The Experts below are selected from a list of 39 Experts worldwide ranked by ideXlab platform

Lara De Luca - One of the best experts on this subject based on the ideXlab platform.

Antonio Conto - One of the best experts on this subject based on the ideXlab platform.

Ketil Hylland - One of the best experts on this subject based on the ideXlab platform.

  • Testing REACH draft technical guidance notes for conducting Chemical Safety assessments—The experience of a downstream user of a preparation
    Regulatory Toxicology and Pharmacology, 2008
    Co-Authors: Anne Lill Gade, Steinar Øvrebø, Ketil Hylland
    Abstract:

    The goal of REACH is the safe use of Chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the Chemical Safety Report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for Chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

V. Riihimäki - One of the best experts on this subject based on the ideXlab platform.

  • HUMAN HEALTH RISK ASSESSMENT FOR METALLIC CHROMIUM AND TRIVALENT CHROMIUM IN ACCORDANCE WITH EUROPEAN UNION LEGISLATION
    2020
    Co-Authors: M. Luotamo, V. Riihimäki
    Abstract:

    The Unit of Toxicological Risk Assessment of the Finnish Institute of Occupational Health (FIOH) is conducting a 'Health Risk Assessment for Metallic Chromium and Trivalent Chromium' under the sponsorship of the International Chromium Development Association (ICDA) and the International Stainless Steel Forum (ISSF). This risk assessment will be conducted in accordance with the current European Union legislation in force (Council Regulation 793/93/EEC, Commission Regulation 1488/94/EEC, Dir. 67/548/EEC), but also to meet the regulatory obligations as set out in the European Commission REACH legislation proposal (Consultation Document, the Registration, Evaluation, Authorisation and Restrictions of Chemicals). Further aims include outlining the criteria for the setting of occupational exposure limits for metallic chromium and trivalent chromium compounds. Human Health Risk Assessment according to the current legislation shall entail hazard identification of the toxic end points (acute toxicity, irritation/corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity) including, as appropriate, dose (concentration) - response assessment, and derivation of the N(L)OAELs (No (Lowest) Observed Adverse Effect Level) and/or DNELs (Derived No Effect Level). Exposure assessments for workers, consumers and humans exposed via the environment take into account all the known intended uses. Risk characterisation will compare the typical and/or reasonable worst case exposure estimates to the N(L)OAELs or DNELs to determine Margins of Safety (MOS) for all human populations by each exposure scenario and type of effect, followed by conclusions about the presence or absence of risk. Although all of the key elements of existing legislation remain in REACH, the principal change is that, the burden of proof will be transferred from the member state authorities to industry. The new proposed format of Chemical Safety Report (CSR) will include Risk Management Measures (RMM) as an essential part of the Report in addition to the risk assessment. The RMM plays a role in the evaluation of further testing needs and advocating reasons for possible waiwer of requirements.

Frans Møller Christensen - One of the best experts on this subject based on the ideXlab platform.

  • REGULATORY RISK ASSESSMENT OF NANOMATERIALS IN THE EU
    2020
    Co-Authors: Karin Aschberger, Nanna Isabella Bloch Hartmann, Stefania Gottardo, Zuzana Klöslova, Valeria Amenta, Frans Møller Christensen
    Abstract:

    In the EU the Safety of nanomaterials (NMs) is regulated by a legal framework, which implicitly or explicitly (recent revisions) addresses NMs. NMs are implicitly covered by the substance definition of REACH Regulation 1907/2006 and therefore have to be registered if produced or imported ≥ 1 tonne/year per manufacturer/importer and a Chemical Safety Report has to be prepared when the volume is ≥ 10 tonnes/year. Regardless of tonnage, NMs have to be classified for dangerous properties (CLP Regulation 1272/2008) and are also regulated by sector specific legislation. Recently revised legislations on biocides, cosmetic products, and food/food contact materials include specific provisions for NMs, including a definition, specific consideration of their risk and labelling and/or Reporting requirements. Guidance for NM specific risk assessment is available for industrial substances, food/feed and cosmetic products. In addition, specific working groups have been established to develop best practices of NMs Safety assessment and to facilitate harmonization of assessment practices and methodologies.

  • Defining Occupational and Consumer Exposure Limits for Nanomaterials - First Experiences from REACH Registrations
    Journal of Physics: Conference Series, 2013
    Co-Authors: Karin Aschberger, Z Klöslova, G Falck, Frans Møller Christensen
    Abstract:

    By 1 December 2010 substances manufactured or imported in the EU ≥ 1000 t (as well as certain other substances) had to be registered under the REACH Regulation 1907/2006. The Joint Research Centre (JRC) in close cooperation with the European Chemicals Agency (ECHA) carried out an analysis and assessment of what type of information on nanomaterials was provided in the received registrations. The aim of the assessment was to develop options for an adaptation of the REACH regulation to ensure proper information generation and Reporting and an appropriate risk/Safety assessment of nanomaterials (Nano Support project). It should be noted that this analysis and assessment was not a compliance check of the dossiers. From 26000 submitted registration dossiers covering 4700 substances finally 25 dossiers (19 substances) were identified to cover nanomaterials or nanoforms of a substance. It is possible that other dossiers are considered to cover nanomaterials or nanoforms by the registrants, however such dossiers could not be identified to address nanoforms given the information contained in those dossiers. The identified 25 dossiers were subject to a detailed analysis and assessment of information provided for all endpoints including substance identity, physico-Chemical properties, human health, environmental fate & behaviour, ecotoxicity, PBT6 assessment, Classification and Labelling as well as the attached Chemical Safety Report documenting the Chemical Risk/Safety Assessment. In order to evaluate how the Safety of workers and consumers was ensured, it was appropriate to check how the Derived No (Minimum) Effect Levels (DN(M)ELs) were established for substances, covering nanomaterials or nanoforms. DNELs were established mainly for long term inhalation exposure of workers. Half of the assessed dossiers included an oral long term DNEL for the general population. DNELs were usually not specific for nanosized forms and, in the few cases where they were calculated for nanosized materials, they were not derived from hazard data for the nanoform. Different methods for deriving the DNELs were applied and few dossiers derived DNELs by applying the default assessment factors in the REACH guidance. Several DNELs were based on available Occupational Exposure Limits (OELs) for inhalable and respirable dust or the nuisance dust levels, which have not been established for nanosized materials. In general lower (i.e. less strict) assessment factors were applied with different types of justification. All DNELs were expressed in the mass metrics. It is important to note that submission, identification and selection of the dossiers addressed in this study was done before the adoption of the EC recommendation (2011/696/EU) on a definition of nanomaterial and before the publication of the revised ECHA guidance documents that include recommendations for nanomaterials.