ECHA

‘Delivering meaningful safe-use advice to end users’ – this is ECHA’s vision for improving the flow and usability of safe use data throughout the supply chain. It was broadly supported by the Member State competent authorities in their November meeting. ECHA will now, together with the European Commission, Member States and industry, start working on a development and implementation plan.

One of the actions of the second review of REACH was to improve the workability and quality of extended safety data sheets (eSDSs). This action is divided into two parts: the first focuses on harmonised formats and IT tools for eSDSs to be further developed by industry, making them more fit-for-purpose for end users, the second is on introducing minimum requirements for exposure scenarios (ESs) and related methods for mixtures.

“The REACH review gave specific tasks to ECHA, the Commission and industry. However, when we started to scope these issues, we realised that we needed to be holistic: to look at the whole system, from the needs of the end user of the chemical to the REACH registrant. That is how we came up with our vision – starting bottom-up, from the needs of end users,” says Kevin Pollard, Head of ECHA’s Exposure and Supply Chain Unit.

Workflow for key players

To achieve the ambitious vision, ECHA has worked together with a broad range of stakeholders to propose a technical system; a workflow involving three key players – end users, formulators and REACH registrants. The system is based to a large extent on tools which have already been developed and tested under the Exchange Network for Exposure Scenarios (ENES) work programmes, but also identifies a number of missing elements.

Kevin Pollard. Image: ECHA.

“Information flowing down to the end user needs to also be beneficial to small and medium-sized companies, so that they can advise their customers on safe use and protect their workers.”

The core idea of the system is to make sure that end users of chemicals – such as industries manufacturing products or offering cleaning or repair services – receive meaningful advice on relevant operational conditions and risk management measures. To make this happen, formulators and REACH registrants need to have the resources and tools in place to do their job well. In particular, they need representative information on how the substances are used: the typical conditions of use and risk management measures in place for each substance.

“Information flowing down to the end user needs to also be beneficial to small and medium-sized companies, so that they can advise their customers on safe use and protect their workers. Currently, many of them either receive too much information through the exposure scenarios and in a raw format, or no information at all,” Mr Pollard explains. In addition, considerable value can be added by equipping SME end users with tools to help them use REACH information when demonstrating compliance with OSH and pieces of environmental legislation.

Formulators, that produce mixtures which are then supplied to other formulators or to end users, take the information they receive from registrants related to individual substances and turn this into meaningful advice for their products. They either check that the content of the exposure scenarios received from registrants match with their product’s conditions or carry out a downstream user chemical safety assessment themselves.

Subsequently, they compile activity-specific advice on safe use to be included in the extended safety data sheets for mixtures. “Formulators need to be better equipped with tools that enable them to process information received from registrants in the SDSs and exposure scenarios. This would enable them to confirm or update the on-site assessment to protect their workers and the environment as well as the product safety assessment for their mixtures and safe use advice for their customers.”

Last but not least, REACH registrants need to demonstrate the safe use of their substances by performing chemical safety assessments. “Registrants would have more relevant and representative information on use, operational conditions and corresponding risk management measures for their assessment if the implementation of use maps and corresponding phrase libraries by industry sectors were enhanced,” Mr Pollard explains.

The aim of these efforts is to ensure a better functioning system for safe use advice but also to benefit the work of authorities. Better safety data would help inspectors’ enforcement work for REACH, occupational health and safety as well as other environmental regulations. It is also expected that the overall information on uses on the European market would improve and speed up the implementation of EU-wide regulatory risk management under the Integrated Regulatory Strategy (IRS). “Additionally, national authorities would be in a better position to recognise unsafe use at national level and take action,” Mr Pollard adds.

Looking ahead, key building blocks for further development with stakeholders will cover:

• broadening the range of market sectors with use maps;
• tools for formulators and end users to check conformity with incoming extended safety data sheets; and
• enabling SDS authoring tools to import data from the REACH chemical safety assessment to provide exposure scenarios in XML format to downstream users.

A schema presenting the workflow and how all the building blocks function together is available in Appendix 5 of the September REACH Review Action 3 workshop report.

Minimum requirements for exposure scenarios

Through the REACH review, the European Commission tasked itself to consider including minimum requirements for exposure scenarios. According to the feedback ECHA has gathered from its stakeholders, most believe that mandatory legal requirements are fundamental to improving effectiveness, enforceability and to harmonise communication between key actors and the corresponding IT systems.

“We believe the Commission is willing to consider updating Annex II to REACH, which lays down the requirements for the compilation of safety data sheets, or is even open to the idea of an implementing act to give a legal framework for building exposure scenarios. Our stakeholders told us that the framework should define the content and structure of an exposure scenario and ideally include a common data exchange standard, like XML format and phrases,” Kevin Pollard says.

Methodology for mixture SDSs

The REACH review also tasked ECHA to develop a methodology for mixture SDSs – those that formulators compile for another formulator or an end user. At present, there is, among other things, no common understanding on how formulators should assess the conformity of their mixture compositions and the foreseen conditions of use against the exposure scenarios received. Nor is there a specific tool for consolidating exposure scenarios or for assessing the aggregated exposure for mixtures.

“To improve the exposure scenario-related information, our stakeholders prefer the current tools to be further refined and gaps to be closed rather than developing alternative approaches. One thing is to have a method, but we also need, where possible, automation and tools that can be used to manage the flow of thousands of registered substances on the market,” Mr Pollard says and adds, “overall, a major investment is needed from industry to develop tools and eventually update their registration dossiers with more fit-for-purpose information. If this investment is not done, the system will not work as intended.”

Did you know?   Safety data sheets (SDSs) include information about the properties of substances; their hazards; instructions for handling; disposal and transport; and also first-aid, fire-fighting and exposure control measures. They are the main tool for ensuring that manufacturers and importers communicate enough information down the supply chain to allow their substances and mixtures to be used safely.   Exposure scenarios (ESs) contain the appropriate risk management measures and operational conditions to ensure that all the risks arising from the use of a substance can be controlled adequately. Exposure scenarios may appear in an annex of the safety data sheets, in which case the documents are referred to as 'extended safety data sheets' (eSDSs).

Further information:

Workshop on REACH Review Action 3

Extended safety data sheets

Infographic: communication in the supply chain

Downstream users

CARACAL – Competent Authorities for Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) and Classification, Labelling and Packaging (CLP)

Interview by Hanna-Kaisa Torkkeli

Published on: 14 November 2019

Top image: © Pexels/Pixabay

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