Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Friedrich-Henkel-Weg 1–25
44149 Dortmund
phone +49 231 9071-0
Assessing the availability and quality of occupational exposure data in REACH registration dossiers
and Safety Data Sheets
Angela Kämpfer, Dag Rother, Nicoletta Godas
Contact: Angela Kämpfer
BAuA – Federal Institute for Occupational Safety and Health 4.1 Exposure Scenarios
Kaempfer.Angela@baua.bund.de or reach2sds@baua.bund.de +49 (0) 231 9071 2459
1. Obtain sound & robust information on the completeness of REACH registration dossiers (100 – 1,000 tpa) and corresponding SDSs regarding the required occupational exposure data and RMM
2. Understand the process and challenges of translating the information from the dossier to the SDS
3. Obtain sound information on the applicability of the SDS to perform an adequate workplace risk assessment
4. Suggest approaches to improve the translational processes and to reduce the challenges for the relevant stakeholders as part of a workshop
Goals
Division 4 Hazardous Substances and Biological Agents, Federal Institute for Occupational Safety and Health (BAuA), Friedrich- Henkel-Weg 1-25, 44149 Dortmund, Germany
Backgr ound
With the ratification of the Regulation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) in 2006, the European Union (EU) requires all chemical substances placed on the EU/EEA market to be registered. In a chemical safety assessment (CSA), the registrants shall address hazards, potential exposure by developing Exposure Scenarios (ES), and assess the risk for human health and the environment arising from the exposure along the supply chain. For substances classified as hazardous according to the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP), the registrants are required to compile and communicate a safety data sheet (SDS) to enable downstream users (DU) to handle the substance safely.
Project Aims
Materials & Methods
Example Decision Tree
Fig.2 Decision Tree 1 Dossier Analysis : Analysing the relevance of the dossier for the project
• Binary decision tree design (‚yes‘ or ‚no‘) for essential information
• Essential information are
• Information required according to REACH
• Boundary conditions set by developers of exposure estimation models
• Information that can lead to a classification of a parameter as compliant, non-compliant or complex
• Non-essential information (NEI) will be collected and are
• Of interest for the project (e.g. consistency check with SDSs)
• Not able to classify a parameter as compliant, non-compliant or complex
Markers of interest were defined for the analysis of registration dossiers and SDSs using (1) the REACH regulation, (2) ECHA guidance documents, (3) German national OSH legislation and (4) information on appropriate exposure estimation models (e.g. ECETOC TRA, Stoffenmanager, MEASE).
For the dossier analysis, these markers included ‚dossier relevance‘,
‚exposure assessment‘, and ‚applicability of RMM‘. The markers for the SDS analysis focused on compliance with the information requirements (Art.31, EC/1907/2006) and the completeness of the hazard and RMM information.
Based on these markers, decision trees were developed, which allow the grading of a document as compliant (i.e. fulfilling legal requirements and/or being within boundaries identified by model developers), non-compliant (clearly not fulfilling or out of boundaries), or complex (in case of not strictly defined requirements / criteria or need for detailed analysis).
The results of the decision tree-guided analysis will be used to perform a consistency check to investigate the information transfer between dossier and SDS. To gather additional information on the business-internal compi- lation and use of SDSs, a questionnaire was developed and will be distributed to the lead registrants.
In a separate step, the adequacy and applicability of the information on exposure and OSH measures contained in the SDSs, will be validated by applying the EMKG (‚easy-to-use workplace control banding scheme for hazardous substances‘) on a group of random samples [2] .
Information & Updates
In 2016, the BAuA initiated the project REACH2SDS – From Registra- tion dossier via safety data sheet to workplace risk assessment.
Supported by ECHA, the project aims to evaluate the availability and quality of occupational exposure data and risk management measures (RMM) in lead-registration dossiers and the corresponding SDSs. With analysing the SDS, we intent to examine the risk communication along the supply chain, which should allow the relevant DU to perform an adequate business-internal workplace risk assessment.
The project aims to generate insights on the status of occupational safety and health (OSH)-relevant information provided as part of REACH registrations. The information shall be used to develop recommendations to facilitate the implementation of REACH and to improve its interface with OSH legislation.
Fig.1 REACH time line & deadlines [1]
Reference: [1] Kallio, Niina; REACH effects/impact on workplaces, https://oshwiki.eu/wiki/REACH_effects/impact_on_workplaces;
accessed: 25.04.2017; [2] EMKG: https://www.baua.de/DE/Themen/Arbeitsgestaltung-im-Betrieb/Gefahrstoffe/EMKG/Einfaches- Massnahmenkonzept-EMKG.html
