Registration Evaluation Authorisation Of Chemicals Research Articles

Alkyl pyrrolidone solvents N–methyl–2–pyrrolidone (NMP) and N–ethyl–2–pyrrolidone (NEP) in urine of children and adolescents in Germany – human biomonitoring results of the German Environmental Survey 2014–2017 (GerES V)

N-methyl-2-pyrrolidone (NMP) and its substitute N-ethyl-2-pyrrolidone (NEP) are aprotic solvents used in many technical applications, but also in carpets, and consumer products such as cleaning agents, and cosmetics. NMP and NEP are classified as reproductive toxicants. As a substance of very high concern (SVHC), NMP is included in the European REACH (Registration, Evaluation, Authorisation of Chemicals) candidate listfor authorisation. NMP and NEP metabolites were measured in more than 2100 urine samples of 3- to 17-year-old children and adolescents, participating in the population-representative German Environmental Survey for Children and Adolescents 2014–2017 (GerESV). The two NMP metabolites 5-hydroxy-N-methyl-2-pyrrolidone (5-HNMP) and 2-hydroxy-N-methylsuccinimide (2-HMSI) could be detected and quantified in all urine samples, and the two NEP metabolites 5-hydroxy-N-ethylpyrrolidone (5-HNEP) and 2-hydroxy-N-ethylsuccinimide (2-HESI) in 32% and 87% of the urine samples. Geometric mean concentrations were 103.1 µg/L (88.21 µg/gcreatinine) for the sum of NMP metabolites and 11.86 µg/L (10.15 µg/gcreatinine) for the sum of NEP metabolites, thus remaining below the current health-based human biomonitoring values.For NMP, highest exposure was found in young children, but exposure pathways could not be revealed. Exposure to NEP was highest in adolescents and participants with low socio-economic status or migration background. Associations to usage of personal care products suggested the choice of products to have a distinct impact on NEP exposure.The presented data can be used by the German Human Biomonitoring Commission to derive new reference values (RV95) for NMP and NEP for children and adolescents in Germany. This will facilitate to recognise changing exposure levels in this population group in Germany.

PM10-bound arsenic emissions from the artistic glass industry in Murano (Venice, Italy) before and after the enforcement of REACH authorisation

The island of Murano (Venice, Italy) is famous worldwide for its artistic glass production. Diarsenic trioxide was a main ingredient of the raw glass mixture until 2015, when the authorisation process of European REACH Regulation (Registration Evaluation Authorisation of Chemicals) entered into force, effectively forbidding the use of arsenic. A total of 3077 PM10 samples were collected across the Venice area in 2013–2017. This period included the REACH Sunset Date (May 2015). High arsenic concentrations were recorded in Murano before the Sunset Date (average 383 ng/m3), representing a serious concern for public health. Other sites in Venice complied with the EU target value. In 2013, concentrations were 36-folds higher than model estimation computed over the maximum-allowed emission scenario. Polar plot analysis indicated Murano as the major source of arsenic contamination. The concentration significantly dropped after the REACH implementation, thus meeting the European target values. However, high peaks of arsenic were still detected; inspections on raw and finished glass materials confirmed that some factories were still using arsenic. Results reported serious airborne arsenic pollution in Murano before the REACH implementation. This work represents an interesting case study on the effectiveness of the European REACH process.

Eco-innovation and regulatory push/pull effect in the case of REACH regulation: empirical evidence based on survey data

ABSTRACTNumerous theoretical and empirical studies provide evidence of a positive correlation between eco-innovation and environmental regulation. However, few analyses explain how environmental policies drive eco-innovation. This article studies eco-innovation-friendly mechanisms in the design of European REACH (Registration, Evaluation, Authorization of Chemicals) regulation. The aim of REACH, which became effective in 2007, is ‘to ensure a high level of protection of human health and the environment while improving competitiveness and innovation’ which makes it appropriate and original for analysing the relationship between environmental regulation and eco-innovation. The primary contribution of this article is to provide a new theoretical and empirical perspective on eco-innovation by showing how design regulation is able to push and pull the environment innovation, based on an original survey related to REACH regulation. The econometric model shows that (1) regulatory-push mechanisms seem to be more important drivers than regulatory-pull mechanisms; (2) the process of authorization and the obligation to transmit information throughout the supply chain play an important role in ‘pushing’ eco-innovation, suggesting that policymakers should promote new ‘green knowledge’ to encourage eco-innovation; (3) extending obligations has a significantly positive effect on ‘pulling’ eco-innovation and (4) only well-designed instruments, appropriate for the techno-industrial and institutional contexts in which they are to be applied, lead to innovation.

Environmental Risk Assessment of Emerging Pollutants in Water: Approaches Under Horizontal and Vertical EU Legislation

In Europe, under the framework of environmental legislation, various protocols have been developed for assessing the environmental risk of chemicals. For the “new chemicals,” environmental risk assessment (ERA) was introduced at 1980s. A decade later, pharmaceuticals were considered in the discussion for further ERA studies. Pesticides and biocides undergo a rigorous assessment following Directives 91/414/EEC and 98/8/EC. Registration, Evaluation, Authorisation of Chemicals (REACH) is the most important development in this field. REACH covers nanotechnology-based materials, but present methodologies may not be appropriate. The authors give a critical overview of the approaches under European water legislation, which cover the ERA frameworks for emerging contaminants.

REGULATION Carbon loses its exemption status under REACH

Health and safety data on all forms of carbon sold in the European Union will soon be required, according to the first European Commission (EC) proposal to amend the Registration, Evaluation & Authorization of Chemicals (REACH) program. Representatives of EU governments voted in favor of removing an exemption for carbon under REACH to close a loophole in the law that allows nanoscale forms of carbon to be sold without testing. Environmental groups applaud the proposal but say that it is just a first step in ensuring the safety of nanomaterials. REACH applies only to chemicals produced in volumes greater than 1 metric ton per year per company, says Ninja Reineke, a senior policy officer on chemicals at the international conservation organization World Wildlife Fund. Many nanoparticles are produced in small volumes and would therefore still be exempt from testing under REACH, she adds. The impact of the proposal on the chemical industry is unclear. EC ...

REVISION LOOMS FOR U.S. CHEMICAL LAW

THE U.S. SYSTEM for regulating commercial chemicals may be on the verge of a major shake-up. Momentum for such a change is due in part to a lack of information about the toxicity of many chemicals. The Environmental Protection Agency regulates the manufacture of commercial chemicals under the 1976 Toxic Substances Control Act (TSCA). To determine if it needs to control any of the chemicals that are on the market, EPA must have toxicity data. Although TSCA authorizes the agency to force chemical manufacturers to test their products for potential toxicity, doing so is cumbersome, time-consuming, and expensive for the cash-strapped agency. A number of factors, both international and domestic, are increasing the probability that Congress will overhaul TSCA. The chemical industry likely won’t be enthusiastic about the result. First, the European Union’s recent law—Registration, Evaluation & Authorization of Chemicals (REACH)—is reverberating through supply chains worldwide. It has its opponents, but the law is...

Review of Estimation Models for Biodegradation

AbstractThis paper reviews the state‐of‐the‐art of in silico methods for estimating the readily biodegradability of organic chemicals, and describes their (potential) applicability in the identification of chemicals that are persistent or very persistent in the environment, such as Persistent Organic Pollutants (POPs). The paper is based on an in‐depth review performed by the European Chemicals Bureau (ECB) of the European Commission's Joint Research Centre in support of the development of technical guidance for the implementation of the Registration, Evaluation, Authorisation of Chemicals (REACH) legislation, and is one of the series of minireviews in this journal. The review covers the most commonly used approaches for estimating the ready biodegradability of organic compounds, such as group contribution approaches, expert systems, probabilistic approaches and hybrid approaches. The main sources of experimental data used to develop the models are also briefly described. The review concludes with an appraisal of the challenges of developing new models and some recommendations are made for further research.

EARLY WARNING ON CHEMICAL REGULATIONS

WHEN U.S. MANUFACTURERS gathered earlier this month to figure out how to respond strategically to emerging chemical regulations abroad, they made little progress. In contrast to their inconclusive discussions, the U.S. military described its system for following and influencing the development of domestic environmental regulations that could affect use and availability of chemicals. The Aug. 9-10 conference, held in Baltimore and organized by the American National Standards Institute (ANSI), was billed as a forum for developing a sustainable approach to emerging chemical issues. There, industry representatives tried to lay the groundwork for unifying the voices of U.S. manufacturers so they can influence the development of policies on chemicals elsewhere in the world. Much of the discussion, however, focused on how the European Union's new legislation, the Registration, Evaluation & Authorization of Chemicals (REACH), is affecting global operations and supply chains. We never want to get caught in a re...

U.S. LOBBYING ON REACH ASSAILED

A REPORT THAT DETAILS lobbying by the chemical industry and the Bush Administration to weaken a European Union chemicals proposal is ruffling feathers in Congress and the EU. The report, released by Rep. Henry A. Waxman (D-Calif.) on April 1, documents involvement of U.S. officials, including Secretary of State Colin L. Powell, in an effort with the chemical industry aimed at relaxing the EU proposal. The EU plan is known as Registration, Evaluation & Authorization of Chemicals (REACH). According to the report, the Bush Administration based its lobbying campaign solely on the American Chemistry Council's analysis of REACH'S anticipated impacts, such as the estimate that the plan would cost billions of dollars to implement. The report found no evidence that the U.S. government performed its own analysis of REACH or subjected the ACC study to peer review. Waxman says, Many in Congress were surprised to learn of the intensity and ...

THE STATE OF REGULATION

INDUSTRY'S ANNUAL CONFERENCE ON chemical regulation, held for more than a decade, traditionally has focused almost exclusively on policies related to one U.S. law—the Toxic Substances Control Act (TSCA). Extensive discussions by Environmental Protection Agency officials on getting new chemicals to market and on testing older compounds are always a key part of the gathering, hosted by the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the American Chemistry Council (ACC). But international issues, most notably the European Union's proposed Registration, Evaluation & Authorization of Chemicals (REACH) program, took up a significant share of this year's conference, held March 9—10. Robert H. Donkers, environment counselor at the EU office in Washington, D.C., warned chemical industry representatives that REACH is practically a done deal. He disparaged notions that the new EU chemicals legislation will not be adopted. It will be law, I guarantee, he said. However, he allowed that some deta...

REGULATORY POLICIES EVOLVE

THE EUROPEAN UNION'S NEW policy on chemicals. A treaty to curb production of persistent organic pollutants. A developing global plan for managing chemicals. Testing of high-production-volume chemicals. Evolution of the Environmental Protection Agency's enforcement efforts on chemical controls. These and other policies were plumbed at the 10th annual Global Chemical Regulations Conference, held earlier this month in Baltimore. The conference, which covered developments under the U.S. Toxic Substances Control Act (TSCA) and international efforts on chemical management, was organized by the Synthetic Organic Chemical Manufacturers Association and the American Chemistry Council (ACC). International chemical regulation issues constituted a large portion of the conference program. Joe J. Mayhew, ACC vice president of regulatory and technical affairs, discussed the EU's planned Registration, Evaluation, & Authorization of Chemicals (REACH) policy. This would require registration, testing, labeling, and, for some...

Shifting the Burden of Proof in Chemicals Legislation: the Guiding Principle of the Reform Debate under Scrutiny

Summary: The ``shifting of the burden of proof'' is at the heart of the debate on European chemicals law reform which was started by the European Commission's White Paper ``Strategy for a future chemicals policy.'' This article analyses the allocation of the burden of proof in existing legislation on chemicals and the White Paper's approach within the framework of Registration Evaluation Authorisation of Chemicals (REACH). It also deals with the legal aspect of the authorisation concept in the White Paper, in particular from the viewpoint of the principle of proportionality.