Purpose and Necessity of Nanoparticle Regulation
|
|
- Marybeth Richards
- 6 years ago
- Views:
Transcription
1 I. Introduction Purpose and Necessity of Nanoparticle Regulation A rapidly emerging new field of study is nanotechnology and its real-life applications. Nanotechnology involves the study and application of nanoscale materials (between 1 and 100 nanometers) in fields ranging from materials sciences to pharmaceuticals. Nanoparticles are used in everyday items, ranging from cosmetics such as sunscreen and eyeshadow to clothing. Various controversies have emerged regarding nanoparticles, such as its chemical definition, the extent to which it should be regulated, its effects on the environment, and whether it s safe for consumers. Despite nanotechnology s ability to have life-changing applications, regulation on nanoparticles has been lax and incomplete. Instead of creating national and international regulatory frameworks, industries and international organizations have shied away from the behemoth task and instead adhered to existing chemical regulation guidelines that are insufficient for regulating nanoparticles. This article aims to raise awareness about the importance of nanoparticle regulation, review current legislation, propose policy solutions, and cite past examples of where the failure to regulate emerging biotechnologies has led to severe impacts on the environment and human health. II. Resolving the Definition Debate a. Definition of Nanoparticle One major controversy within nanoparticle regulation is the definition of what a nanoparticle is. It is widely agreed that nano is anything from 1 to 100 nanometers (Lovestam et al.), yet this is where the divergence occurs: there is a disagreement on whether agglomeration or aggregation of nanoparticles should be considered. Aggregation and agglomeration are often used interchangeably, yet these two terms are inherently different, which only led to more confusion in nanoparticle regulation (Nichols et al. 2104). The ISO Technical Specification defines agglomeration as collection of weakly-bound particles or mixtures of the two where the resulting external surface area is similar to the sum of the surface areas of the individual components (Linsinger, Roebben, and Gilliland 13). Essentially, agglomerates are not fixed units and can be changed by various conditions such as temperature, ph, and pressure (Walter 10), meaning that the physical properties of agglomerates can be changed by its environment and chemical composition. Agglomerates can either break down into smaller agglomerates or condense into larger ones. In contrast, aggregation is particle[s] comprising stronglybonded or fused particles where the resulting external surface area may be significantly smaller than the sum of the calculated surface areas of the individual components (Linsinger, Roebben, and Gilliland 13). Even though the definitions provided by the ISO are widely accepted, the definitions are often used interchangeably, and many industries often have their own definitions, which adds confusion to nanoparticle regulation in addressing whether nanoparticles include agglomeration, aggregation, or both (Nichols et al. 2104). b. Definition of Chemical substance A key issue that needs to be resolved is what constitutes as a chemical substance. There is no specific legislation that regulates nanoparticles, but rather, even though nanoparticles behave differently, nanoparticles are regulated by existing legislation under the umbrella term chemical substance. Defining chemical substance is imperative to ensuring that there is uniform international nanoparticle regulation. For instance, the Environmental Protection Agency (EPA) defines a chemical substance based on molecular identity (Lebedev 23). This means that nanoparticles used in consumer products, such as titanium dioxide (TiO 2) in sunscreen are declared as safe, since despite clear functional differences
2 between bulk-sized and nanoscale TiO 2 molecules, its bulk form (which contains the same molecular identity as the nanoscale form) was previously approved (Lin 374). The TiO 2 molecules in its bulk form has a significantly greater physical size compared to its nanosized form, making its physical and chemical properties different. Some legislation, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH 2006) and the Classification, Labelling and Packaging Regulation (CLP 2008) legislation of the European Chemicals Agency (ECHA) defines chemical substance as not just based on molecular identity, but including all physical states, crystal structures, and dimensions of a substance (Alessandrelli and Polci 148). However, by 2007, ECHA still treated bulk material and nano-sized material as the same substance (Alessandrelli and Polci 148). c. Dangers of Nanoparticles Treating nano-sized and bulk-sized materials as the same is dangerous. Even though nanoparticles such as TiO2 are often used in food preservatives and may not be toxic, numerous studies have shown that their nanoscale size make them hazardous. Experiments on daphnia (commonly known as waterfleas) have shown that nano-sized TiO 2 causes severe growth retardation, mortality, and reproductive defects. Some studies demonstrate that when inhaled, nano-sized TiO 2 can damage the pulmonary wall and cause pulmonary tumors (Ostiguy and Cloutier). In addition, TiO 2 particles may be toxic to the environment. TiO 2 nanoparticles, through oxidative stress, damage the cell membranes of Bacillus licheniformis, a type of common soil bacterium (Maurer-Jones et al.). Other types of nanoparticles, such as copper and zinc nanoparticles, can cause DNA damage in plants and terminate root elongation, which is necessary for plant survival (Lin and Xing). Thus, standards must be better defined so the safety of nanoparticles can be determined, measured, and regulated when necessary. III. Nanoparticle Testing Standards Even if the definitional debate of nanoparticle can be resolved, standards for testing procedures and timelines still pose problems for policymakers. In the United States, the Environmental Protection Agency (EPA) controls most substances emitted into the environment under the Toxic Substances Control Act (TSCA). As the TSCA defines chemical substance based on molecular identity, nanoparticles are no longer new substances, so it is not required for manufacturers to notify the EPA prior to manufacture (Lebedev 24). The definition of chemical substance in the TSCA is: "any organic or inorganic substance of a particular molecular identity, including -- (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical" (PC). The EPA can require notice under the significant new use clause (Lebedev 25); however, even if nanoparticles are created with significantly new properties and used for significantly new purposes, they are still regulated as existing substances, making regulation extremely difficult. Furthermore, the main issue with the TSCA is that it creates an exemption for any food, food additive, drug, cosmetic, or device (Lebedev 25). This essentially cordons off nanoparticles outside of EPA control, as most nanoparticles are used in cosmetic products and drugs. In order to successfully control a chemical substance, the EPA needs to prove that the substance may present an unreasonable risk or injury to health or the environment (Lebedev 25). This is a heavy burden on the EPA, as before testing can even be conducted, the EPA has to also prove that the possibility of risk is more than theoretical (Lebedev 25). Limited data on the toxicity of nanoparticles and lack of knowledge on nanoparticle toxicity testing methods makes this extremely difficult (Lebedev 25), severely hindering the EPA s regulatory power. This introduces another significant issue in nanoparticle regulation, which is the lack of standardized testing methods. Nanoparticles cannot be tested under traditional chemical substance risk assessments, as the risks
3 of chemical substances are assessed based on their chemical identity, which ignores the specific characteristics of nano-sized particles. Present nanoparticle testing follows a case-by-case scenario, where substances will only be tested when a case arises, as there is no hazard identification system in place (Commission). This means that dangers regarding nanoparticle products are only addressed when the threat arises, and threats are often not recognized until it has caused irreversible harm. Each specific property of nanoparticles needs to be taken into consideration and every alteration in nanoparticle property (such as physical, optical, and chemical properties) will affect the overall hazard level, making a hazard identification system extremely difficult to create (Europe). Additionally, nanoparticles can break down, condense, or have its chemical and physical properties altered due to how the product is handled over its life cycle. Seeing as there are hazard identification systems for other chemical substances, it is logical that with its increasing consumer applications, one is created for nanoparticles as well. Besides this, as nanoparticles are implemented in everyday products, their properties change over their life cycle, making its toxicity at different stages during their shelf life different (Europe). So far, little attention has been given to how toxicity of nanoparticles in consumer products change over time (Europe), making nanoparticle testing extremely difficult and expensive for regulatory agencies, further hindering their ability to successfully govern industries. IV. Past Failure to Regulate New Substances: Lessons from Microplastics There are multiple cases of where past failures to regulate new chemical substances led to irreversible damage, with the most notable example being microplastics. Microplastic is generally defined as plastic particles with a diameter up to 5mm, and just like nanoparticles, an internationally agreed definition does not exist (Girard et al. 6). A clear and universally agreed upon definition is necessary for enforcement and regulation. Microplastics are usually in the form of microbeads, which are small pieces of manufactured polyethylene plastic often used in cosmetic products such as exfoliants and toothpaste (Commerce). Canada defines microbeads in the Canadian Environmental Protection Act as synthetic polymers that, at the time of their manufacture, are greater than 0.1 μm and less than or equal to 5 mm in size. However, the definition was then narrowed to a diameter between 0.5µm and 2mm (Girard et al. 7). The United States does not provide a lower limit but defines it as having an upper limit of up to 5mm (Girard et al. 7). The definitional debate, which is highly reminiscent of the definitional debate over nanoparticles, is where the first issue occurs: essentially, microplastics over 2mm or under 0.5µm in diameter are still allowed (Girard et al. 7). This encompasses nanoplastics, which harm the environment due to its high similarity with microplastics (Girard et al. 7). In 2015, the United States passed the Microbead-Free Waters Act of 2015, which defines microbeads as any solid plastic that is less than 5 mm in length (Girard et al. 18), which does not take in account biodegradability and hence resolves potential loopholes. Despite recent collective international efforts to regulate microbeads, undoubtedly, the damage has already done. The dangers of plastic litter as a pollutant to the environment was recognized almost twenty years ago, has received widespread attention and is the subject of various regulations (Gorycka 2). However, microplastic pollution was not recognized until after the 1970s, and the first conference to bring awareness to the dangers of microplastic did not occur until the International Research Workshop on the Occurrence, Effects, and Fate of Microplastic Marine Debris in 2008 (Gorycka). It is estimated that the volume of microplastic litter has tripled in the North Pacific as of 2005 during the last decade, and the amount of microplastic debris in the waters off Japan increases 10 times for every 2 to 3 years (Gorycka). Mass accumulation of plastic litter has shown to damage the marine food chain and cause deaths of aquatic animals (Gorycka). Additionally, due to its size, microplastics are not sifted out during the wastewater treatment process, making it being released into bodies of water, causing irreversible harm (Hellmann). This is the reason for why Illinois became the first state to ban microplastics in cosmetic products in 2014 (Hellmann).
4 Even though substantive research has been conducted on the accumulation of plastics in marine creatures, specific research about the effect of microplastics in animals is a newer area of research (Steensgaard et al. 290). Since microplastics are roughly the same size as plankton, the possibility of it being ingested by greater number and variety of aquatic animals increases significantly, with ingestion causing blockage in the digestive tract and harm caused to the organism by absorbing chemicals from the microplastic (Gorycka). In addition, microplastics with different properties lead to different consequences; for instance, plastics with a high density, such as polyvinyl chloride (which is one of the most common compositions of microbeads), can accumulate easily in sediments, which increases ingestion by filter feeders such as clams and sponges (Smithsonian Museum of Natural History; The Government of Canada; Gorycka). Regarding humans, ingestion of microparticles can enter the circulatory system through the gut, yet more research needs to be done on the exact risks caused (Galloway 351). This lesson from the failure to recognize the dangers of microplastics and regulate it efficiently should serve as a warning sign to the importance of regulating nanoparticle usage. V. Recent Efforts in Nanoparticle Regulation There has been increasing international efforts to resolve challenges facing nanoparticle regulation. More resources have been dedicated to the research and development of nanoparticles. For instance, the European Commission Directorate-General for Research and Innovation has enacted the European Union (EU) Nanosafety Cluster, which are working groups dedicated to analyzing nanoparticle risks, model nanoparticle release, research existing nanoparticle regulations, and establish standard testing and data management systems (Cluster). The working groups are not yet coming up with standards to measure nanoparticle risk, but are rather carrying out risk profiles of products with nanoparticles with industry partners and then moving on from that point towards more research. Most notably, the various working groups are grouping the various definition for nanoparticle in existing international regulatory frameworks based on characteristic, networking with industries to implement Safe by Design (SbD) methods, and devising a model that estimates how an engineered nanomaterial is released along a product chain (Cluster)Despite the efforts and the strides taken in nanoparticle research, however, no legislation unique to regulating nanoparticles has been proposed. VI. Policy Proposals The first step is to resolve the conflict over agglomeration and aggregation, and both situations should not affect how nanoparticle is defined. Instead, the physical properties of nanoparticles should be defined at when it was manufactured and not during the remaining stages of its life cycle. For instance, when a cookie is sold, its price and type is determined based on its ingredients and size. The type and size of a cookie should not be defined when it is eaten halfway or when it becomes cookie crumbs, but rather should be defined as by the ingredients labelled by the manufacturers when produced. This is the same scenario for nanoparticles, where unlike cookie crumbs, the nano-scale does make a difference in function. In order to pass any effective policy, a standard definition for nanoparticle must be established. Nanoparticles must be regulated, under existing chemical legislation, as new substances. A proposed universal definition for a nanomaterial is: Any particle, substance, or material between 0 and 100 nanometers when measured before releasing to consumers. Aggregation and agglomeration are not taken into account. The term material is then defined as a single or closely bound ensemble of substances at least one of which is in a condensed phase, where the constituents of substances are atoms and molecules (Lovestam et al. 22). This covers inorganic, organic, and manufactured nanomaterials such as liposomes, nano-emulsions, micelles, and other forms of nanocarriers applied in the cosmetic and food sectors (Lovestam et al. 22). The term substance is defined by REACH as a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be sepa- rated without affecting the stability of the substance or changing its composition (Lovestam et al. 10). As substance is already
5 defined clearly in REACH, the utilization of REACH s definition of substance in defining engineered nanomaterial allows nanoparticles to be regulated under REACH as well when separate legislation for regulating nanoparticles is still being revised. The next step is then to provide a universal definition for chemical substance. The definition of chemical substance must be altered to define substances based on both physical properties and chemical identity instead of only molecular identity to allow a distinction between nanoscale substances and its parent bulk size substance. A proposed definition is: a chemical substance is: any substance of a specific combination of physical and chemical identity that exhibit a certain behavior. Although it may take time for legislational changes to be made, regulations should be made regarding manufactures. Manufacturers should follow the aforementioned ProSafe (Promotion of Safe by Design) implementation concept created by the European Union that integrates innovations, regulatory affairs, and data handling. ProSafe includes the development of a Safety Dossier (Appendix B) and Safety Profile (Hohener, Hock, and Lehmann). The Safety Dossier contains a flowchart for risk assessment, with stages ranging from hazard assessment to corporate and social responsibility (Hohener, Hock, and Lehmann). As a part of the EU NANoREG project, ProSafe provides a value chain as a basis for arranging innovation and R&D projects (Hohener, Hock, and Lehmann). Manufacturers should align research according to NANoREG s SbD concept, ProSafe Safety Dossier and Safety Profile. An image of the illustration of the value chain is shown in Appendix A. Within SbD, there is a harmonized inventory with databases, characterization, detection of nanomaterials in complex biologic and environmental samples, grouping, exposure and the life cycle, and knowledge-sharing methods(hohener, Hock, and Lehmann). Governments should require manufacturers to follow the SbD implementation methods as closely as possible to ensure that the environmental and health risks of nanoparticles can be minimized as much as possible. Regardign R&D, it should be enforced that any company that utilizes nanoparticles in its products much participate with organizations such as the EU NanoSafety Cluster project as industry partners to help progress research in risk assessments of nanoparticles. With more power comes more responsibility, and manufacturers need to take on some burdens for the materials they use. In addition, laws need to require manufacturers to explicitly label products that contain nanoparticles so that consumers can be aware of what they are using. Lastly, the burdens of regulatory agencies must be decreased. When new nanomaterials are manufactured, testing should be made mandatory regardless of whether there s a potential for risk. Although this may lengthen the approval process and increase administrative costs, companies should split burdens with regulatory bodies and be required to pay half of the testing costs. In addition, if regulatory bodies such as the EPA cannot handle testing, testing should be partly financed by a tax on nanotechnology products or be turned over to neutral third parties.
6 Appendix A: Overview of the NANoREG SbD concept and ProSafe Safety Dossier and Safety Profile
7 Appendix B: Structure of ProSafe Safety Dossier
European Chemicals Agency (ECHA)Topical Scientific Workshop: Regulatory Challenges in Risk Assessment of Nanomaterials
European Chemicals Agency (ECHA)Topical Scientific Workshop: Regulatory Challenges in Risk Assessment of Nanomaterials Jim Alwood - Office of Pollution Prevention and Toxics October 23, 2014 Legislation
More informationNanomaterials under REACH
Nanomaterials under REACH ECHA Workshop on nanomaterials, 30-31 May 2012, Helsinki Maila Puolamaa and Andrej Kobe Overview REACH aims and legal basis CA/59/2008 : Nanomaterials in REACH Activities at EU
More informationUpdate of current activities
Update of current activities Zuzana Klöslová ECHA: Dir E & Task force on NMs 25 th - 27 th September, 2013 Chémia 2013, Liptovský Ján, Slovakia *Some slides are courtesy of ECHA 24 September 2013 1 1 Content
More informationStep-by-Step Guide to the REACH Regulations
Step-by-Step Guide to the REACH Regulations Version 5 October 2008 REACH Regulations A Premier Farnell Company Guide to compliance with the EU REACH Regulations The EU REACH regulations were adopted in
More informationTSCA SECTION 13 IMPORTER CERTIFICATION PROCEDURE
TSCA SECTION 13 IMPORTER CERTIFICATION PROCEDURE INTRODUCTION PURPOSE To outline the steps required for the importation of chemical substances (including microorganisms) and provide either positive or
More informationControlled Substances: TSCA the Toxic Substances Control Act
The select agent list and relevant regulatory program information are maintained by the CDC and can be found on the select agent web site http://www.selectagents.gov/. The regulations covering select agents
More informationNanomaterials, REACH and CLP - what is going on at the regulatory front
Nanomaterials, REACH and CLP - what is going on at the regulatory front NanoKokkola 23 September 2014 Outi Tunnela Helpdesk Unit European Chemicals Agency EU Approach to Nanotechnologies Safe: ensure a
More informationThe Danish register for mandatory registration of nanoproducts. Flemming Ingerslev, Section of Chemicals The Danish Environmental Protection Agency
The Danish register for mandatory registration of nanoproducts Flemming Ingerslev, Section of Chemicals The Danish Environmental Protection Agency Overview Background and purpose of the registry Preparation
More informationLetter to non European Union customers
15 October 2014 Letter to non European Union customers Dear customer, Subject: REACH and DuPont DuPont s intention to support customers outside the European Union This communication related to REACH focuses
More informationCanada s Experience with Chemicals Assessment and Management and its Application to Nanomaterials
Canada s Experience with Chemicals Assessment and Management and its Application to Nanomaterials European Chemicals Agency (ECHA) Topical Scientific Workshop: Regulatory Challenges in Risk Assessment
More informationDefinition and regulation in terms of mechanism of action and intended use
Definition and regulation in terms of mechanism of action and intended use 1 - Nanomaterial-containing medical devices 2 - (Ingestible) medical devices composed of substances IMDRF-3 / 20 March 2013 /
More informationPeter Kearns, PhD OECD, ENV/EHS BIPM, April 2015
EXPOSURE MEASUREMENT AND EXPOSURE MITIGATION: ACTIVITIES OF OECD S WORKING PARTY ON MANUFACTURED NANOMATERIALS Peter Kearns, PhD OECD, ENV/EHS BIPM, April 2015 Areas covered by the OECD Programme Testing
More informationCommunicating business-to-business product information Dr. Markus Pridöhl
Communicating business-to-business product information Dr. Markus Pridöhl Brussels, Oct 2 nd 2008 Manufactured nanomaterials according to OECD Elemental nanomaterials Fullerenes (C 60 ) Multi-walled carbon
More informationHazard Communication for Dangerous and Harmful Materials
Hazard Communication for Dangerous and Harmful Materials Yu-Li Huang Department of Safety, Health and Environmental Engineering National Kaohsiung First University of Science & Technology 1 Outline Overview
More informationRegulation of nanomaterials: What are they? How are they regulated? And who decides? By Roger Hanshaw
Regulation of nanomaterials: What are they? How are they regulated? And who decides? By Roger Hanshaw Few developments in science and technology have presented more opportunity to revolutionize so many
More informationRegulating Nanotechnologies in the EU and US: Towards Effectiveness and Convergence
the EU and US: Towards Effectiveness and Convergence Project Consortium: London School of Economics (LSE) Chatham House Environmental Law Institute (ELI) Project on Emerging Nanotechnologies (PEN) Project
More informationINTRODUCTION. REACH Compliance. Importers / Retailers. Delhi,
INTRODUCTION REACH Compliance for Importers / Retailers Delhi, 6.11.08 1 INTRODUCTION Registration, Evaluation, Authorisation ti and Restriction ti of Chemicals In force since 01.06.07 850 Pages of EU
More informationTraceability of nanomaterials Nano-databases and notification requirements
Report Traceability of nanomaterials Nano-databases and notification requirements June 2012 Ökopol GmbH Institut für Ökologie und Politik Nernstweg 32-34 D-22765 Hamburg Imprint ÖKOPOL GmbH Institut für
More informationGPS summary for Sodium Hypochlorite CAS: Brzeg Dolny
GPS summary for Sodium Hypochlorite CAS: 7681-52-9 Brzeg Dolny 01.07.2011 Zawartość Sodium hydroxide... 3 General Statement... 3 Chemical Identity... 3 Use and Applications... 3 Physical/Chemical Properties...
More informationGlobal Harmonization and Hazard Communication
Global Harmonization and Hazard Communication HAZARD COMMUNICATION Major changes to the Hazard Communication Standard Hazard classification: Chemical manufacturers and importers are required to determine
More informationAssessment and Regulation of Nanomaterials under the European Biocides Regulation Isabel Günther
FEDERAL INSTITUTE FOR RISK ASSESSMENT Assessment and Regulation of Nanomaterials under the European Biocides Regulation Isabel Günther Silver-containing active substances notified under 98/8/EC Biocidal
More informationApplication of RIP 3.10 on Guidance for identification and naming of substances
Application of RIP 3.10 on Guidance for identification and naming of substances - Reaction mixtures, naming rules, phase-in criterion (a), impurities Date December 2007 Revision 0 Disclaimer The information
More informationNanocrystalline Cellulose:
Nanocrystalline Cellulose: International Standardization & Metrological Approaches Alan Steele National Research Council Institute for National Measurement Standards TAPPI International Conference on Nano
More informationRegulation of Nanomaterials in Consumer Products A European Perspective
FEDERAL INSTITUTE FOR RISK ASSESSMENT Regulation of Nanomaterials in Consumer Products A European Perspective Andreas Luch Nanomaterials: What is so Special about the Nanoscale? 0.1 1 Water molecule Glucose
More informationThe role of the authorities, SVHC substances, data issues
The role of the authorities, SVHC substances, data issues T E O D O R A K R I S T O F T E O D O R A _ K R I S T O F @ U M L. E D U V I S I T I N G S C H O L A R E N V I R O N M E N T A L S C I E N T I
More informationTrends in the Sound Management of Chemicals Perspectives from Asia and Pacific
Trends in the Sound Management of Chemicals Perspectives from Asia and Pacific 3 rd and 4 th Dec. 2009 Yoshiaki TOTOKI Waste Management and Resources Project Institute for Global Environmental Strategies
More informationVERSION 3.0 MARKS & SPENCER NOVEMBER 2015 ECP MINUMUM STANDARDS REACH. Registration, Evaluation and Authorisation of Chemicals
VERSION 3.0 MARKS & SPENCER NOVEMBER 2015 ECP MINUMUM STANDARDS REACH Registration, Evaluation and Authorisation of Chemicals VERSION 3 NOVEMBER 2015 ENVIRONMENTAL & CHEMICAL POLICY FOR TEXTILE PROCESSING
More informationCharacterization Methods of Manufactured Nanomaterials for EHS Studies
Characterization Methods of Manufactured Nanomaterials for EHS Studies Steven W Brown, MS, CIH International Standards Organization Technical Committee #229 on Nanotechnologies Convener Work Group #3 Environmental
More informationWHAT S WRONG WITH THIS PICTURE?
1606 WHAT S WRONG WITH THIS PICTURE? Hazard Communication & GHS Leader s Guide Aurora Pictures Program Synopsis WHAT S WRONG WITH THIS PICTURE? Hazard Communication & GHS This video holds the viewer's
More informationModule H.i. Establishing Legal Limits on Lead in Paint: The European Union Experience
Module H.i. Establishing Legal Limits on Lead in Paint: The European Union Experience 1 Establishing Legal Limits on Lead in Paint The European Union Experience Dr Jutta Emig German Federal Ministry for
More informationIntroduction to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
Introduction to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Lennart Dock lennart.dock@kemi.se Swedish Chemicals Agency Lorens van Dam Lorens.van.dam@msb.se Swedish
More informationState-of-the-science in Metrology & Metrics for Nanomaterials Regulation
Topic 3: Metrology and dose metrics for hazard and exposure assessment throughout the life cycle State-of-the-science in Metrology & Metrics for Nanomaterials Regulation Dr Steve Hankin Head of Section,
More informationRegulatory preparedness workshop Ispra, 5-6 October NANoREG Foresight (System) Platform. Christian Micheletti
Regulatory preparedness workshop Ispra, 5-6 October 2017 NANoREG Foresight (System) Platform Christian Micheletti Context: NANoREG project 2 A common European approach to the regulatory testing of Manufactured
More informationHAZARD COMMUNICATION PROGRAM
HAZARD COMMUNICATION PROGRAM PREPARED BY ENVIRONMENTAL HEALTH AND SAFETY OFFICE REVISION 1/2016 TABLE OF CONTENTS Purpose... 1 Background... 1 Scope... 1 Responsibilities... 1 Definitions... 2 Hazard Classification...
More informationChallenges of Nanomaterial Regulation in Europe. November 8th 2016, Grenoble Dr. Julia Donauer
Challenges of Nanomaterial Regulation in Europe November 8th 2016, Grenoble Dr. Julia Donauer 1 Nanomaterials Food / Food Contact Cosmetics Biocides 2 Challenges for manufacturers (1) Worker health protection
More informationPolicy landscape: the role of REACH in chemicals management
Policy landscape: the role of REACH in chemicals management HAZBREF Stakeholder conference 19-20 March 2018 Elina Karhu European Chemicals Agency (ECHA) Content Basic pillars of the EU chemical legislation
More informationAnnex XV dossier. PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR 1A OR 1B, PBT, vpvb OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN
Annex XV dossier PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR 1A OR 1B, PBT, vpvb OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN Substance Name: N-Methylacetamide EC Number: 201-182-6 CAS Number:
More informationSECTION 1. Identification of the substance/mixture and of the company/undertaking. Low Density Polyethylene LF2207M
SECTION 1. Identification of the substance/mixture and of the company/undertaking Product identifier Trade name Synonyms Polyethylene; LDPE Relevant identified uses of the substance or mixture and uses
More informationLarry R. Glass, Ph.D., M.P.H. Xerox Corporation
REACH COMPLIANCE LSS Project Registration Of Chemicals Evaluation Authorization & Restriction Larry R. Glass, Ph.D., M.P.H. Xerox Corporation Overview of REACH Regulation European Regulation Signed into
More informationThe Korean REACH Overview & Regulatory Implementation. Yukyung KIM Ministry of Environment, KOREA
Overview & Regulatory Implementation Ministry of Environment, KOREA 1 2 2 3 3 Toxic Chemicals Act (enacted in 1992) Lack of chemical info. No system for transferring chemical info. Household chemicals
More informationThe Globally Harmonized System (GHS) for Hazard Classification and Labelling. Development of a Worldwide System for Hazard Communication
The Globally Harmonized System (GHS) for Hazard Classification and Labelling Development of a Worldwide System for Hazard Communication Why is the GHS needed? No country has the ability to identify and
More informationUnilever s approach to assuring the safety of novel nanomaterials - supporting the risk assessment science
Unilever s approach to assuring the safety of novel nanomaterials - supporting the risk assessment science Bobbie Bradford Safety & Environmental Assurance Centre Unilever s brands Unilever s Mission is
More informationQUESTIONNAIRE: REACH INTRODUCTION
QUESTIONNAIRE: REACH INTRODUCTION Note: For some of the questions there is more than one correct answer. 1. What does the abbreviation REACH stand for? Please complete the letters.! Registration! Evaluation!
More informationProduct Stewardship Summary
Product Stewardship Summary Methyldiethanolamine General Statement Methyldiethanolamine is an alkyl alkanolamine that is used in gas treatment applications and serves as an intermediate in the synthesis
More informationHAZARD COMMUNICATION PROGRAM
Revision 1.0 JANUARY 2, 2018 HAZARD COMMUNICATION PROGRAM UNC CHARLOTTE 9201 UNIVERSITY CITY BLVD., CHARLOTTE, NC 28223 January 2018 Hazard Communication Program 1 Table of Contents Purpose... 3 Background...
More informationChina Chemical Regulations Overview
China Chemical Regulations Overview CIRS Your Compliance Expert Ethan Zheng CIRS ethan.zheng@cirs-group.com 1 What to be Regulated? Pesticide Food Food Additive Chemical Substances Raw Material, Intermediate
More informationProperties criteria - BETA
Properties criteria - BETA - according to Regulation (EC) No. 1272/2008 (CLP) VALID FROM 2018-07-01 Introduction The BETA register is a part of the BASTA system. Products that are registered in the BETA
More informationPRODUCT SAFETY SUMMARY (GPS) SODIUM-HYDROXIDE
This Product Safety Summary is intended to provide a general overview of the chemical substance in the context of ICCA (International Council of Chemical Associations) Global Product Strategy. The information
More informationREACH Pre-registration & Registration - Questions and Answers
MEMO/08/240 Brussels, 11 th April 2008 REACH Pre-registration & Registration - Questions and Answers The EU's new chemicals legislation REACH (Registration, Evaluation, Authorisation and Restriction of
More informationThe Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Purpose, scope and application
The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Purpose, scope and application Purpose of the GHS (1) (a) (b) (c) (d) To enhance the protection of human health and the
More information2018 PROCESSOR INVENTORY NOTIFICATION ACTIVE-INACTIVE REQUIREMENTS
2018 PROCESSOR INVENTORY NOTIFICATION ACTIVE-INACTIVE REQUIREMENTS NOTIFICATION DEADLINE Processor Reporting October 5, 2018 WHAT IS TSCA? REPORTING TIMELINE WHAT IS A PROCESSOR? RETROSPECTIVE REPORTING
More informationPUBLIC EMPLOYEE HAZARDOUS CHEMICAL PROTECTION AND RIGHT TO KNOW ACT O.C.G.A
PUBLIC EMPLOYEE HAZARDOUS CHEMICAL PROTECTION AND RIGHT TO KNOW ACT O.C.G.A. 45-22-2 Georgia s Right to Know Law Federal regulations require that all employees be trained on the Hazard Communications Standard
More informationCDER Risk Assessment to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products
CDER Risk Assessment to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products Celia N. Cruz, Ph.D. CDER Nanotechnology Working Group Office of Pharmaceutical Science 1 Disclaimer The
More informationQUESTIONNAIRE: REACH INTRODUCTION
QUESTIONNAIRE: REACH INTRODUCTION Note: For some of the questions there is more than one correct answer. 1. What does the abbreviation REACH mean? Please complete the letters.! R! E! A! CH 2. Who is responsible
More informationJoint Research Centre
Joint Research Centre the European Commission's in-house science service Serving society Stimulating innovation Supporting legislation The EU Commission's definition of nanomaterial: implementation and
More informationPrinciples in Chemical legislation. what the graduate should know
Principles in Chemical legislation what the graduate should know regulations and responsibilities basic obligations of producers, importers, distributers and downstream users sources of information Safety
More informationSection II Assessing Polymers
26 Clean Production Action GreenScreen v1.4 (January 2018) Section II Assessing Polymers 13. Purpose Section II outlines the procedure to be used to assess and classify hazards of polymers. Follow the
More informationAbstract. Keywords. 1. Introduction. Sarisak Soontornchai
The Educational Review, USA, 28, 2(4), 245-252 http://www.hillpublisher.com/journals/er Opinions of the University Students towards Two Learning Object Modules (LOM) on Globally Harmonized System of Classification
More informationNanotechnology and Exposure: The Pathway to a Safe and Healthy Environment. Professor Candace Tsai Colorado State University
Nanotechnology and Exposure: The Pathway to a Safe and Healthy Environment Professor Candace Tsai Colorado State University Bogotá, 14-15 FEB 2017 Nanotechnology and Nanomaterials Engineered Nanoparticles-
More informationGHS Hazard Commmunication Right-to-Understand. Helping you comply with 29 CFR
GHS Hazard Commmunication Right-to-Understand Helping you comply with 29 CFR 1910.1200 Purpose of Hazard Communication (Hazcom) Classify the potential hazards of all chemicals. Ensure employees are aware
More informationMaterials U.S. Perspective
Scott Fetter REACH Impact on Aerospace JSF/F-35 Pollution Prevention Activities Progress Update since 2004 ISO Review F-35 Air Systems Integration Environmental Safety and Health Lead Lockheed Martin Aeronautics
More informationOffice of Environmental Health and Safety. Radiation Safety Awareness Training
Office of Environmental Health and Safety Radiation Safety Awareness Training 5425 Woodward Ste 300 Detroit, MI 48202 Office: 313.577.1200 Fax:313.993.4079 www.oehs.wayne.edu Health Physics / Radiation
More informationStatus of the Implementation of GHS in China
Status of the Implementation of GHS in China Content Law and regulation system of chemical management Institutions Implementing GHS in China Management on the Import and Export of Chemicals Problems and
More informationThe new regulation REACH INTRODUCTION. Pedro Guerra
The new regulation REACH INTRODUCTION Pedro Guerra 1 INTRODUCTION Regulation (CE) 1906/2006 (REACH) regulates the Registration, Evaluation, Authorization and Restriction of chemical substances and preparations.
More informationGlobal Product Strategy (GPS) Safety Summary. Tetrahydrofuran
Global Product Strategy (GPS) Safety Summary Tetrahydrofuran This GPS Safety Summary is a high-level summary intended to provide the general public with an overview of product safety information on this
More informationCONTINUOUS FLOW CHEMISTRY (PROCESSING) FOR INTERMEDIATES AND APIs
CONTINUOUS FLOW CHEMISTRY (PROCESSING) FOR INTERMEDIATES AND APIs Sripathy Venkatraman, Section Head at AMRI Abstract Many contract manufacturing organizations (CMOs) offer continuous flow chemistry, but
More informationNanomaterials and waste water treatment Opportunities and issues to consider
Nanomaterials and waste water treatment Opportunities and issues to consider Dr David Carlander Engineered nanomaterials in the waste water treatment process and associated environments NanoForum 2013
More informationNew Policies on Chemical Environmental Management in China. Gao Yingxin Chemical Registration Center of MEP September 9, 2010
New Policies on Chemical Environmental Management in China Gao Yingxin Chemical Registration Center of MEP September 9, 2010 Measures on Environmental Management of New Chemical Substances Strengthened
More informationHazCom and Global Harmonization Are You In Compliance? BISC June, 2018
HazCom and Global Harmonization Are You In Compliance? BISC June, 2018 Objectives To provide an overview of the GHS Standard Contents of the OSHA standard Hazard Classification Required Training Chemical
More informationEntry Guide for "DIC RAW MATERIAL SURVEY" for Form Version 4.1
Entry Guide for "DIC RAW MATERIAL SURVEY" for Form Version 4.1 - Find proper selection among drop-down list if explanation below is marked with "*". - You can leave from an inquiry cell empty if your SDS
More informationEnvironmental and IH Considerations in Nanomaterial Production and Use
Environmental and IH Considerations in Nanomaterial Production and Use Elizabeth McMeekin, PE PPG Industries, Inc. emcmeekin@ppg.com Commercialization of NanoMaterials Conference Nov. 12, 2007 NanoMaterials
More informationHazard Communication Standard: Safety Data Sheets
BRIEF Hazard Communication Standard: Safety Data Sheets The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), revised in 2012, requires that the chemical manufacturer, distributor, or importer
More informationExisting Systems of Product Labelling
FEDERAL INSTITUTE FOR RISK ASSESSMENT Existing Systems of Product Labelling Axel Hahn Overview Labelling Where Labelling is implemented CE and other Examples Nano - Labelling The Product - Identification
More informationnanomaterials? Worry About? Should we worry about Should we Did you know? What are nanomaterials?
worry about nanomaterials? Nanomaterials contain particles which are smaller than 100 nanometres (0.0000001 metres) across. Their size means they often possess very different properties from the same materials
More information7/8/2013. What is GHS?
What is GHS? 0 Globally Harmonized System of Classification and Labeling of Chemicals 0 A standardized approach to classifying and labeling chemicals based on hazards 0 A United Nations program meant to
More informationSECTION 3 PRODUCT COMPOSITION The test kit is composed of QuSTICK Strep A Reagent Stick, Reagent A, Reagent B, Positive Control, and Negative Control.
SECTION 1 PRODUCT AND COMPANY IDENTIFICATION Product Identification: Ref No. 6000, 6000-025, etc. Test kit contains QuSTICK Strep A Reagent Stick, Reagent A, Reagent B, Positive Control, and Negative Control.
More informationGuidelines for the Labelling of Chemical Products
UFV 2008/759 Guidelines for the Labelling of Chemical Products Uppsala University Approved by the University Director 29 May 2008, revised 21 December 2015 Contents Labelling of chemical products 3 Responsibility
More informationChemicals in products - legislation
Chemicals in products - legislation Karin Rumar, Senior Technical Officer Enforcement karin.rumar@kemi.se EU Chemicals legislation General legislation Products legislation CLP Detergents Cosmetics VOC
More informationNanosystems and chemical weapons: considerations about the potential risk of illicit use of nanosized materials
Nanosystems and chemical weapons: considerations about the potential risk of illicit use of nanosized materials ISTM Matteo Guidotti National Research Council (CNR) Istitute of Molecular Sciences and Technologies
More informationHELSINKI COMMISSION Baltic Marine Environment Protection Commission
HELSINKI COMMISSION Baltic Marine Environment Protection Commission HELCOM RECOMMENDATION 24/10 Adopted 25 June 2003, having regard to Article 20, Paragraph 1 b) of the 1992 Helsinki Convention IMPLEMENTATION
More informationEnvironmental Risk Assessment of Nanomedicines
Environmental Risk Assessment of Nanomedicines Specific methodological issues and implications for risk assessment Silvia Berkner, Petra Apel Umweltbundesamt, Germany Outline Regulatory background Current
More informationReaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate
GPS Safety Summary This Product Safety Summary is intended to provide a general overview of the chemical substance in the context of ICCA Global Product Strategy. The information on the Summary is basic
More information开原亨泰精细化工厂. Kaiyuan Hengtai Fine Chemicals Factory. Material Safety Data Sheet. 4-Aminobutyric acid. Approved By IATA Regulation
Material Safety Data Sheet Approved By IATA Regulation SECTION 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product name Company information manufacturer No.18,YiheRoad,Kaiyuan City, Liaoning Province,
More informationTowards a responsible development of Nanomaterials
Towards a responsible development of Nanomaterials EVONIK Occupational Health Policy Dr. Hans-Jürgen Wiegand, Global Coordination Product Stewardship Evonik Degussa GmbH February 2009 CASG Workshop Responsible
More informationThe Globally Harmonized System (GHS) for Hazard Classification and Labelling. Development of a Worldwide System for Hazard Communication
The Globally Harmonized System (GHS) for Hazard Classification and Labelling Development of a Worldwide System for Hazard Communication What is the GHS? A common and coherent approach to defining and classifying
More information2009/48/EC Chemical safety assessment
2009/48/EC Chemical safety assessment Christian Wetterberg Director External Relations, LEGO Group TIE Webinar 23 May 2013 Toy Industries of Europe (TIE) More than 80% of all decisions on socio-economic
More informationEuropean harmonisation of product notification- Status 2014
European harmonisation of product notification- Status 2014 Ronald de Groot Dutch National Poisons Information Center University Medical Center Utrecht The Netherlands Poisons Centers Informing the public
More informationREACH (EU Strategy for new chemicals) & Success Service. Dr. Andreas Kicherer
REACH (EU Strategy for new chemicals) & Success Service Dr. Andreas Kicherer Agenda REACH What is it How are Turkish plastic manufacturers affected What help does BASF Success offer What additional Sustainability
More informationContents Introduction Purpose Background What is a hazardous chemical? What is the GHS?...
CHEMICAL LABELLING SAFETY HEALTH & WELLBEING CONTENTS Contents... 1 1 Introduction... 3 2 Purpose... 3 3 Background... 3 3.1 What is a hazardous chemical?... 3 3.2 What is the GHS?... 3 4 Standard labelling
More informationGreen Chemistry & Related Regulatory Developments
Green Chemistry & Related Regulatory Developments Dr. Rashmi Naidu Director, Technical Services NS Support Services Pvt. Ltd (Technical Support Centre to SSS (Europe) AB, Sweden) Industrial Green Chemistry
More informationSafety Data Sheets (SDS)
Safety Data Sheets (SDS) The following content is taken directly from the Government s Occupational Health and Safety Administration (OSHA) website. The following is a description of what a proper SDS
More informationBiocidal Products Committee (BPC)
1(8) Biocidal Products Committee (BPC) Opinion on a request according to Article 75(1)(g) of Regulation (EU) No 528/2012 HeiQ AGS-20 ECHA/BPC/001/2014 Adopted 10 April 2014 Annankatu 18, P.O. Box 400,
More informationKeeping up with Global Regulatory Changes Asia Perspective
Keeping up with Global Regulatory Changes Asia Perspective Overview of new chemical registration requirements in the Region s key markets Hironori Takamura, Principal Consultant - Japan Eunjae Shin, Principal
More information7 Product-related Environmental Activities
Contents 7.1 Our Policy 7-1 7.1.1 Environmental Statement 7-1 7.1.2 Environmental Vision 7-1 7.2 Reduction of Chemical Substances in Products 7-2 7.2.1 Product development with maximum efforts not to use
More informationC h a p t e r 5 : W o r k p l a c e H a z a r d o u s M a t e r i a l s I n f o r m a t i o n S y s t e m ( W H M I S )
C h a p t e r 5 : W o r k p l a c e H a z a r d o u s M a t e r i a l s I n f o r m a t i o n S y s t e m ( W H M I S ) Overview WHMIS is a provincial legislative response to provincial employees and employers
More informationControl Standard for Handling Chemical Substances in Products, Parts and Materials
Control Standard for Handling Chemical Substances in Products, Parts and Materials (for Suppliers) The 9 th Edition Hitachi Maxell, Ltd. 1 Contents 1. Purpose...3 2. Scope... 3 3. Terms and definitions..3
More informationRisk Management under the. Chemicals Management Plan
Risk Management under the Population Exposure Assessment Chemicals Management Plan Approaches and Tools for Health Risk Assessment under CMP Stakeholder Advisory Council meeting Health Canada PAHO Workshop
More informationThule Group Prohibited and Restricted Substances Framework
Thule Group Prohibited and Restricted Substances Framework Contents 1 Introduction... 2 2 The P&R Substances Framework... 2 2.1 Prohibited & Restricted Substances List (P&R List)... 2 2.2 Testing... 2
More informationHAZCOM - Training
HAZCOM - Training 1910.1200 1 The OSHA HazCom Standard The Right-To-Know SDS (Safety Data Sheets) Chemical Listings Labels and Warnings Notifying Employees of Workplace Hazardous Chemical Locations (authorized
More informationHow to comply with K-REACH
How to comply with K-REACH (K-REACH : Act on the Registration and Evaluation of Chemical Substances) October 21 st, 2014 Moonsun RYU Risk Assessment Center Korea Testing & Research Institute ASTM International
More information