European Chemicals Research Articles

International Conference on Green Chemistry on 5th /6th November 2018 in Vienna

Under the Austrian EU presidency, the Austrian Ministry for Sustainability and Tourism (BMNT) organised a conference on Green Chemistry on 5th/6th November 2018 in Vienna. This article outlines key findings of the conference. The conference aimed to gather chemical as well as policy experts, stakeholders and various practitioners of green chemistry to discuss the current scientific status in this field, but also the need and opportunities for integrating the principles of green chemistry in European chemicals legislation. The event discussed perspectives how to foster and better integrate into the legal frameworks the principles of ‘Green Chemistry’, which guide the design of chemical substances, products and processes to avoid hazards and reduce resource use – thus offering potentials for industries to ensure their compliance and also for ‘Circular Economies’.

Hazardous substances turn up in EU products

Some 88% of chemical suppliers are failing to tell European customers when their products contain substances of very high concern (SVHCs), according to a study by the European Chemicals Agency (ECHA), the body responsible for implementing chemical regulations in the European Union. The failure is a breach of the regulations, which classify SVHCs as present when at concentrations of more than 0.1% by weight. The same study found that SVHCs are present in 12% of consumer products such as footwear and electronic accessories. Chemicals classified as SVHCs have restricted uses. For the study, ECHA inspected 682 consumer products made by 405 companies across 15 European countries. SVHCs identified in the consumer goods include various phthalates, heavy metals, and short-chain chloroparaffins. ECHA says the problem can be solved if companies improve knowledge of their products and better communicate this information to customers. The agency plans to publish new guidance on communication

Is It Safe to Paint Your Wall White? A Case Study on Titanium Dioxide Classification.

Titanium dioxide (TiO2 ) is in the process of being classified as a suspected carcinogenic substance (Carc 2). The present case study probes the outcomes of this potential classification in terms of the reduction of hazardous exposure to TiO2 due to its classification. Furthermore, the case study examines the elements that are causing ambiguity during the classification process. This study was conducted by walking through the process from the present exposure to TiO2 to the hazard assessment associated with TiO2 exposure, to the regulatory classification process, and to practical outcomes affecting TiO2 usage. Finally, the impact of the classification on exposure, which was originally considered potentially hazardous, is evaluated. The case study shows that TiO2 classification as a carcinogen will not directly reduce respiratory exposure to TiO2 , which was the original reason for the classification. Instead, the classification will lead to restrictions on recycling. Moreover, the classification will have an impact on certain solid artifacts and liquid mixtures for which hazardous exposure was not detected. Altogether, the present case raises questions concerning hazard communications associated with the Carc 2 classification; treatment of poorly soluble low toxicity (PSLT) particles and nanoparticles in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling and Packaging (CLP) classifications; and use of human exposure studies for the purposes of chemical regulations. Based on the present study, the following recommendations are made: the final decision on the TiO2 classification should be reconsidered together with those of other PSLT particles and take into account extensive developments in the field of nanoscience. Furthermore, the European Chemicals Agency (ECHA) should develop state-of-the-art guidance on how to use the available human exposure data. Finally, the authorities that are in charge of European Union chemicals management are advised to further develop the regulatory network to utilize the information generated in REACH processes as efficiently as possible and to verify that the connections between the regulations result in the intended outcome. Integr Environ Assess Manag 2019;00:1-12. © 2019 SETAC.

ECHA proposes tight controls for BPA, flame retardant, and glycol ethers

The European Chemicals Agency (ECHA) is proposing strict regulation of many uses of bisphenol A (BPA), the flame retardant dechlorane plus, two glycol ethers, and several metal-containing compounds. If the European Commission concurs with this plan, which ECHA released Oct. 1, companies in most cases will be prohibited from using the substances unless they apply for and receive authorization from ECHA to do so. However, the proposal would not affect use of BPA, an estrogenic compound, in the manufacture of materials such as polycarbonate. ECHA classifies BPA as toxic for reproduction. The proposal would tightly control use of dechlorane plus, a polychlorinated flame retardant used in adhesives, sealants, polymers, computers, electronics, and vehicle textiles. ECHA deems this substance very persistent and very bioaccumulative. ECHA considers ethylene glycol monoethyl ether and ethylene glycol monomethyl ethertoxic for reproduction. The proposal would require authorization for uses of these substances other...

Safety of titanium dioxide nanoparticles in cosmetics.

Titanium dioxide (TiO2 ) is widely used in a variety of products including cosmetics. TiO2 in its nanoparticle form (nano-TiO2 ) is now the only form used as an ultraviolet (UV) filter in sunscreens, but also in some day creams, foundations and lip balms. While its efficacy as a UV filter is proven in the prevention of skin cancers and sunburns, some concerns have been raised about its safety. Indeed, considering its small size, nano-TiO2 is suspected to penetrate dermal, respiratory or gastrointestinal barriers, disseminate in the body and therefore constitute a potential risk to the consumer. At the skin level, most studies performed in humans or animals showed that nano-TiO2 did not penetrate beyond the outer layers of stratum corneum to viable cells and did not reach the general circulation, either in healthy or in compromised skin. The Scientific Committee on Consumer Safety (SCCS) considers nano-TiO2 as a non-sensitizer and as mild- or non-irritant to skin and concludes in no evidence of carcinogenicity (supported by the European Chemicals Agency), mutagenicity or reproductive toxicity after dermal exposure to nano-TiO2 . According to the SCCS, nano-TiO2 from sunscreens does not present any health risk when applied on the skin at a concentration up to 25%. However, the SCCS does not recommend the use of nano-TiO2 in formulations that may lead to exposure of the consumer's lungs by inhalation (sprayable products and powders). Indeed, even if human data are sparse and inconsistent, lung inflammation was reported in animals. In 2016, the EU Cosmetic Regulation made nano-TiO2 as an authorized UV filter, except in products that could lead to exposure of the lungs. After oral exposure, nano-TiO2 absorption and toxicity are limited. The incidental oral exposure to nano-TiO2 contained in lip balms is thus not expected to induce adverse health effects.

Empirical analysis of regulative risk assessment processes of nanomaterials under the Toxic Substances Control Act (TSCA) and European Union regulation concerning the Registration, Evaluation, Authorization and restriction of Chemicals (REACH)

An empirical analysis of regulative risk assessment processes of nanomaterials under the Toxic Substances Control Act (TSCA) and Regulation (EC) No 1907/2006 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was performed. Risk assessment that has regulatory applicability must be based on legally binding norms, and “process” refers here to the approach taken by the regulatory bodies in the U.S. and the EU to implement those norms. Data consisted of the number of notifications/dossiers for the nanomaterials or the substances that contain also nanoform received by the Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA), and decisions of the Agencies. The data was analyzed using descriptive statistics and classification. The analysis focused on the challenges in detection of nanomaterials and information collection that are the core functions of risk-based regulation and may create dissimilar compliance requirements for companies. The results show that a loophole in detection of nanomaterials and information collection on them exists in the EU under the REACH, and that regulative risk assessment processes performed by the ECHA and EPA under the REACH and the TSCA, respectively, may result in different compliance requirements for companies. The differences arise partly from the legal provisions that determine the authority and obligations of the Agencies, but also from the decision making practices adopted by the Agencies.

Establish data infrastructure to compile and exchange environmental screening data on a European scale

Robust techniques based on liquid (LC) and gas chromatography (GC) coupled with high-resolution mass spectrometry (HR-MS) enable sensitive screening, identification, and (semi)quantification of thousands of substances in a single sample. Recent progress in computational sciences has enabled archiving and processing of HR-MS ‘big data’ at the routine level. As a result, community-based databases containing thousands of environmental pollutants are rapidly growing and large databases of substances with unique identifiers allowing for inter-comparison at the global scale have become available. A data-archiving infrastructure is proposed, allowing for retrospective screening of HR-MS data, which will help define the ‘chemical universe’ of organic substances and enable prioritisation of toxicants causing adverse environmental effects at the local, river basin, and national and European scale in support of the European water and chemicals management policy.

Mixture risks threaten water quality: the European Collaborative Project SOLUTIONS recommends changes to the WFD and better coordination across all pieces of European chemicals legislation to improve protection from exposure of the aquatic environment to multiple pollutants

Evidence is mounting that chemicals can produce joint toxicity even when combined at levels that singly do not pose risks. Environmental Quality Standards (EQS) defined for single pollutants under the Water Framework Directive (WFD) do not protect from mixture risks, nor do they enable prioritization of management options. Despite some provisions for mixtures of specific groups of chemicals, the WFD is not fit for purpose for protecting against or managing the effects of coincidental mixtures of water-borne pollutants. The conceptual tools for conducting mixture risk assessment are available and ready for use in regulatory and risk assessment practice. Extension towards impact assessment using cumulative toxic unit and mixture toxic pressure analysis based on chemical monitoring data or modelling has been suggested by the SOLUTIONS project. Problems exist in the availability of the data necessary for mixture risk assessments. Mixture risk assessments cannot be conducted without essential input data about exposures to chemicals and their toxicity. If data are missing, mixture risk assessments will be biassed towards underestimating risks. The WFD itself is not intended to provide toxicity data. Data gaps can only be closed if proper feedback links between the WFD and other EU regulations for industrial chemicals (REACH), pesticides (PPPR), biocides (BPR) and pharmaceuticals are implemented. Changes of the WFD alone cannot meet these requirements. Effect-based monitoring programmes developed by SOLUTIONS should be implemented as they can capture the toxicity of complex mixtures and provide leads for new candidate chemicals that require attention in mixture risk assessment. Efforts of modelling pollutant levels and their anticipated mixture effects in surface water can also generate such leads. New pollutant prioritization schemes conceived by SOLUTIONS, applied in the context of site prioritization, will help to focus mixture risk assessments on those chemicals and sites that make substantial contributions to mixture risks.

EU court tosses challenges to regulations

The European Union General Court hasrejected separate legal challenges to regulation of the plastics chemical bisphenol A (BPA) and of the solvent 1-bromopropane. The court dismissed both cases Sept. 20. In one suit, PlasticsEurope, an association of manufacturers, challenged the European Chemicals Agency (ECHA) description in 2017 of BPA, an estrogenic chemical, as “a substance with endocrine disrupting properties that may have serious effects on human health.” ECHA added BPA to its list of substances of very high concern in 2017. Chemicals on the list are candidates for strict control under the EU’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) law. In the second suit, chemical maker ICL challenged a 2017 regulation restricting 1-bromopropane, also known as n-propyl bromide, without any exemptions for specific uses. The court rebuffed industry arguments in both cases. In a related development, ECHA is proposing to restrict the use of calcium cyanamide as a

EU database for hazardous waste

The European Chemicals Agency (ECHA), the body responsible for implementing chemical regulation across the European Union, has unveiled plans to introduce a hazardous waste database in 2021 to ensure that the waste is safe to recycle. According to recent guidelines from ECHA, suppliers of substances of very high concern (SVHCs) will have to provide information for the database when more than 0.1% of the weight of a finished product, such as an electronic device, is an SVHC. The agency plans to roll out a prototype database in early 2020.

Tailoring Color and Surface Morphology of Electrodeposited Chromium By Application of Pulsed Current

The electrodeposition of chromium layers for decorative purposes plays an important role in the surface finishing industry, especially for applications in sanitary, automotive, plating on plastics and similar fields. As the use of conventional hexavalent chromium based electrolytes is strongly restricted in several countries,1 the demand for alternative plating systems increased during the last years. The most promising alternative is the electrodeposition from trivalent chromium based electrolytes considering environmental safety, quality of the deposits and cost issues.2 Commercially applicable processes are already known since several decades.3 However, trivalent chromium based processes cannot fully meet the requirements on surface appearance of the layers.4 This is crucial for the above mentioned applications as slight differences in color can have a high impact on final implementation of the plated parts. In this work chromium layers plated from different electrolytes were characterized by colorimetry, SEM and AFM. A relation between optical appearance and surface morphology was found and supported by a model based on the theory of light scattering on rough surfaces.5 In case of chromium(III) sulfate based electrolytes, grain size and roughness increase with increasing layer thickness, leading to a color shift from blueish to yellowish. To achieve a blueish appearance while having sufficient resistance against corrosion and wear, a fine-grained surface structure has to be obtained at high layer thickness. By application of pulsed cathodic current, grain growth is suppressed and nucleation is re-initiated at each current pulse, giving a surface grain size of 60 to 100 nm. Up to a chromium thickness of 200 nm, the color value still in the blueish range (b* < 0 in the L*a*b* color system). However, special characteristics of chromium electrodeposition from trivalent solutions have to be considered for choosing suitable pulse parameters in large scale applications. European Chemicals Agency, Authorisation List, EC No. 215-607-8, 231-801-5, 231-889-5, 231-906-6, 232-140-5, 232-143-1, 234-190-3, 236-881-5. Z. X. Zeng, A. M. Liang, and J. Y. Zhang, Recent Pat. Mater. Sci., 2 (1), 50 (2009).S. L. Handy, C. F. Oduoza, and T. Pearson, Trans. IMF, 84 (6), 300 (2006).D. L. Snyder, Plat. Surf. Finish., 90 (11), 34 (2003).M. Leimbach, C. Tschaar, D. Zapf, M. Kurniawan, U. Schmidt, and A. Bund, J. Electrochem. Soc., 166 (6), D205 (2019).

Weight of epidemiological evidence for titanium dioxide risk assessment: current state and further needs.

We address here the importance of epidemiological evidence in risk assessment and decision-making in Europe. To illustrate this, titanium dioxide (TiO2) was used as a model compound. TiO2 is widely used as an odorless white pigment and opacifying agent. A recent systematic review assessing the weight of evidence on the relationship between exposure to TiO2 (all forms) and cancer in humans questions the assumptions that TiO2 is an inert material of low toxicity. Based on this new data, France submitted a proposal to classify TiO2 as a possible human carcinogen under the European regulation. The European Chemicals Agency Risk assessment committee concluded that TiO2 (all forms) warrants a classification as a suspected human carcinogen via inhalation (Category-2) under the CLP regulation (for Classification, Labeling and Packaging of chemicals). No considerations was given to TiO2 particle size, which may affect human health effects. Consequently, further epidemiological studies are needed to assess possible associations between different physical-chemical characteristics of TiO2 exposures and their impact on human health. This would allow strengthening the evidence on which to build the most appropriate regulation and to guaranty safe use given any exposure route of any TiO2 particle shape or size.

GenX chemical queued up for EU regulation

Chemours’s GenX chemical and related fluoroethers are now considered “substances of very high concern” in the European Union. The European Chemicals Agency says later this month it will add hexaflu...

Polymers Used in US Household Cleaning Products: Assessment of Data Availability for Ecological Risk Assessment.

ABSTRACTThe purpose of this study was to identify, characterize, and assess data needs for ecological risk of household cleaning product polymers currently being used in the United States (US). Because of their range in properties and functions, polymers are used in a wide variety of household cleaning products, including fabric, dish, and hard surface cleaners. Understanding their potential environmental impact is essential for good ingredient and product stewardship. The household cleaning product polymers were first identified using several databases. Of the 185 polymers initially identified, 120 were eliminated from the list because they did not fit the definition of a polymer, were not well defined (e.g., no Chemical s Service [CAS] or trade name only), or were not in current use. Forty‐seven of the remaining polymers had either adequate environmental fate and hazard data and/or sufficient data for conducting a comprehensive ecological risk assessment and were determined to be of low concern by either the United States Environmental Protection Agency (USEPA), the European Chemicals Agency (ECHA), and/or the Human and Environmental Risk Assessment (HERA) Project. The remaining 18 polymers were determined to need further review because of a lack of publicly available information for conducting ecological risk assessments. Additional data for these 18 polymers could be obtained by accessing privately held data, conducting laboratory tests on their fate and effects in aquatic environments, or by conducting read‐across of similar structured polymers. These steps can be utilized by industry to determine where best to dedicate future environmental stewardship efforts. Integr Environ Assess Manag 2019;15:621–632. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

EU quadruples REACH compliance checks

The European Chemicals Agency (ECHA) says it intends to quadruple the number of checks it undertakes on the registrations of thousands of chemical substances used in the bloc. The move is part of a...

Sex and Gender Analysis of Toxicity and Epidemiology Data on Environmental Chemicals in the Three Major Toxicology Databases.

Background: As sex and gender are important considerations in the assessment of toxic chemicals, we investigated whether sex and gender issues have been adequately considered in toxicological databases. Materials and Methods: A systemic review was conducted on the toxicity and epidemiology data of eight environmental chemicals (i.e., cadmium [Cd], lead [Pb], benzene, toluene, formaldehyde, and tetrachloroethylene [TCE], bis(2-ethylhexyl) phthalate [DEHP], and bisphenol A [BPA]) that appear in three toxicological databases (i.e., Hazardous Substances Data Bank, Integrated Risk Information System, and the European Chemicals Agency databases). Results: Systemic reviews on 4160 data entries pertaining to eight chemicals in three databases revealed that only 13.5% of these were sourced from male and female combined (MF) studies, whereas, 40.6% of the total number of examined entries was sourced from the study in which the sex of the subject was not mentioned. Conclusions: To accurately evaluate the hazardous effect of chemicals, toxicity tests should be designed and conducted for both sexes, and the corresponding endpoints should cover gender concerns. Therefore, databases listing toxicity data as part of the open source literature should select information from MF toxicity and epidemiology studies.

The implementation of RAAF in the OECD QSAR Toolbox

The Read-Across Assessment Framework (RAAF) was developed by the European Chemicals Agency (ECHA) as an internal tool providing a framework for a consistent, structured and transparent assessment of grouping of chemicals and read-across. Following a RAAF-based evaluation, also developers and users of read-across predictions outside ECHA can judge whether their read-across rationale is sufficiently robust from a regulatory perspective. The aim of this paper is to describe the implementation of RAAF functionalities in the OECD QSAR Toolbox report. These can be activated in the prediction report after performing a readacross prediction. Once the user manually selects the appropriate scenario, the RAAF assessment elements appear and are automatically aligned with the suitable category elements of the Toolbox report. Subsequently, these are evaluated as part of the category consistency assessment functionality. The implementation of the RAAF functionality is illustrated in practice with two examples.

Re-evaluation of polihexanide use in wound antisepsis in order to clarify ambiguities of two animal studies.

Due to classification of the agent polihexanide (PHMB) in category 2 'may cause cancer' by the Committee for Risk Assessment of the European Chemicals Agency in 2011, the users of wound antiseptics may be highly confused. In 2017, this statement was updated, defining PHMB up to 0.1% as a preservative safe in all cosmetic products. In the interest of patient safety, a scientific clarification of the potential carcinogenicity of PHMB is necessary. A multidisciplinary team (MDT) of microbiologists, surgeons, dermatologists and biochemists conducted a benefit-risk assessment to clarify the hazard of antiseptic use of PHMB. In two animal studies, from which the assessment of a carcinogenic risk was derived, PHMB was administered orally over two years in extremely high concentrations far above the NO(A)EL (no-observed-(adverse-) effect level) in rats and mice. Feeding in the NO(A)EL range resulted in no abnormal effects. In one male in the highest dose group of 4000ppm PHMB, an adenocarcinoma was found, which the author attributed to chronic inflammation of the colon with systemic atypical exposure. The increasing incidence of hemangiosarcomas highly probably resulted from increased endothelial proliferation, triggered by the exceedingly high dosage fed, because PHMB is not genotoxic and there is no evidence for epigenetic effects. It is well known that PHMB is not absorbed when applied topically. Considering the absence of genotoxicity and epigenetic effects together with the interpretation of the animal studies, it is the consensus of the multidisciplinary experts that a carcinogenic risk from PHMB-use for wound antisepsis can be ruled out. On this basis and considering their effectiveness, tolerability and clinical evidence, the indications for PHMB based wound antiseptics are justified.

Quantifying the impact of cascading use: A comparative integrated assessment of the European pine chemicals industry

In recent years, following the amendment to the European renewable energy directive (RED), there is an increasing interest to exploit Crude Tall Oil (CTO) for energetic purposes. This study conducted an integrated assessment to quantify the environmental, economic and social impact of these two competing material and energetic routes that consume CTO as a feedstock. The integrated assessment follows a cradle-to-grave approach to compare the impact on climate change from the production of bio-chemicals to that generated from the production of renewable diesel from CTO. In addition, the economic and social impact assessment estimates the total economic added value as well as the total number of direct, indirect and induced jobs generated by the two respective routes utilising CTO. The environmental assessment showed that the application of CTO for bio-chemicals has 23% lower greenhouse gas emissions than its application for renewable diesel. The economic assessment showed that the European pine chemicals industry generated at least 4 times higher added value than that generated from renewable diesel. Finally, when analysing the social impact, the utilisation of 650,000 of CTO to produce bio-chemicals generated around 9100 jobs. On the other hand, the renewable diesel production route was estimated to generate only 400 jobs. Therefore, the integrated assessment concludes that, diverting and utilising CTO to produce biofuels does not present a sustainable case when compared to its established use in the production of bio-chemicals.

Tight EU regulation of GenX proposed

Chemours’s GenX chemical, a polymer-processing aid, would become a candidate for strict regulation in the European Union under a proposal from the Dutch government. GenX is used to produce nonstick coatings and other products. It is an ammonium salt that hydrolyzes into hexafluoropropylene oxide dimer acid (HFPO-DA), which is persistent in the environment and mobile in water. The Dutch proposal says HFPO-DA “adversely impacts human health” at intake levels that could be as low as 21 ng/kg of body weight per day. Animal tests with the chemical have shown harm to the liver, kidneys, blood, and immune system. In contrast, the US Environmental Protection Agency in November proposed a safe daily level for ingestion of 80 ng/kg per day for GenX and HFPO-DA combined. After a public comment period on the Dutch proposal, the European Chemicals Agency (ECHA) will determine whether GenX, HFPO-DA, and related compounds meet criteria for “substances