Action area 4: Support to formulators

 

Action 4.1: Harmonisation of the safety advice among co-registrants

Develop advice for registrants of the same substance to harmonise the information they provide on the conditions of safe use in their extended safety data sheets. This will increase efficiency for the recipients of the safety data sheets, as the same advice is received from all suppliers.

Status: Not started

No particular action yet defined under the CSA/ES Roadmap.

However, the work on improved use maps including the exposure assessment inputs are a key contribution to this action.

Contact Person(s)

  • Erwin Annys , Cefic 
    Email: ean(at)cefic.be

[Last update: August 2015]

Action 4.2: Harmonised layout for the ES for communication

This project aims to reach an agreement among industry actors on a common layout format for the exposure scenarios in the supply chain. This will result in efficiency gains for registrants and for downstream users in generating and understanding/applying the information, respectively.

Status: Completed

A four section layout format was agreed. An annotated template and illustrative example for exposure scenario for communication were published in August 2014 (action 1.2).

Guidance for structured short titles for a table of content for exposure scenarios annexed to a safety data sheet was published in November 2014. The experience with its implementation will be gathered to identify update needs.

Contact Person(s)

  • Mercedes Viñas, Directorate C - Registration, ECHA
    Email: mercedes.vinas (at) echa.europa.eu
  • Francesca Angiulli, DUCC 
    Email: francesca.angiulli (at) aise.eu

[Last update: May 2016]

Action 4.3: Understanding the formulators' options when receiving an extended SDS

Downstream users have a number of options to respond to the exposure scenarios which they receive from their suppliers. This action aims to clarify those options and provide appropriate support.

Status: Completed

General principles were incorporated into the 2013 version of the ECHA Guidance for Downstream Users. ECHA's Practical Guide 13 "How downstream users can handle exposure scenarios" has been updated with additional information and examples in May 2016.

Contact Person(s)

  • Monique Pillet, Directorate D - Risk Management, ECHA
    Email: monique.pillet(at)echa.europa.eu

[Last update: October 2016]

Action 4.4: Converting substance exposure scenarios into advice on the safe use of a mixture

This action seeks an agreement on the high level principles for linking the exposure scenario information on substances to the safe use advice for mixtures.

Status: Completed

Agreed general principles were incorporated into the 2013 version of the ECHA Guidance for Downstream Users. The two main approaches identified, referred to as top-down and bottom-up approaches, have been further developed since then.

Top-down approaches

A methodology has been developed to identify the components that determine the risk management measure, termed lead component identification (LCID). The Practical Guide was published by Cefic/VCI in April 2016.

Bottom-up approaches

A safe use of mixtures information (SUMI) template has been developed which presents safe use advice information for mixtures in an easy to read format. Guidelines on the methodology were published by DUCC in December 2015.  A library of SUMIs, containing sector-specific advice for common uses, is expected to be finalised in 2015. This work is closely connected to sector-specific worker exposure descriptions (SWEDs, see action 2.3.A).

SUMIs/SWEDs aim to define the existing conditions of use for mixtures as the key information to the registrants' exposure assessments. Registrants are then expected to check the properties of their substances against them to i) demonstrate control of risk or ii) identify the need to modify the use conditions. If risk is controlled formulators would receive a SUMI reference from their suppliers with the exposure scenario and could directly apply that information for their advice on safe use of their products.

Contact Person(s)

  • Top-down methods
    • Steven Van de Broeck, Cefic
      Email: sva(at)cefic.be
    • Angelika Hanschmidt, VCI
      Email: hanschmidt(at)vci.de
  • Bottom-up methods
    • Laura Portugal, DUCC
      Email: laura.portugal(at)aise.eu

[Last update: May 2016]

Action 4.5: Exemplify the downstream user (DU) CSR

Collect experience and identify the needs for further support on carrying out a downstream user CSR, and develop and publish practical examples to support downstream users in this task.

Status: Completed

The ECHA Practical Guide 17 on " How to prepare a downstream user chemical safety report"  was published in September 2015.

Contact Person(s)

  • Monique Pillet, Directorate D - Risk Management, ECHA
    Email: monique.pillet(at)echa.europa.eu

[Last update: May 2016]

Action 4.6: Improving understanding on how downstream user (DU) reports are used by authorities

Collect on-going experiences from ECHA on receiving and processing the information contained in the notifications from downstream users who operate outside the conditions of use described in the exposure scenario they have received.

Status: Completed

A report describing the downstream user reporting system, and how the information in the downstream user reports has been used so far, is now available.

Contact Person(s)

  • Laura Walin, Directorate C - Registration, ECHA
    Email: laura.walin(at)echa.europa.eu

[Last update: October 2016]

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