Substances Of Very High Concern Research Articles

Impact of European chemicals regulation on the industrial use of plasticizers and patterns of substitution in Scandinavia

REACH aims at promoting the safe use of chemicals in Europe, inter alia by identification and regulation of substances of very high concern (SVHCs). Once identified, SVHCs need to be substituted by safer alternatives. However, substitutes are frequently not safer than the substances that they replace but rather show similar hazard profiles, resulting in regrettable substitution. This paper investigates the impact of chemicals regulation on substitution of chemicals by analyzing time trends in the industrial use of chemicals from 2000 to 2014 in Scandinavia. It is shown that the use of ten water-relevant SVHCs decreased by about 90% in the considered period in Sweden as compared to a control group of unregulated substances which decreased by only 20%. A closer inspection of the use of 23 highly used plasticizers revealed that the use of regulated phthalate plasticizers decreased while the use of non-phthalate plasticizers increased. A first comparison of hazardous properties showed that during the 15-years period chemical substitution drastically reduced the chemical hazard burden of plasticizers in Scandinavia for both, the environment and human health. This study shows that regulation and the related discussion on chemicals safety have significantly reduced the chemical hazard burden from plasticizers in Scandinavia since the year 2000. It is assumed that similar trends can be found for the whole European Union. To combat regrettable substitution, mitigation options are suggested, including information-based tools for the identification of safer alternatives and an improved accessibility of information on production volumes and uses of chemicals to allow for an improved assessment of chemical's risk.

Tailoring PVDF Membranes Surface Topography and Hydrophobicity by a Sustainable Two-Steps Phase Separation Process

This work validates a sustainable way to produce customized PVDF membranes, suitable for contactors applications, in which DMSO is employed as nonhazardous solvent, in place of substances of very high concern (SVHC), by a combination of vapor-induced and liquid-induced phase separation (VIPS and LIPS) stages, and without using any chemical additive as pore forming. The experimental results highlight the key role of the kinetic and thermodynamic parameters of the phase separation processes involved in the control of the surface and transport properties of the PVDF membranes. Namely, combining VIPS and LIPS techniques in a controlled way, allowed to produce symmetric porous membranes with customized rough surface topography (root-mean-square roughness up to 0.67 μm) and hydrophobicity (water contact angle up to 140°) according to a biomimetic behavior as that of lotus leaves surfaces, through an environmental friendly fabrication process. The resulting membranes are characterized by a high porosity (total p...

Short-chain perfluoroalkyl acids: environmental concerns and a regulatory strategy under REACH

BackgroundShort-chain PFASs (per- and polyfluoroalkyl substances) are widely used as alternatives to long-chain PFASs. Long-chain PFASs become gradually regulated under REACH (EC No. 1907/2006) and other international regulations, due to having persistent, bioaccumulative and toxic properties and/or being toxic for reproduction. The increasingly used short-chain PFASs are assumed to have a lower bioaccumulation potential. Nonetheless, they have other properties of concern and are already widely distributed in the environment, also in remote regions. The REACH Regulation does not directly address these emerging properties of concern, complicating the implementation of regulatory measures. Therefore, this study illustrates these environmental concerns and provides a strategy for a regulation of short-chain PFASs within REACH.ResultsShort-chain PFASs have a high mobility in soil and water, and final degradation products are extremely persistent. This results in a fast distribution to water resources, and consequently, also to a contamination of drinking water resources. Once emitted, short-chain PFASs remain in the environment. A lack of appropriate water treatment technologies results in everlasting background concentrations in the environment, and thus, organisms are permanently and poorly reversibly exposed. Considering such permanent exposure, it is very difficult to estimate long-term adverse effects in organisms. Short-chain PFASs enrich in edible parts of plants and the accumulation in food chains is unknown. Regarding these concerns and uncertainties, especially with respect to the precautionary principle, short-chain PFASs are of equivalent concern to PBT substances. Therefore, they should be identified as substances of very high concern (SVHC) under REACH. The SVHC identification should be followed by a restriction under REACH, which is the most efficient way to minimize the environmental and human exposure of short-chain PFASs in the European Union.ConclusionDue to an increasing use of short-chain PFASs, an effective regulation is urgently needed. The concerns of short-chain PFASs do not match the “classical” concerns as defined under REACH, but are not of minor concern. Therefore, it is of advantage to clearly define the concerns of short-chain PFASs. This might facilitate the following restriction process under REACH.

The German REACH Congress 2016: a workshop report.

In October 2016, the German REACH Congress was held at the German Federal Institute for Risk Assessment (BfR) in Berlin. Here, the associated improvement made in the fields of consumer protection and the progress in and experiences gained from the implementation of the authorisation procedure were discussed. Several speakers from EU institutions, German authorities, industry, and civil society organisations were invited to present their views. There was a shared consensus that REACH contributes to the advancement of consumer protection against chemical risks, mainly because more and higher quality information on substance-related hazards and potential exposures becomes available. In addition, risk management measures, particularly regarding restrictions on uses, scale down consumer exposures to chemicals. Opportunities for improvements identified at the congress include the quality of registration dossiers and the management of and communication on substances of very high concern (SVHC) that may be present in consumer articles. Although regarded as being in an early implementation phase, the authorisation process was generally found to be operational and progressing well. Criticism was expressed with regard to the consistency of authorisation decisions and the costs and uncertainties related to authorisation applications. Consumer protection legislation consists of several legal provisions which are interlinked. The congress participants agreed that REACH is an important element of this legal framework as it enhances and complements other legal provisions.

Prioritizing substances of genotoxic concern for in-depth safety evaluation using non-animal approaches: The example of food contact materials.

Due to the exponentially growing number of substances requiring safety evaluation, efficient prioritisation strategies are needed to identify those of highest concern. To limit unnecessary animal testing, such strategies should respect the 3R principles (Replacement, Reduction, Refinement). In the present study, a strategy based on non-animal approaches was developed to prioritize non-evaluated printed paper and board food contact material (FCM) substances for further in-depth safety evaluation. Within the strategy, focus was put on genotoxicity, a key toxicological endpoint when evaluating safety. By combining in silico predictions with existing in vitro and in vivo genotoxicity data from publicly available literature sources and results from in vitro gene mutation experiments, the 106 study substances could all be assigned to one of the four priority classes (ranging from low to very high concern). Importantly, 19 substances were considered of very high concern due to in vivo genotoxicity. Five of these are furthermore listed as a Substance of Very High Concern (SVHC) by the European Chemicals Agency (ECHA), in addition to demonstrating physicochemical properties linked to a high migration potential as well as oral bioavailability and being used in primary food packaging materials. The current animal-free strategy proved useful for the priority ranking of printed paper and board FCM substances, but it can also be considered to prioritize other substances of emerging concern.

Roads and motorized transport as major sources of priority substances? A data register study

ABSTRACTA data register study was performed in order to identify the amounts of hazardous substances in products related to motorized transport in Norway during 2012. The hazardous substances were selected from legislative investigations performed by the European Chemicals Agency (ECHA), European Union (EU), and Norwegian Environment Agency (NEA). Information regarding hazardous substances in 52 selected product categories associated with traffic-related activities was obtained from the Norwegian Product Register administrated by the NEA. Substances present on ECHA list of substances of very high concern (SVHC), NEA national priority list, and priority substances under the EU Water Framework Directive (WFD) were given most attention, with substances from ECHA community rolling action plan (CoRAP) also included. Results showed that selected products contained a diverse range of substances that were classified as hazardous to either human or environmental health. The quantities of hazardous substances in the selected products were 120 tons (SVHC), 280 tons (Norway priority list), and 2,400 tons (WFD). It proved difficult to pinpoint these quantities only to traffic-related operations since product categories included compounds used for other activities. However, data illustrate that large quantities of hazardous substances are employed concurrent with being prioritized for reduction/elimination by national and international authorities. A list of substances with annual use in 2012 >1 ton was prepared to aid a prioritization for further actions such as substitution, phasing out, or environmental monitoring. The list contains substances that are toxic to humans, especially as adverse reproductive/carcinogenic agents, and/or pose a threat to the environment.

Where are the SVHCs?

BackgroundThe European chemicals regulation REACH includes the legal duty for suppliers to inform consumers on request about the presence of substances of very high concern (SVHCs) in articles. Since this requirement has been in force now for 10 years, the intention of this study was to find out whether information on SVHCs is adequately communicated to the consumer today. Data on the presence of SVHCs in articles were collected as a prerequisite for the subsequent requests for a targeted choice of articles to examine the operability of the ‘right to know.’ResultsLiterature data show that SVHCs have been measured and described in a large variety of commodities. 32% of 334 information requests for articles which were suspected to contain SVHCs were answered by suppliers and a minor number of these answers were of good quality. Only two respondents indicated the presence of SVHCs in their articles. Suppliers are not legally obliged to respond to requests if their articles are free of SVHCs. Therefore, the absence of a response might be interpreted as an indication that SVHCs are present below 0.1% in the articles in question. However, there are certain doubts that only two out of 334 articles suspected contain SVHCs.ConclusionsThe data question whether the ambitious aims of the SVHC regime can be achieved under the present conditions. Measures are proposed on how to improve implementation of the information requirement and to amend the legal criteria in the upcoming REACH revision.

Towards a proportionality assessment of risk reduction measures aimed at restricting the use of persistent and bioaccumulative substances.

International chemicals legislation aims at adequately controlling persistent organic pollutants (POPs) and substances of very high concern (SVHCs), such as persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances, with a view to progressively substitute these substances with suitable less-hazardous alternatives. Using cost-effectiveness analysis (CEA) to assess the (dis)proportionality of measures to control such substances (collectively called "PBT" in the present paper) requires benchmarks. The present paper provides building blocks for possible benchmarks by looking at the cost-effectiveness estimates for regulatory measures that have been applied or considered for various PBT substances. These cost-effectiveness estimates vary widely, and the main factors possibly explaining this variation are discussed. The available cost estimates currently do not allow deriving a value for society's willingness to pay to reduce PBT presence, use, and emissions because decisions referring explicitly to these estimates are scarce. Roughly speaking, the available evidence suggests that measures costing less than €1000 per kilogram PBT use or emission reduction will usually not be rejected for reasons of disproportionate costs, whereas for measures with costs above €50 000 per kilogram PBT such a rejection is likely. More research is needed to strengthen the evidence base and further elaborate a systematic approach toward proportionality benchmarking. Integr Environ Assess Manag 2017;13:1100-1112. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Substances of Very High Concern in Food Contact Materials: Migration and Regulatory Background

Food contact materials (FCMs) are needed to produce, transport, process and store our food. Although essential for handling and protecting food from farm to fork, FCMs are often not inert, and chemical components may partition into food. In Europe, FCMs are regulated under the FCM Framework Regulation 1935/2004 which covers their effects on human health. Environmental effects of FCM substances are included in the scope of the European Chemicals Regulation [Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)] which aims at substituting Substances of Very High Concern (SVHCs) by safer alternatives. In this study, we focus on 10 FCM substances that are SVHCs and already included in the authorization list of REACH (Annex XIV): We show their possible application in the manufacture of FCMs and give evidence or highlight the absence thereof for migration into food or food simulants. An overview on migration of four phthalates (diisobutyl phthalate, dibutyl phthalate, benzyl butyl phthalate and bis(2‐ethylhexyl) phthalate) and 4,4′‐methylenedianiline from FCMs is provided, based on peer‐reviewed studies and notifications from the Rapid Alert System for Food and Feed. Different approaches in evaluating and handling SVHCs under REACH and the European FCM legislation are discussed, and recommendations on how to increase the safety of FCMs are included. Combining better enforcement, an explicit ban of SVHCs without specific authorization for use in FCMs, and re‐evaluations of previously authorized FCM substances could lead to safer FCMs. In conclusion, a harmonization between REACH and European FCM legislation is desirable for improving legal certainty for FCM users as well as in the interest of public health. Copyright © 2017 John Wiley & Sons, Ltd.

The Substitution Principle within the REACH Regulation: Nuclear Receptor-Bound Endocrine Disruptors

Within the REACH Regulation (EC/1907/2006), the substitution principle for chemicals classified as Substances of Very High Concern (SVHC) for either human health or environmental risks has been implemented in order to support their replacement by suitable alternatives. Considering the thousands of chemicals to be tested within the frame of REACH, animal testing by internationally-accepted guidelines sounds unreasonable in terms of the required time, costs as well ethical issues. Hence, REACH recommended also the use of alternative methods to animal experimentation although no validated in silico or in vitro tools were available when regulation entried into force. To search for suitable alternatives to SVHC having an Endocrine Disruptor (ED)-like Mode-of-Action (MoA) by means of an integrated, tiered in silico-in vitro approach, the EU-granted project LIFE-EDESIA (contract no. LIFE12 ENV/IT/000633) is combining computational-based tools and cell-based bioassays, in order to develop a no-animal testing procedure to screen for chemicals having less or no toxicity in terms of endocrine disruption-like activities. A general view of the no-animal testing approach implementing REACH and the substitution principle will be given, emphasising ligand-nuclear receptor (NR) assessment by molecular docking (one of the LIFE-EDESIA in silico approaches) and the use of clinical biomarkers in in vitro toxicology to detect ED-like adverse effects in cell-based bioassays.

REACH compliant epoxides used in the synthesis of Fe(III)-based aerogel monoliths for target fabrication

Aerogel materials manufactured from metal oxides have been used as components in numerous high-energy density physics targets. These aerogels have been identified to be used as a future target material in the AWE fielded campaigns at the US National Ignition Facility. A wide variety of metal oxide aerogels are required for future campaigns and therefore a versatile manufacturing route is sought; as such, an epoxide-assisted sol–gel route was investigated. Under the European Union Registration, Evaluation, Authorization and Restriction of Chemicals legislation, the most commonly used epoxide, propylene oxide, is recognized as a substance of very high concern (SVHC). This work sought to investigate suitable alternative epoxides for use in target manufacture. The outcome was the identification of synthesis routes for stable metal oxide aerogel monoliths using epoxides not subject to the above restrictions.

Screening for potential endocrine disruptors in fish: evidence from structural alerts and in vitro and in vivo toxicological assays.

BackgroundThe European chemicals’ legislation REACH aims to protect man and the environment from substances of very high concern (SVHC). Chemicals like endocrine disruptors (EDs) may be subject to authorization. Identification of (potential) EDs with regard to the environment is limited because specific experimental assessments are not standard requirements under REACH. Evidence is based on a combination of in vitro and in vivo experiments (if available), expert judgement, and structural analogy with known EDs.ObjectivesThe objectives of this study are to review and refine structural alerts for the indication of potential estrogenic and androgenic endocrine activities based on in vitro studies; to analyze in vivo mammalian long-term reproduction studies with regard to estrogen- and androgen-sensitive endpoints in order to identify potential indicators for endocrine activity with regard to the environment; to assess the consistency of potential estrogenic and androgenic endocrine activities based on in vitro assays and in vivo mammalian long-term reproduction studies and fish life-cycle tests; and to evaluate structural alerts, in vitro assays, and in vivo mammalian long-term reproduction studies for the indication of potential estrogenic and androgenic endocrine disruptors in fish.ResultsScreening for potential endocrine activities in fish via estrogenic and androgenic modes of action based on structural alerts provides similar information as in vitro receptor-mediated assays. Additional evidence can be obtained from in vivo mammalian long-term reproduction studies. Conclusive confirmation is possible with fish life-cycle tests. Application of structural alerts to the more than 33,000 discrete organic compounds of the EINECS inventory indicated 3585 chemicals (approx. 11%) as potential candidates for estrogenic and androgenic effects that should be further investigated. Endocrine activities of the remaining substances cannot be excluded; however, because the structural alerts perform much better for substances with (very) high estrogenic and androgenic activities, there is reasonable probability that the most hazardous candidates have been identified.ConclusionsThe combination of structural alerts, in vitro receptor-based assays, and in vivo mammalian studies may support the priority setting for further assessments of chemicals with potential environmental hazards due to estrogenic and androgenic activities.Electronic supplementary materialThe online version of this article (doi:10.1186/s12302-016-0094-5) contains supplementary material, which is available to authorized users.

Time matters: A stock-pollution approach to authorisation decision-making for PBT/vPvB chemicals under REACH

A core aim of the European chemicals legislation REACH is to ensure that the risks caused by substances of very high concern (SVHC) are adequately controlled. Authorisation – i.e. the formal approval of certain uses of SVHC for a limited time - is a key regulatory instrument in order to achieve this goal. For SVHC which are, in addition to their toxicity, (very) persistent and/or (very) bioaccumulative (PBT/vPvB chemicals), decision-making on the authorisation is conditional on a socio-economic analysis (SEA). In a SEA companies must demonstrate that the gains from keeping a chemical in use outweigh expected damage costs for society.The current setup of the REACH authorisation process, including existing guidance on performing a SEA, ignores that PBT/vPvB chemicals are stock pollutants. This paper explores the implications of incorporating stock pollution effects of these chemicals into a SEA on authorisation decision-making. We develop a cost-benefit approach which includes stock dynamics of PBT/vPvB chemicals. This allows identifying the decision rules for granting or refusing an authorisation. Furthermore, we generalize the model to an entire set of damage functions. We show that ignoring stock pollution effects in a SEA may lead to erroneous decisions on the use of PBT/vPvB chemicals because long-term impacts are not adequately captured. Using a historic case of DDT soil contamination as an illustrative example we discuss information requirements and challenges for authorisation decisions on the use of PBT/vPvB chemicals under REACH.

SVHC in imported articles: REACH authorisation requirement justified under WTO rules.

The purpose of the REACH Regulation is to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. To this end, REACH introduces, among other instruments, the authorisation regime for substances of very high concern (SVHC) that are listed on Annex XIV of the regulation. After expiration of the transitional period for each Annex XIV-SVHC, articles, such as most products of daily use, produced in the European Economic Area (EEA) may not contain such substances unless an authorisation was granted for the specific use or this use falls within the scope of an exemption from the authorisation requirement. The authorisation scheme does, however, only apply to SVHC used in the EEA. As a consequence, REACH does not regulate SVHC entering the European market as part of imported articles which burden human health and the environment. Moreover, from an economic perspective, domestic articles are subject to stricter requirements than those which are produced abroad, putting actors from within the EEA at competitive disadvantage and thus impeding the intention of REACH to enhance competitiveness and innovation. One option to close this regulatory gap could be to extend the authorisation requirement to SVHC present in imported articles. A legal appraisal on behalf of the German Environment Agency (UBA) assesses whether such option would be in accordance with the specifications of WTO world trade law. It concludes that, measured by the standards of the WTO dispute settlement practice, such an extended authorisation scheme would neither violate the principles of national treatment and most-favoured nation treatment. Also, such regulation would not constitute an unnecessary obstacle to trade, since the extended authorisation requirement would pursue a legitimate objective covered by the regulatory autonomy of the EU and, furthermore, the regulation would not be more trade-restrictive than necessary. The contribution at hand summarises the main findings while taking into account first reactions to the legal appraisal.

Comparative occupational risk assessment to support the substitution of Substances of Very High Concern: Alternatives assessment for diarsenic trioxide in Murano artistic glass production

In the framework of REACH Regulation (1907/2006/EC), the assessment of health and environmental risks posed by chemical substitutes of Substances of Very High Concern requires transparent approaches, suitable to provide all stakeholders with the information needed to select safer chemicals and minimize the potential for unintended consequences. A comparative assessment for diarsenic trioxide (As2O3) and proposed chemical alternatives (cerium dioxide CeO2 and blast furnace slag) in Murano artistic glass production was performed. The assessment followed a structured, stepwise framework including a detailed analysis of production processes, development of occupational exposure scenarios and comparative assessment of occupational health risks. Several occupational exposure models were compared and the most suitable ones (MEASE, TRAw and ART models) were applied to the selected scenarios. The study concluded that, from the perspective of occupational health risks, the use of CeO2 together with blast furnace slag represents a safer alternative to As2O3 and, given the correct implementation of Personal Protection Measures, health risks will be controlled for all production phases. The study demonstrated that, due to similar physico-chemical properties of the considered substances, toxicological factors constitutes the main driver of occupational risks, and at the same time allowed to identify critical issues in the comparative assessment procedure. The proposed approach can guide the evaluation of risks of chemical alternatives with the aim of supporting the decision-making process in the transition towards safer productions.

A Successful Case to Adopt Green Purchasing System

In recent years, public attention to environmental protection has grown to an unprecedented level. Many international textile brands have switched to purchasing textile materials that comply with environmental standards. Brand companies in EU, US, Japan, and many other advanced nations will release their restricted substance lists (RSLs) on a regular basis to indicate the substances they restrict using and the content of substances of very high concern (SVHC). However, with the rapid growth of the list of restricted substances and SVHC, the requirement for constant updating and confirming RSLs with buyers has become a serious burden on Taiwan’s textile industry. This paper introduces a successful case of adoption of Green Textile Cloud Services (GTCS) in Taiwan. This company uses GTCS to enhance its efficiency in managing RSLs of different customers and establish effective green supply chain purchasing and outsourcing policies.

The Implementation of the REACH Authorisation Procedure on Chemical Substances of Concern: What Kind of Legitimacy?

With the increasing “agencification” of policy making in the European Union (EU), normative questions regarding the legitimacy of EU agencies have become ever more important. This article analyses the role of expertise and legitimacy with regard to the European Chemicals Agency ECHA. Based on the REACH regulation, so-called Substances of Very High Concern (SVHCs) are subject to authorisation. The authorisation procedure aims to ensure the good functioning of the internal market, while assuring that risks of SVHCs are properly controlled. Since ECHA has become operational in 2008, recurring decisions on SVHCs have been made. The question posed in this article is: to what extent can decision making in the REACH authorisation procedure be assessed as legitimate? By drawing on the notion of throughput legitimacy, this article argues that decision making processes in the authorisation procedure are characterized by insufficient legitimacy.

Risk and the Precautionary Principle in the Implementation of REACH

The adoption of the REACH regulation, setting out to reformchemicals policy of the European Union (EU), was accompanied by intense controversy over the role of the precautionary principle. Analysing decision making on so called Substances of Very High Concern (SVHCs), this article demonstrates that despite legal underpinning, precaution plays a limited role in the implementation of the REACH authorisation procedure. Due to ambiguous legislative provisions, the controversiesof the legislativeprocessare carriedover tothe implementationprocess.

Rapid screening and identification of multi-class substances of very high concern in textiles using liquid chromatography-hybrid linear ion trap orbitrap mass spectrometry

A new analytical method was established and validated for the analysis of 19 substances of very high concern (SVHCs) in textiles, including phthalic acid esters (PAEs), organotins (OTs), perfluorochemicals (PFCs) and flame retardants (FRs). After ultrasonic extraction in methanol, the textile samples were analyzed by high performance liquid chromatography-hybrid linear ion trap Orbitrap high resolution mass spectrometry (HPLC-LTQ/Orbitrap). The values of LOQ were in the range of 2–200mg/kg. Recoveries at two levels (at the LOQ and at half the limit of regulation) ranged from 68% to 120%, and the repeatability was lower than 13%. This method was successfully applied to the screening of SVHCs in commercial textile samples and is useful for the fast screening of various SVHCs.

Toxic hazards of leather industry and technologies to combat threat: a review

Abstract Leather industry has significant economic influence; however, it suffers from the negative impact due to environmental pollution caused by tannery wastes produced during leather processing processes. The tanning processes contribute significantly to chemical oxygen demand (COD), total dissolved solids (TDS), chlorides, sulfates and heavy metal pollution. The chemicals discharged into aquatic systems end up in highly polluted sediments and salinisation of rivers. European Chemical Agency (ECHA) has prioritized some of the hazardous chemicals used in leather under Substances of Very High Concern (SVHC) and substances for Authorization. The situation has highlighted the need for greener technologies. Out of the two broad categories of technical methods, the first group involves the introduction of processing technologies by decreasing the effluent pollution load, avoiding the use of harmful chemicals and producing solid wastes that can be used as by-products. The other category is related to the treatment of wastewater, handling and processing of solid waste in an environment-friendly manner. Both methods have been applied to prevent negative impact on the environment during leather production. The methods have been reviewed for their technical suitability and commercial feasibility and it was felt that combination of both is essential. The technologies can have up-front additional costs but have to be balanced against multiple benefits in terms of environmental cleanup, improved labour productivity, material quality consistency and better international image. By using the best available technologies and optimized systems the leather industry can evolve as an environment friendly technology.