- Getting ready for the Biocidal Products Regulation
- World of biocides brought up to date
- Steering the work to make the new biocides regulation a success
- From our stakeholders: "Support for small enterprises is crucial"
- Setting up national biocides helpdesks
- New online tools for biocides applications
- Raising awareness on the new Biocidal Products Regulation
- Working together for better communication on the safe use of chemicals
- What to do when receiving an extended safety data sheet?
- Working towards the REACH dossier evaluation goal
- Setting the scene for applications for authorisation
- Board of Appeal members' term in office prolonged
- Guest column: Reflections on the review of REACH
- Making use of derived no-effect levels generated under REACH
- Call for creative ideas to overcome REACH challenges
- Croatia joins the EU chemicals management framework
- Debating chemicals policy
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Article related to: Communicating about safety
What to do when receiving an extended safety data sheet?
Handling extended safety data sheets (eSDS) as a downstream user is challenging. In addition to the existing obligation to follow the supplier's advice in the main body of the safety data sheet, the downstream users now have to carefully check if their own uses are covered in the exposure scenarios received, and whether their conditions of use are equivalent to those specified in the exposure scenarios.
Dr Steffen Pfeiffer.
Dr Roger Van der Linden.
Our company, Borealis, is a leading provider of innovative solutions in the fields of polyolefins, base chemicals and fertilisers with headquarters in Vienna, Austria. We currently employ around 6 200 people, operate in over 120 countries and have registered over 80 substances. As a large chemical company, we have many roles under REACH, including the role of downstream user.
As a downstream user, we have received almost 1 000 safety data sheets in the last year at our operating locations in Europe. About 10% of these were extended safety data sheets, with exposure scenarios attached. These exposure scenarios are for the uses that the supplier has identified as relevant, and they describe the appropriate risk management measures for given operational conditions for each use.
How do we make sure that the supplier's extended safety data sheets support our uses? Here are the three steps that we follow:
- Step 1: Verify that our own uses are covered in the supplier's safety data sheet.
We compare the uses listed in the supplier's safety data sheet with the uses in our plants. The exposure scenarios use standardised codes to describe the uses, for example as process category (PROC) and environmental release category (ERC). It has taken time, experience and training for our employees to become familiar with these codes and to be able to translate the uses of a chemical in our plant into this system.
- Step 2: Check if the operational conditions are respected.
We compare the operational conditions for the uses within the applicable exposure scenario(s) with the real conditions in our own plant or location.
- Step 3: Ensure that the risk management measures are implemented.
If the risk management measures that we implement are identical to those recommended in the extended safety data sheet, our own use can be considered as safe.
Otherwise, we need to look into it in more detail and decide what we should do. When possible, we check if the deviation can be compensated by another measure, a procedure called scaling. For example, if the duration of exposure is longer than in the supplier exposure scenario but the concentration is lower, scaling might show that the exposure level is the same or lower, and so our use is supported.
How we check exposure scenarios
The exposure scenarios are checked by local staff in the various plants who have been trained in several workshops. We have developed an Excel tool which helps to check the exposure scenarios and which also documents this check at the same time.
We generate one document per substance, per location and per supplier. In this document, the "cover" worksheet details the substance, supplier, the safety data sheet, who performed the check and what the outcome was (Figure 1).
In the following worksheets, we fill in the data on uses and conditions of use from the extended safety data sheets and compare it with our own uses and conditions of use (Steps 1 and 2 above). As a location can contain several plants, the exposure scenario check is done at plant level for the worker exposure and at location level for the environmental part, as shown in Figure 2. The tool automatically generates a "safe use" or a "no safe use" message.
The tool is easy to use and files can be shown to auditors or enforcement authorities to demonstrate legal compliance and that downstream user obligations have been fulfilled.
Making sure risk management measures are implemented
We hold regular meetings at which we monitor the status of the exposure scenario check, to ensure we meet the six or 12 months legal deadline. We also discuss any difficulties with the non-standardised exposure scenarios, and what to do if we get a "no safe use" message. If scaling is not applicable or does not result in safe use, we might contact our supplier to ask him to support our use.
We have established a technical support role to our procurement team, termed raw material owner, who is familiar with both REACH and our suppliers. This person undertakes technical communication with the suppliers and we have found it to be very effective.
Alternatively we may implement additional risk management measures, or create a downstream user chemical safety report to demonstrate safe use conditions.
We find that our approach is very suitable for a large company like Borealis with several locations and think it is also likely to be suitable for smaller or medium-sized companies.
Further information: www.borealisgroup.com
Text by Dr Steffen Pfeiffer and Dr Roger Van der Linden from Borealis. Images: Borealis
Disclaimer: The views presented in this article do not represent the views of the European Chemicals Agency.
Figure 1. Cover sheet of the Excel tool developed by Borealis to handle extended safety data sheets.
If you would like to contribute to the ECHA Newsletter by writing about your experience in fulfilling downstream user obligations, contact email@example.com.
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)