China
Africa
Explore chapters and articles related to this topic
Introduction
Published in Nertila Kuraj, REACH and the Environmental Regulation of Nanotechnology, 2019
(1) Registration represents the gateway into the REACH system. It stipulates that chemicals, both new and existing, manufactured and/or imported in quantities over 1 tonne per producer or importer per year (hereafter t/y), are to be registered with the European Chemicals Agency (ECHA).25 The duty to register is a tiered one. REACH foresees four tiers based on the volume of production. Each tier, and the requirements it entails, is analysed in Chapter 3. Suffice to say here that the duty to provide data for registration purposes is incremental: the higher the quantity of production, the wider the data set and testing on health and environmental risks to be submitted to the ECHA. In addition, at the 10 t/y of volume of production, the obligation to prepare a chemical safety report (CSR) is triggered. This report must contain a chemical safety assessment (CSA) of the chemical, meaning that the producer shall provide information to all the users of the chemical through transparent and reliable information on the exposure scenarios used in assessing the chemical hazard.
Review of Generic Scenario Environmental Release and Occupational Exposure Models Used in Chemical Risk Assessment
Published in Journal of Occupational and Environmental Hygiene, 2023
William M Barrett, David E. Meyer, Raymond L. Smith, Sudhakar Takkellapati, Michael A. Gonzalez
Under the Regulation, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation in the European Union, chemical manufacturers, and importers (M&I) are required to demonstrate that chemicals can be used safely across all identified uses (Money et al. 2011). Exposure Scenarios are used by M&I to communicate risks associated with chemicals, and risk management measures (RMM) to downstream users (DU) (Marquart et al. 2007). Exposure scenarios are developed as part of a chemical safety assessment and can be appended to a safety data sheet (SDS) by the chemical’s M&I and provide information related to control of worker, consumer, and environmental exposures across the chemical’s life cycle (European Chemicals Agency 2020). Under REACH, guidance on defining the conditions of use for a chemical at various stages of its lifecycle has been developed (European Chemicals Agency 2015) and is used to conduct exposure assessments and environmental release estimates for inclusion in chemical SDSs (European Chemicals Agency 2020).
Comparison of ConsExpo estimated exposure levels to glycol ethers during professional cleaning work to existing regulatory occupational exposure limit values
Published in International Journal of Occupational Safety and Ergonomics, 2023
The author identified ConsExpo [40] as a suitable tool for the exposure estimations. ConsExpo is a Web-based modelling tool for estimating consumer exposure to substances in various products in a wide range of exposure scenarios [41]. At the same time, ConsExpo functions well for industrial chemical safety assessment (CSA) as is required by the chemical regulation (EU) 1907/2006 on Registration, Evaluation and Authorization of Chemicals, REACH and for biocides [40]. One can carry out exposure assessment using a tiered approach, starting with simple first-order models that estimate the upper level of exposure and working down to more detailed and complex models when the exposure estimation may need refining. More data input is necessary for a more detailed exposure assessment [42].
Review of reference values for the assessment of inhalation risks for workers at industrial contaminated sites
Published in Human and Ecological Risk Assessment: An International Journal, 2022
Maria Dalma Mangiapia, Iason Verginelli, Renato Baciocchi, Maria Paola Bogliolo, Simona Berardi
Further reference limits addressing the objective of health protection have been introduced by the Regulation (EC) n. 1907/2006, named "Registration, Evaluation, Authorization of Chemicals” Regulation (REACH). Under REACH, manufacturers, importers and downstream users should ensure that they manufacture, place on the market or use substances not adversely affecting human health. With this regulation, the ECHA was established. It has defined the guidelines on chemical safety assessment that producers and importers must perform as part of the substance registration process. Chemical safety assessment shall include, as first steps, a human health hazard assessment for different exposure scenarios, to derive levels of exposure to the substance above which humans should not be exposed, known as Derived No-Effect Level (DNEL) or Derived Minimum Effect Level (DMEL). In analogy with RfC/IUR and OELs, these limits are set by extrapolating from experimental studies a critical effect as a point of departure, to be corrected using uncertainty factors. DN(M)ELs were set for a considerably higher number of substances and are generally lower than OELs, as they respond to a more conservative risk management approach (Schenk and Johanson 2019). Note that there is an ongoing debate in Europe, about the need to harmonize social and product legislation to avoid discordant limit values for the same substance (European Commission – European Chemical Agency 2017).