The REACH registration process is in the final stages of its aim to improve the communication of information on the safe use of chemical substances in the supply chain.
With the 2018 Registration, Evaluation, Authorisation and Restriction of Chemicals registration deadline for low-volume chemicals less than a year away, registrants are busy with the preparation of dossiers and exposure scenarios, or ES, for their substances.
Many tools to standardize and harmonize the communication of safe-use information have been made available as part of the European Chemicals Agency, or ECHA, Chemical Safety Report/Exposure Scenario, or CSR/ES, Roadmap. Not only are manufacturers and importers working to integrate these tools into their IT systems, but downstream users and software providers will as well. Formulators are required to provide information on the conditions of safe use to the end users of their mixtures.
How are formulators to compile safe use information for a mixture from the Exposure Scenarios of substances provided by the supplier?
One of the action areas of the CSR/ES Roadmap is to support formulators by developing the methodologies to do exactly that. Industry sector associations representing formulators (e.g., the AISE, which is the International Association for Soaps, Detergents and Maintenance Products; the European Council of the Paint, Printing Ink and Artists’ Colours Industry, better known as CEPE; and the Downstream Users of Chemicals Co-ordination Group, also known as DUCC) have developed the Safe Use of Mixtures Information, or SUMI, approach while those representing suppliers (The European Chemical Industry Council, known as Cefic, and the German Chemical Industry Association, better known as VCI) have published the Lead Component Identification, or LCID, methodology.
As discussed in a previous Sphera Insights post on SUMI and LCID, the “bottom-up” SUMI approach is based on an end use of the mixture within a specific sector while the “top-down” LCID methodology is based on the substances contributing to the mixture classification. When a sector-specific bottom-up approach is available and it can be validated that all the conditions of use in a sector-specific worker exposure description are covered by the ES of all the relevant substances, the corresponding SUMI can be appended to the SDS of the mixture. Otherwise, the LCID methodology may be applied.
The LCID Methodology
The LCID methodology makes the “worst case” assumption that the priority substances and lead components “generally require the most stringent risk management measures. … It is assumed that they are also applicable for other hazardous components”. It is not only the Classification, Labelling and Packaging-based translation of its Dangerous Preparations Directive-based predecessor (DPD+ methodology), but introduced significant changes such as the use of reference values (either DNEL, which stand for derived no-effect levels, or PNEC, which stands for Predicted No-Effect Concentration) in the place of concentration limits of hazards, the grouping of additive hazards and the consideration of local effects and ozone depletion.
LCID is more comprehensive than DPD+ in the sense that DNELs take into account the assessment factors used to derive them, and the grouping of additive hazards gives them more weight. According to the practical guide for LCID: “Calculation according to LCID is possible as long as at least one of the [reference] values is available for all relevant components for all relevant routes of exposure,” where the reference values include DNELs, NO(A)ELs, NO(A)ECs, LD50s, LC50s and derived ATEs (all of which are toxicity reference values).
The variety of reference values may seem to allow the LCID methodology to be applied to most mixtures without too much trouble. However, lead components are identified using DNELs only, more specifically the long-term systemic ones. The other reference values are used in the “backup” approach to identify lead component “candidates” following which safe-use information must be derived on a case-by-case basis if they do not have a DNEL. Also keep in mind that NO(A)EL/Cs must be comparable, i.e., have the same species and duration for a given route of exposure.
The Challenge
During the development of the LCID practical guide and Excel-based tool, industry, consultants, competent authorities and ECHA conducted a test run. The results and ease of use were dependent not only on data availability but also on the number of mixtures. The availability of DNEL data from suppliers’ eSDSs, REACH dossiers and other databases is currently no match for the number and complexity of many formulators’ mixtures.
The challenge not only of formulators but also of software providers is the implementation of automated solutions for the LCID methodology. What is the best way forward given the current data availability? Is there a pragmatic approach that can be easily explained to end users and enforcement authorities?
What approach are you using?
A “hybrid” approach that incorporates currently available data into the LCID methodology appears to be the answer. We are working closely with our customers to develop an approach that we can deliver as early as possible and will allow them to derive safe-use information for their mixtures as efficiently as possible. Stay tuned!
