One of the main goals of REACH is to ensure the safe use of substances. This goal will only be achieved if the wealth of information on hazard and risks gathered into the registration dossiers is communicated effectively to those who use the substances. Especially formulators face this communication challenge. In this article we will highlight some of the issues these companies encounter and provide insights that can help companies to communicate the critical health and safety information more effectively.
By Leo van der Biessen, Jean-Marc Abbing, Randy Cleijsen, Christiaan van Daalen
The challenge of REACH
To increase the level of protection during the handling of chemicals and sharply decrease the high number of 100,000 European casualties per year due to exposure at the workplace. This will only happen when the correct health and safety information is passed down the supply chain in such a manner that it helps the users to improve their game. This is especially challenging for formulators as they must select the relevant data in the extended Safety Data Sheets (eSDSs) of the substances and prepare readable and meaningful information which will allow their users to handle mixtures safely.
The status quo
REACH has been tremendously successful in the generation of data on the hazards and risks of substances. Unfortunately industry struggles with communication of this data in the supply chains. This has a number of causes, of which we deem the following the most important:
- The amount of data in the eSDSs is overwhelming. It is hard for users to extract the essential information they need.
- The variability of the data in the eSDS appendices. This variability not only relates to the format and structure of the eSDS. Also operational conditions and risk management needed for safe use can be quite different for the exact same substance.
- The operational conditions and risk management measures listed do not always reflect reality or what is feasible.
- Formulators are lacking tools to aggregate the eSDS information. As a result they do not communicate, or communicate unreadable and therefore useless data (e.g. all eSDSs available for the substances in the mixture). This makes it virtually impossible for secondary formulators or downstream users to assess safe use of their mixtures. A complicating factor is that formulators do not want to share the exact composition of their mixtures.
- Poor data management resulting in companies not using the latest relevant information.
Our experience shows that questions from downstream users about the content of a supplier eSDS – or even the reporting of missing uses – hardly ever results in any answer from the supplier. The legally obliged timeframe for this is 1 month. ECHA, Competent Authorities and industry have recognized the problem and created the Exchange Network on Exposure Scenarios (ENES), that aims to improve the quality of eSDS information and create tools for effective communication. This is including but not limited to: an EScom standard with standardized phrases and a system of electronic data exchange through XML-files, better descriptions of the operational conditions and risk management measures for sectors of industry and tools to help formulators select the relevant information.
Our solution for formulators
Royal HaskoningDHV developed basically a three step program:
Step 1: Make sure the right data is available
Step 2: Select the substance(s) which determine the risk of the mixture
Step 3: Generate meaningful information
In Step 1 the latest eSDSs are collected. The quality of the eSDS is checked and the best ones are selected. The necessary phys-chem and hazard data for Step 2 is extracted and appended when missing. If needed the procedures on data management are improved in this step. During the quality check we look at the completeness of the document, the implementation of the hierarchy of control and uses covered.
In Step 2 the substance(s) that determine(s) the hazard and risk of the mixture is/are determined. Based on good industrial hygiene practices and the tools generated in the ENES programme, Royal HaskoningDHV has created a protocol and a set of rules to assess the combined hazard in risk of substances within a mixture. Based on the physicochemical properties of the substances, the relevant limit value and the activities performed, the relative contribution of a substance to the risk of an activity is calculated using the reciprocal procedure as suggested by the ACGIH. This is done for all relevant exposure routes. The substances that contribute most to the hazard and risk of the mixture are lead substances. The information of the eSDSs of those substances is used in the initial preparation of safe use information for the mixture. If substances are classified as CMR or sensitizing, they are individually assessed. In order for the downstream user to be able to assess the risk of this mixture, a mixture specific limit value and mixture specific concentration is calculated for the lead substance(s). These values take into account the toxicity of other components in the mixture, assuming simple addition. This is in most cases a conservative approach unless clear toxicological evidence points to the contrary. This approach also allows for adaptation of the lead substance to be used, either for CBI purposes or to reduce the amount of mixture eSDS appendices to be communicated.
During Step 3 relevant health and safety information is extracted from the lead substance(s) eSDS. This information is cross-checked with the data from the eSDS of the other substances in order to ensure compliance with REACH. Then the information is transferred to an eSDS appendix. For mixtures marketed to end-users the newly developed Safe Use of Mixture Information (SUMI) sheet is in our opinion the most effective method to present the information. A SUMI is a single page sheet listing how a product can be used safely and which risk management measures the user should take to protect himself and the environment. SUMIs are based on practices within a certain sector and therefore sector specific. For numerous sectors we are able to determine good practices from our wide experience, for others we delve into good practices listed by industry. In the coming years more and more sectors will produce such sector specific descriptions and safe use conditions, in our view leading to a great improvement of worker safety.
