possible to register a substance if your company is not based in the EU.The SIEFs will bring new challenges. Some 『pre-registrants』 may simply be consultants hoping for work (「gold diggers」) while others may be aiming to charge exorbitant rates for the data they have to offer (「jackals」).[13]
Ⅳ 歐盟的GMP到底是指南呢,還是法規
歐盟GMP屬於EudraLex - Volume 4,這個Eudralex是歐盟葯品法規集錦,所以歐盟的GMP應該屬於法規。
中國內GMP也說明了是屬於中國葯品管理容法的,違反GMP就相當於違反中國葯品管理法。
美國FDA cGMP也在文中定義了它的法律地位。
Ⅵ 歐盟中指令與法規到底有那些不同 如ROHS指令和EN ISO等等
歐盟法規就是文件,就跟法律條條款款一樣的。指令就是針對這個法規的編碼或者編號。
Ⅶ CE認證范圍 原文出處 歐盟法規高手進
「CE」標志是一種安全認證標志,被視為製造商打開並進入歐洲市場的護照。CE代表歐洲統一(CONFORMITE EUROPEENNE)。凡是貼有「CE」標志的產品就可在歐盟各成員國內銷售,無須符合每個成員國的要求,從而實現了商品在歐盟成員國范圍內的自由流通。
CE是法語COMMUNATE EUROPEIA的縮寫,英文意思為EUROPEAN CONFORMITY,即歐洲共同體,事實上,CE還是歐共體許多國家語種中的"歐共體"這一片語的縮寫,原來用英語片語EUROPEAN COMMUNITY 縮寫為EC,後因歐共體在法文是COMMUNATE EUROPEIA,義大利文為COMUNITA EUROPEA,葡萄牙文為COMUNIDADE EUROPEIA,西班牙文為COMUNIDADE EUROPE等,故改EC為CE。
在歐盟市場「CE」標志屬強制性認證標志,不論是歐盟內部企業生產的產品,還是其他國家生產的產品,要想在歐盟市場上自由流通,就必須加貼「CE」標志,以表明產品符合歐盟《技術協調與標准化新方法》指令的基本要求。這是歐盟法律對產品提出的一種強制性要求。
CE認證是構成歐洲指令核心的"主要要求",即只限於產品不危及人類、動物和貨品的安全方面的基本安全要求,而不是一般質量要求,協調指令只規定主要要求,一般指令要求是標準的任務。因此准確的含義是:CE標志是安全合格標志而非質量合格標志。
樓主復制的是幾年前的老黃歷了,歐盟官網上只有英文,沒有中文。
Ⅷ 歐盟汽車技術法規 2005/55/EC 誰有中文版的
終於找復到制了!
詳細下載網址是:
http://www.zhb.gov.cn/info/bgw/bbgth/200804/W020080411291780583756.pdf
Ⅸ 以下2個歐盟法規是否已經廢除,請幫忙了,我查到的是已經廢除了,但是不知道是否還可以使用其內部條例,謝
已經廢除了.
Ⅹ 想問下關於歐盟法律的命名規律
EC=European Council 歐洲理事會的簡寫抄
EU=European Union 歐盟的簡寫
EEC=European Economic Community歐洲經濟共同體的簡寫
放在前面的是按照文件號和年份,主要是以前沒有形成歐盟的時候的寫法
形成EU後,都是按照年份和文件號編制的。