Regulatory efforts regarding Bisphenol A are subject to on-going discussions, including the underlying scientific assessment of the intrinsic properties of the substance and related risks. In this context, the businessassociationPlasticsEuropechallengedseveraldecisions relating to the inclusion of Bisphenol A in the list of substances qualifying as candidates for authorisation according to Regulation (EC) No. 1907/2006 (REACH)1. Most recently the General Court has issued two rulings anddismissed the corresponding actions by PlasticsEurope. By upholding the underlying decisions regarding the initial inclusion of Bisphenol A in the candidate list aswell as a subsequently added justification to that inclusion, the General Court for the first time clarified essential details regarding the procedure and scientific requirements which have to be met to include substances in the candidate list.
{"title":"General Court: Further Clarification on SVHC Status of Bisphenol A","authors":"M. Ahlhaus, M. Öttinger","doi":"10.21552/icrl/2019/3/7","DOIUrl":"https://doi.org/10.21552/icrl/2019/3/7","url":null,"abstract":"Regulatory efforts regarding Bisphenol A are subject to on-going discussions, including the underlying scientific assessment of the intrinsic properties of the substance and related risks. In this context, the businessassociationPlasticsEuropechallengedseveraldecisions relating to the inclusion of Bisphenol A in the list of substances qualifying as candidates for authorisation according to Regulation (EC) No. 1907/2006 (REACH)1. Most recently the General Court has issued two rulings anddismissed the corresponding actions by PlasticsEurope. By upholding the underlying decisions regarding the initial inclusion of Bisphenol A in the candidate list aswell as a subsequently added justification to that inclusion, the General Court for the first time clarified essential details regarding the procedure and scientific requirements which have to be met to include substances in the candidate list.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122436352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Although the market is currently weakening somewhat, the South Korean chemical market has experienced strong growth in recent decades. The market volume in 2012 was approximately 125 billion euros, which catapulted South Korea to 6th place in the ranking of the leading chemical nations. In 2017, Korea accounted for 2.9% of world chemical sales.1 According to Statistics Korea, there were2 about 4,800 companies (with ten ormore employees) in the chemical and pharmaceutical industries in SouthKorea in 2016. They employed a total of around 171,000 people and produced products worthUS$130 billion. Almost 90% of the companies are small to mediumsized enterprises (SMEs) with less than 50 employees. The Korean chemical industry is thus characterised by small and medium-sized enterprises with little experience in the field of safe chemicalmanagement. Since the July 2011 free trade agreement between South Korea and the EU many chemicals can now be traded duty-reduced or duty-free, which has boosted trade in chemical products. The strong growth is mainly due to the progressive development of Korean competencies in new fields of technology, which often require the use of special high-tech materials. Consequently, Korea is not only amajorproducer but alsohas ahighdemand for chemical products, which is met by imports, mainly from Japan, China, the USA and Germany. In 2013, for example, Korea imported chemical products worth approximately US $ 47 billion.3
{"title":"Legal Requirements of Korean Biocide Regulation (K-BPR) and Korean REACH (K-REACH)","authors":"D. Drohmann, D. Peters, A. Seo","doi":"10.21552/ICRL/2019/1/7","DOIUrl":"https://doi.org/10.21552/ICRL/2019/1/7","url":null,"abstract":"Although the market is currently weakening somewhat, the South Korean chemical market has experienced strong growth in recent decades. The market volume in 2012 was approximately 125 billion euros, which catapulted South Korea to 6th place in the ranking of the leading chemical nations. In 2017, Korea accounted for 2.9% of world chemical sales.1 According to Statistics Korea, there were2 about 4,800 companies (with ten ormore employees) in the chemical and pharmaceutical industries in SouthKorea in 2016. They employed a total of around 171,000 people and produced products worthUS$130 billion. Almost 90% of the companies are small to mediumsized enterprises (SMEs) with less than 50 employees. The Korean chemical industry is thus characterised by small and medium-sized enterprises with little experience in the field of safe chemicalmanagement. Since the July 2011 free trade agreement between South Korea and the EU many chemicals can now be traded duty-reduced or duty-free, which has boosted trade in chemical products. The strong growth is mainly due to the progressive development of Korean competencies in new fields of technology, which often require the use of special high-tech materials. Consequently, Korea is not only amajorproducer but alsohas ahighdemand for chemical products, which is met by imports, mainly from Japan, China, the USA and Germany. In 2013, for example, Korea imported chemical products worth approximately US $ 47 billion.3","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121807962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
On 29 November 2019, ECHA published a short news release and amended versions of several Q&A entries as well as their Practical guide: How to act in dossier evaluation, describing its new approach regarding dossier updates during a dossier evaluation process. Although this seems to be a reaction to the Board of Appeal decision in the case A-001-2018 of 9 April 2019 (BrüggemannChemical), the published approach stands in clear contrast to the findings of the Board of Appeal in this case.
{"title":"Dossier Updates During Dossier Evaluation: ECHA’s New Approach","authors":"M. Ahlhaus, M. Öttinger","doi":"10.21552/icrl/2019/4/9","DOIUrl":"https://doi.org/10.21552/icrl/2019/4/9","url":null,"abstract":"On 29 November 2019, ECHA published a short news release and amended versions of several Q&A entries as well as their Practical guide: How to act in dossier evaluation, describing its new approach regarding dossier updates during a dossier evaluation process. Although this seems to be a reaction to the Board of Appeal decision in the case A-001-2018 of 9 April 2019 (BrüggemannChemical), the published approach stands in clear contrast to the findings of the Board of Appeal in this case.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125249080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In this article on the increasing importance of global data sharing, we focus on the development of international chemical control legislations. Many countries and regions around the world have recently implemented chemical control legislations, which are often harmo-nized with EU-REACH. Therefore, it has not only become possible, but even necessary to or-ganize data sharing, which is already performed within REACH consortia and Letter of Access management, also on a global level. We examine the opportunities and risks of global data sharing. Additionally, we look at how global data sharing will look like and how it is performed in practice. There are important advantages of global data sharing such as re-ducing costs and reduced animal testing as well as avoiding conflicting data. However, there is a high demand for efficient administration and strong cooperation amongst all stakehold-ers.
{"title":"Global Data Sharing: Requirements from Chemical Regulation","authors":"M. Rectanus, D. Peters","doi":"10.21552/ICRL/2019/2/6","DOIUrl":"https://doi.org/10.21552/ICRL/2019/2/6","url":null,"abstract":"In this article on the increasing importance of global data sharing, we focus on the development of international chemical control legislations. Many countries and regions around the world have recently implemented chemical control legislations, which are often harmo-nized with EU-REACH. Therefore, it has not only become possible, but even necessary to or-ganize data sharing, which is already performed within REACH consortia and Letter of Access management, also on a global level. We examine the opportunities and risks of global data sharing. Additionally, we look at how global data sharing will look like and how it is performed in practice. There are important advantages of global data sharing such as re-ducing costs and reduced animal testing as well as avoiding conflicting data. However, there is a high demand for efficient administration and strong cooperation amongst all stakehold-ers.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"267 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122832647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article outlines the importance of assessing the technical equivalence regarding the chemical composition and hazard profile for different new sources of an active substance compared to the reference source of the same active substance used for the initial risk assessement. The legal provisions of past directives and two current regulations as last amended, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EU) No 528/2012 concerning the placing on the market and use of biocidal products, are addressed in detail. Moreover, the harmonised procedures for assessing technical equivalence of different sources, based on the information presented in different supporting guidelines, are portrayed and discussed. Following the presentation of all legal provisions, a two-tiered approach as proposed for assessing the equivalence of different sources of active substances is presented in detail.
本文概述了与用于初始风险评估的同一种活性物质的参考来源相比，评估一种活性物质的不同新来源的化学成分和危害概况的技术等效性的重要性。详细阐述了过去指令和最近修订的两个现行法规的法律规定，即关于植物保护产品投放市场的法规(EC) No 1107/2009和关于生物杀灭剂产品投放市场和使用的法规(EU) No 528/2012。此外，还描述和讨论了根据不同的辅助准则所提供的资料评估不同来源的技术等效性的统一程序。在介绍了所有法律规定之后，详细介绍了评估不同来源活性物质等效性的两层方法。
{"title":"The Paramount Importance of Technical Equivalence Assessment for Active Substances in Crop Protection and Biocidal Products","authors":"Hanna Skarpos","doi":"10.21552/ICRL/2019/1/5","DOIUrl":"https://doi.org/10.21552/ICRL/2019/1/5","url":null,"abstract":"This article outlines the importance of assessing the technical equivalence regarding the chemical composition and hazard profile for different new sources of an active substance compared to the reference source of the same active substance used for the initial risk assessement. The legal provisions of past directives and two current regulations as last amended, Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and Regulation (EU) No 528/2012 concerning the placing on the market and use of biocidal products, are addressed in detail. Moreover, the harmonised procedures for assessing technical equivalence of different sources, based on the information presented in different supporting guidelines, are portrayed and discussed. Following the presentation of all legal provisions, a two-tiered approach as proposed for assessing the equivalence of different sources of active substances is presented in detail.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"100 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124600582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The REACH Regulation places many of the individual decisions adopted by the European Chemicals Agency (‘ECHA’) under the competence of its Board of Appeal. Decisions of the Board of Appeal can be challenged before the General Court and, if permission is granted, the judgment of the General Court can be appealed to the Court of Justice. The provisions in the REACH Regulation regarding the Board of Appeal and its powers are quite succinct. In essence, the Board of Appeal is an independent part of ECHA and may exercise any power that falls within ECHA’s competence. The Board of Appeal is composed of three members, two of whom are currently legally qualified, and one of whom is technically qualified. The REACH Regulation and the Rules of Procedure of the Board of Appeal ensure they are suitably qualified, independent and impartial. They are assisted by legal and scientific advisors. The legislative history of the REACH Regulation suggests that the Board of Appeal was initially expected to deal with a large number of relatively straightforward cases every year. The cases before the Board of Appeal have turned out to be a fraction of the expected number, but the impact, com-plexity and importance of the cases has turned out to be considerably greater. This opinion piece will examine four processes under the REACH Regulation in which the Board of Appeal has left a mark, and explore its main contributions and challenges over the last ten years.
{"title":"Administrative Precedent and the Application of the REACH Regulation - 10 Years of the ECHA Board of Appeal","authors":"A. Fasey, L. Bolzonello","doi":"10.21552/icrl/2019/3/6","DOIUrl":"https://doi.org/10.21552/icrl/2019/3/6","url":null,"abstract":"The REACH Regulation places many of the individual decisions adopted by the European Chemicals Agency (‘ECHA’) under the competence of its Board of Appeal. Decisions of the Board of Appeal can be challenged before the General Court and, if permission is granted, the judgment of the General Court can be appealed to the Court of Justice. The provisions in the REACH Regulation regarding the Board of Appeal and its powers are quite succinct. In essence, the Board of Appeal is an independent part of ECHA and may exercise any power that falls within ECHA’s competence. The Board of Appeal is composed of three members, two of whom are currently legally qualified, and one of whom is technically qualified. The REACH Regulation and the Rules of Procedure of the Board of Appeal ensure they are suitably qualified, independent and impartial. They are assisted by legal and scientific advisors. The legislative history of the REACH Regulation suggests that the Board of Appeal was initially expected to deal with a large number of relatively straightforward cases every year. The cases before the Board of Appeal have turned out to be a fraction of the expected number, but the impact, com-plexity and importance of the cases has turned out to be considerably greater. This opinion piece will examine four processes under the REACH Regulation in which the Board of Appeal has left a mark, and explore its main contributions and challenges over the last ten years.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115646422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
China has been developing and reforming its chemical regulations against a background of rising environmental concerns and a number chemicals accidents. The legal systemof chemical regulation inChina now consists of laws, administrative regulations, departmental rules and standards. Diverse chemical regulations and administrative application procedures are governed by different authorities. In January 2019, the Chinese Ministry of Ecology and Environment published the draft regulation on Environmental Risk Assessment and Control of Chemical Substances with the aim of establishing an overall system formanaging of both existing and new chemical substances. This draft regulationwill bringmany changes to the current chemicalmanagement system in China by the time it is implemented.
{"title":"Chemical Regulations in China: An Overview","authors":"Siming Sun","doi":"10.21552/ICRL/2019/2/9","DOIUrl":"https://doi.org/10.21552/ICRL/2019/2/9","url":null,"abstract":"China has been developing and reforming its chemical regulations against a background of rising environmental concerns and a number chemicals accidents. The legal systemof chemical regulation inChina now consists of laws, administrative regulations, departmental rules and standards. Diverse chemical regulations and administrative application procedures are governed by different authorities. In January 2019, the Chinese Ministry of Ecology and Environment published the draft regulation on Environmental Risk Assessment and Control of Chemical Substances with the aim of establishing an overall system formanaging of both existing and new chemical substances. This draft regulationwill bringmany changes to the current chemicalmanagement system in China by the time it is implemented.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125859208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
New chemical innovation is not as celebrated as innovation in electronics, materials, software, or other sectors, but it is every bit as important. Many believe, as do we, that new chemical innovation is essential to achieving sustainable development. For this reason, a close look at the 2016 amendments to the Toxic Substances Control Act (TSCA) and the U.S. Environmental Protection Agency’s (EPA) implementation of them offers valuable insights into whether the new U.S. industrial chemical management law and EPA policy initiatives implementing it are aligned with this goal. This article discusses EPA’s implementation of the TSCA amendments as they relate to new chemical innovation and highlights EPA policy positions and institutional practices that EPA should reconsider to align more closely with the goal of more sustainable new chemical technologies.
{"title":"Chemical Innovation and New TSCA: The Good, the Bad, and the Evolving","authors":"L. Bergeson, R. Engler","doi":"10.21552/icrl/2019/4/5","DOIUrl":"https://doi.org/10.21552/icrl/2019/4/5","url":null,"abstract":"New chemical innovation is not as celebrated as innovation in electronics, materials, software, or other sectors, but it is every bit as important. Many believe, as do we, that new chemical innovation is essential to achieving sustainable development. For this reason, a close look at the 2016 amendments to the Toxic Substances Control Act (TSCA) and the U.S. Environmental Protection Agency’s (EPA) implementation of them offers valuable insights into whether the new U.S. industrial chemical management law and EPA policy initiatives implementing it are aligned with this goal. This article discusses EPA’s implementation of the TSCA amendments as they relate to new chemical innovation and highlights EPA policy positions and institutional practices that EPA should reconsider to align more closely with the goal of more sustainable new chemical technologies.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127360957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
It is not an easy task to draw out the matrix of chemicals legislation that ECHA is part of. But let me offer you one representation of it. On one hand, there are many pieces of product legislation with an interface for chemicals – for example, those addressing toys, biocides, plant protection products, food additives and food contact materials. On the other hand, there are a number of pieces of legislation that protect certain populations – the most prominent for ECHA’s daily work being the legislation that protects workers. The European Commission’s environment policy contains various compartments, for example, the Water Framework Directive, which is closely related to ECHA’s work.
{"title":"Foreword ∙ Getting our Chemicals Legislation Working Better Across the Board","authors":"Bjorn Hansen","doi":"10.21552/icrl/2019/2/4","DOIUrl":"https://doi.org/10.21552/icrl/2019/2/4","url":null,"abstract":"It is not an easy task to draw out the matrix of chemicals legislation that ECHA is part of. But let me offer you one representation of it. On one hand, there are many pieces of product legislation with an interface for chemicals – for example, those addressing toys, biocides, plant protection products, food additives and food contact materials. On the other hand, there are a number of pieces of legislation that protect certain populations – the most prominent for ECHA’s daily work being the legislation that protects workers. The European Commission’s environment policy contains various compartments, for example, the Water Framework Directive, which is closely related to ECHA’s work.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124733099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
On November 5, 2018, the Chinese Ministry of Ecology and Environment (MEE) issued the draft of the RegulationsonPollutionDischargeLicensing (PDLR) to solicit public comments. It marked a new step towards the goal of establishing a permit-center regulatory system covering all kinds of regulated pollutant discharge.1 This report will summarise the recent developments in Chinese pollutant permit regulation, introduce the new norms, institutions and comment on its characteristics. It concludes by highlighting the challenges brought by the reform and providing suggestions to affected enterprises.
{"title":"China Reforms its Pollutant Discharge Permit (PDP) System","authors":"Y. Huang","doi":"10.21552/icrl/2019/4/7","DOIUrl":"https://doi.org/10.21552/icrl/2019/4/7","url":null,"abstract":"On November 5, 2018, the Chinese Ministry of Ecology and Environment (MEE) issued the draft of the RegulationsonPollutionDischargeLicensing (PDLR) to solicit public comments. It marked a new step towards the goal of establishing a permit-center regulatory system covering all kinds of regulated pollutant discharge.1 This report will summarise the recent developments in Chinese pollutant permit regulation, introduce the new norms, institutions and comment on its characteristics. It concludes by highlighting the challenges brought by the reform and providing suggestions to affected enterprises.","PeriodicalId":375592,"journal":{"name":"International Chemical Regulatory and Law Review","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130805193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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