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Digital Tools and the Right to Know 数字工具和知情权
Pub Date : 1900-01-01 DOI: 10.21552/delphi/2019/3/8
A. Rolke, H. Rath, J. Backmann
the of a revolutionary for the as the avail-ability of sustainability-related information on sales products. Consumers will be able to obtain all kinds of information on aspects they care about, even be-yond sustainability. This report examines the driving forces behind this development and the technological basis, and how these developments are taking place in different industrial sectors. We also show that this process is embedded in a much broader development, which will result in of and with and
可持续性相关的销售产品信息的可用性是革命性的。消费者将能够获得他们所关心的各个方面的各种信息,甚至超越了可持续性。本报告审查了这一发展背后的驱动力和技术基础,以及这些发展如何在不同的工业部门发生。我们还表明,这一进程嵌入在一个更广泛的发展中,这将导致和
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引用次数: 2
The SCIP Database under Directive (EU) 2018/851 指令(EU) 2018/851下的SCIP数据库
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2019/4/4
Tim Becker
With the forthcoming database on substances of concern in articles as such or in complex objects (products) (hereafter SCIP database)1 the EU’s co-legislators have introduced a highly ambitious project for all parties involved at the EU, national and global level. The requirement is set out in Article 9(1)(i) and (2) of Directive 2008/98/EC on waste, as revised by Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 (hereafter Waste Framework Directive, WFD or revised WFD). At its recent SCIP workshop 20192the EuropeanChemicals Agency (ECHA) presented and discussedwith numerous participants from industry, authorities and NGOs the current state of play of the database, which ECHA should establish by 5 January 2020. In particular, the scope of ECHA’s detailed information requirements for SCIP notifications was criticized from the industry side for exceeding legal boundaries, while others argued in support of the ECHA plans. This question is of high practical relevance. Essentially, the issue at stake is whether industry can rely on existing systems and data already communicated under Article 33(1) of Regulation (EC) No 1907/2006 (REACH), or whether additional data has to be collected from often long and complex global supply chains for the purpose of SCIP notifications, which are due as from 5 January 2021. Against this background, the present article aims to take a closer look at the legal background for the new SCIP provisions and discuss ECHA’s detailed information requirements from a legal point of view, based on the underlying rationale of the European Commission (EC). We will see that the role of recitals in EU law for the interpretation of enacting terms is one of the key legal issues raised in this context.
随着即将推出的关于物品或复杂物体(产品)中所关注物质的数据库(以下简称SCIP数据库)1,欧盟的共同立法者已经为欧盟、国家和全球层面的所有相关方引入了一个雄心勃勃的项目。该要求载于关于废物的指令2008/98/EC第9(1)(i)和(2)条,并经欧洲议会和理事会2018年5月30日指令(EU) 2018/851(以下简称废物框架指令,WFD或修订的WFD)修订。在最近的SCIP研讨会20192上,欧洲化学品管理局(ECHA)与来自行业、当局和非政府组织的众多参与者介绍并讨论了ECHA应在2020年1月5日前建立的数据库的现状。特别是,ECHA对SCIP通知的详细信息要求的范围被业界批评为超出了法律界限,而其他人则支持ECHA的计划。这个问题具有高度的实际意义。从本质上讲,关键问题是行业是否可以依赖根据法规(EC) No 1907/2006 (REACH)第33(1)条已经传达的现有系统和数据,或者是否必须从通常漫长而复杂的全球供应链中收集额外的数据以进行SCIP通知,这些通知将于2021年1月5日到期。在此背景下,本文旨在深入研究新SCIP条款的法律背景,并基于欧盟委员会(EC)的基本原理,从法律角度讨论ECHA的详细信息要求。我们将看到,在欧盟法律中,对于颁布条款的解释,复述的作用是在此背景下提出的关键法律问题之一。
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引用次数: 0
The Authorisation Scheme for Biocidal Products in Switzerland 瑞士生物杀灭剂产品的授权方案
Pub Date : 1900-01-01 DOI: 10.21552/ICRL/2019/2/5
D. Kappes, Brunhilde Kolp Buchs
The Swiss Ordinance on Biocidal Products is technically equivalent to the Biocidal Products Regulation (BPR) of the EU. As a result, the requirements concerning the harmonised authorisation procedures and the lists of active substances in the EU and Switzerland are identical. Therefore, in 2015 both parties renewed the existing chapter on ‘Biocidal Products’ in the EUCHMutual Recognition Agreement, which until 2013 had been based on the Biocidal Products Directive. Due to mutual recognition of authorisations of biocidal products, technical barriers to trade are avoided while maintaining the high level of protection. Furthermore, Switzerland participates in several BPR expert groups on EU level. This international exchange of knowledge and experience offers the opportunity to continuously improve the assessment techniques and to contribute to its harmonised development. Switzerland has to comply with the acquis. Consequently its room for manoeuvre concerning pragmatic solutions, eg for niche products, is therefore limited. The population benefits from the high level of protection. On the one hand, industry benefits from the same requirements and the possibility of mutual recognition of authorisations. On the other hand, small and medium enterprises operating only on the relatively small Swiss market suffer under the costs for the dossier preparation and the fees. Overall, the positive effects are likely to predominate due to the high level of protection.
瑞士生物杀灭剂条例在技术上等同于欧盟的生物杀灭剂条例(BPR)。因此,欧盟和瑞士关于统一授权程序和活性物质清单的要求是相同的。因此,在2015年,双方更新了欧盟相互承认协议中现有的“生物杀灭剂产品”章节,该章节直到2013年都是基于生物杀灭剂产品指令。由于相互承认杀菌剂产品的授权,避免了技术性贸易壁垒,同时保持了高水平的保护。此外,瑞士还参加了欧盟一级的几个业务流程再造专家组。这种知识和经验的国际交流为不断改进评估技术和促进其协调发展提供了机会。瑞士必须遵守收购协议。因此,它在务实解决方案(如针对利基产品)方面的回旋余地是有限的。民众受益于高水平的保护。一方面,行业受益于相同的要求和相互认可授权的可能性。另一方面,只在相对较小的瑞士市场上经营的中小型企业则承受着档案准备和费用的成本。总的来说,由于高水平的保护,积极的影响可能占主导地位。
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引用次数: 0
Food Contact Material Regulations in Key Markets – An Awakening Giant 关键市场的食品接触材料法规——一个觉醒的巨人
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2019/3/4
Ioan Paraschiv, Raymond L. Sobocinski
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引用次数: 0
New Law and Policy 新法例及政策
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2018/4/10
T. Schulz
The French state secretary, Ms Brune Poirson, has announced1 that the French government intends to ban nanoscale titanium dioxide in food by the end of 2018. The announcement is of particular interest since titanium dioxide is broadly used as an additive in cosmetics, paints and further consumer-related products. Known as E171, nano titanium dioxide is present in many foods, primarily as a whitener or to increase opacity. However, in many cases E171 does not fall under the EU definition of ‘nanomaterial’ since it does not contain more than 50% nanoparticles as regards its size distribution. Recently published studies had updated the safety concerns about nano titanium dioxide.
法国国务秘书布吕纳·波尔森女士宣布,法国政府打算在2018年底前禁止在食品中使用纳米级二氧化钛。由于二氧化钛广泛用作化妆品、油漆和其他消费相关产品的添加剂,因此该公告特别令人感兴趣。被称为E171的纳米二氧化钛存在于许多食物中,主要是作为增白剂或增加不透明度。然而,在许多情况下,E171不属于欧盟对“纳米材料”的定义,因为就其尺寸分布而言,它不包含超过50%的纳米颗粒。最近发表的研究报告更新了对纳米二氧化钛的安全担忧。
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引用次数: 0
Between the Old and the New Scheme: Management of New Chemical Substances in China 新旧方案之间:中国新化学物质的管理
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2020/2/4
N. Wang, N. He, L. Chen
The existing regulatory framework for new chemical substances in China has been put in place for nearly a decade, delivering tangible results in advancing chemical management and promoting the well-regulated development of the chemical sector. In April this year, to address problems identified in its implementation, the Chinese authorities introduced a new scheme, known as MEE Order No. 12, which will take effect starting from 1 January 2021. With an enhanced focus on environmental risks, the new scheme is expected to enable more efficient and targeted regulation and contribute to the country’s environmental protection efforts.
中国现有的新化学物质监管体系已建立近10年,在推进化学品管理、促进化工行业有序发展方面取得了实实在在的成效。今年4月,为了解决在实施过程中发现的问题,中国当局推出了一项新计划,即MEE第12号命令,将于2021年1月1日起生效。随着对环境风险的进一步关注,新计划有望实现更有效和有针对性的监管,并为国家的环境保护工作做出贡献。
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引用次数: 0
A Review of the Regulatory Landscape on Management of Chemicals in Argentina 对阿根廷化学品管理监管情况的审查
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2019/3/5
J. Sales, Agustín Harte
Argentina is the second largest economy in South America, and it ranks third in all Latin America in terms of Gross Domestic Product (GDP). With a population nearing 45 million people and a significant amount of natural resources, it is regarded as an emerging economy. Industrial production accounts for approximately 22%of the country’s GDP,1 and the country’s imports amount to approximately $67 billion,2 with chemical products taking almost 15% of those imports. It is therefore an attractive destination for exports coming from European chemical companies. Overall, the European Economic Area accounts for almost 20% of the total imports in Argentina. As is the case in many Latin American countries, the regulatory system currently established in Argentina, in relation to themanagement of chemicals, is somewhat complex and heterogeneous. Different pieces of legislation are in place that impact themanufacture, import and commercialisation of chemicals in the country, which frequently involve a wide variety of ministries, secretariats, and offices. It is useful to become familiarised with those regulatory bodies. The following list highlights the main regulatory actors involved in the management of chemical products in Argentina. • Secretaría de Gobierno de Ambiente y Desarrollo Sostenible (SGAyDS) –Secretariat of Environment and Sustainable Development • Ministerio de Salud y Desarrollo Social – Ministry of Health and Social Development • Superintendencia de Riesgos del Trabajo (SRT) – Superintendence of Labour Risks • Ministerio de Agricultura, Ganadería y Pesca (MAGPyA) – Ministry of Agriculture, Livestock Rising and Fishery • Instituto Nacional de Alimentos (INAL) National Food Institute’ • Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) National Administration for Drugs, Food andMedical Technology • Dirección deVigilancia de Productos para la Salud (DVS) – Directorate for Health Products Survelliance (under ANMAT) • Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA) – National Service for Agricultural Food Health and Quality • Instituto Argentino de Normalización y Certificación (IRAM) – Argentina Institute for Normalization and Certification
阿根廷是南美洲第二大经济体,国内生产总值(GDP)在整个拉丁美洲排名第三。它拥有近4500万人口和丰富的自然资源,被视为一个新兴经济体。工业生产约占该国GDP的22% 1,该国的进口总额约为670亿美元2,其中化工产品占进口总额的近15%。因此,对欧洲化工企业的出口来说,中国是一个有吸引力的目的地。总体而言,欧洲经济区占阿根廷进口总额的近20%。与许多拉丁美洲国家的情况一样,目前在阿根廷建立的有关化学品管理的管理制度有些复杂和不一致。影响该国化学品生产、进口和商业化的不同立法已经到位,这通常涉及各种部委、秘书处和办公室。熟悉这些监管机构是很有用的。以下清单突出了阿根廷化学产品管理中涉及的主要监管行为者。•Secretaría环境与社会保障政府(SGAyDS) -环境与可持续发展秘书处•社会与社会保障部-卫生和社会发展部•劳动风险监管局(SRT) -劳动风险监管•农业部,Ganadería Pesca (MAGPyA) -农业部;畜禽养殖和渔业•国家食品研究所(INAL)国家食品研究所•Administración国家药品管理局(ANMAT)食品和医疗技术•Dirección卫生产品监督局(DVS) -卫生产品监督局(ANMAT下)•国家农业食品卫生和质量服务局(SENASA) -国家农业食品卫生和质量服务局•阿根廷研究所Normalización y Certificación (IRAM) -阿根廷标准化和认证研究所
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引用次数: 0
Regulatory Opportunities and Challenges in Commercialising Biobased Chemicals 生物基化学品商业化的监管机遇和挑战
Pub Date : 1900-01-01 DOI: 10.21552/ICRL/2019/1/6
L. Bergeson
The 21st Century has witnessed intense renewed interest in commercialising new biobased chemicals, defined generally to include chemicals that are derived fromplants andother renewablematerials. The Toxic Substances Control Act (TSCA) is the U.S. law that regulates industrial chemical substances, including biobased chemicals, used in applications other than food, drugs, cosmetics, and pesticides, or uses that are regulated by other federal authorities. TSCA was significantly amended in 2016, and stakeholders need now more than ever to understand how TSCA applies to biobased chemicals to appreciate the implications of new TSCA on their commercial operations. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.
21世纪,人们对新型生物基化学品的商业化产生了浓厚的兴趣,生物基化学品通常包括从植物和其他可再生材料中提取的化学品。《有毒物质控制法》(TSCA)是美国法律,规定工业化学物质,包括生物基化学物质,用于食品、药品、化妆品和杀虫剂以外的应用,或由其他联邦当局监管的用途。TSCA于2016年进行了重大修订,利益相关者现在比以往任何时候都更需要了解TSCA如何适用于生物基化学品,以了解新TSCA对其商业运营的影响。这样做将更好地确保不间断的业务运营和一致的TSCA合规。
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引用次数: 0
Risk of Regrettable Substitution under EU REACH: Level Playing Field in the EU Regulatory Context 欧盟REACH下令人遗憾的替代风险:欧盟监管背景下的公平竞争环境
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2020/1/6
D. Drohmann, F. Hernández
The substitution process is an important tool defined in the REACH Regulation to remove the risks derived from the use of hazardous chemicals. However, when the alternative substance is suitable in technical and economic terms, but it is just as harmful or potentially worse as the replaced one, the process results in regrettable substitution. The absence of information regarding the hazard properties of the substitute substance, inconsistencies on implementation of the European chemicals Regulations, and the lack of interest of some part of the industry to manage stringent classifications, are the main reasons why this situation is generated. Change in the paradigm ‘No data, no market’ to ‘No data, no problem’, and replacement with the ‘Least regulated alternative’ instead of the ‘Least hazardous alternative’ are the results of the regrettable substitution scenarios. In order to avoid this practice, EU Authorities and the chemical industry should work together to achieve solutions, like clarifying the objective of substitution, improving the regulatory processes, or involving industry and stakeholders into rigorous evaluations of potential alternatives to substances of concern. This will guarantee a level playing field for companies on the European market of chemicals in front of regrettable substitution.
替代过程是REACH法规中定义的一种重要工具,用于消除使用危险化学品带来的风险。然而,当替代物质在技术和经济方面是合适的,但它与被取代的物质一样有害或可能更糟时,这一过程就会导致令人遗憾的替代。造成这种情况的主要原因是缺乏关于替代物质的危险特性的资料,欧洲化学品条例的执行不一致,以及工业界某些部门对管理严格的分类缺乏兴趣。从“没有数据,就没有市场”的模式转变为“没有数据,就没有问题”,用“监管最少的替代方案”取代“危害最小的替代方案”,是令人遗憾的替代方案的结果。为了避免这种做法,欧盟当局和化学工业应该共同努力实现解决方案,如澄清替代的目标,改进监管程序,或让工业和利益相关者参与对关注物质的潜在替代品的严格评估。这将保证欧洲化学品市场上的公司在令人遗憾的替代品面前有一个公平的竞争环境。
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引用次数: 3
Actions Brought Against Delegated Commission Regulation 2020/217 Concerning Classification of Titanium Dioxide 针对授权委员会关于二氧化钛分类的法规2020/217提起的诉讼
Pub Date : 1900-01-01 DOI: 10.21552/icrl/2020/2/9
T. Schulz
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引用次数: 0
期刊
International Chemical Regulatory and Law Review
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