Downstream user obligations

Europe was the first region to apply risk assessment following a standardized process as part of EU REACH. The United States are exploring a similar route but nothing is defined yet.

Manufacturers and importers were the main players during the first registration periods. Emphasis is now shifting to downstream users. For example, on reception of their updated safety data sheets, downstream users have 12 months to fulfill the obligations contained therein:
  • Classification, Labeling and Packaging (CLP)
  • Extended Safety Datasheet (ext-SDS)
  • Risk Management Measures (RMM)
Classification, Labeling and Packaging (CLP)
On December 1, 2010, new package labeling requirements went into effect for suppliers of pure substances (not mixtures), including companies that repack pure products to sell them in a different format (e.g. a drum or can). The obligation to apply CLP requirements for mixtures will come in force on 1 June 2015.
Actors of the supply chain must contribute to
the hazard and risk assessment of substances
Extended Safety Datasheet (ext-SDS)
The EU REACH regulation requires additional information on hazards associated with identified uses, i.e. exposure scenarios (ES), to be annexed to the SDS of classified substances. This forms the extended SDS (ext-SDS). ExxonMobil Chemical provides an ext-SDS for each relevant product to its downstream users, as required by REACH and CLP.

Exposure scenarios and extended safety datasheets are made available to users of a classified substance without delay once the hazard information becomes available. Downstream users (DUs) must verify whether the exposure scenarios they receive via an ext-SDS describe the conditions for their applicable uses on-site:
  • First, a check needs to be done to see if the identified uses of a DU are included via the ES titles, use descriptors, main exposure determinants.
  • Then, a check to see if all recommended operational conditions (OCs) and risk management measures (RMMs) are in place.
DUs must also pass on exposure scenarios further down the supply chain where relevant.

Risk Management Measures (RMM)

Downstream users are required to comply with RMMs within 12 months of receiving a product's registration number from their supplier.

When DUs are in compliance with the conditions in the relevant ESs, this needs to be documented and information made available to the authorities in case of inspections. If not, several options are available:
  • Implementation of the recommended RMMs and OCs;
  • Communication to the supplier of the on-site conditions the DU has in place, with a request to update the relevant ES accordingly;
  • Preparation of a DU chemical safety assessment;
  • Scaling: recalculate exposure & risk using modeling tools using the on-site conditions.
Our self-tutorial presentation identifies which are real obligations, which are mere recommendations and what the timeline for each one is. It also provides a visual representation of the process to help memorize the key steps.

Further guidance on exposure assessment is available from ECHA (the European Chemicals Agency):

Page glossary

  • Classification
  • CLP
  • Effect
  • EU
  • Exposure
  • Hazard
  • Labeling
  • Preparation
  • Regulation
  • Risk
  • Risk Assessment
  • RMMs
  • Safety
  • SDS
  • Substance