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Article related to: communicating_about_safety
Generating safe use information for mixtures – status and next steps
Our guest writers from the European Chemical Industry Council (Cefic) and the Downstream Users of Chemicals Coordination Group (DUCC) are returning to the topic of generating safe use information for mixtures featured in the October 2013 Newsletter. The two associations have identified approaches and methods used or being developed by companies and industry sectors for safe use communication for mixtures. They report here on their findings and on the next steps.
An inventory of methods and approaches to identify and communicate safe use information for mixtures was made in order to have a general overview of the ways that are currently being used or developed. Fifteen different methods were identified, and they were presented and discussed at ENES 5. Naturally, this is not an exhaustive compilation of methods, nor is it a list of recommended methods. However, it reflects the level of activity and the overall approaches that are being taken.
It was found that each approach has its merits and there is no ‘one size fits all' methodology. General observations from the exercise were:
- Several industry sectors (e.g. lubricants, detergents, paints) are working on methodologies to identify safe use information for sector specific products and related uses. These methodologies are typically so called ‘bottom up approaches' because the starting point is the mixture, its composition, use description and use conditions.
- In contrast to the sector specific approaches, more generic methodologies (or ‘top down' approaches) are being developed that can be used to identify safe use information for each type of mixture, regardless of the composition and/ or intended use. However, in many cases these methodologies also include mechanisms to take into account the mixture composition and the intended uses.
Looking in more detail at the several methodologies we see that:
- In almost all of the cases, whether it's a sector specific or more generic approach, safe use information for mixtures is highly driven by risk driving substances (RDS). Until now the selection of risk dri- ving substances is mostly done using the DPD+* methodology developed by Cefic, but the Critical Component Approach (CCA) referred to in the ECHA guidance appears to evolve as a future alternative. However, the CCA is not yet fully elaborated and there is the need to develop an agreed and widely accepted convention on how to apply the CCA.
- Once risk driving substances have been identified, the next step is to extract and/or consolidate relevant safe use information. Transparent rules for the systematic selection and/or scaling of the operational conditions and/or risk management measures for the relevant risk driving substances are needed and may be standardised to allow automatic or partly automatic processing of such data in the future. A concept was presented including a simple calculation tool (working prototype) that can be further developed to support formulators in the consolidation.
- Communicating safe use information for the mixture through an annex to the safety data sheet is regarded as the preferred way so far, for reasons of practicality and clarity. However, inclusion of this information in the main body of the safety data sheet is also an option in most of the cases.
- Each methodology aims to keep the burden for the formulators as small as possible through automation and by keeping the required level of expertise needed to apply a methodology as low as possible.
- In all cases, more testing on a large variety of mixtures from different sectors will be needed to further identify benefits and limitations of each approach. More detailed information on the methodologies can be found on the ENES section of ECHA's website. ECHA will publish more information on the methodologies in the coming months.
General conclusions and the way forward
Although industry has already invested a lot in the development of methods and approaches to compile safe use information for mixtures, further work and testing are needed to gain more experience in using the methods. When doing so, it's important that experiences are shared among the parties involved in order to get the best out of the different approaches.
As mentioned above, the ‘one size fits all' method doesn't exist. Nevertheless, there are many more similarities than differences in the various generic approaches.
Therefore it would be beneficial to create a common concept addressing aspects like the selection of risk driving substances. This could lead to one or two generic methodologies broadly used within industry. Sector specific methodologies may also benefit from such a common framework as they have some similar challenges. Industry and its stakeholders will exchange experiences and start developing a common concept for a generic approach in the coming months. Feedback on the progress will be given at the upcoming ENES meeting in May 2014.
* Cefic has prepared a methodology based on the Dangerous Preparations Directive (DPD), enhanced for certain health exposure pathways with consideration of the volatility of the substances concerned. It is known as the DPD+ method.
Text by contributors from Cefic and DUCC
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